Mich77
2021-12-02
like thanks a lot
U.S. FDA declines to approve BeyondSpring's neutropenia drug, shares plunge<blockquote>美国FDA拒绝批准BeyondSpring的中性粒细胞减少症药物，股价暴跌</blockquote>
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lot","highlighted":1,"essential":1,"paper":1,"likeSize":6,"commentSize":1,"repostSize":0,"favoriteSize":0,"link":"https://laohu8.com/post/603590405","repostId":1126563366,"repostType":4,"repost":{"id":"1126563366","kind":"news","pubTimestamp":1638421637,"share":"https://www.laohu8.com/m/news/1126563366?lang=zh_CN&edition=full","pubTime":"2021-12-02 13:07","market":"us","language":"en","title":"U.S. FDA declines to approve BeyondSpring's neutropenia drug, shares plunge<blockquote>美国FDA拒绝批准BeyondSpring的中性粒细胞减少症药物，股价暴跌</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1126563366","media":"Reuters","summary":"Dec 1 (Reuters) - BeyondSpring Inc(BYSI.O)said on Wednesday the U.S. Food and Drug Administration (F","content":"<p>Dec 1 (Reuters) - BeyondSpring Inc(BYSI.O)said on Wednesday the U.S. Food and Drug Administration (FDA) had declined to approve its drug candidate for prevention of chemotherapy-induced neutropenia, citing need for an additional study, sending its shares down nearly 61%.</p><p><blockquote>路透12月1日-BeyondSpring Inc(BYSI.O)周三表示，美国。美国食品和药物管理局(FDA)以需要进行额外研究为由拒绝批准其用于预防化疗引起的中性粒细胞减少症的候选药物，导致其股价下跌近61%。</blockquote></p><p> The regulator indicated that results from the company's late-stage trial did not provide enough evidence on the benefits of the drug, plinabulin, and that a second trial would be required to support the marketing application, the company said.</p><p><blockquote>该公司表示，监管机构表示，该公司后期试验的结果没有提供足够的证据证明普那布林药物的益处，需要进行第二次试验来支持上市申请。</blockquote></p><p> \"BeyondSpring's prospect to profitability is solely reliant on the clinical, regulatory, and commercial success of plinabulin,\" William Blair analyst Andy Hsieh said, downgrading the company to \"market perform\" factoring in the capital investment and time needed to conduct a second late-stage trial.</p><p><blockquote>William Blair分析师Andy Hsieh表示：“BeyondSpring的盈利前景完全依赖于普那布林的临床、监管和商业成功。”考虑到进行第二次后期试验所需的资本投资和时间，他将该公司的评级下调至“市场表现”阶段试验。</blockquote></p><p> Neutropenia, a decrease in the number of white blood cells (WBCs) is a common complication of chemotherapy that kills healthy WBCs along with cancer cells, increasing a patient's susceptibility to infections.</p><p><blockquote>中性粒细胞减少症，即白细胞（WBC）数量的减少是化疗的常见并发症，化疗会杀死健康的WBC和癌细胞，增加患者对感染的易感性。</blockquote></p><p> About 60,000 cancer patients in the United States are hospitalized with the condition and 4,000 die of fever associated with neutropenia, according to the U.S. Centers for Disease Control and Prevention.</p><p><blockquote>根据美国疾病控制与预防中心的数据，美国约有60,000名癌症患者因该病住院，4,000人死于与中性粒细胞减少症相关的发烧。</blockquote></p><p> BeyondSpring said in November last year plinabulin in combination with an anti-infection drug met the main goal in its late-stage trial, demonstrating improvement in the rate of prevention of neutropenia.</p><p><blockquote>BeyondSpring去年11月表示，普那布林联合抗感染药物在其后期试验中达到了主要目标，表明中性粒细胞减少症的预防率有所提高。</blockquote></p><p> The company's neutropenia program is the farthest along in its pipeline, followed by its study of plinabulin as a potential second or third line treatment for non-small-cell lung cancer.</p><p><blockquote>该公司的中性粒细胞减少症项目是其管道中进展最快的，其次是普那布林作为非小细胞肺癌潜在二线或三线治疗方法的研究。</blockquote></p><p> Plinabulin is also under regulatory review in China for neutropenia prevention and Jiangsu Hengrui Pharma has obtained the rights to sell and co-develop the drug in the region.</p><p><blockquote>普那布林也在中国接受监管审查，用于预防中性粒细胞减少症，江苏恒瑞医药已获得该药物在该地区的销售和共同开发权利。</blockquote></p><p> Shares in the company, which said it intends to work with the FDA to determine the drug's pathway for neutropenia prevention, were trading at $4.93.</p><p><blockquote>该公司表示打算与FDA合作确定该药物预防中性粒细胞减少症的途径，其股价为4.93美元。</blockquote></p><p></p>","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\" 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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\">\nU.S. FDA declines to approve BeyondSpring's neutropenia drug, shares plunge<blockquote>美国FDA拒绝批准BeyondSpring的中性粒细胞减少症药物，股价暴跌</blockquote>\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">Reuters</strong><span class=\"h-time small\">2021-12-02 13:07</span>\n</p>\n</h4>\n</header>\n<article>\n<p>Dec 1 (Reuters) - BeyondSpring Inc(BYSI.O)said on Wednesday the U.S. Food and Drug Administration (FDA) had declined to approve its drug candidate for prevention of chemotherapy-induced neutropenia, citing need for an additional study, sending its shares down nearly 61%.</p><p><blockquote>路透12月1日-BeyondSpring Inc(BYSI.O)周三表示，美国。美国食品和药物管理局(FDA)以需要进行额外研究为由拒绝批准其用于预防化疗引起的中性粒细胞减少症的候选药物，导致其股价下跌近61%。</blockquote></p><p> The regulator indicated that results from the company's late-stage trial did not provide enough evidence on the benefits of the drug, plinabulin, and that a second trial would be required to support the marketing application, the company said.</p><p><blockquote>该公司表示，监管机构表示，该公司后期试验的结果没有提供足够的证据证明普那布林药物的益处，需要进行第二次试验来支持上市申请。</blockquote></p><p> \"BeyondSpring's prospect to profitability is solely reliant on the clinical, regulatory, and commercial success of plinabulin,\" William Blair analyst Andy Hsieh said, downgrading the company to \"market perform\" factoring in the capital investment and time needed to conduct a second late-stage trial.</p><p><blockquote>William Blair分析师Andy Hsieh表示：“BeyondSpring的盈利前景完全依赖于普那布林的临床、监管和商业成功。”考虑到进行第二次后期试验所需的资本投资和时间，他将该公司的评级下调至“市场表现”阶段试验。</blockquote></p><p> Neutropenia, a decrease in the number of white blood cells (WBCs) is a common complication of chemotherapy that kills healthy WBCs along with cancer cells, increasing a patient's susceptibility to infections.</p><p><blockquote>中性粒细胞减少症，即白细胞（WBC）数量的减少是化疗的常见并发症，化疗会杀死健康的WBC和癌细胞，增加患者对感染的易感性。</blockquote></p><p> About 60,000 cancer patients in the United States are hospitalized with the condition and 4,000 die of fever associated with neutropenia, according to the U.S. Centers for Disease Control and Prevention.</p><p><blockquote>根据美国疾病控制与预防中心的数据，美国约有60,000名癌症患者因该病住院，4,000人死于与中性粒细胞减少症相关的发烧。</blockquote></p><p> BeyondSpring said in November last year plinabulin in combination with an anti-infection drug met the main goal in its late-stage trial, demonstrating improvement in the rate of prevention of neutropenia.</p><p><blockquote>BeyondSpring去年11月表示，普那布林联合抗感染药物在其后期试验中达到了主要目标，表明中性粒细胞减少症的预防率有所提高。</blockquote></p><p> The company's neutropenia program is the farthest along in its pipeline, followed by its study of plinabulin as a potential second or third line treatment for non-small-cell lung cancer.</p><p><blockquote>该公司的中性粒细胞减少症项目是其管道中进展最快的，其次是普那布林作为非小细胞肺癌潜在二线或三线治疗方法的研究。</blockquote></p><p> Plinabulin is also under regulatory review in China for neutropenia prevention and Jiangsu Hengrui Pharma has obtained the rights to sell and co-develop the drug in the region.</p><p><blockquote>普那布林也在中国接受监管审查，用于预防中性粒细胞减少症，江苏恒瑞医药已获得该药物在该地区的销售和共同开发权利。</blockquote></p><p> Shares in the company, which said it intends to work with the FDA to determine the drug's pathway for neutropenia prevention, were trading at $4.93.</p><p><blockquote>该公司表示打算与FDA合作确定该药物预防中性粒细胞减少症的途径，其股价为4.93美元。</blockquote></p><p></p>\n<div class=\"bt-text\">\n\n\n<p> 来源：<a href=\"https://www.reuters.com/business/healthcare-pharmaceuticals/beyondspring-says-us-fda-declined-approve-neutropenia-prevention-drug-2021-12-01/\">Reuters</a></p>\n<p>为提升您的阅读体验，我们对本页面进行了排版优化</p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"BYSI":"万春药业"},"source_url":"https://www.reuters.com/business/healthcare-pharmaceuticals/beyondspring-says-us-fda-declined-approve-neutropenia-prevention-drug-2021-12-01/","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1126563366","content_text":"Dec 1 (Reuters) - BeyondSpring Inc(BYSI.O)said on Wednesday the U.S. Food and Drug Administration (FDA) had declined to approve its drug candidate for prevention of chemotherapy-induced neutropenia, citing need for an additional study, sending its shares down nearly 61%.\nThe regulator indicated that results from the company's late-stage trial did not provide enough evidence on the benefits of the drug, plinabulin, and that a second trial would be required to support the marketing application, the company said.\n\"BeyondSpring's prospect to profitability is solely reliant on the clinical, regulatory, and commercial success of plinabulin,\" William Blair analyst Andy Hsieh said, downgrading the company to \"market perform\" factoring in the capital investment and time needed to conduct a second late-stage trial.\nNeutropenia, a decrease in the number of white blood cells (WBCs) is a common complication of chemotherapy that kills healthy WBCs along with cancer cells, increasing a patient's susceptibility to infections.\nAbout 60,000 cancer patients in the United States are hospitalized with the condition and 4,000 die of fever associated with neutropenia, according to the U.S. Centers for Disease Control and Prevention.\nBeyondSpring said in November last year plinabulin in combination with an anti-infection drug met the main goal in its late-stage trial, demonstrating improvement in the rate of prevention of neutropenia.\nThe company's neutropenia program is the farthest along in its pipeline, followed by its study of plinabulin as a potential second or third line treatment for non-small-cell lung cancer.\nPlinabulin is also under regulatory review in China for neutropenia prevention and Jiangsu Hengrui Pharma has obtained the rights to sell and co-develop the drug in the region.\nShares in the company, which said it intends to work with the FDA to determine the drug's pathway for neutropenia prevention, were trading at 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