18年来首个“老年痴呆症”药物获批，这意味着什么？

华尔街见闻2021-06-08

发生了什么？6月7日，美国渤健公司(Biogen Inc.)$(BIIB)$旗下的阿尔茨海默症药物获批上市，这是2003年来首款获美国食品和药物管理局批准的此类药物，然而目前围绕该药物的争议依然很大。这款药物的通用名为aducanumab，将以Aduhelm的商品名进行销售。渤健每年对这种药物的收费为5.6万美元，并且承诺至少四年内不涨价。据介绍，该药物具有清除大脑淀粉样蛋白斑块的能力，被认为可以...

Source Link

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

Fred_6810
2021-06-12
Fred_6810
希望真的有效。
大家好我是王剛88888
2021-06-09
大家好我是王剛88888
Buy
浴缸潜水员
2021-06-08
浴缸潜水员
今年諾獎有戲。
- 小甘多多:
  [微笑]
yonglee7
2021-06-08
yonglee7
[財迷] [財迷] [財迷]
风雪腊梅
2021-06-08
风雪腊梅
[開心] [開心] [開心]
远离中丐
2021-06-08
远离中丐
意味着老年化問題會越來越嚴重

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2141259936?lang=en_US&edition=fundamental","thumbnail":"https://static.tigerbbs.com/df4ec61541b268a5353585001973d7cb","is_english":false,"pubTime":"2021-06-08 09:01","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2141259936","market":"us","top_or_hot":-1,"title":"18年来首个“老年痴呆症”药物获批，这意味着什么？","media":"华尔街见闻","content":"<div>\n<p>发生了什么？6月7日，美国渤健公司(Biogen Inc.)$(BIIB)$旗下的阿尔茨海默症药物获批上市，这是2003年来首款获美国食品和药物管理局批准的此类药物，然而目前围绕该药物的争议依然很大。这款药物的通用名为aducanumab，将以Aduhelm的商品名进行销售。渤健每年对这种药物的收费为5.6万美元，并且承诺至少四年内不涨价。据介绍，该药物具有清除大脑淀粉样蛋白斑块的能力，被认为可以...</p>\n\n<a href=\"https://wallstreetcn.com/articles/3632396\">Source Link</a>\n\n</div>\n","source":"wallstreetcn_api","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>18年来首个“老年痴呆症”药物获批，这意味着什么？</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\n18年来首个“老年痴呆症”药物获批，这意味着什么？\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-06-08 09:01 北京时间&nbsp;&nbsp;&nbsp;<a href=https://wallstreetcn.com/articles/3632396><strong>华尔街见闻</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>发生了什么？6月7日，美国渤健公司(Biogen Inc.)$(BIIB)$旗下的阿尔茨海默症药物获批上市，这是2003年来首款获美国食品和药物管理局批准的此类药物，然而目前围绕该药物的争议依然很大。这款药物的通用名为aducanumab，将以Aduhelm的商品名进行销售。渤健每年对这种药物的收费为5.6万美元，并且承诺至少四年内不涨价。据介绍，该药物具有清除大脑淀粉样蛋白斑块的能力，被认为可以...</p>\n\n<a href=\"https://wallstreetcn.com/articles/3632396\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":null,"symbol_name":null,"start_time":0,"source_url":"https://wallstreetcn.com/articles/3632396","article_id":"2141259936","we_media_id":null,"thumbnails":["https://static.tigerbbs.com/df4ec61541b268a5353585001973d7cb"],"rights":{"source":"wallstreetcn_api","url":"https://wallstreetcn.com/articles/3632396","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2141259936","pubTimestamp":1623114070,"columns":[],"sourceInfo":{"source_id":"wallstreetcn_api","name":"华尔街见闻"},"weMediaInfo":null,"summary":"受到Aduhelm获批消息利好带动，美国渤健公司隔夜一度暴涨60%。但目前Aduhelm对阿尔茨海默症治疗的效果，有效率和副作用，仍然未被验证，来自医生和研究人员的反馈也充满了分歧。","collect":0,"end_time":0,"defaultTopTitle":"wallstreetcn.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{},"translate_title":"The first \"Alzheimer's\" drug has been approved in 18 years. What does this mean?","themeId":null,"isJumpTheme":false,"ttsUrl":"https://static.tigerbbs.com/966b76bc3db8c9dc1096d6069433fea5","symbols_score_info":{},"content_text":"发生了什么？6月7日，美国渤健公司(Biogen Inc.)$(BIIB)$旗下的阿尔茨海默症药物获批上市，这是2003年来首款获美国食品和药物管理局批准的此类药物，然而目前围绕该药物的争议依然很大。这款药物的通用名为aducanumab，将以Aduhelm的商品名进行销售。渤健每年对这种药物的收费为5.6万美元，并且承诺至少四年内不涨价。据介绍，该药物具有清除大脑淀粉样蛋白斑块的能力，被认为可以减缓早期症状患者的疾病进展。长期以来，淀粉样蛋白的过度积累被视为引发阿尔茨海默症的罪魁祸首之一，它破坏了脑细胞之间的交流，从而导致认知功能问题。然而，目前这款药物治疗的效果，有效率和副作用，仍然未被验证，来自医生和研究人员的反馈也充满了分歧，既有乐观的，也有持批判态度的。渤健周一早间曾停牌近3小时，之后复牌时受到Aduhelm获批消息的利好带动，连续突破了300美元和400美元两道关口，日内涨幅曾一度达到60%以上，而在之后则出现回吐。截至收盘，渤健上涨38.34%，报395.85美元。市场预计，最新药物的批准将为公司带来数十亿美元的收入。而美股生物医药板块也受到利好影响出现拉升，纳斯达克生物科技指数在消息公布之后曾涨逾5%。为什么重要？阿尔茨海默症(AD)是导致全球老年人死亡的第三大原因，仅次于心脑血管疾病和癌症。据世界卫生组织估计，目前全球约有3500万至5000万阿尔茨海默症患者，并且每年预计将有1000万新增患者。有机构预测，到2050年，全球阿尔茨海默症患者数量将达到1.5亿。阿尔茨海默症发病机制至今仍未被研究透彻，且目前还没有治疗该病症或逆转大脑疾病进程的方法，尽管一些疗法可以部分缓解一些症状。因此，作为18年来首款获批的药物，Aduhelm有望给阿尔茨海默症患者和他们的家人带来一丝希望。乔治敦大学(Georgetown University)神经学副教授、痴呆症和帕金森病实验室主任Charbel Moussa对MarketWatch表示：“阿尔茨海默症是我们所知道的最难以置信的疾病之一。”Moussa称对这种疾病的研究必须进行划分，以便更深入地挖掘大脑是如何运作的，为什么化学物质不能正确地传播，对日常生活活动(如洗澡和穿衣服)的影响，以及病人及其照顾者的生活质量。他说：“现在Aduhelm的批准就是打开潘多拉的盒子。”也有观点认为，这款药物的上市将改变阿尔茨海默症目前的治疗方式，至少对一些患者来说是这样，FDA的批准可能会为未来的治疗铺平道路。圣路易斯华盛顿大学(Washington University in St. Louis)的神经学家Erik Musiek在接受彭博采访中表示，如果FDA愿意接受淀粉样蛋白的减少作为批准的充分证据，这可能为其他药物打开大门，“如果你所需要的只是清理斑块，那肯定是另一种情况。”美国阿尔茨海默症协会首席执行官Harry Johns表示，“对于阿尔茨海默症患者来说，这只是新的一天，我们相信这将推动更多的创新和投资。”为什么分歧巨大？目前，围绕Aduhelm还存在着巨大的争议和不确定性，这款药物要使患者真正获益，还有很长的路要走。尽管获得FDA批准上市，但关于这种治疗方法仍有许多未知之处，目前并没有确凿的证据表明该药物减缓了记忆和大脑功能的衰退。而且这是一种必须在医生办公室使用的静脉注射药物，并可能出现脑肿胀和出血等副作用。据彭博，在渤健公司进行的一项大型试验中，该药物总体上是无效的。在另一项类似的研究中，高剂量的药物在18个月内将疾病的发展速度仅降低了22%。而部分临床医生对此药物同样抱有怀疑态度。据CNBC，部分医生表示，由于支撑Aduhelm的临床数据喜忧参半，如果该药品真的上市，他们不会在处方中开出此药。美国医生John DenBoer在接受MarketWatch采访中表示，尽管这是一个乐观的时刻，但FDA的批准只是制药公司在开发药物时面临的众多障碍之一，而且“批准并不意味着有效”。DenBoer是Smart Brain Aging公司的首席执行官，也是电影《这是痴呆症》(This is Dementia)的制片人。许多众所周知的“抗阿尔茨海默症”药物都失败了。DenBoer警告说，这种疗法在任何阶段都不能治愈或部分逆转阿尔茨海默氏症——这些目标都是不切实际的，至少对于目前正在对抗阿尔茨海默氏症的研究人员来说是如此：目前我们所使用的最好的药物最多只有5%的疗效，而且仅在疾病的早期阶段。如果你能在早期将这种疾病的强度降低10%，这将对许多人产生真正的影响，并改变他们的生活，我认为这是一个非常令人钦佩的目标。不过需要注意的是，FDA本次批准Aduhelm并非完全无条件，而是需要进行“第四阶段”临床研究。对此，FDA在新闻稿当中表示，渤健提交的材料中来自于两项三期临床试验的数据非常复杂，而且仍有不确定性残留。根据FDA的说法，“如果验证性试验不能证实该药物预期的临床效益”，该机构和制药公司可能会将该药物撤出市场。但是在验证性试验进行期间，渤健仍然可以出售Aduhelm。","kind":"highlight","is_publish_news":false,"is_publish_highlight":true,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"},"commentList":[{"id":186041991,"gmtCreate":1623466804613,"gmtModify":1704204435074,"author":{"id":"3563140991934227","authorId":"3563140991934227","name":"Fred_6810","avatar":"https://static.tigerbbs.com/fbe236f23155302a4dcecbf04d2e9040","vip":1,"crmLevel":8,"crmLevelSwitch":0,"idStr":"3563140991934227","authorIdStr":"3563140991934227"},"htmlText":"希望真的有效。","listText":"希望真的有效。","text":"希望真的有效。","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/186041991","repostId":2141259936,"repostType":4,"repost":{"id":"2141259936","kind":"highlight","pubTimestamp":1623114070,"share":"https://ttm.financial/m/news/2141259936?lang=en_US&edition=fundamental","pubTime":"2021-06-08 09:01","market":"us","language":"zh","title":"The first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?","url":"https://stock-news.laohu8.com/highlight/detail?id=2141259936","media":"华尔街见闻","summary":"受到Aduhelm获批消息利好带动，美国渤健公司隔夜一度暴涨60%。但目前Aduhelm对阿尔茨海默症治疗的效果，有效率和副作用，仍然未被验证，来自医生和研究人员的反馈也充满了分歧。","content":"<p><h2>What happened?</h2>On June 7, Biogen Inc.<a href=\"https://laohu8.com/S/BIIB\">$(BIIB) $</a>Its Alzheimer's drug was approved for marketing. This is the first such drug approved by the US Food and Drug Administration since 2003. However, there is still a lot of controversy surrounding the drug.</p><p><b>The generic name of this drug is aducanumab and will be sold under the trade name Aduhelm. Bojian charges $56,000 a year for this drug and promises not to raise the price for at least four years.</b></p><p>According to reports, the drug has the ability to clear amyloid plaques in the brain and is believed to slow down disease progression in patients with early symptoms. For a long time, the excessive accumulation of amyloid protein has been regarded as one of the chief culprits of Alzheimer's disease, which disrupts the communication between brain cells, leading to cognitive function problems.</p><p><b>However, at present, the effect, efficiency and side effects of this drug treatment have not been verified, and the feedback from doctors and researchers is full of differences, both optimistic and critical.</b></p><p>Bojian suspended trading for nearly 3 hours on Monday morning. After that, when it resumed trading, it was driven by the news of Aduhelm's approval. It broke through the two barriers of $300 and $400 in succession. The intraday increase once reached more than 60%, and then it retreated. As of the close, Bojian rose 38.34% to $395.85. The market expects that the approval of the latest drug will generate billions of dollars in revenue for the company.</p><p>The biomedical sector of the U.S. stock market also rose due to the positive impact. The Nasdaq Biotechnology Index rose by more than 5% after the news was announced.</p><p><img src=\"https://static.tigerbbs.com/1f6fdbfe3f9a0412cd40fd0ea058e36e\" tg-width=\"743\" tg-height=\"443\" referrerpolicy=\"no-referrer\"></p><p><h2>Why is it important?</h2>Alzheimer's disease (AD) is the third leading cause of death among the elderly worldwide, second only to cardiovascular and cerebrovascular diseases and cancer.</p><p>According to estimates by the World Health Organization, there are currently about 35 million to 50 million Alzheimer's patients worldwide, and 10 million new patients are expected to be added every year. Some institutions predict that by 2050, the number of Alzheimer's patients worldwide will reach 150 million.</p><p>The pathogenesis of Alzheimer's disease has not been thoroughly studied, and there is currently no way to treat the disease or reverse the process of brain disease, although some therapies can partially relieve some symptoms.</p><p><b>Therefore, as the first approved drug in 18 years, Aduhelm is expected to bring a glimmer of hope to Alzheimer's patients and their families.</b></p><p>\"Alzheimer's is one of the most incredible diseases we know,\" Charbel Moussa, associate professor of neurology and director of the Dementia and Parkinson's Laboratory at Georgetown University, told MarketWatch.</p><p>Moussa said research on the disease must be divided in order to dig deeper into how the brain works, why chemicals don't spread correctly, the impact on activities of daily living (such as bathing and dressing), and the quality of life of patients and their caregivers. He said: \"Now Aduhelm's approval is to open<a href=\"https://laohu8.com/S/0NQC.UK\">Pandora</a>The box. \"</p><p><b>There are also views that the launch of this drug will change the current treatment of Alzheimer's disease, at least for some patients, and FDA approval may pave the way for future treatments.</b></p><p>Erik Musiek, a neurologist at Washington University in St. Louis, told Bloomberg in an interview that if the FDA is willing to accept the reduction in amyloid as sufficient evidence for approval, it could open the door to other drugs, \"if all you need is plaque cleanup, that's definitely another situation.\"</p><p>Harry Johns, CEO of the American Alzheimer's Association, said, \"This is just a new day for Alzheimer's patients, and we believe it will drive more innovation and investment.\"</p><p><h2>Why is the disagreement huge?</h2>At present, there is still huge controversy and uncertainty surrounding Aduhelm. There is still a long way to go before this drug can truly benefit patients.</p><p>Despite being approved by the FDA for marketing, there is still much unknown about this treatment, and there is currently no conclusive evidence that the drug slows down the decline of memory and brain function.<b>And it's an intravenous drug that must be used in the doctor's office, and can have side effects such as brain swelling and bleeding.</b></p><p>According to Bloomberg, in a large trial conducted by Biogen, the drug was generally ineffective. In another similar study, high doses of the drug reduced the rate of disease progression by only 22% over 18 months.</p><p>Some clinicians are also skeptical about this drug. According to CNBC, some doctors said that due to the mixed clinical data supporting Aduhelm, they would not prescribe the drug in their prescriptions if the drug was actually marketed.</p><p>While this is an optimistic moment, FDA approval is just one of many hurdles pharmaceutical companies face when developing drugs, and \"approval is not meant to work,\" American physician John DenBoer told MarketWatch in an interview. DenBoer is the CEO of Smart Brain Aging and the producer of the film This is Dementia.</p><p>Many well-known \"anti-Alzheimer's\" drugs have failed. DenBoer warns that this therapy will not cure or partially reverse Alzheimer's at any stage-goals that are unrealistic, at least for researchers currently fighting Alzheimer's:</p><p>At present, the best drugs we use are only 5% effective at most, and only in the early stages of the disease. If you can reduce the intensity of this disease by 10% at an early stage, it will have a real impact on many people and change their lives, which I think is a very admirable goal. However, it should be noted that the FDA's approval of Aduhelm this time is not completely unconditional, but requires \"Phase IV\" clinical research. In this regard, the FDA stated in a press release that the data from two phase III clinical trials in the materials submitted by Bojian are very complex, and there are still uncertainties.</p><p><b>According to the FDA, the agency and pharmaceutical companies may pull the drug off the market \"if confirmatory trials do not confirm the anticipated clinical benefits of the drug.\" But while confirmatory trials are ongoing, Bojian can still sell Aduhelm.</b></p>","source":"wallstreetcn_api","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>The first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nThe first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">华尔街见闻</strong><span class=\"h-time small\">2021-06-08 09:01</span>\n</p>\n</h4>\n</header>\n<article>\n<p><h2>What happened?</h2>On June 7, Biogen Inc.<a href=\"https://laohu8.com/S/BIIB\">$(BIIB) $</a>Its Alzheimer's drug was approved for marketing. This is the first such drug approved by the US Food and Drug Administration since 2003. However, there is still a lot of controversy surrounding the drug.</p><p><b>The generic name of this drug is aducanumab and will be sold under the trade name Aduhelm. Bojian charges $56,000 a year for this drug and promises not to raise the price for at least four years.</b></p><p>According to reports, the drug has the ability to clear amyloid plaques in the brain and is believed to slow down disease progression in patients with early symptoms. For a long time, the excessive accumulation of amyloid protein has been regarded as one of the chief culprits of Alzheimer's disease, which disrupts the communication between brain cells, leading to cognitive function problems.</p><p><b>However, at present, the effect, efficiency and side effects of this drug treatment have not been verified, and the feedback from doctors and researchers is full of differences, both optimistic and critical.</b></p><p>Bojian suspended trading for nearly 3 hours on Monday morning. After that, when it resumed trading, it was driven by the news of Aduhelm's approval. It broke through the two barriers of $300 and $400 in succession. The intraday increase once reached more than 60%, and then it retreated. As of the close, Bojian rose 38.34% to $395.85. The market expects that the approval of the latest drug will generate billions of dollars in revenue for the company.</p><p>The biomedical sector of the U.S. stock market also rose due to the positive impact. The Nasdaq Biotechnology Index rose by more than 5% after the news was announced.</p><p><img src=\"https://static.tigerbbs.com/1f6fdbfe3f9a0412cd40fd0ea058e36e\" tg-width=\"743\" tg-height=\"443\" referrerpolicy=\"no-referrer\"></p><p><h2>Why is it important?</h2>Alzheimer's disease (AD) is the third leading cause of death among the elderly worldwide, second only to cardiovascular and cerebrovascular diseases and cancer.</p><p>According to estimates by the World Health Organization, there are currently about 35 million to 50 million Alzheimer's patients worldwide, and 10 million new patients are expected to be added every year. Some institutions predict that by 2050, the number of Alzheimer's patients worldwide will reach 150 million.</p><p>The pathogenesis of Alzheimer's disease has not been thoroughly studied, and there is currently no way to treat the disease or reverse the process of brain disease, although some therapies can partially relieve some symptoms.</p><p><b>Therefore, as the first approved drug in 18 years, Aduhelm is expected to bring a glimmer of hope to Alzheimer's patients and their families.</b></p><p>\"Alzheimer's is one of the most incredible diseases we know,\" Charbel Moussa, associate professor of neurology and director of the Dementia and Parkinson's Laboratory at Georgetown University, told MarketWatch.</p><p>Moussa said research on the disease must be divided in order to dig deeper into how the brain works, why chemicals don't spread correctly, the impact on activities of daily living (such as bathing and dressing), and the quality of life of patients and their caregivers. He said: \"Now Aduhelm's approval is to open<a href=\"https://laohu8.com/S/0NQC.UK\">Pandora</a>The box. \"</p><p><b>There are also views that the launch of this drug will change the current treatment of Alzheimer's disease, at least for some patients, and FDA approval may pave the way for future treatments.</b></p><p>Erik Musiek, a neurologist at Washington University in St. Louis, told Bloomberg in an interview that if the FDA is willing to accept the reduction in amyloid as sufficient evidence for approval, it could open the door to other drugs, \"if all you need is plaque cleanup, that's definitely another situation.\"</p><p>Harry Johns, CEO of the American Alzheimer's Association, said, \"This is just a new day for Alzheimer's patients, and we believe it will drive more innovation and investment.\"</p><p><h2>Why is the disagreement huge?</h2>At present, there is still huge controversy and uncertainty surrounding Aduhelm. There is still a long way to go before this drug can truly benefit patients.</p><p>Despite being approved by the FDA for marketing, there is still much unknown about this treatment, and there is currently no conclusive evidence that the drug slows down the decline of memory and brain function.<b>And it's an intravenous drug that must be used in the doctor's office, and can have side effects such as brain swelling and bleeding.</b></p><p>According to Bloomberg, in a large trial conducted by Biogen, the drug was generally ineffective. In another similar study, high doses of the drug reduced the rate of disease progression by only 22% over 18 months.</p><p>Some clinicians are also skeptical about this drug. According to CNBC, some doctors said that due to the mixed clinical data supporting Aduhelm, they would not prescribe the drug in their prescriptions if the drug was actually marketed.</p><p>While this is an optimistic moment, FDA approval is just one of many hurdles pharmaceutical companies face when developing drugs, and \"approval is not meant to work,\" American physician John DenBoer told MarketWatch in an interview. DenBoer is the CEO of Smart Brain Aging and the producer of the film This is Dementia.</p><p>Many well-known \"anti-Alzheimer's\" drugs have failed. DenBoer warns that this therapy will not cure or partially reverse Alzheimer's at any stage-goals that are unrealistic, at least for researchers currently fighting Alzheimer's:</p><p>At present, the best drugs we use are only 5% effective at most, and only in the early stages of the disease. If you can reduce the intensity of this disease by 10% at an early stage, it will have a real impact on many people and change their lives, which I think is a very admirable goal. However, it should be noted that the FDA's approval of Aduhelm this time is not completely unconditional, but requires \"Phase IV\" clinical research. In this regard, the FDA stated in a press release that the data from two phase III clinical trials in the materials submitted by Bojian are very complex, and there are still uncertainties.</p><p><b>According to the FDA, the agency and pharmaceutical companies may pull the drug off the market \"if confirmatory trials do not confirm the anticipated clinical benefits of the drug.\" But while confirmatory trials are ongoing, Bojian can still sell Aduhelm.</b></p>\n<div class=\"bt-text\">\n\n\n<p> source：<a href=\"https://wallstreetcn.com/articles/3632396\">华尔街见闻</a></p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"https://static.tigerbbs.com/df4ec61541b268a5353585001973d7cb","relate_stocks":{},"source_url":"https://wallstreetcn.com/articles/3632396","is_english":false,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2141259936","content_text":"发生了什么？6月7日，美国渤健公司(Biogen Inc.)$(BIIB)$旗下的阿尔茨海默症药物获批上市，这是2003年来首款获美国食品和药物管理局批准的此类药物，然而目前围绕该药物的争议依然很大。这款药物的通用名为aducanumab，将以Aduhelm的商品名进行销售。渤健每年对这种药物的收费为5.6万美元，并且承诺至少四年内不涨价。据介绍，该药物具有清除大脑淀粉样蛋白斑块的能力，被认为可以减缓早期症状患者的疾病进展。长期以来，淀粉样蛋白的过度积累被视为引发阿尔茨海默症的罪魁祸首之一，它破坏了脑细胞之间的交流，从而导致认知功能问题。然而，目前这款药物治疗的效果，有效率和副作用，仍然未被验证，来自医生和研究人员的反馈也充满了分歧，既有乐观的，也有持批判态度的。渤健周一早间曾停牌近3小时，之后复牌时受到Aduhelm获批消息的利好带动，连续突破了300美元和400美元两道关口，日内涨幅曾一度达到60%以上，而在之后则出现回吐。截至收盘，渤健上涨38.34%，报395.85美元。市场预计，最新药物的批准将为公司带来数十亿美元的收入。而美股生物医药板块也受到利好影响出现拉升，纳斯达克生物科技指数在消息公布之后曾涨逾5%。为什么重要？阿尔茨海默症(AD)是导致全球老年人死亡的第三大原因，仅次于心脑血管疾病和癌症。据世界卫生组织估计，目前全球约有3500万至5000万阿尔茨海默症患者，并且每年预计将有1000万新增患者。有机构预测，到2050年，全球阿尔茨海默症患者数量将达到1.5亿。阿尔茨海默症发病机制至今仍未被研究透彻，且目前还没有治疗该病症或逆转大脑疾病进程的方法，尽管一些疗法可以部分缓解一些症状。因此，作为18年来首款获批的药物，Aduhelm有望给阿尔茨海默症患者和他们的家人带来一丝希望。乔治敦大学(Georgetown University)神经学副教授、痴呆症和帕金森病实验室主任Charbel Moussa对MarketWatch表示：“阿尔茨海默症是我们所知道的最难以置信的疾病之一。”Moussa称对这种疾病的研究必须进行划分，以便更深入地挖掘大脑是如何运作的，为什么化学物质不能正确地传播，对日常生活活动(如洗澡和穿衣服)的影响，以及病人及其照顾者的生活质量。他说：“现在Aduhelm的批准就是打开潘多拉的盒子。”也有观点认为，这款药物的上市将改变阿尔茨海默症目前的治疗方式，至少对一些患者来说是这样，FDA的批准可能会为未来的治疗铺平道路。圣路易斯华盛顿大学(Washington University in St. Louis)的神经学家Erik Musiek在接受彭博采访中表示，如果FDA愿意接受淀粉样蛋白的减少作为批准的充分证据，这可能为其他药物打开大门，“如果你所需要的只是清理斑块，那肯定是另一种情况。”美国阿尔茨海默症协会首席执行官Harry Johns表示，“对于阿尔茨海默症患者来说，这只是新的一天，我们相信这将推动更多的创新和投资。”为什么分歧巨大？目前，围绕Aduhelm还存在着巨大的争议和不确定性，这款药物要使患者真正获益，还有很长的路要走。尽管获得FDA批准上市，但关于这种治疗方法仍有许多未知之处，目前并没有确凿的证据表明该药物减缓了记忆和大脑功能的衰退。而且这是一种必须在医生办公室使用的静脉注射药物，并可能出现脑肿胀和出血等副作用。据彭博，在渤健公司进行的一项大型试验中，该药物总体上是无效的。在另一项类似的研究中，高剂量的药物在18个月内将疾病的发展速度仅降低了22%。而部分临床医生对此药物同样抱有怀疑态度。据CNBC，部分医生表示，由于支撑Aduhelm的临床数据喜忧参半，如果该药品真的上市，他们不会在处方中开出此药。美国医生John DenBoer在接受MarketWatch采访中表示，尽管这是一个乐观的时刻，但FDA的批准只是制药公司在开发药物时面临的众多障碍之一，而且“批准并不意味着有效”。DenBoer是Smart Brain Aging公司的首席执行官，也是电影《这是痴呆症》(This is Dementia)的制片人。许多众所周知的“抗阿尔茨海默症”药物都失败了。DenBoer警告说，这种疗法在任何阶段都不能治愈或部分逆转阿尔茨海默氏症——这些目标都是不切实际的，至少对于目前正在对抗阿尔茨海默氏症的研究人员来说是如此：目前我们所使用的最好的药物最多只有5%的疗效，而且仅在疾病的早期阶段。如果你能在早期将这种疾病的强度降低10%，这将对许多人产生真正的影响，并改变他们的生活，我认为这是一个非常令人钦佩的目标。不过需要注意的是，FDA本次批准Aduhelm并非完全无条件，而是需要进行“第四阶段”临床研究。对此，FDA在新闻稿当中表示，渤健提交的材料中来自于两项三期临床试验的数据非常复杂，而且仍有不确定性残留。根据FDA的说法，“如果验证性试验不能证实该药物预期的临床效益”，该机构和制药公司可能会将该药物撤出市场。但是在验证性试验进行期间，渤健仍然可以出售Aduhelm。","news_type":1,"symbols_score_info":{}},"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"CN"},{"id":180577303,"gmtCreate":1623216035202,"gmtModify":1704198557660,"author":{"id":"3568341343298894","authorId":"3568341343298894","name":"大家好我是王剛88888","avatar":"https://static.tigerbbs.com/d84a1454474c28ae62985e96195561d3","vip":1,"crmLevel":12,"crmLevelSwitch":0,"idStr":"3568341343298894","authorIdStr":"3568341343298894"},"htmlText":"Buy","listText":"Buy","text":"Buy","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/180577303","repostId":2141259936,"repostType":2,"repost":{"id":"2141259936","kind":"highlight","pubTimestamp":1623114070,"share":"https://ttm.financial/m/news/2141259936?lang=en_US&edition=fundamental","pubTime":"2021-06-08 09:01","market":"us","language":"zh","title":"The first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?","url":"https://stock-news.laohu8.com/highlight/detail?id=2141259936","media":"华尔街见闻","summary":"受到Aduhelm获批消息利好带动，美国渤健公司隔夜一度暴涨60%。但目前Aduhelm对阿尔茨海默症治疗的效果，有效率和副作用，仍然未被验证，来自医生和研究人员的反馈也充满了分歧。","content":"<p><h2>What happened?</h2>On June 7, Biogen Inc.<a href=\"https://laohu8.com/S/BIIB\">$(BIIB) $</a>Its Alzheimer's drug was approved for marketing. This is the first such drug approved by the US Food and Drug Administration since 2003. However, there is still a lot of controversy surrounding the drug.</p><p><b>The generic name of this drug is aducanumab and will be sold under the trade name Aduhelm. Bojian charges $56,000 a year for this drug and promises not to raise the price for at least four years.</b></p><p>According to reports, the drug has the ability to clear amyloid plaques in the brain and is believed to slow down disease progression in patients with early symptoms. For a long time, the excessive accumulation of amyloid protein has been regarded as one of the chief culprits of Alzheimer's disease, which disrupts the communication between brain cells, leading to cognitive function problems.</p><p><b>However, at present, the effect, efficiency and side effects of this drug treatment have not been verified, and the feedback from doctors and researchers is full of differences, both optimistic and critical.</b></p><p>Bojian suspended trading for nearly 3 hours on Monday morning. After that, when it resumed trading, it was driven by the news of Aduhelm's approval. It broke through the two barriers of $300 and $400 in succession. The intraday increase once reached more than 60%, and then it retreated. As of the close, Bojian rose 38.34% to $395.85. The market expects that the approval of the latest drug will generate billions of dollars in revenue for the company.</p><p>The biomedical sector of the U.S. stock market also rose due to the positive impact. The Nasdaq Biotechnology Index rose by more than 5% after the news was announced.</p><p><img src=\"https://static.tigerbbs.com/1f6fdbfe3f9a0412cd40fd0ea058e36e\" tg-width=\"743\" tg-height=\"443\" referrerpolicy=\"no-referrer\"></p><p><h2>Why is it important?</h2>Alzheimer's disease (AD) is the third leading cause of death among the elderly worldwide, second only to cardiovascular and cerebrovascular diseases and cancer.</p><p>According to estimates by the World Health Organization, there are currently about 35 million to 50 million Alzheimer's patients worldwide, and 10 million new patients are expected to be added every year. Some institutions predict that by 2050, the number of Alzheimer's patients worldwide will reach 150 million.</p><p>The pathogenesis of Alzheimer's disease has not been thoroughly studied, and there is currently no way to treat the disease or reverse the process of brain disease, although some therapies can partially relieve some symptoms.</p><p><b>Therefore, as the first approved drug in 18 years, Aduhelm is expected to bring a glimmer of hope to Alzheimer's patients and their families.</b></p><p>\"Alzheimer's is one of the most incredible diseases we know,\" Charbel Moussa, associate professor of neurology and director of the Dementia and Parkinson's Laboratory at Georgetown University, told MarketWatch.</p><p>Moussa said research on the disease must be divided in order to dig deeper into how the brain works, why chemicals don't spread correctly, the impact on activities of daily living (such as bathing and dressing), and the quality of life of patients and their caregivers. He said: \"Now Aduhelm's approval is to open<a href=\"https://laohu8.com/S/0NQC.UK\">Pandora</a>The box. \"</p><p><b>There are also views that the launch of this drug will change the current treatment of Alzheimer's disease, at least for some patients, and FDA approval may pave the way for future treatments.</b></p><p>Erik Musiek, a neurologist at Washington University in St. Louis, told Bloomberg in an interview that if the FDA is willing to accept the reduction in amyloid as sufficient evidence for approval, it could open the door to other drugs, \"if all you need is plaque cleanup, that's definitely another situation.\"</p><p>Harry Johns, CEO of the American Alzheimer's Association, said, \"This is just a new day for Alzheimer's patients, and we believe it will drive more innovation and investment.\"</p><p><h2>Why is the disagreement huge?</h2>At present, there is still huge controversy and uncertainty surrounding Aduhelm. There is still a long way to go before this drug can truly benefit patients.</p><p>Despite being approved by the FDA for marketing, there is still much unknown about this treatment, and there is currently no conclusive evidence that the drug slows down the decline of memory and brain function.<b>And it's an intravenous drug that must be used in the doctor's office, and can have side effects such as brain swelling and bleeding.</b></p><p>According to Bloomberg, in a large trial conducted by Biogen, the drug was generally ineffective. In another similar study, high doses of the drug reduced the rate of disease progression by only 22% over 18 months.</p><p>Some clinicians are also skeptical about this drug. According to CNBC, some doctors said that due to the mixed clinical data supporting Aduhelm, they would not prescribe the drug in their prescriptions if the drug was actually marketed.</p><p>While this is an optimistic moment, FDA approval is just one of many hurdles pharmaceutical companies face when developing drugs, and \"approval is not meant to work,\" American physician John DenBoer told MarketWatch in an interview. DenBoer is the CEO of Smart Brain Aging and the producer of the film This is Dementia.</p><p>Many well-known \"anti-Alzheimer's\" drugs have failed. DenBoer warns that this therapy will not cure or partially reverse Alzheimer's at any stage-goals that are unrealistic, at least for researchers currently fighting Alzheimer's:</p><p>At present, the best drugs we use are only 5% effective at most, and only in the early stages of the disease. If you can reduce the intensity of this disease by 10% at an early stage, it will have a real impact on many people and change their lives, which I think is a very admirable goal. However, it should be noted that the FDA's approval of Aduhelm this time is not completely unconditional, but requires \"Phase IV\" clinical research. In this regard, the FDA stated in a press release that the data from two phase III clinical trials in the materials submitted by Bojian are very complex, and there are still uncertainties.</p><p><b>According to the FDA, the agency and pharmaceutical companies may pull the drug off the market \"if confirmatory trials do not confirm the anticipated clinical benefits of the drug.\" But while confirmatory trials are ongoing, Bojian can still sell Aduhelm.</b></p>","source":"wallstreetcn_api","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>The first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nThe first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">华尔街见闻</strong><span class=\"h-time small\">2021-06-08 09:01</span>\n</p>\n</h4>\n</header>\n<article>\n<p><h2>What happened?</h2>On June 7, Biogen Inc.<a href=\"https://laohu8.com/S/BIIB\">$(BIIB) $</a>Its Alzheimer's drug was approved for marketing. This is the first such drug approved by the US Food and Drug Administration since 2003. However, there is still a lot of controversy surrounding the drug.</p><p><b>The generic name of this drug is aducanumab and will be sold under the trade name Aduhelm. Bojian charges $56,000 a year for this drug and promises not to raise the price for at least four years.</b></p><p>According to reports, the drug has the ability to clear amyloid plaques in the brain and is believed to slow down disease progression in patients with early symptoms. For a long time, the excessive accumulation of amyloid protein has been regarded as one of the chief culprits of Alzheimer's disease, which disrupts the communication between brain cells, leading to cognitive function problems.</p><p><b>However, at present, the effect, efficiency and side effects of this drug treatment have not been verified, and the feedback from doctors and researchers is full of differences, both optimistic and critical.</b></p><p>Bojian suspended trading for nearly 3 hours on Monday morning. After that, when it resumed trading, it was driven by the news of Aduhelm's approval. It broke through the two barriers of $300 and $400 in succession. The intraday increase once reached more than 60%, and then it retreated. As of the close, Bojian rose 38.34% to $395.85. The market expects that the approval of the latest drug will generate billions of dollars in revenue for the company.</p><p>The biomedical sector of the U.S. stock market also rose due to the positive impact. The Nasdaq Biotechnology Index rose by more than 5% after the news was announced.</p><p><img src=\"https://static.tigerbbs.com/1f6fdbfe3f9a0412cd40fd0ea058e36e\" tg-width=\"743\" tg-height=\"443\" referrerpolicy=\"no-referrer\"></p><p><h2>Why is it important?</h2>Alzheimer's disease (AD) is the third leading cause of death among the elderly worldwide, second only to cardiovascular and cerebrovascular diseases and cancer.</p><p>According to estimates by the World Health Organization, there are currently about 35 million to 50 million Alzheimer's patients worldwide, and 10 million new patients are expected to be added every year. Some institutions predict that by 2050, the number of Alzheimer's patients worldwide will reach 150 million.</p><p>The pathogenesis of Alzheimer's disease has not been thoroughly studied, and there is currently no way to treat the disease or reverse the process of brain disease, although some therapies can partially relieve some symptoms.</p><p><b>Therefore, as the first approved drug in 18 years, Aduhelm is expected to bring a glimmer of hope to Alzheimer's patients and their families.</b></p><p>\"Alzheimer's is one of the most incredible diseases we know,\" Charbel Moussa, associate professor of neurology and director of the Dementia and Parkinson's Laboratory at Georgetown University, told MarketWatch.</p><p>Moussa said research on the disease must be divided in order to dig deeper into how the brain works, why chemicals don't spread correctly, the impact on activities of daily living (such as bathing and dressing), and the quality of life of patients and their caregivers. He said: \"Now Aduhelm's approval is to open<a href=\"https://laohu8.com/S/0NQC.UK\">Pandora</a>The box. \"</p><p><b>There are also views that the launch of this drug will change the current treatment of Alzheimer's disease, at least for some patients, and FDA approval may pave the way for future treatments.</b></p><p>Erik Musiek, a neurologist at Washington University in St. Louis, told Bloomberg in an interview that if the FDA is willing to accept the reduction in amyloid as sufficient evidence for approval, it could open the door to other drugs, \"if all you need is plaque cleanup, that's definitely another situation.\"</p><p>Harry Johns, CEO of the American Alzheimer's Association, said, \"This is just a new day for Alzheimer's patients, and we believe it will drive more innovation and investment.\"</p><p><h2>Why is the disagreement huge?</h2>At present, there is still huge controversy and uncertainty surrounding Aduhelm. There is still a long way to go before this drug can truly benefit patients.</p><p>Despite being approved by the FDA for marketing, there is still much unknown about this treatment, and there is currently no conclusive evidence that the drug slows down the decline of memory and brain function.<b>And it's an intravenous drug that must be used in the doctor's office, and can have side effects such as brain swelling and bleeding.</b></p><p>According to Bloomberg, in a large trial conducted by Biogen, the drug was generally ineffective. In another similar study, high doses of the drug reduced the rate of disease progression by only 22% over 18 months.</p><p>Some clinicians are also skeptical about this drug. According to CNBC, some doctors said that due to the mixed clinical data supporting Aduhelm, they would not prescribe the drug in their prescriptions if the drug was actually marketed.</p><p>While this is an optimistic moment, FDA approval is just one of many hurdles pharmaceutical companies face when developing drugs, and \"approval is not meant to work,\" American physician John DenBoer told MarketWatch in an interview. DenBoer is the CEO of Smart Brain Aging and the producer of the film This is Dementia.</p><p>Many well-known \"anti-Alzheimer's\" drugs have failed. DenBoer warns that this therapy will not cure or partially reverse Alzheimer's at any stage-goals that are unrealistic, at least for researchers currently fighting Alzheimer's:</p><p>At present, the best drugs we use are only 5% effective at most, and only in the early stages of the disease. If you can reduce the intensity of this disease by 10% at an early stage, it will have a real impact on many people and change their lives, which I think is a very admirable goal. However, it should be noted that the FDA's approval of Aduhelm this time is not completely unconditional, but requires \"Phase IV\" clinical research. In this regard, the FDA stated in a press release that the data from two phase III clinical trials in the materials submitted by Bojian are very complex, and there are still uncertainties.</p><p><b>According to the FDA, the agency and pharmaceutical companies may pull the drug off the market \"if confirmatory trials do not confirm the anticipated clinical benefits of the drug.\" But while confirmatory trials are ongoing, Bojian can still sell Aduhelm.</b></p>\n<div class=\"bt-text\">\n\n\n<p> source：<a href=\"https://wallstreetcn.com/articles/3632396\">华尔街见闻</a></p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"https://static.tigerbbs.com/df4ec61541b268a5353585001973d7cb","relate_stocks":{},"source_url":"https://wallstreetcn.com/articles/3632396","is_english":false,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2141259936","content_text":"发生了什么？6月7日，美国渤健公司(Biogen Inc.)$(BIIB)$旗下的阿尔茨海默症药物获批上市，这是2003年来首款获美国食品和药物管理局批准的此类药物，然而目前围绕该药物的争议依然很大。这款药物的通用名为aducanumab，将以Aduhelm的商品名进行销售。渤健每年对这种药物的收费为5.6万美元，并且承诺至少四年内不涨价。据介绍，该药物具有清除大脑淀粉样蛋白斑块的能力，被认为可以减缓早期症状患者的疾病进展。长期以来，淀粉样蛋白的过度积累被视为引发阿尔茨海默症的罪魁祸首之一，它破坏了脑细胞之间的交流，从而导致认知功能问题。然而，目前这款药物治疗的效果，有效率和副作用，仍然未被验证，来自医生和研究人员的反馈也充满了分歧，既有乐观的，也有持批判态度的。渤健周一早间曾停牌近3小时，之后复牌时受到Aduhelm获批消息的利好带动，连续突破了300美元和400美元两道关口，日内涨幅曾一度达到60%以上，而在之后则出现回吐。截至收盘，渤健上涨38.34%，报395.85美元。市场预计，最新药物的批准将为公司带来数十亿美元的收入。而美股生物医药板块也受到利好影响出现拉升，纳斯达克生物科技指数在消息公布之后曾涨逾5%。为什么重要？阿尔茨海默症(AD)是导致全球老年人死亡的第三大原因，仅次于心脑血管疾病和癌症。据世界卫生组织估计，目前全球约有3500万至5000万阿尔茨海默症患者，并且每年预计将有1000万新增患者。有机构预测，到2050年，全球阿尔茨海默症患者数量将达到1.5亿。阿尔茨海默症发病机制至今仍未被研究透彻，且目前还没有治疗该病症或逆转大脑疾病进程的方法，尽管一些疗法可以部分缓解一些症状。因此，作为18年来首款获批的药物，Aduhelm有望给阿尔茨海默症患者和他们的家人带来一丝希望。乔治敦大学(Georgetown University)神经学副教授、痴呆症和帕金森病实验室主任Charbel Moussa对MarketWatch表示：“阿尔茨海默症是我们所知道的最难以置信的疾病之一。”Moussa称对这种疾病的研究必须进行划分，以便更深入地挖掘大脑是如何运作的，为什么化学物质不能正确地传播，对日常生活活动(如洗澡和穿衣服)的影响，以及病人及其照顾者的生活质量。他说：“现在Aduhelm的批准就是打开潘多拉的盒子。”也有观点认为，这款药物的上市将改变阿尔茨海默症目前的治疗方式，至少对一些患者来说是这样，FDA的批准可能会为未来的治疗铺平道路。圣路易斯华盛顿大学(Washington University in St. Louis)的神经学家Erik Musiek在接受彭博采访中表示，如果FDA愿意接受淀粉样蛋白的减少作为批准的充分证据，这可能为其他药物打开大门，“如果你所需要的只是清理斑块，那肯定是另一种情况。”美国阿尔茨海默症协会首席执行官Harry Johns表示，“对于阿尔茨海默症患者来说，这只是新的一天，我们相信这将推动更多的创新和投资。”为什么分歧巨大？目前，围绕Aduhelm还存在着巨大的争议和不确定性，这款药物要使患者真正获益，还有很长的路要走。尽管获得FDA批准上市，但关于这种治疗方法仍有许多未知之处，目前并没有确凿的证据表明该药物减缓了记忆和大脑功能的衰退。而且这是一种必须在医生办公室使用的静脉注射药物，并可能出现脑肿胀和出血等副作用。据彭博，在渤健公司进行的一项大型试验中，该药物总体上是无效的。在另一项类似的研究中，高剂量的药物在18个月内将疾病的发展速度仅降低了22%。而部分临床医生对此药物同样抱有怀疑态度。据CNBC，部分医生表示，由于支撑Aduhelm的临床数据喜忧参半，如果该药品真的上市，他们不会在处方中开出此药。美国医生John DenBoer在接受MarketWatch采访中表示，尽管这是一个乐观的时刻，但FDA的批准只是制药公司在开发药物时面临的众多障碍之一，而且“批准并不意味着有效”。DenBoer是Smart Brain Aging公司的首席执行官，也是电影《这是痴呆症》(This is Dementia)的制片人。许多众所周知的“抗阿尔茨海默症”药物都失败了。DenBoer警告说，这种疗法在任何阶段都不能治愈或部分逆转阿尔茨海默氏症——这些目标都是不切实际的，至少对于目前正在对抗阿尔茨海默氏症的研究人员来说是如此：目前我们所使用的最好的药物最多只有5%的疗效，而且仅在疾病的早期阶段。如果你能在早期将这种疾病的强度降低10%，这将对许多人产生真正的影响，并改变他们的生活，我认为这是一个非常令人钦佩的目标。不过需要注意的是，FDA本次批准Aduhelm并非完全无条件，而是需要进行“第四阶段”临床研究。对此，FDA在新闻稿当中表示，渤健提交的材料中来自于两项三期临床试验的数据非常复杂，而且仍有不确定性残留。根据FDA的说法，“如果验证性试验不能证实该药物预期的临床效益”，该机构和制药公司可能会将该药物撤出市场。但是在验证性试验进行期间，渤健仍然可以出售Aduhelm。","news_type":1,"symbols_score_info":{}},"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"EN"},{"id":117292166,"gmtCreate":1623141936755,"gmtModify":1704196931180,"author":{"id":"3532132223347993","authorId":"3532132223347993","name":"浴缸潜水员","avatar":"https://static.tigerbbs.com/b4d01d6abe944b89aee8c87b329e931f","vip":1,"crmLevel":2,"crmLevelSwitch":1,"idStr":"3532132223347993","authorIdStr":"3532132223347993"},"htmlText":"今年諾獎有戲。","listText":"今年諾獎有戲。","text":"今年諾獎有戲。","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":1,"repostSize":0,"link":"https://ttm.financial/post/117292166","repostId":2141259936,"repostType":4,"repost":{"id":"2141259936","kind":"highlight","pubTimestamp":1623114070,"share":"https://ttm.financial/m/news/2141259936?lang=en_US&edition=fundamental","pubTime":"2021-06-08 09:01","market":"us","language":"zh","title":"The first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?","url":"https://stock-news.laohu8.com/highlight/detail?id=2141259936","media":"华尔街见闻","summary":"受到Aduhelm获批消息利好带动，美国渤健公司隔夜一度暴涨60%。但目前Aduhelm对阿尔茨海默症治疗的效果，有效率和副作用，仍然未被验证，来自医生和研究人员的反馈也充满了分歧。","content":"<p><h2>What happened?</h2>On June 7, Biogen Inc.<a href=\"https://laohu8.com/S/BIIB\">$(BIIB) $</a>Its Alzheimer's drug was approved for marketing. This is the first such drug approved by the US Food and Drug Administration since 2003. However, there is still a lot of controversy surrounding the drug.</p><p><b>The generic name of this drug is aducanumab and will be sold under the trade name Aduhelm. Bojian charges $56,000 a year for this drug and promises not to raise the price for at least four years.</b></p><p>According to reports, the drug has the ability to clear amyloid plaques in the brain and is believed to slow down disease progression in patients with early symptoms. For a long time, the excessive accumulation of amyloid protein has been regarded as one of the chief culprits of Alzheimer's disease, which disrupts the communication between brain cells, leading to cognitive function problems.</p><p><b>However, at present, the effect, efficiency and side effects of this drug treatment have not been verified, and the feedback from doctors and researchers is full of differences, both optimistic and critical.</b></p><p>Bojian suspended trading for nearly 3 hours on Monday morning. After that, when it resumed trading, it was driven by the news of Aduhelm's approval. It broke through the two barriers of $300 and $400 in succession. The intraday increase once reached more than 60%, and then it retreated. As of the close, Bojian rose 38.34% to $395.85. The market expects that the approval of the latest drug will generate billions of dollars in revenue for the company.</p><p>The biomedical sector of the U.S. stock market also rose due to the positive impact. The Nasdaq Biotechnology Index rose by more than 5% after the news was announced.</p><p><img src=\"https://static.tigerbbs.com/1f6fdbfe3f9a0412cd40fd0ea058e36e\" tg-width=\"743\" tg-height=\"443\" referrerpolicy=\"no-referrer\"></p><p><h2>Why is it important?</h2>Alzheimer's disease (AD) is the third leading cause of death among the elderly worldwide, second only to cardiovascular and cerebrovascular diseases and cancer.</p><p>According to estimates by the World Health Organization, there are currently about 35 million to 50 million Alzheimer's patients worldwide, and 10 million new patients are expected to be added every year. Some institutions predict that by 2050, the number of Alzheimer's patients worldwide will reach 150 million.</p><p>The pathogenesis of Alzheimer's disease has not been thoroughly studied, and there is currently no way to treat the disease or reverse the process of brain disease, although some therapies can partially relieve some symptoms.</p><p><b>Therefore, as the first approved drug in 18 years, Aduhelm is expected to bring a glimmer of hope to Alzheimer's patients and their families.</b></p><p>\"Alzheimer's is one of the most incredible diseases we know,\" Charbel Moussa, associate professor of neurology and director of the Dementia and Parkinson's Laboratory at Georgetown University, told MarketWatch.</p><p>Moussa said research on the disease must be divided in order to dig deeper into how the brain works, why chemicals don't spread correctly, the impact on activities of daily living (such as bathing and dressing), and the quality of life of patients and their caregivers. He said: \"Now Aduhelm's approval is to open<a href=\"https://laohu8.com/S/0NQC.UK\">Pandora</a>The box. \"</p><p><b>There are also views that the launch of this drug will change the current treatment of Alzheimer's disease, at least for some patients, and FDA approval may pave the way for future treatments.</b></p><p>Erik Musiek, a neurologist at Washington University in St. Louis, told Bloomberg in an interview that if the FDA is willing to accept the reduction in amyloid as sufficient evidence for approval, it could open the door to other drugs, \"if all you need is plaque cleanup, that's definitely another situation.\"</p><p>Harry Johns, CEO of the American Alzheimer's Association, said, \"This is just a new day for Alzheimer's patients, and we believe it will drive more innovation and investment.\"</p><p><h2>Why is the disagreement huge?</h2>At present, there is still huge controversy and uncertainty surrounding Aduhelm. There is still a long way to go before this drug can truly benefit patients.</p><p>Despite being approved by the FDA for marketing, there is still much unknown about this treatment, and there is currently no conclusive evidence that the drug slows down the decline of memory and brain function.<b>And it's an intravenous drug that must be used in the doctor's office, and can have side effects such as brain swelling and bleeding.</b></p><p>According to Bloomberg, in a large trial conducted by Biogen, the drug was generally ineffective. In another similar study, high doses of the drug reduced the rate of disease progression by only 22% over 18 months.</p><p>Some clinicians are also skeptical about this drug. According to CNBC, some doctors said that due to the mixed clinical data supporting Aduhelm, they would not prescribe the drug in their prescriptions if the drug was actually marketed.</p><p>While this is an optimistic moment, FDA approval is just one of many hurdles pharmaceutical companies face when developing drugs, and \"approval is not meant to work,\" American physician John DenBoer told MarketWatch in an interview. DenBoer is the CEO of Smart Brain Aging and the producer of the film This is Dementia.</p><p>Many well-known \"anti-Alzheimer's\" drugs have failed. DenBoer warns that this therapy will not cure or partially reverse Alzheimer's at any stage-goals that are unrealistic, at least for researchers currently fighting Alzheimer's:</p><p>At present, the best drugs we use are only 5% effective at most, and only in the early stages of the disease. If you can reduce the intensity of this disease by 10% at an early stage, it will have a real impact on many people and change their lives, which I think is a very admirable goal. However, it should be noted that the FDA's approval of Aduhelm this time is not completely unconditional, but requires \"Phase IV\" clinical research. In this regard, the FDA stated in a press release that the data from two phase III clinical trials in the materials submitted by Bojian are very complex, and there are still uncertainties.</p><p><b>According to the FDA, the agency and pharmaceutical companies may pull the drug off the market \"if confirmatory trials do not confirm the anticipated clinical benefits of the drug.\" But while confirmatory trials are ongoing, Bojian can still sell Aduhelm.</b></p>","source":"wallstreetcn_api","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>The first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nThe first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">华尔街见闻</strong><span class=\"h-time small\">2021-06-08 09:01</span>\n</p>\n</h4>\n</header>\n<article>\n<p><h2>What happened?</h2>On June 7, Biogen Inc.<a href=\"https://laohu8.com/S/BIIB\">$(BIIB) $</a>Its Alzheimer's drug was approved for marketing. This is the first such drug approved by the US Food and Drug Administration since 2003. However, there is still a lot of controversy surrounding the drug.</p><p><b>The generic name of this drug is aducanumab and will be sold under the trade name Aduhelm. Bojian charges $56,000 a year for this drug and promises not to raise the price for at least four years.</b></p><p>According to reports, the drug has the ability to clear amyloid plaques in the brain and is believed to slow down disease progression in patients with early symptoms. For a long time, the excessive accumulation of amyloid protein has been regarded as one of the chief culprits of Alzheimer's disease, which disrupts the communication between brain cells, leading to cognitive function problems.</p><p><b>However, at present, the effect, efficiency and side effects of this drug treatment have not been verified, and the feedback from doctors and researchers is full of differences, both optimistic and critical.</b></p><p>Bojian suspended trading for nearly 3 hours on Monday morning. After that, when it resumed trading, it was driven by the news of Aduhelm's approval. It broke through the two barriers of $300 and $400 in succession. The intraday increase once reached more than 60%, and then it retreated. As of the close, Bojian rose 38.34% to $395.85. The market expects that the approval of the latest drug will generate billions of dollars in revenue for the company.</p><p>The biomedical sector of the U.S. stock market also rose due to the positive impact. The Nasdaq Biotechnology Index rose by more than 5% after the news was announced.</p><p><img src=\"https://static.tigerbbs.com/1f6fdbfe3f9a0412cd40fd0ea058e36e\" tg-width=\"743\" tg-height=\"443\" referrerpolicy=\"no-referrer\"></p><p><h2>Why is it important?</h2>Alzheimer's disease (AD) is the third leading cause of death among the elderly worldwide, second only to cardiovascular and cerebrovascular diseases and cancer.</p><p>According to estimates by the World Health Organization, there are currently about 35 million to 50 million Alzheimer's patients worldwide, and 10 million new patients are expected to be added every year. Some institutions predict that by 2050, the number of Alzheimer's patients worldwide will reach 150 million.</p><p>The pathogenesis of Alzheimer's disease has not been thoroughly studied, and there is currently no way to treat the disease or reverse the process of brain disease, although some therapies can partially relieve some symptoms.</p><p><b>Therefore, as the first approved drug in 18 years, Aduhelm is expected to bring a glimmer of hope to Alzheimer's patients and their families.</b></p><p>\"Alzheimer's is one of the most incredible diseases we know,\" Charbel Moussa, associate professor of neurology and director of the Dementia and Parkinson's Laboratory at Georgetown University, told MarketWatch.</p><p>Moussa said research on the disease must be divided in order to dig deeper into how the brain works, why chemicals don't spread correctly, the impact on activities of daily living (such as bathing and dressing), and the quality of life of patients and their caregivers. He said: \"Now Aduhelm's approval is to open<a href=\"https://laohu8.com/S/0NQC.UK\">Pandora</a>The box. \"</p><p><b>There are also views that the launch of this drug will change the current treatment of Alzheimer's disease, at least for some patients, and FDA approval may pave the way for future treatments.</b></p><p>Erik Musiek, a neurologist at Washington University in St. Louis, told Bloomberg in an interview that if the FDA is willing to accept the reduction in amyloid as sufficient evidence for approval, it could open the door to other drugs, \"if all you need is plaque cleanup, that's definitely another situation.\"</p><p>Harry Johns, CEO of the American Alzheimer's Association, said, \"This is just a new day for Alzheimer's patients, and we believe it will drive more innovation and investment.\"</p><p><h2>Why is the disagreement huge?</h2>At present, there is still huge controversy and uncertainty surrounding Aduhelm. There is still a long way to go before this drug can truly benefit patients.</p><p>Despite being approved by the FDA for marketing, there is still much unknown about this treatment, and there is currently no conclusive evidence that the drug slows down the decline of memory and brain function.<b>And it's an intravenous drug that must be used in the doctor's office, and can have side effects such as brain swelling and bleeding.</b></p><p>According to Bloomberg, in a large trial conducted by Biogen, the drug was generally ineffective. In another similar study, high doses of the drug reduced the rate of disease progression by only 22% over 18 months.</p><p>Some clinicians are also skeptical about this drug. According to CNBC, some doctors said that due to the mixed clinical data supporting Aduhelm, they would not prescribe the drug in their prescriptions if the drug was actually marketed.</p><p>While this is an optimistic moment, FDA approval is just one of many hurdles pharmaceutical companies face when developing drugs, and \"approval is not meant to work,\" American physician John DenBoer told MarketWatch in an interview. DenBoer is the CEO of Smart Brain Aging and the producer of the film This is Dementia.</p><p>Many well-known \"anti-Alzheimer's\" drugs have failed. DenBoer warns that this therapy will not cure or partially reverse Alzheimer's at any stage-goals that are unrealistic, at least for researchers currently fighting Alzheimer's:</p><p>At present, the best drugs we use are only 5% effective at most, and only in the early stages of the disease. If you can reduce the intensity of this disease by 10% at an early stage, it will have a real impact on many people and change their lives, which I think is a very admirable goal. However, it should be noted that the FDA's approval of Aduhelm this time is not completely unconditional, but requires \"Phase IV\" clinical research. In this regard, the FDA stated in a press release that the data from two phase III clinical trials in the materials submitted by Bojian are very complex, and there are still uncertainties.</p><p><b>According to the FDA, the agency and pharmaceutical companies may pull the drug off the market \"if confirmatory trials do not confirm the anticipated clinical benefits of the drug.\" But while confirmatory trials are ongoing, Bojian can still sell Aduhelm.</b></p>\n<div class=\"bt-text\">\n\n\n<p> source：<a href=\"https://wallstreetcn.com/articles/3632396\">华尔街见闻</a></p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"https://static.tigerbbs.com/df4ec61541b268a5353585001973d7cb","relate_stocks":{},"source_url":"https://wallstreetcn.com/articles/3632396","is_english":false,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2141259936","content_text":"发生了什么？6月7日，美国渤健公司(Biogen Inc.)$(BIIB)$旗下的阿尔茨海默症药物获批上市，这是2003年来首款获美国食品和药物管理局批准的此类药物，然而目前围绕该药物的争议依然很大。这款药物的通用名为aducanumab，将以Aduhelm的商品名进行销售。渤健每年对这种药物的收费为5.6万美元，并且承诺至少四年内不涨价。据介绍，该药物具有清除大脑淀粉样蛋白斑块的能力，被认为可以减缓早期症状患者的疾病进展。长期以来，淀粉样蛋白的过度积累被视为引发阿尔茨海默症的罪魁祸首之一，它破坏了脑细胞之间的交流，从而导致认知功能问题。然而，目前这款药物治疗的效果，有效率和副作用，仍然未被验证，来自医生和研究人员的反馈也充满了分歧，既有乐观的，也有持批判态度的。渤健周一早间曾停牌近3小时，之后复牌时受到Aduhelm获批消息的利好带动，连续突破了300美元和400美元两道关口，日内涨幅曾一度达到60%以上，而在之后则出现回吐。截至收盘，渤健上涨38.34%，报395.85美元。市场预计，最新药物的批准将为公司带来数十亿美元的收入。而美股生物医药板块也受到利好影响出现拉升，纳斯达克生物科技指数在消息公布之后曾涨逾5%。为什么重要？阿尔茨海默症(AD)是导致全球老年人死亡的第三大原因，仅次于心脑血管疾病和癌症。据世界卫生组织估计，目前全球约有3500万至5000万阿尔茨海默症患者，并且每年预计将有1000万新增患者。有机构预测，到2050年，全球阿尔茨海默症患者数量将达到1.5亿。阿尔茨海默症发病机制至今仍未被研究透彻，且目前还没有治疗该病症或逆转大脑疾病进程的方法，尽管一些疗法可以部分缓解一些症状。因此，作为18年来首款获批的药物，Aduhelm有望给阿尔茨海默症患者和他们的家人带来一丝希望。乔治敦大学(Georgetown University)神经学副教授、痴呆症和帕金森病实验室主任Charbel Moussa对MarketWatch表示：“阿尔茨海默症是我们所知道的最难以置信的疾病之一。”Moussa称对这种疾病的研究必须进行划分，以便更深入地挖掘大脑是如何运作的，为什么化学物质不能正确地传播，对日常生活活动(如洗澡和穿衣服)的影响，以及病人及其照顾者的生活质量。他说：“现在Aduhelm的批准就是打开潘多拉的盒子。”也有观点认为，这款药物的上市将改变阿尔茨海默症目前的治疗方式，至少对一些患者来说是这样，FDA的批准可能会为未来的治疗铺平道路。圣路易斯华盛顿大学(Washington University in St. Louis)的神经学家Erik Musiek在接受彭博采访中表示，如果FDA愿意接受淀粉样蛋白的减少作为批准的充分证据，这可能为其他药物打开大门，“如果你所需要的只是清理斑块，那肯定是另一种情况。”美国阿尔茨海默症协会首席执行官Harry Johns表示，“对于阿尔茨海默症患者来说，这只是新的一天，我们相信这将推动更多的创新和投资。”为什么分歧巨大？目前，围绕Aduhelm还存在着巨大的争议和不确定性，这款药物要使患者真正获益，还有很长的路要走。尽管获得FDA批准上市，但关于这种治疗方法仍有许多未知之处，目前并没有确凿的证据表明该药物减缓了记忆和大脑功能的衰退。而且这是一种必须在医生办公室使用的静脉注射药物，并可能出现脑肿胀和出血等副作用。据彭博，在渤健公司进行的一项大型试验中，该药物总体上是无效的。在另一项类似的研究中，高剂量的药物在18个月内将疾病的发展速度仅降低了22%。而部分临床医生对此药物同样抱有怀疑态度。据CNBC，部分医生表示，由于支撑Aduhelm的临床数据喜忧参半，如果该药品真的上市，他们不会在处方中开出此药。美国医生John DenBoer在接受MarketWatch采访中表示，尽管这是一个乐观的时刻，但FDA的批准只是制药公司在开发药物时面临的众多障碍之一，而且“批准并不意味着有效”。DenBoer是Smart Brain Aging公司的首席执行官，也是电影《这是痴呆症》(This is Dementia)的制片人。许多众所周知的“抗阿尔茨海默症”药物都失败了。DenBoer警告说，这种疗法在任何阶段都不能治愈或部分逆转阿尔茨海默氏症——这些目标都是不切实际的，至少对于目前正在对抗阿尔茨海默氏症的研究人员来说是如此：目前我们所使用的最好的药物最多只有5%的疗效，而且仅在疾病的早期阶段。如果你能在早期将这种疾病的强度降低10%，这将对许多人产生真正的影响，并改变他们的生活，我认为这是一个非常令人钦佩的目标。不过需要注意的是，FDA本次批准Aduhelm并非完全无条件，而是需要进行“第四阶段”临床研究。对此，FDA在新闻稿当中表示，渤健提交的材料中来自于两项三期临床试验的数据非常复杂，而且仍有不确定性残留。根据FDA的说法，“如果验证性试验不能证实该药物预期的临床效益”，该机构和制药公司可能会将该药物撤出市场。但是在验证性试验进行期间，渤健仍然可以出售Aduhelm。","news_type":1,"symbols_score_info":{}},"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"comments":[{"id":4635176,"gmtCreate":1623161916330,"gmtModify":1663228208831,"authorId":3574148235876178,"author":{"id":3574148235876178,"idStr":"3574148235876178","authorId":3574148235876178,"name":"小甘多多","avatar":"https://static.tigerbbs.com/34276edc2e67103fc93cfbaf5264eac6","vip":1,"crmLevel":11,"crmLevelSwitch":0,"individualDisplayBadges":[]},"repliedAuthorId":0,"objectId":117292166,"type":1,"supId":0,"prevId":0,"content":"[微笑]","text":"[微笑]","html":"[微笑]"}],"langContent":"CN"},{"id":117189874,"gmtCreate":1623122463398,"gmtModify":1704196545711,"author":{"id":"3585356839802810","authorId":"3585356839802810","name":"yonglee7","avatar":"https://static.tigerbbs.com/8accecec1ddca2ff5d0b1ba4e54edbca","vip":1,"crmLevel":11,"crmLevelSwitch":0,"idStr":"3585356839802810","authorIdStr":"3585356839802810"},"htmlText":"[財迷]&nbsp;[財迷]&nbsp;[財迷]&nbsp;","listText":"[財迷]&nbsp;[財迷]&nbsp;[財迷]&nbsp;","text":"[財迷] [財迷] [財迷]","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/117189874","repostId":2141259936,"repostType":4,"repost":{"id":"2141259936","kind":"highlight","pubTimestamp":1623114070,"share":"https://ttm.financial/m/news/2141259936?lang=en_US&edition=fundamental","pubTime":"2021-06-08 09:01","market":"us","language":"zh","title":"The first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?","url":"https://stock-news.laohu8.com/highlight/detail?id=2141259936","media":"华尔街见闻","summary":"受到Aduhelm获批消息利好带动，美国渤健公司隔夜一度暴涨60%。但目前Aduhelm对阿尔茨海默症治疗的效果，有效率和副作用，仍然未被验证，来自医生和研究人员的反馈也充满了分歧。","content":"<p><h2>What happened?</h2>On June 7, Biogen Inc.<a href=\"https://laohu8.com/S/BIIB\">$(BIIB) $</a>Its Alzheimer's drug was approved for marketing. This is the first such drug approved by the US Food and Drug Administration since 2003. However, there is still a lot of controversy surrounding the drug.</p><p><b>The generic name of this drug is aducanumab and will be sold under the trade name Aduhelm. Bojian charges $56,000 a year for this drug and promises not to raise the price for at least four years.</b></p><p>According to reports, the drug has the ability to clear amyloid plaques in the brain and is believed to slow down disease progression in patients with early symptoms. For a long time, the excessive accumulation of amyloid protein has been regarded as one of the chief culprits of Alzheimer's disease, which disrupts the communication between brain cells, leading to cognitive function problems.</p><p><b>However, at present, the effect, efficiency and side effects of this drug treatment have not been verified, and the feedback from doctors and researchers is full of differences, both optimistic and critical.</b></p><p>Bojian suspended trading for nearly 3 hours on Monday morning. After that, when it resumed trading, it was driven by the news of Aduhelm's approval. It broke through the two barriers of $300 and $400 in succession. The intraday increase once reached more than 60%, and then it retreated. As of the close, Bojian rose 38.34% to $395.85. The market expects that the approval of the latest drug will generate billions of dollars in revenue for the company.</p><p>The biomedical sector of the U.S. stock market also rose due to the positive impact. The Nasdaq Biotechnology Index rose by more than 5% after the news was announced.</p><p><img src=\"https://static.tigerbbs.com/1f6fdbfe3f9a0412cd40fd0ea058e36e\" tg-width=\"743\" tg-height=\"443\" referrerpolicy=\"no-referrer\"></p><p><h2>Why is it important?</h2>Alzheimer's disease (AD) is the third leading cause of death among the elderly worldwide, second only to cardiovascular and cerebrovascular diseases and cancer.</p><p>According to estimates by the World Health Organization, there are currently about 35 million to 50 million Alzheimer's patients worldwide, and 10 million new patients are expected to be added every year. Some institutions predict that by 2050, the number of Alzheimer's patients worldwide will reach 150 million.</p><p>The pathogenesis of Alzheimer's disease has not been thoroughly studied, and there is currently no way to treat the disease or reverse the process of brain disease, although some therapies can partially relieve some symptoms.</p><p><b>Therefore, as the first approved drug in 18 years, Aduhelm is expected to bring a glimmer of hope to Alzheimer's patients and their families.</b></p><p>\"Alzheimer's is one of the most incredible diseases we know,\" Charbel Moussa, associate professor of neurology and director of the Dementia and Parkinson's Laboratory at Georgetown University, told MarketWatch.</p><p>Moussa said research on the disease must be divided in order to dig deeper into how the brain works, why chemicals don't spread correctly, the impact on activities of daily living (such as bathing and dressing), and the quality of life of patients and their caregivers. He said: \"Now Aduhelm's approval is to open<a href=\"https://laohu8.com/S/0NQC.UK\">Pandora</a>The box. \"</p><p><b>There are also views that the launch of this drug will change the current treatment of Alzheimer's disease, at least for some patients, and FDA approval may pave the way for future treatments.</b></p><p>Erik Musiek, a neurologist at Washington University in St. Louis, told Bloomberg in an interview that if the FDA is willing to accept the reduction in amyloid as sufficient evidence for approval, it could open the door to other drugs, \"if all you need is plaque cleanup, that's definitely another situation.\"</p><p>Harry Johns, CEO of the American Alzheimer's Association, said, \"This is just a new day for Alzheimer's patients, and we believe it will drive more innovation and investment.\"</p><p><h2>Why is the disagreement huge?</h2>At present, there is still huge controversy and uncertainty surrounding Aduhelm. There is still a long way to go before this drug can truly benefit patients.</p><p>Despite being approved by the FDA for marketing, there is still much unknown about this treatment, and there is currently no conclusive evidence that the drug slows down the decline of memory and brain function.<b>And it's an intravenous drug that must be used in the doctor's office, and can have side effects such as brain swelling and bleeding.</b></p><p>According to Bloomberg, in a large trial conducted by Biogen, the drug was generally ineffective. In another similar study, high doses of the drug reduced the rate of disease progression by only 22% over 18 months.</p><p>Some clinicians are also skeptical about this drug. According to CNBC, some doctors said that due to the mixed clinical data supporting Aduhelm, they would not prescribe the drug in their prescriptions if the drug was actually marketed.</p><p>While this is an optimistic moment, FDA approval is just one of many hurdles pharmaceutical companies face when developing drugs, and \"approval is not meant to work,\" American physician John DenBoer told MarketWatch in an interview. DenBoer is the CEO of Smart Brain Aging and the producer of the film This is Dementia.</p><p>Many well-known \"anti-Alzheimer's\" drugs have failed. DenBoer warns that this therapy will not cure or partially reverse Alzheimer's at any stage-goals that are unrealistic, at least for researchers currently fighting Alzheimer's:</p><p>At present, the best drugs we use are only 5% effective at most, and only in the early stages of the disease. If you can reduce the intensity of this disease by 10% at an early stage, it will have a real impact on many people and change their lives, which I think is a very admirable goal. However, it should be noted that the FDA's approval of Aduhelm this time is not completely unconditional, but requires \"Phase IV\" clinical research. In this regard, the FDA stated in a press release that the data from two phase III clinical trials in the materials submitted by Bojian are very complex, and there are still uncertainties.</p><p><b>According to the FDA, the agency and pharmaceutical companies may pull the drug off the market \"if confirmatory trials do not confirm the anticipated clinical benefits of the drug.\" But while confirmatory trials are ongoing, Bojian can still sell Aduhelm.</b></p>","source":"wallstreetcn_api","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>The first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nThe first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">华尔街见闻</strong><span class=\"h-time small\">2021-06-08 09:01</span>\n</p>\n</h4>\n</header>\n<article>\n<p><h2>What happened?</h2>On June 7, Biogen Inc.<a href=\"https://laohu8.com/S/BIIB\">$(BIIB) $</a>Its Alzheimer's drug was approved for marketing. This is the first such drug approved by the US Food and Drug Administration since 2003. However, there is still a lot of controversy surrounding the drug.</p><p><b>The generic name of this drug is aducanumab and will be sold under the trade name Aduhelm. Bojian charges $56,000 a year for this drug and promises not to raise the price for at least four years.</b></p><p>According to reports, the drug has the ability to clear amyloid plaques in the brain and is believed to slow down disease progression in patients with early symptoms. For a long time, the excessive accumulation of amyloid protein has been regarded as one of the chief culprits of Alzheimer's disease, which disrupts the communication between brain cells, leading to cognitive function problems.</p><p><b>However, at present, the effect, efficiency and side effects of this drug treatment have not been verified, and the feedback from doctors and researchers is full of differences, both optimistic and critical.</b></p><p>Bojian suspended trading for nearly 3 hours on Monday morning. After that, when it resumed trading, it was driven by the news of Aduhelm's approval. It broke through the two barriers of $300 and $400 in succession. The intraday increase once reached more than 60%, and then it retreated. As of the close, Bojian rose 38.34% to $395.85. The market expects that the approval of the latest drug will generate billions of dollars in revenue for the company.</p><p>The biomedical sector of the U.S. stock market also rose due to the positive impact. The Nasdaq Biotechnology Index rose by more than 5% after the news was announced.</p><p><img src=\"https://static.tigerbbs.com/1f6fdbfe3f9a0412cd40fd0ea058e36e\" tg-width=\"743\" tg-height=\"443\" referrerpolicy=\"no-referrer\"></p><p><h2>Why is it important?</h2>Alzheimer's disease (AD) is the third leading cause of death among the elderly worldwide, second only to cardiovascular and cerebrovascular diseases and cancer.</p><p>According to estimates by the World Health Organization, there are currently about 35 million to 50 million Alzheimer's patients worldwide, and 10 million new patients are expected to be added every year. Some institutions predict that by 2050, the number of Alzheimer's patients worldwide will reach 150 million.</p><p>The pathogenesis of Alzheimer's disease has not been thoroughly studied, and there is currently no way to treat the disease or reverse the process of brain disease, although some therapies can partially relieve some symptoms.</p><p><b>Therefore, as the first approved drug in 18 years, Aduhelm is expected to bring a glimmer of hope to Alzheimer's patients and their families.</b></p><p>\"Alzheimer's is one of the most incredible diseases we know,\" Charbel Moussa, associate professor of neurology and director of the Dementia and Parkinson's Laboratory at Georgetown University, told MarketWatch.</p><p>Moussa said research on the disease must be divided in order to dig deeper into how the brain works, why chemicals don't spread correctly, the impact on activities of daily living (such as bathing and dressing), and the quality of life of patients and their caregivers. He said: \"Now Aduhelm's approval is to open<a href=\"https://laohu8.com/S/0NQC.UK\">Pandora</a>The box. \"</p><p><b>There are also views that the launch of this drug will change the current treatment of Alzheimer's disease, at least for some patients, and FDA approval may pave the way for future treatments.</b></p><p>Erik Musiek, a neurologist at Washington University in St. Louis, told Bloomberg in an interview that if the FDA is willing to accept the reduction in amyloid as sufficient evidence for approval, it could open the door to other drugs, \"if all you need is plaque cleanup, that's definitely another situation.\"</p><p>Harry Johns, CEO of the American Alzheimer's Association, said, \"This is just a new day for Alzheimer's patients, and we believe it will drive more innovation and investment.\"</p><p><h2>Why is the disagreement huge?</h2>At present, there is still huge controversy and uncertainty surrounding Aduhelm. There is still a long way to go before this drug can truly benefit patients.</p><p>Despite being approved by the FDA for marketing, there is still much unknown about this treatment, and there is currently no conclusive evidence that the drug slows down the decline of memory and brain function.<b>And it's an intravenous drug that must be used in the doctor's office, and can have side effects such as brain swelling and bleeding.</b></p><p>According to Bloomberg, in a large trial conducted by Biogen, the drug was generally ineffective. In another similar study, high doses of the drug reduced the rate of disease progression by only 22% over 18 months.</p><p>Some clinicians are also skeptical about this drug. According to CNBC, some doctors said that due to the mixed clinical data supporting Aduhelm, they would not prescribe the drug in their prescriptions if the drug was actually marketed.</p><p>While this is an optimistic moment, FDA approval is just one of many hurdles pharmaceutical companies face when developing drugs, and \"approval is not meant to work,\" American physician John DenBoer told MarketWatch in an interview. DenBoer is the CEO of Smart Brain Aging and the producer of the film This is Dementia.</p><p>Many well-known \"anti-Alzheimer's\" drugs have failed. DenBoer warns that this therapy will not cure or partially reverse Alzheimer's at any stage-goals that are unrealistic, at least for researchers currently fighting Alzheimer's:</p><p>At present, the best drugs we use are only 5% effective at most, and only in the early stages of the disease. If you can reduce the intensity of this disease by 10% at an early stage, it will have a real impact on many people and change their lives, which I think is a very admirable goal. However, it should be noted that the FDA's approval of Aduhelm this time is not completely unconditional, but requires \"Phase IV\" clinical research. In this regard, the FDA stated in a press release that the data from two phase III clinical trials in the materials submitted by Bojian are very complex, and there are still uncertainties.</p><p><b>According to the FDA, the agency and pharmaceutical companies may pull the drug off the market \"if confirmatory trials do not confirm the anticipated clinical benefits of the drug.\" But while confirmatory trials are ongoing, Bojian can still sell Aduhelm.</b></p>\n<div class=\"bt-text\">\n\n\n<p> source：<a href=\"https://wallstreetcn.com/articles/3632396\">华尔街见闻</a></p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"https://static.tigerbbs.com/df4ec61541b268a5353585001973d7cb","relate_stocks":{},"source_url":"https://wallstreetcn.com/articles/3632396","is_english":false,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2141259936","content_text":"发生了什么？6月7日，美国渤健公司(Biogen Inc.)$(BIIB)$旗下的阿尔茨海默症药物获批上市，这是2003年来首款获美国食品和药物管理局批准的此类药物，然而目前围绕该药物的争议依然很大。这款药物的通用名为aducanumab，将以Aduhelm的商品名进行销售。渤健每年对这种药物的收费为5.6万美元，并且承诺至少四年内不涨价。据介绍，该药物具有清除大脑淀粉样蛋白斑块的能力，被认为可以减缓早期症状患者的疾病进展。长期以来，淀粉样蛋白的过度积累被视为引发阿尔茨海默症的罪魁祸首之一，它破坏了脑细胞之间的交流，从而导致认知功能问题。然而，目前这款药物治疗的效果，有效率和副作用，仍然未被验证，来自医生和研究人员的反馈也充满了分歧，既有乐观的，也有持批判态度的。渤健周一早间曾停牌近3小时，之后复牌时受到Aduhelm获批消息的利好带动，连续突破了300美元和400美元两道关口，日内涨幅曾一度达到60%以上，而在之后则出现回吐。截至收盘，渤健上涨38.34%，报395.85美元。市场预计，最新药物的批准将为公司带来数十亿美元的收入。而美股生物医药板块也受到利好影响出现拉升，纳斯达克生物科技指数在消息公布之后曾涨逾5%。为什么重要？阿尔茨海默症(AD)是导致全球老年人死亡的第三大原因，仅次于心脑血管疾病和癌症。据世界卫生组织估计，目前全球约有3500万至5000万阿尔茨海默症患者，并且每年预计将有1000万新增患者。有机构预测，到2050年，全球阿尔茨海默症患者数量将达到1.5亿。阿尔茨海默症发病机制至今仍未被研究透彻，且目前还没有治疗该病症或逆转大脑疾病进程的方法，尽管一些疗法可以部分缓解一些症状。因此，作为18年来首款获批的药物，Aduhelm有望给阿尔茨海默症患者和他们的家人带来一丝希望。乔治敦大学(Georgetown University)神经学副教授、痴呆症和帕金森病实验室主任Charbel Moussa对MarketWatch表示：“阿尔茨海默症是我们所知道的最难以置信的疾病之一。”Moussa称对这种疾病的研究必须进行划分，以便更深入地挖掘大脑是如何运作的，为什么化学物质不能正确地传播，对日常生活活动(如洗澡和穿衣服)的影响，以及病人及其照顾者的生活质量。他说：“现在Aduhelm的批准就是打开潘多拉的盒子。”也有观点认为，这款药物的上市将改变阿尔茨海默症目前的治疗方式，至少对一些患者来说是这样，FDA的批准可能会为未来的治疗铺平道路。圣路易斯华盛顿大学(Washington University in St. Louis)的神经学家Erik Musiek在接受彭博采访中表示，如果FDA愿意接受淀粉样蛋白的减少作为批准的充分证据，这可能为其他药物打开大门，“如果你所需要的只是清理斑块，那肯定是另一种情况。”美国阿尔茨海默症协会首席执行官Harry Johns表示，“对于阿尔茨海默症患者来说，这只是新的一天，我们相信这将推动更多的创新和投资。”为什么分歧巨大？目前，围绕Aduhelm还存在着巨大的争议和不确定性，这款药物要使患者真正获益，还有很长的路要走。尽管获得FDA批准上市，但关于这种治疗方法仍有许多未知之处，目前并没有确凿的证据表明该药物减缓了记忆和大脑功能的衰退。而且这是一种必须在医生办公室使用的静脉注射药物，并可能出现脑肿胀和出血等副作用。据彭博，在渤健公司进行的一项大型试验中，该药物总体上是无效的。在另一项类似的研究中，高剂量的药物在18个月内将疾病的发展速度仅降低了22%。而部分临床医生对此药物同样抱有怀疑态度。据CNBC，部分医生表示，由于支撑Aduhelm的临床数据喜忧参半，如果该药品真的上市，他们不会在处方中开出此药。美国医生John DenBoer在接受MarketWatch采访中表示，尽管这是一个乐观的时刻，但FDA的批准只是制药公司在开发药物时面临的众多障碍之一，而且“批准并不意味着有效”。DenBoer是Smart Brain Aging公司的首席执行官，也是电影《这是痴呆症》(This is Dementia)的制片人。许多众所周知的“抗阿尔茨海默症”药物都失败了。DenBoer警告说，这种疗法在任何阶段都不能治愈或部分逆转阿尔茨海默氏症——这些目标都是不切实际的，至少对于目前正在对抗阿尔茨海默氏症的研究人员来说是如此：目前我们所使用的最好的药物最多只有5%的疗效，而且仅在疾病的早期阶段。如果你能在早期将这种疾病的强度降低10%，这将对许多人产生真正的影响，并改变他们的生活，我认为这是一个非常令人钦佩的目标。不过需要注意的是，FDA本次批准Aduhelm并非完全无条件，而是需要进行“第四阶段”临床研究。对此，FDA在新闻稿当中表示，渤健提交的材料中来自于两项三期临床试验的数据非常复杂，而且仍有不确定性残留。根据FDA的说法，“如果验证性试验不能证实该药物预期的临床效益”，该机构和制药公司可能会将该药物撤出市场。但是在验证性试验进行期间，渤健仍然可以出售Aduhelm。","news_type":1,"symbols_score_info":{}},"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"CN"},{"id":117180526,"gmtCreate":1623122430365,"gmtModify":1704196548776,"author":{"id":"3581155580868820","authorId":"3581155580868820","name":"风雪腊梅","avatar":"https://static.tigerbbs.com/6098bb5390cb75567a6e67bf6a793e29","vip":1,"crmLevel":1,"crmLevelSwitch":0,"idStr":"3581155580868820","authorIdStr":"3581155580868820"},"htmlText":"[開心]&nbsp;[開心]&nbsp;[開心]&nbsp;","listText":"[開心]&nbsp;[開心]&nbsp;[開心]&nbsp;","text":"[開心] [開心] [開心]","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/117180526","repostId":2141259936,"repostType":4,"repost":{"id":"2141259936","kind":"highlight","pubTimestamp":1623114070,"share":"https://ttm.financial/m/news/2141259936?lang=en_US&edition=fundamental","pubTime":"2021-06-08 09:01","market":"us","language":"zh","title":"The first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?","url":"https://stock-news.laohu8.com/highlight/detail?id=2141259936","media":"华尔街见闻","summary":"受到Aduhelm获批消息利好带动，美国渤健公司隔夜一度暴涨60%。但目前Aduhelm对阿尔茨海默症治疗的效果，有效率和副作用，仍然未被验证，来自医生和研究人员的反馈也充满了分歧。","content":"<p><h2>What happened?</h2>On June 7, Biogen Inc.<a href=\"https://laohu8.com/S/BIIB\">$(BIIB) $</a>Its Alzheimer's drug was approved for marketing. This is the first such drug approved by the US Food and Drug Administration since 2003. However, there is still a lot of controversy surrounding the drug.</p><p><b>The generic name of this drug is aducanumab and will be sold under the trade name Aduhelm. Bojian charges $56,000 a year for this drug and promises not to raise the price for at least four years.</b></p><p>According to reports, the drug has the ability to clear amyloid plaques in the brain and is believed to slow down disease progression in patients with early symptoms. For a long time, the excessive accumulation of amyloid protein has been regarded as one of the chief culprits of Alzheimer's disease, which disrupts the communication between brain cells, leading to cognitive function problems.</p><p><b>However, at present, the effect, efficiency and side effects of this drug treatment have not been verified, and the feedback from doctors and researchers is full of differences, both optimistic and critical.</b></p><p>Bojian suspended trading for nearly 3 hours on Monday morning. After that, when it resumed trading, it was driven by the news of Aduhelm's approval. It broke through the two barriers of $300 and $400 in succession. The intraday increase once reached more than 60%, and then it retreated. As of the close, Bojian rose 38.34% to $395.85. The market expects that the approval of the latest drug will generate billions of dollars in revenue for the company.</p><p>The biomedical sector of the U.S. stock market also rose due to the positive impact. The Nasdaq Biotechnology Index rose by more than 5% after the news was announced.</p><p><img src=\"https://static.tigerbbs.com/1f6fdbfe3f9a0412cd40fd0ea058e36e\" tg-width=\"743\" tg-height=\"443\" referrerpolicy=\"no-referrer\"></p><p><h2>Why is it important?</h2>Alzheimer's disease (AD) is the third leading cause of death among the elderly worldwide, second only to cardiovascular and cerebrovascular diseases and cancer.</p><p>According to estimates by the World Health Organization, there are currently about 35 million to 50 million Alzheimer's patients worldwide, and 10 million new patients are expected to be added every year. Some institutions predict that by 2050, the number of Alzheimer's patients worldwide will reach 150 million.</p><p>The pathogenesis of Alzheimer's disease has not been thoroughly studied, and there is currently no way to treat the disease or reverse the process of brain disease, although some therapies can partially relieve some symptoms.</p><p><b>Therefore, as the first approved drug in 18 years, Aduhelm is expected to bring a glimmer of hope to Alzheimer's patients and their families.</b></p><p>\"Alzheimer's is one of the most incredible diseases we know,\" Charbel Moussa, associate professor of neurology and director of the Dementia and Parkinson's Laboratory at Georgetown University, told MarketWatch.</p><p>Moussa said research on the disease must be divided in order to dig deeper into how the brain works, why chemicals don't spread correctly, the impact on activities of daily living (such as bathing and dressing), and the quality of life of patients and their caregivers. He said: \"Now Aduhelm's approval is to open<a href=\"https://laohu8.com/S/0NQC.UK\">Pandora</a>The box. \"</p><p><b>There are also views that the launch of this drug will change the current treatment of Alzheimer's disease, at least for some patients, and FDA approval may pave the way for future treatments.</b></p><p>Erik Musiek, a neurologist at Washington University in St. Louis, told Bloomberg in an interview that if the FDA is willing to accept the reduction in amyloid as sufficient evidence for approval, it could open the door to other drugs, \"if all you need is plaque cleanup, that's definitely another situation.\"</p><p>Harry Johns, CEO of the American Alzheimer's Association, said, \"This is just a new day for Alzheimer's patients, and we believe it will drive more innovation and investment.\"</p><p><h2>Why is the disagreement huge?</h2>At present, there is still huge controversy and uncertainty surrounding Aduhelm. There is still a long way to go before this drug can truly benefit patients.</p><p>Despite being approved by the FDA for marketing, there is still much unknown about this treatment, and there is currently no conclusive evidence that the drug slows down the decline of memory and brain function.<b>And it's an intravenous drug that must be used in the doctor's office, and can have side effects such as brain swelling and bleeding.</b></p><p>According to Bloomberg, in a large trial conducted by Biogen, the drug was generally ineffective. In another similar study, high doses of the drug reduced the rate of disease progression by only 22% over 18 months.</p><p>Some clinicians are also skeptical about this drug. According to CNBC, some doctors said that due to the mixed clinical data supporting Aduhelm, they would not prescribe the drug in their prescriptions if the drug was actually marketed.</p><p>While this is an optimistic moment, FDA approval is just one of many hurdles pharmaceutical companies face when developing drugs, and \"approval is not meant to work,\" American physician John DenBoer told MarketWatch in an interview. DenBoer is the CEO of Smart Brain Aging and the producer of the film This is Dementia.</p><p>Many well-known \"anti-Alzheimer's\" drugs have failed. DenBoer warns that this therapy will not cure or partially reverse Alzheimer's at any stage-goals that are unrealistic, at least for researchers currently fighting Alzheimer's:</p><p>At present, the best drugs we use are only 5% effective at most, and only in the early stages of the disease. If you can reduce the intensity of this disease by 10% at an early stage, it will have a real impact on many people and change their lives, which I think is a very admirable goal. However, it should be noted that the FDA's approval of Aduhelm this time is not completely unconditional, but requires \"Phase IV\" clinical research. In this regard, the FDA stated in a press release that the data from two phase III clinical trials in the materials submitted by Bojian are very complex, and there are still uncertainties.</p><p><b>According to the FDA, the agency and pharmaceutical companies may pull the drug off the market \"if confirmatory trials do not confirm the anticipated clinical benefits of the drug.\" But while confirmatory trials are ongoing, Bojian can still sell Aduhelm.</b></p>","source":"wallstreetcn_api","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>The first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nThe first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">华尔街见闻</strong><span class=\"h-time small\">2021-06-08 09:01</span>\n</p>\n</h4>\n</header>\n<article>\n<p><h2>What happened?</h2>On June 7, Biogen Inc.<a href=\"https://laohu8.com/S/BIIB\">$(BIIB) $</a>Its Alzheimer's drug was approved for marketing. This is the first such drug approved by the US Food and Drug Administration since 2003. However, there is still a lot of controversy surrounding the drug.</p><p><b>The generic name of this drug is aducanumab and will be sold under the trade name Aduhelm. Bojian charges $56,000 a year for this drug and promises not to raise the price for at least four years.</b></p><p>According to reports, the drug has the ability to clear amyloid plaques in the brain and is believed to slow down disease progression in patients with early symptoms. For a long time, the excessive accumulation of amyloid protein has been regarded as one of the chief culprits of Alzheimer's disease, which disrupts the communication between brain cells, leading to cognitive function problems.</p><p><b>However, at present, the effect, efficiency and side effects of this drug treatment have not been verified, and the feedback from doctors and researchers is full of differences, both optimistic and critical.</b></p><p>Bojian suspended trading for nearly 3 hours on Monday morning. After that, when it resumed trading, it was driven by the news of Aduhelm's approval. It broke through the two barriers of $300 and $400 in succession. The intraday increase once reached more than 60%, and then it retreated. As of the close, Bojian rose 38.34% to $395.85. The market expects that the approval of the latest drug will generate billions of dollars in revenue for the company.</p><p>The biomedical sector of the U.S. stock market also rose due to the positive impact. The Nasdaq Biotechnology Index rose by more than 5% after the news was announced.</p><p><img src=\"https://static.tigerbbs.com/1f6fdbfe3f9a0412cd40fd0ea058e36e\" tg-width=\"743\" tg-height=\"443\" referrerpolicy=\"no-referrer\"></p><p><h2>Why is it important?</h2>Alzheimer's disease (AD) is the third leading cause of death among the elderly worldwide, second only to cardiovascular and cerebrovascular diseases and cancer.</p><p>According to estimates by the World Health Organization, there are currently about 35 million to 50 million Alzheimer's patients worldwide, and 10 million new patients are expected to be added every year. Some institutions predict that by 2050, the number of Alzheimer's patients worldwide will reach 150 million.</p><p>The pathogenesis of Alzheimer's disease has not been thoroughly studied, and there is currently no way to treat the disease or reverse the process of brain disease, although some therapies can partially relieve some symptoms.</p><p><b>Therefore, as the first approved drug in 18 years, Aduhelm is expected to bring a glimmer of hope to Alzheimer's patients and their families.</b></p><p>\"Alzheimer's is one of the most incredible diseases we know,\" Charbel Moussa, associate professor of neurology and director of the Dementia and Parkinson's Laboratory at Georgetown University, told MarketWatch.</p><p>Moussa said research on the disease must be divided in order to dig deeper into how the brain works, why chemicals don't spread correctly, the impact on activities of daily living (such as bathing and dressing), and the quality of life of patients and their caregivers. He said: \"Now Aduhelm's approval is to open<a href=\"https://laohu8.com/S/0NQC.UK\">Pandora</a>The box. \"</p><p><b>There are also views that the launch of this drug will change the current treatment of Alzheimer's disease, at least for some patients, and FDA approval may pave the way for future treatments.</b></p><p>Erik Musiek, a neurologist at Washington University in St. Louis, told Bloomberg in an interview that if the FDA is willing to accept the reduction in amyloid as sufficient evidence for approval, it could open the door to other drugs, \"if all you need is plaque cleanup, that's definitely another situation.\"</p><p>Harry Johns, CEO of the American Alzheimer's Association, said, \"This is just a new day for Alzheimer's patients, and we believe it will drive more innovation and investment.\"</p><p><h2>Why is the disagreement huge?</h2>At present, there is still huge controversy and uncertainty surrounding Aduhelm. There is still a long way to go before this drug can truly benefit patients.</p><p>Despite being approved by the FDA for marketing, there is still much unknown about this treatment, and there is currently no conclusive evidence that the drug slows down the decline of memory and brain function.<b>And it's an intravenous drug that must be used in the doctor's office, and can have side effects such as brain swelling and bleeding.</b></p><p>According to Bloomberg, in a large trial conducted by Biogen, the drug was generally ineffective. In another similar study, high doses of the drug reduced the rate of disease progression by only 22% over 18 months.</p><p>Some clinicians are also skeptical about this drug. According to CNBC, some doctors said that due to the mixed clinical data supporting Aduhelm, they would not prescribe the drug in their prescriptions if the drug was actually marketed.</p><p>While this is an optimistic moment, FDA approval is just one of many hurdles pharmaceutical companies face when developing drugs, and \"approval is not meant to work,\" American physician John DenBoer told MarketWatch in an interview. DenBoer is the CEO of Smart Brain Aging and the producer of the film This is Dementia.</p><p>Many well-known \"anti-Alzheimer's\" drugs have failed. DenBoer warns that this therapy will not cure or partially reverse Alzheimer's at any stage-goals that are unrealistic, at least for researchers currently fighting Alzheimer's:</p><p>At present, the best drugs we use are only 5% effective at most, and only in the early stages of the disease. If you can reduce the intensity of this disease by 10% at an early stage, it will have a real impact on many people and change their lives, which I think is a very admirable goal. However, it should be noted that the FDA's approval of Aduhelm this time is not completely unconditional, but requires \"Phase IV\" clinical research. In this regard, the FDA stated in a press release that the data from two phase III clinical trials in the materials submitted by Bojian are very complex, and there are still uncertainties.</p><p><b>According to the FDA, the agency and pharmaceutical companies may pull the drug off the market \"if confirmatory trials do not confirm the anticipated clinical benefits of the drug.\" But while confirmatory trials are ongoing, Bojian can still sell Aduhelm.</b></p>\n<div class=\"bt-text\">\n\n\n<p> source：<a href=\"https://wallstreetcn.com/articles/3632396\">华尔街见闻</a></p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"https://static.tigerbbs.com/df4ec61541b268a5353585001973d7cb","relate_stocks":{},"source_url":"https://wallstreetcn.com/articles/3632396","is_english":false,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2141259936","content_text":"发生了什么？6月7日，美国渤健公司(Biogen Inc.)$(BIIB)$旗下的阿尔茨海默症药物获批上市，这是2003年来首款获美国食品和药物管理局批准的此类药物，然而目前围绕该药物的争议依然很大。这款药物的通用名为aducanumab，将以Aduhelm的商品名进行销售。渤健每年对这种药物的收费为5.6万美元，并且承诺至少四年内不涨价。据介绍，该药物具有清除大脑淀粉样蛋白斑块的能力，被认为可以减缓早期症状患者的疾病进展。长期以来，淀粉样蛋白的过度积累被视为引发阿尔茨海默症的罪魁祸首之一，它破坏了脑细胞之间的交流，从而导致认知功能问题。然而，目前这款药物治疗的效果，有效率和副作用，仍然未被验证，来自医生和研究人员的反馈也充满了分歧，既有乐观的，也有持批判态度的。渤健周一早间曾停牌近3小时，之后复牌时受到Aduhelm获批消息的利好带动，连续突破了300美元和400美元两道关口，日内涨幅曾一度达到60%以上，而在之后则出现回吐。截至收盘，渤健上涨38.34%，报395.85美元。市场预计，最新药物的批准将为公司带来数十亿美元的收入。而美股生物医药板块也受到利好影响出现拉升，纳斯达克生物科技指数在消息公布之后曾涨逾5%。为什么重要？阿尔茨海默症(AD)是导致全球老年人死亡的第三大原因，仅次于心脑血管疾病和癌症。据世界卫生组织估计，目前全球约有3500万至5000万阿尔茨海默症患者，并且每年预计将有1000万新增患者。有机构预测，到2050年，全球阿尔茨海默症患者数量将达到1.5亿。阿尔茨海默症发病机制至今仍未被研究透彻，且目前还没有治疗该病症或逆转大脑疾病进程的方法，尽管一些疗法可以部分缓解一些症状。因此，作为18年来首款获批的药物，Aduhelm有望给阿尔茨海默症患者和他们的家人带来一丝希望。乔治敦大学(Georgetown University)神经学副教授、痴呆症和帕金森病实验室主任Charbel Moussa对MarketWatch表示：“阿尔茨海默症是我们所知道的最难以置信的疾病之一。”Moussa称对这种疾病的研究必须进行划分，以便更深入地挖掘大脑是如何运作的，为什么化学物质不能正确地传播，对日常生活活动(如洗澡和穿衣服)的影响，以及病人及其照顾者的生活质量。他说：“现在Aduhelm的批准就是打开潘多拉的盒子。”也有观点认为，这款药物的上市将改变阿尔茨海默症目前的治疗方式，至少对一些患者来说是这样，FDA的批准可能会为未来的治疗铺平道路。圣路易斯华盛顿大学(Washington University in St. Louis)的神经学家Erik Musiek在接受彭博采访中表示，如果FDA愿意接受淀粉样蛋白的减少作为批准的充分证据，这可能为其他药物打开大门，“如果你所需要的只是清理斑块，那肯定是另一种情况。”美国阿尔茨海默症协会首席执行官Harry Johns表示，“对于阿尔茨海默症患者来说，这只是新的一天，我们相信这将推动更多的创新和投资。”为什么分歧巨大？目前，围绕Aduhelm还存在着巨大的争议和不确定性，这款药物要使患者真正获益，还有很长的路要走。尽管获得FDA批准上市，但关于这种治疗方法仍有许多未知之处，目前并没有确凿的证据表明该药物减缓了记忆和大脑功能的衰退。而且这是一种必须在医生办公室使用的静脉注射药物，并可能出现脑肿胀和出血等副作用。据彭博，在渤健公司进行的一项大型试验中，该药物总体上是无效的。在另一项类似的研究中，高剂量的药物在18个月内将疾病的发展速度仅降低了22%。而部分临床医生对此药物同样抱有怀疑态度。据CNBC，部分医生表示，由于支撑Aduhelm的临床数据喜忧参半，如果该药品真的上市，他们不会在处方中开出此药。美国医生John DenBoer在接受MarketWatch采访中表示，尽管这是一个乐观的时刻，但FDA的批准只是制药公司在开发药物时面临的众多障碍之一，而且“批准并不意味着有效”。DenBoer是Smart Brain Aging公司的首席执行官，也是电影《这是痴呆症》(This is Dementia)的制片人。许多众所周知的“抗阿尔茨海默症”药物都失败了。DenBoer警告说，这种疗法在任何阶段都不能治愈或部分逆转阿尔茨海默氏症——这些目标都是不切实际的，至少对于目前正在对抗阿尔茨海默氏症的研究人员来说是如此：目前我们所使用的最好的药物最多只有5%的疗效，而且仅在疾病的早期阶段。如果你能在早期将这种疾病的强度降低10%，这将对许多人产生真正的影响，并改变他们的生活，我认为这是一个非常令人钦佩的目标。不过需要注意的是，FDA本次批准Aduhelm并非完全无条件，而是需要进行“第四阶段”临床研究。对此，FDA在新闻稿当中表示，渤健提交的材料中来自于两项三期临床试验的数据非常复杂，而且仍有不确定性残留。根据FDA的说法，“如果验证性试验不能证实该药物预期的临床效益”，该机构和制药公司可能会将该药物撤出市场。但是在验证性试验进行期间，渤健仍然可以出售Aduhelm。","news_type":1,"symbols_score_info":{}},"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"CN"},{"id":117104286,"gmtCreate":1623120308645,"gmtModify":1704196499030,"author":{"id":"3578823424287855","authorId":"3578823424287855","name":"远离中丐","avatar":"https://static.tigerbbs.com/8cfb2615fe8174859eb60c4077226ed9","vip":1,"crmLevel":12,"crmLevelSwitch":0,"idStr":"3578823424287855","authorIdStr":"3578823424287855"},"htmlText":"意味着老年化問題會越來越嚴重","listText":"意味着老年化問題會越來越嚴重","text":"意味着老年化問題會越來越嚴重","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/117104286","repostId":2141259936,"repostType":4,"repost":{"id":"2141259936","kind":"highlight","pubTimestamp":1623114070,"share":"https://ttm.financial/m/news/2141259936?lang=en_US&edition=fundamental","pubTime":"2021-06-08 09:01","market":"us","language":"zh","title":"The first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?","url":"https://stock-news.laohu8.com/highlight/detail?id=2141259936","media":"华尔街见闻","summary":"受到Aduhelm获批消息利好带动，美国渤健公司隔夜一度暴涨60%。但目前Aduhelm对阿尔茨海默症治疗的效果，有效率和副作用，仍然未被验证，来自医生和研究人员的反馈也充满了分歧。","content":"<p><h2>What happened?</h2>On June 7, Biogen Inc.<a href=\"https://laohu8.com/S/BIIB\">$(BIIB) $</a>Its Alzheimer's drug was approved for marketing. This is the first such drug approved by the US Food and Drug Administration since 2003. However, there is still a lot of controversy surrounding the drug.</p><p><b>The generic name of this drug is aducanumab and will be sold under the trade name Aduhelm. Bojian charges $56,000 a year for this drug and promises not to raise the price for at least four years.</b></p><p>According to reports, the drug has the ability to clear amyloid plaques in the brain and is believed to slow down disease progression in patients with early symptoms. For a long time, the excessive accumulation of amyloid protein has been regarded as one of the chief culprits of Alzheimer's disease, which disrupts the communication between brain cells, leading to cognitive function problems.</p><p><b>However, at present, the effect, efficiency and side effects of this drug treatment have not been verified, and the feedback from doctors and researchers is full of differences, both optimistic and critical.</b></p><p>Bojian suspended trading for nearly 3 hours on Monday morning. After that, when it resumed trading, it was driven by the news of Aduhelm's approval. It broke through the two barriers of $300 and $400 in succession. The intraday increase once reached more than 60%, and then it retreated. As of the close, Bojian rose 38.34% to $395.85. The market expects that the approval of the latest drug will generate billions of dollars in revenue for the company.</p><p>The biomedical sector of the U.S. stock market also rose due to the positive impact. The Nasdaq Biotechnology Index rose by more than 5% after the news was announced.</p><p><img src=\"https://static.tigerbbs.com/1f6fdbfe3f9a0412cd40fd0ea058e36e\" tg-width=\"743\" tg-height=\"443\" referrerpolicy=\"no-referrer\"></p><p><h2>Why is it important?</h2>Alzheimer's disease (AD) is the third leading cause of death among the elderly worldwide, second only to cardiovascular and cerebrovascular diseases and cancer.</p><p>According to estimates by the World Health Organization, there are currently about 35 million to 50 million Alzheimer's patients worldwide, and 10 million new patients are expected to be added every year. Some institutions predict that by 2050, the number of Alzheimer's patients worldwide will reach 150 million.</p><p>The pathogenesis of Alzheimer's disease has not been thoroughly studied, and there is currently no way to treat the disease or reverse the process of brain disease, although some therapies can partially relieve some symptoms.</p><p><b>Therefore, as the first approved drug in 18 years, Aduhelm is expected to bring a glimmer of hope to Alzheimer's patients and their families.</b></p><p>\"Alzheimer's is one of the most incredible diseases we know,\" Charbel Moussa, associate professor of neurology and director of the Dementia and Parkinson's Laboratory at Georgetown University, told MarketWatch.</p><p>Moussa said research on the disease must be divided in order to dig deeper into how the brain works, why chemicals don't spread correctly, the impact on activities of daily living (such as bathing and dressing), and the quality of life of patients and their caregivers. He said: \"Now Aduhelm's approval is to open<a href=\"https://laohu8.com/S/0NQC.UK\">Pandora</a>The box. \"</p><p><b>There are also views that the launch of this drug will change the current treatment of Alzheimer's disease, at least for some patients, and FDA approval may pave the way for future treatments.</b></p><p>Erik Musiek, a neurologist at Washington University in St. Louis, told Bloomberg in an interview that if the FDA is willing to accept the reduction in amyloid as sufficient evidence for approval, it could open the door to other drugs, \"if all you need is plaque cleanup, that's definitely another situation.\"</p><p>Harry Johns, CEO of the American Alzheimer's Association, said, \"This is just a new day for Alzheimer's patients, and we believe it will drive more innovation and investment.\"</p><p><h2>Why is the disagreement huge?</h2>At present, there is still huge controversy and uncertainty surrounding Aduhelm. There is still a long way to go before this drug can truly benefit patients.</p><p>Despite being approved by the FDA for marketing, there is still much unknown about this treatment, and there is currently no conclusive evidence that the drug slows down the decline of memory and brain function.<b>And it's an intravenous drug that must be used in the doctor's office, and can have side effects such as brain swelling and bleeding.</b></p><p>According to Bloomberg, in a large trial conducted by Biogen, the drug was generally ineffective. In another similar study, high doses of the drug reduced the rate of disease progression by only 22% over 18 months.</p><p>Some clinicians are also skeptical about this drug. According to CNBC, some doctors said that due to the mixed clinical data supporting Aduhelm, they would not prescribe the drug in their prescriptions if the drug was actually marketed.</p><p>While this is an optimistic moment, FDA approval is just one of many hurdles pharmaceutical companies face when developing drugs, and \"approval is not meant to work,\" American physician John DenBoer told MarketWatch in an interview. DenBoer is the CEO of Smart Brain Aging and the producer of the film This is Dementia.</p><p>Many well-known \"anti-Alzheimer's\" drugs have failed. DenBoer warns that this therapy will not cure or partially reverse Alzheimer's at any stage-goals that are unrealistic, at least for researchers currently fighting Alzheimer's:</p><p>At present, the best drugs we use are only 5% effective at most, and only in the early stages of the disease. If you can reduce the intensity of this disease by 10% at an early stage, it will have a real impact on many people and change their lives, which I think is a very admirable goal. However, it should be noted that the FDA's approval of Aduhelm this time is not completely unconditional, but requires \"Phase IV\" clinical research. In this regard, the FDA stated in a press release that the data from two phase III clinical trials in the materials submitted by Bojian are very complex, and there are still uncertainties.</p><p><b>According to the FDA, the agency and pharmaceutical companies may pull the drug off the market \"if confirmatory trials do not confirm the anticipated clinical benefits of the drug.\" But while confirmatory trials are ongoing, Bojian can still sell Aduhelm.</b></p>","source":"wallstreetcn_api","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>The first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nThe first \"Alzheimer's disease\" drug approved in 18 years, what does this mean?\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">华尔街见闻</strong><span class=\"h-time small\">2021-06-08 09:01</span>\n</p>\n</h4>\n</header>\n<article>\n<p><h2>What happened?</h2>On June 7, Biogen Inc.<a href=\"https://laohu8.com/S/BIIB\">$(BIIB) $</a>Its Alzheimer's drug was approved for marketing. This is the first such drug approved by the US Food and Drug Administration since 2003. However, there is still a lot of controversy surrounding the drug.</p><p><b>The generic name of this drug is aducanumab and will be sold under the trade name Aduhelm. Bojian charges $56,000 a year for this drug and promises not to raise the price for at least four years.</b></p><p>According to reports, the drug has the ability to clear amyloid plaques in the brain and is believed to slow down disease progression in patients with early symptoms. For a long time, the excessive accumulation of amyloid protein has been regarded as one of the chief culprits of Alzheimer's disease, which disrupts the communication between brain cells, leading to cognitive function problems.</p><p><b>However, at present, the effect, efficiency and side effects of this drug treatment have not been verified, and the feedback from doctors and researchers is full of differences, both optimistic and critical.</b></p><p>Bojian suspended trading for nearly 3 hours on Monday morning. After that, when it resumed trading, it was driven by the news of Aduhelm's approval. It broke through the two barriers of $300 and $400 in succession. The intraday increase once reached more than 60%, and then it retreated. As of the close, Bojian rose 38.34% to $395.85. The market expects that the approval of the latest drug will generate billions of dollars in revenue for the company.</p><p>The biomedical sector of the U.S. stock market also rose due to the positive impact. The Nasdaq Biotechnology Index rose by more than 5% after the news was announced.</p><p><img src=\"https://static.tigerbbs.com/1f6fdbfe3f9a0412cd40fd0ea058e36e\" tg-width=\"743\" tg-height=\"443\" referrerpolicy=\"no-referrer\"></p><p><h2>Why is it important?</h2>Alzheimer's disease (AD) is the third leading cause of death among the elderly worldwide, second only to cardiovascular and cerebrovascular diseases and cancer.</p><p>According to estimates by the World Health Organization, there are currently about 35 million to 50 million Alzheimer's patients worldwide, and 10 million new patients are expected to be added every year. Some institutions predict that by 2050, the number of Alzheimer's patients worldwide will reach 150 million.</p><p>The pathogenesis of Alzheimer's disease has not been thoroughly studied, and there is currently no way to treat the disease or reverse the process of brain disease, although some therapies can partially relieve some symptoms.</p><p><b>Therefore, as the first approved drug in 18 years, Aduhelm is expected to bring a glimmer of hope to Alzheimer's patients and their families.</b></p><p>\"Alzheimer's is one of the most incredible diseases we know,\" Charbel Moussa, associate professor of neurology and director of the Dementia and Parkinson's Laboratory at Georgetown University, told MarketWatch.</p><p>Moussa said research on the disease must be divided in order to dig deeper into how the brain works, why chemicals don't spread correctly, the impact on activities of daily living (such as bathing and dressing), and the quality of life of patients and their caregivers. He said: \"Now Aduhelm's approval is to open<a href=\"https://laohu8.com/S/0NQC.UK\">Pandora</a>The box. \"</p><p><b>There are also views that the launch of this drug will change the current treatment of Alzheimer's disease, at least for some patients, and FDA approval may pave the way for future treatments.</b></p><p>Erik Musiek, a neurologist at Washington University in St. Louis, told Bloomberg in an interview that if the FDA is willing to accept the reduction in amyloid as sufficient evidence for approval, it could open the door to other drugs, \"if all you need is plaque cleanup, that's definitely another situation.\"</p><p>Harry Johns, CEO of the American Alzheimer's Association, said, \"This is just a new day for Alzheimer's patients, and we believe it will drive more innovation and investment.\"</p><p><h2>Why is the disagreement huge?</h2>At present, there is still huge controversy and uncertainty surrounding Aduhelm. There is still a long way to go before this drug can truly benefit patients.</p><p>Despite being approved by the FDA for marketing, there is still much unknown about this treatment, and there is currently no conclusive evidence that the drug slows down the decline of memory and brain function.<b>And it's an intravenous drug that must be used in the doctor's office, and can have side effects such as brain swelling and bleeding.</b></p><p>According to Bloomberg, in a large trial conducted by Biogen, the drug was generally ineffective. In another similar study, high doses of the drug reduced the rate of disease progression by only 22% over 18 months.</p><p>Some clinicians are also skeptical about this drug. According to CNBC, some doctors said that due to the mixed clinical data supporting Aduhelm, they would not prescribe the drug in their prescriptions if the drug was actually marketed.</p><p>While this is an optimistic moment, FDA approval is just one of many hurdles pharmaceutical companies face when developing drugs, and \"approval is not meant to work,\" American physician John DenBoer told MarketWatch in an interview. DenBoer is the CEO of Smart Brain Aging and the producer of the film This is Dementia.</p><p>Many well-known \"anti-Alzheimer's\" drugs have failed. DenBoer warns that this therapy will not cure or partially reverse Alzheimer's at any stage-goals that are unrealistic, at least for researchers currently fighting Alzheimer's:</p><p>At present, the best drugs we use are only 5% effective at most, and only in the early stages of the disease. If you can reduce the intensity of this disease by 10% at an early stage, it will have a real impact on many people and change their lives, which I think is a very admirable goal. However, it should be noted that the FDA's approval of Aduhelm this time is not completely unconditional, but requires \"Phase IV\" clinical research. In this regard, the FDA stated in a press release that the data from two phase III clinical trials in the materials submitted by Bojian are very complex, and there are still uncertainties.</p><p><b>According to the FDA, the agency and pharmaceutical companies may pull the drug off the market \"if confirmatory trials do not confirm the anticipated clinical benefits of the drug.\" But while confirmatory trials are ongoing, Bojian can still sell Aduhelm.</b></p>\n<div class=\"bt-text\">\n\n\n<p> source：<a href=\"https://wallstreetcn.com/articles/3632396\">华尔街见闻</a></p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"https://static.tigerbbs.com/df4ec61541b268a5353585001973d7cb","relate_stocks":{},"source_url":"https://wallstreetcn.com/articles/3632396","is_english":false,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2141259936","content_text":"发生了什么？6月7日，美国渤健公司(Biogen Inc.)$(BIIB)$旗下的阿尔茨海默症药物获批上市，这是2003年来首款获美国食品和药物管理局批准的此类药物，然而目前围绕该药物的争议依然很大。这款药物的通用名为aducanumab，将以Aduhelm的商品名进行销售。渤健每年对这种药物的收费为5.6万美元，并且承诺至少四年内不涨价。据介绍，该药物具有清除大脑淀粉样蛋白斑块的能力，被认为可以减缓早期症状患者的疾病进展。长期以来，淀粉样蛋白的过度积累被视为引发阿尔茨海默症的罪魁祸首之一，它破坏了脑细胞之间的交流，从而导致认知功能问题。然而，目前这款药物治疗的效果，有效率和副作用，仍然未被验证，来自医生和研究人员的反馈也充满了分歧，既有乐观的，也有持批判态度的。渤健周一早间曾停牌近3小时，之后复牌时受到Aduhelm获批消息的利好带动，连续突破了300美元和400美元两道关口，日内涨幅曾一度达到60%以上，而在之后则出现回吐。截至收盘，渤健上涨38.34%，报395.85美元。市场预计，最新药物的批准将为公司带来数十亿美元的收入。而美股生物医药板块也受到利好影响出现拉升，纳斯达克生物科技指数在消息公布之后曾涨逾5%。为什么重要？阿尔茨海默症(AD)是导致全球老年人死亡的第三大原因，仅次于心脑血管疾病和癌症。据世界卫生组织估计，目前全球约有3500万至5000万阿尔茨海默症患者，并且每年预计将有1000万新增患者。有机构预测，到2050年，全球阿尔茨海默症患者数量将达到1.5亿。阿尔茨海默症发病机制至今仍未被研究透彻，且目前还没有治疗该病症或逆转大脑疾病进程的方法，尽管一些疗法可以部分缓解一些症状。因此，作为18年来首款获批的药物，Aduhelm有望给阿尔茨海默症患者和他们的家人带来一丝希望。乔治敦大学(Georgetown University)神经学副教授、痴呆症和帕金森病实验室主任Charbel Moussa对MarketWatch表示：“阿尔茨海默症是我们所知道的最难以置信的疾病之一。”Moussa称对这种疾病的研究必须进行划分，以便更深入地挖掘大脑是如何运作的，为什么化学物质不能正确地传播，对日常生活活动(如洗澡和穿衣服)的影响，以及病人及其照顾者的生活质量。他说：“现在Aduhelm的批准就是打开潘多拉的盒子。”也有观点认为，这款药物的上市将改变阿尔茨海默症目前的治疗方式，至少对一些患者来说是这样，FDA的批准可能会为未来的治疗铺平道路。圣路易斯华盛顿大学(Washington University in St. Louis)的神经学家Erik Musiek在接受彭博采访中表示，如果FDA愿意接受淀粉样蛋白的减少作为批准的充分证据，这可能为其他药物打开大门，“如果你所需要的只是清理斑块，那肯定是另一种情况。”美国阿尔茨海默症协会首席执行官Harry Johns表示，“对于阿尔茨海默症患者来说，这只是新的一天，我们相信这将推动更多的创新和投资。”为什么分歧巨大？目前，围绕Aduhelm还存在着巨大的争议和不确定性，这款药物要使患者真正获益，还有很长的路要走。尽管获得FDA批准上市，但关于这种治疗方法仍有许多未知之处，目前并没有确凿的证据表明该药物减缓了记忆和大脑功能的衰退。而且这是一种必须在医生办公室使用的静脉注射药物，并可能出现脑肿胀和出血等副作用。据彭博，在渤健公司进行的一项大型试验中，该药物总体上是无效的。在另一项类似的研究中，高剂量的药物在18个月内将疾病的发展速度仅降低了22%。而部分临床医生对此药物同样抱有怀疑态度。据CNBC，部分医生表示，由于支撑Aduhelm的临床数据喜忧参半，如果该药品真的上市，他们不会在处方中开出此药。美国医生John DenBoer在接受MarketWatch采访中表示，尽管这是一个乐观的时刻，但FDA的批准只是制药公司在开发药物时面临的众多障碍之一，而且“批准并不意味着有效”。DenBoer是Smart Brain Aging公司的首席执行官，也是电影《这是痴呆症》(This is Dementia)的制片人。许多众所周知的“抗阿尔茨海默症”药物都失败了。DenBoer警告说，这种疗法在任何阶段都不能治愈或部分逆转阿尔茨海默氏症——这些目标都是不切实际的，至少对于目前正在对抗阿尔茨海默氏症的研究人员来说是如此：目前我们所使用的最好的药物最多只有5%的疗效，而且仅在疾病的早期阶段。如果你能在早期将这种疾病的强度降低10%，这将对许多人产生真正的影响，并改变他们的生活，我认为这是一个非常令人钦佩的目标。不过需要注意的是，FDA本次批准Aduhelm并非完全无条件，而是需要进行“第四阶段”临床研究。对此，FDA在新闻稿当中表示，渤健提交的材料中来自于两项三期临床试验的数据非常复杂，而且仍有不确定性残留。根据FDA的说法，“如果验证性试验不能证实该药物预期的临床效益”，该机构和制药公司可能会将该药物撤出市场。但是在验证性试验进行期间，渤健仍然可以出售Aduhelm。","news_type":1,"symbols_score_info":{}},"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"CN"}],"isCommentEnd":false,"newsSizeData":{"likeSize":59,"commentSize":14,"repostSize":0,"favoriteSize":1,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.35.12","shortVersion":"4.35.12","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2141259936","isCrawlerRequest":true}