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2021-11-01

The from WHO will be on Nov 3.

Ocugen shares jumped 8.8% in premarket trading<blockquote>Ocugen股价在盘前交易中上涨8.8%</blockquote>

Ocugen shares jumped 8.8% in premarket trading.Ocugen hopes to launch Phase III Trial of Covaxin in

Ocugen shares jumped 8.8% in premarket trading<blockquote>Ocugen股价在盘前交易中上涨8.8%</blockquote>

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{"i18n":{"language":"zh_CN"},"data":{"magic":2,"id":849590294,"tweetId":"849590294","gmtCreate":1635763928571,"gmtModify":1635763928571,"author":{"id":4095811186634540,"idStr":"4095811186634540","authorId":4095811186634540,"authorIdStr":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","vip":1,"userType":1,"introduction":"","boolIsFan":false,"boolIsHead":false,"crmLevel":1,"crmLevelSwitch":0,"individualDisplayBadges":[],"fanSize":0,"starInvestorFlag":false},"themes":[],"images":[],"coverImages":[],"extraTitle":"","html":"<html><head></head><body>The from WHO will be on Nov 3.&nbsp;</body></html>","htmlText":"<html><head></head><body>The from WHO will be on Nov 3.&nbsp;</body></html>","text":"The from WHO will be on Nov 3.","highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"link":"https://laohu8.com/post/849590294","repostId":1150864664,"repostType":4,"repost":{"id":"1150864664","kind":"news","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1635759555,"share":"https://www.laohu8.com/m/news/1150864664?lang=zh_CN&edition=full","pubTime":"2021-11-01 17:39","market":"us","language":"en","title":"Ocugen shares jumped 8.8% in premarket trading<blockquote>Ocugen股价在盘前交易中上涨8.8%</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1150864664","media":"Tiger Newspress","summary":"Ocugen shares jumped 8.8% in premarket trading.Ocugen hopes to launch Phase III Trial of Covaxin in ","content":"Ocugen shares jumped 8.8% in premarket trading.Ocugen hopes to launch Phase III Trial of Covaxin in U.S.<blockquote>Ocugen股价在盘前交易中上涨8.8%。Ocugen希望在美国启动科瓦克辛病III期试验。</blockquote> <img src=\"https://static.tigerbbs.com/9c40abeceb277bdc16372a037d9cc5f3\" tg-width=\"847\" tg-height=\"618\" width=\"100%\" height=\"auto\"><blockquote></blockquote> Malvern, Pa.-based&nbsp;Ocugen&nbsp;has&nbsp;submitted&nbsp;an Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) to run a Phase III trial of India’s BBV152 (Covaxin), a vaccine against COVID-19.<blockquote>总部位于宾夕法尼亚州马尔文奥库根哈斯已提交美国的研究新药（IND）印度食品药品监督管理局（FDA）将对印度新冠肺炎疫苗BBV152（科瓦克辛）进行III期试验。</blockquote> Part of the trial’s&nbsp;goal&nbsp;is to determine if the vaccine’s immune response in a completed Phase III trial in India would be similar to the response in unvaccinated patients in the U.S. or those who have already received two doses of an mRNA vaccine.<blockquote>该试验的部分目标是确定该疫苗在印度已完成的III期试验中的免疫反应是否与美国未接种疫苗的患者或已经接种两剂mRNA疫苗的患者的反应相似。</blockquote> Covaxin&nbsp;is a whole-virion inactivated COVID-19 product. That means they take the SARS-CoV-2 virus, kill it, and use it as the vaccine. The possible advantage over other vaccines is it creates a broader immunity against the virus, not just the virus’s spike protein, or parts of the spike protein, as most other vaccines do. Covaxin would theoretically have similar efficacy against all variants, although it doesn’t seem to in trials.<blockquote>科瓦克辛是一种全病毒体灭活的新冠肺炎产品。这意味着他们携带新型冠状病毒病毒，杀死它，并将其用作疫苗。相对于其他疫苗的可能优势在于，它可以产生更广泛的针对病毒的免疫力，而不仅仅是病毒的刺突蛋白或刺突蛋白的一部分，就像大多数其他疫苗那样。理论上，科瓦克辛对所有变种都有相似的疗效，尽管在试验中似乎没有。</blockquote> The vaccine was jointly developed by India’s&nbsp;Bharat Biotech&nbsp;and the Indian Council of Medical Research (ICMR). Ocugen has a deal with Bharat to develop the vaccine in the U.S. and Canada. It has been distributed under emergency use authorizations in 17 countries.<blockquote>该疫苗由印度的巴拉特生物技术和印度医学研究委员会（ICMR）。Ocugen与Bharat达成协议，在美国和加拿大开发该疫苗。它已在17个国家根据紧急使用授权分发。</blockquote> The vaccine received emergency authorization in India on January 3, 2021. However, there has been along delayin authorization by the World Health Organization (WHO). This week, it got delayed once again as the WHO asked for additional information and clarifications from Bharat Biotech. The WHO expects to meet again for a final evaluation on November 3, if it receives the data.<blockquote>该疫苗于2021年1月3日在印度获得紧急授权。然而，有一个长延迟经世界卫生组织（世卫组织）授权。本周，由于世卫组织要求巴拉特生物技术公司提供更多信息和澄清，该计划再次被推迟。如果收到数据，世卫组织预计将于11月3日再次开会进行最终评估。</blockquote> Although the WHO approval isn’t necessary for use in India or the U.S., it is necessary for the vaccine to be recognized by foreign countries. It allows for fewer problems for vaccinated people in terms of international travel. WHO’s Emergency use listing (EUL) would mean the vaccine was eligible for global distribution to low- and middle-income countries under COVAX.<blockquote>虽然在印度或美国使用不需要世卫组织的批准，但疫苗需要得到外国的认可。它减少了接种疫苗的人在国际旅行方面的问题。世卫组织的紧急使用清单(EUL)意味着该疫苗有资格在COVAX下向中低收入国家进行全球分发。</blockquote> Shankar Musunuri, Ph.D., chairman, chief executive officer, and co-founder of Ocugen, said of the FDA application, “We are very excited to take this next step in the development of Covaxin, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public. We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population.”<blockquote>Ocugen董事长、首席执行官兼联合创始人Shankar Musunuri博士在谈到FDA申请时表示，“我们很高兴在科瓦克辛的开发中迈出下一步，我们希望这将使我们更接近向美国公众推出一种不同类型的COVID-19疫苗。我们希望根据IND进行的研究如果允许继续进行，将有助于证明来自印度的数据将适用于美国人群。”</blockquote> The Phase III immuno-bridging study, if given the green light, would enroll several hundred healthy U.S. adults. The participants would be given either two doses of Covaxin or placebo, 28 days apart. The primary endpoint would compare&nbsp;blood samples from U.S. participants who received the vaccine with samples in the Phase III trial performed in India. A secondary endpoint is an immunogenic profile of the vaccine. It will also determine safety and tolerability in the U.S. population. Ocugen hopes to wrap up the study in the first half of 2022.<blockquote>如果获得批准，III期免疫桥接研究将招募数百名健康的美国成年人。参与者将接受两剂科瓦克辛或安慰剂，间隔28天。主要终点将比较接受疫苗的美国参与者的血液样本与在印度进行的III期试验中的样本。次要终点是疫苗的免疫原性特征。它还将决定美国人群的安全性和耐受性。Ocugen希望在2022年上半年完成这项研究。</blockquote> The Phase III trial in India performed by Bharat Biotech involved 25,798 participants who received the vaccine or placebo. The primary endpoint was the prevention of symptomatic COVID-19 within at least 14 days after the second dose.<blockquote>Bharat Biotech在印度进行的III期试验涉及25,798名接受疫苗或安慰剂的参与者。主要终点是在第二次给药后至少14天内预防有症状的新冠肺炎。</blockquote> Data from that trial reported 93.4% efficacy against severe COVID-19, 77.8% efficacy against symptomatic COVID-19, and 63.6% against asymptomatic disease. A sub-analysis of the data looked at its effectiveness against variants. The analysis showed that 90% of infections were associated with a variant, and 59% were the Delta variant. The vaccine demonstrated 65.2% efficacy against Delta.<blockquote>该试验的数据报告了对严重新冠肺炎的疗效为93.4%，对有症状新冠肺炎的疗效为77.8%，对无症状疾病的疗效为63.6%。对数据的子分析着眼于其对变异的有效性。分析显示，90%的感染与变异有关，其中59%是德尔塔变异毒株。该疫苗对Delta的有效性为65.2%。</blockquote>","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>Ocugen shares jumped 8.8% in premarket trading<blockquote>Ocugen股价在盘前交易中上涨8.8%</blockquote></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\">\nOcugen shares jumped 8.8% in premarket trading<blockquote>Ocugen股价在盘前交易中上涨8.8%</blockquote>\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\nTiger Newspress \n2021-11-01 17:39\n</div>\n</a>\n</h4>\n</header>\n<article>\nOcugen shares jumped 8.8% in premarket trading.Ocugen hopes to launch Phase III Trial of Covaxin in U.S.<blockquote>Ocugen股价在盘前交易中上涨8.8%。Ocugen希望在美国启动科瓦克辛病III期试验。</blockquote> <img src=\"https://static.tigerbbs.com/9c40abeceb277bdc16372a037d9cc5f3\" tg-width=\"847\" tg-height=\"618\" width=\"100%\" height=\"auto\"><blockquote></blockquote> Malvern, Pa.-based&nbsp;Ocugen&nbsp;has&nbsp;submitted&nbsp;an Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) to run a Phase III trial of India’s BBV152 (Covaxin), a vaccine against COVID-19.<blockquote>总部位于宾夕法尼亚州马尔文奥库根哈斯已提交美国的研究新药（IND）印度食品药品监督管理局（FDA）将对印度新冠肺炎疫苗BBV152（科瓦克辛）进行III期试验。</blockquote> Part of the trial’s&nbsp;goal&nbsp;is to determine if the vaccine’s immune response in a completed Phase III trial in India would be similar to the response in unvaccinated patients in the U.S. or those who have already received two doses of an mRNA vaccine.<blockquote>该试验的部分目标是确定该疫苗在印度已完成的III期试验中的免疫反应是否与美国未接种疫苗的患者或已经接种两剂mRNA疫苗的患者的反应相似。</blockquote> Covaxin&nbsp;is a whole-virion inactivated COVID-19 product. That means they take the SARS-CoV-2 virus, kill it, and use it as the vaccine. The possible advantage over other vaccines is it creates a broader immunity against the virus, not just the virus’s spike protein, or parts of the spike protein, as most other vaccines do. Covaxin would theoretically have similar efficacy against all variants, although it doesn’t seem to in trials.<blockquote>科瓦克辛是一种全病毒体灭活的新冠肺炎产品。这意味着他们携带新型冠状病毒病毒，杀死它，并将其用作疫苗。相对于其他疫苗的可能优势在于，它可以产生更广泛的针对病毒的免疫力，而不仅仅是病毒的刺突蛋白或刺突蛋白的一部分，就像大多数其他疫苗那样。理论上，科瓦克辛对所有变种都有相似的疗效，尽管在试验中似乎没有。</blockquote> The vaccine was jointly developed by India’s&nbsp;Bharat Biotech&nbsp;and the Indian Council of Medical Research (ICMR). Ocugen has a deal with Bharat to develop the vaccine in the U.S. and Canada. It has been distributed under emergency use authorizations in 17 countries.<blockquote>该疫苗由印度的巴拉特生物技术和印度医学研究委员会（ICMR）。Ocugen与Bharat达成协议，在美国和加拿大开发该疫苗。它已在17个国家根据紧急使用授权分发。</blockquote> The vaccine received emergency authorization in India on January 3, 2021. However, there has been along delayin authorization by the World Health Organization (WHO). This week, it got delayed once again as the WHO asked for additional information and clarifications from Bharat Biotech. The WHO expects to meet again for a final evaluation on November 3, if it receives the data.<blockquote>该疫苗于2021年1月3日在印度获得紧急授权。然而，有一个长延迟经世界卫生组织（世卫组织）授权。本周，由于世卫组织要求巴拉特生物技术公司提供更多信息和澄清，该计划再次被推迟。如果收到数据，世卫组织预计将于11月3日再次开会进行最终评估。</blockquote> Although the WHO approval isn’t necessary for use in India or the U.S., it is necessary for the vaccine to be recognized by foreign countries. It allows for fewer problems for vaccinated people in terms of international travel. WHO’s Emergency use listing (EUL) would mean the vaccine was eligible for global distribution to low- and middle-income countries under COVAX.<blockquote>虽然在印度或美国使用不需要世卫组织的批准，但疫苗需要得到外国的认可。它减少了接种疫苗的人在国际旅行方面的问题。世卫组织的紧急使用清单(EUL)意味着该疫苗有资格在COVAX下向中低收入国家进行全球分发。</blockquote> Shankar Musunuri, Ph.D., chairman, chief executive officer, and co-founder of Ocugen, said of the FDA application, “We are very excited to take this next step in the development of Covaxin, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public. We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population.”<blockquote>Ocugen董事长、首席执行官兼联合创始人Shankar Musunuri博士在谈到FDA申请时表示，“我们很高兴在科瓦克辛的开发中迈出下一步，我们希望这将使我们更接近向美国公众推出一种不同类型的COVID-19疫苗。我们希望根据IND进行的研究如果允许继续进行，将有助于证明来自印度的数据将适用于美国人群。”</blockquote> The Phase III immuno-bridging study, if given the green light, would enroll several hundred healthy U.S. adults. The participants would be given either two doses of Covaxin or placebo, 28 days apart. The primary endpoint would compare&nbsp;blood samples from U.S. participants who received the vaccine with samples in the Phase III trial performed in India. A secondary endpoint is an immunogenic profile of the vaccine. It will also determine safety and tolerability in the U.S. population. Ocugen hopes to wrap up the study in the first half of 2022.<blockquote>如果获得批准，III期免疫桥接研究将招募数百名健康的美国成年人。参与者将接受两剂科瓦克辛或安慰剂，间隔28天。主要终点将比较接受疫苗的美国参与者的血液样本与在印度进行的III期试验中的样本。次要终点是疫苗的免疫原性特征。它还将决定美国人群的安全性和耐受性。Ocugen希望在2022年上半年完成这项研究。</blockquote> The Phase III trial in India performed by Bharat Biotech involved 25,798 participants who received the vaccine or placebo. The primary endpoint was the prevention of symptomatic COVID-19 within at least 14 days after the second dose.<blockquote>Bharat Biotech在印度进行的III期试验涉及25,798名接受疫苗或安慰剂的参与者。主要终点是在第二次给药后至少14天内预防有症状的新冠肺炎。</blockquote> Data from that trial reported 93.4% efficacy against severe COVID-19, 77.8% efficacy against symptomatic COVID-19, and 63.6% against asymptomatic disease. A sub-analysis of the data looked at its effectiveness against variants. The analysis showed that 90% of infections were associated with a variant, and 59% were the Delta variant. The vaccine demonstrated 65.2% efficacy against Delta.<blockquote>该试验的数据报告了对严重新冠肺炎的疗效为93.4%，对有症状新冠肺炎的疗效为77.8%，对无症状疾病的疗效为63.6%。对数据的子分析着眼于其对变异的有效性。分析显示，90%的感染与变异有关，其中59%是德尔塔变异毒株。该疫苗对Delta的有效性为65.2%。</blockquote>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"OCGN":"Ocugen"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1150864664","content_text":"Ocugen shares jumped 8.8% in premarket trading.Ocugen hopes to launch Phase III Trial of Covaxin in U.S.\n\nMalvern, Pa.-based Ocugen has submitted an Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) to run a Phase III trial of India’s BBV152 (Covaxin), a vaccine against COVID-19.\nPart of the trial’s goal is to determine if the vaccine’s immune response in a completed Phase III trial in India would be similar to the response in unvaccinated patients in the U.S. or those who have already received two doses of an mRNA vaccine.\nCovaxin is a whole-virion inactivated COVID-19 product. That means they take the SARS-CoV-2 virus, kill it, and use it as the vaccine. The possible advantage over other vaccines is it creates a broader immunity against the virus, not just the virus’s spike protein, or parts of the spike protein, as most other vaccines do. Covaxin would theoretically have similar efficacy against all variants, although it doesn’t seem to in trials.\nThe vaccine was jointly developed by India’s Bharat Biotech and the Indian Council of Medical Research (ICMR). Ocugen has a deal with Bharat to develop the vaccine in the U.S. and Canada. It has been distributed under emergency use authorizations in 17 countries.\nThe vaccine received emergency authorization in India on January 3, 2021. However, there has been along delayin authorization by the World Health Organization (WHO). This week, it got delayed once again as the WHO asked for additional information and clarifications from Bharat Biotech. The WHO expects to meet again for a final evaluation on November 3, if it receives the data.\nAlthough the WHO approval isn’t necessary for use in India or the U.S., it is necessary for the vaccine to be recognized by foreign countries. It allows for fewer problems for vaccinated people in terms of international travel. WHO’s Emergency use listing (EUL) would mean the vaccine was eligible for global distribution to low- and middle-income countries under COVAX.\nShankar Musunuri, Ph.D., chairman, chief executive officer, and co-founder of Ocugen, said of the FDA application, “We are very excited to take this next step in the development of Covaxin, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public. We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population.”\nThe Phase III immuno-bridging study, if given the green light, would enroll several hundred healthy U.S. adults. The participants would be given either two doses of Covaxin or placebo, 28 days apart. The primary endpoint would compare blood samples from U.S. participants who received the vaccine with samples in the Phase III trial performed in India. A secondary endpoint is an immunogenic profile of the vaccine. It will also determine safety and tolerability in the U.S. population. Ocugen hopes to wrap up the study in the first half of 2022.\nThe Phase III trial in India performed by Bharat Biotech involved 25,798 participants who received the vaccine or placebo. The primary endpoint was the prevention of symptomatic COVID-19 within at least 14 days after the second dose.\nData from that trial reported 93.4% efficacy against severe COVID-19, 77.8% efficacy against symptomatic COVID-19, and 63.6% against asymptomatic disease. A sub-analysis of the data looked at its effectiveness against variants. The analysis showed that 90% of infections were associated with a variant, and 59% were the Delta variant. The vaccine demonstrated 65.2% efficacy against Delta.","news_type":1,"symbols_score_info":{"OCGN":0.9}},"isVote":1,"tweetType":1,"viewCount":3127,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":23,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"hasMoreComment":false,"orderType":2}