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君实生物(01877.HK)：暂停供应双抗体疗法并非撤回其在美国的紧急使用授权 _ 东方财富网

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　　格隆汇6月28日丨君实生物(01877.HK)发布公告，公司关注到有媒体报道，埃特司韦单抗(etesevimab，JS016) 1,400mg和巴尼韦单抗(bamlanivimab，LY-CoV555) 700mg双抗体疗法(“双抗体疗法”)在美国被停止分发。公司对报道内容进行了核实，现就主要情况作澄清说明如下：
　　美国疾控中心(CDC)近日监测到SARS-CoV-2的P.1/Gamma突变型(最先于巴西确认)及B.1.351/Beta突变型(最先于南非确认)在美国的总比例已超过11%并呈上升趋势，美国政府相关部门于当地时间2021年6月25日宣布在美国暂停供应双抗体疗法直至另行通知。
　　上述暂停供应双抗体疗法并非撤回其在美国的紧急使用授权(EUA)。根据2021年6月刊登在国际权威学术期刊《细胞》(CELL)的论文Tackling COVID-19 with neutralizing monoclonal antibodies显示，双抗体疗法针对B.1.1.7/Alpha突变型(最早于英国确认，目前占美国的SARS-CoV-2比例约60%)及B.1.617.1突变型(最早于印度确认)均有效。过去数月内美国各地区SARS-CoV-2各突变类型所占比例变化较快，未来双抗体疗法仍有可能在美国恢复使用。公司合作伙伴美国礼来公司将继续在除大中华地区外的其他区域与监管机构持续沟通，确保适当的患者可获得双抗体疗法治疗。
　　公告表示，双抗体疗法的供应与美国疫情的发展及相关监管部门的审批相关，其後续变化存在高度不确定性，对公司未来业绩影响亦具有不确定性。医药产品具有高科技、高风险、高附加值的特点，药品的前期研发以及产品从研制、临床试验报批到投产的周期长、环节多，容易受到一些不确定性因素的影响。敬请广大投资者谨慎决策，注一锢范投资风险。公司将积极推进上述研发项目，并严格按照有关规定及时对项目後续进展情况履行信息披露义务。
（文章来源：格隆汇）

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Welcome To IANS Live - BUSINESS - Lilly gets emergency use permission for its drugs to treat Covid

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IANSLive
New Delhi, June 1 (IANS) American pharmaceutical company Eli Lilly has announced that it has received permission for restricted emergency use of its antibody drugs, bamlanivimab 700mg and etesevimab 1400mg, in India for the treatment of patients with mild to moderate coronavirus disease.

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Eli Lilly's antibody drugs against Covid-19 receive 'emergency' approval in India

Lilly is engaging in dialogue with government and regulatory authorities to donate bamlanivimab and etesevimab to speed up access and provide treatment options for patients with COVID-19, says the company

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Pharmaceutical company in Virginia promotes new COVID antibody treatment

A new COVID-19 antibody treatment recently authorized by the FDA could help prevent hospitalization and severe symptoms by 87%.

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Lilly' Bamlanivimab & Etesevimab Reduce Hospitalizations & Death In Phase 3 Trial For Early COVID-19

INDIANAPOLIS (dpa-AFX) - Eli Lilly and Co.'s (LLY) bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths

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Eli Lilly: U.S. Govt. To Buy Min. 100K Doses Of Bamlanivimab 700 Mg, Etesevimab 1400 Mg Together

INDIANAPOLIS (dpa-AFX) - Eli Lilly and Co. (LLY) announced Friday that the U.S. government has agreed to purchase a minimum of 100,000 doses of bamlanivimab (LY-CoV555) 700 mg and etesevimab

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Eli Lilly Covid-19 antibody drug approved; expected to handle mutations better

Eli Lilly Covid-19 antibody drug approved; expected to handle mutations better
By Riley Griffin
(Bloomberg) – Eli Lilly & Co.’s combination antibody drug for Covid-19 was cleared for emergency use by US regulators, providing doctors with a treatment option that is expected to be better able to combat new coronavirus mutations.
The Food and Drug Administration authorized the treatment for use in Covid-positive adults and children 12 and older who are at high risk of developing severe forms of the disease or progressing to the hospital, according to a fact sheet posted by the agency.
The combo treatment is the second antibody therapy from the Indianapolis-based drugmaker to gain an emergency authorization from the FDA. In November, the agency cleared Bamlanivimab, one of the two antibodies used in the cocktail, for use in non-hospitalized, high-risk patients with mild-to-moderate symptoms of Covid-19.

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Junshi Biosciences: Etesevimab (JS016) Administered with Bamlanivimab Receives FDA Emergency Use Authorization for COVID-19

Etesevimab and bamlanivimab administered together is authorized for treatment of recently diagnosed, mild to moderate COVID-19 in patients who are high risk for progression to severe COVID-19More than

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Eli Lilly scores FDA nod for COVID-19 antibody cocktail, aims to make 1M doses by midyear

Two weeks after Eli Lilly unveiled data showing its COVID-19 combo of bamlanivimab and etesevimab slashed the risk of death and hospitalization for high-risk patients, the antibody cocktail has won its emergency FDA authorization. The nod squares Lilly up to Regeneron, which till now had the only authorized dual-antibody coronavirus cocktail.

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