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2021-12-02

Informative

Glaxo says its vaccine retains activity against key Omicron mutations<blockquote>葛兰素史克表示其疫苗保留了针对关键奥密克戎突变的活性</blockquote>

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These data were generated through pseudo-virus testing of specific individual mutations found in Omicron. To date, sotrovimab has demonstrated ongoing activity against all tested variants of concern and interest defined by the World Health Organization (WHO). The companies are now completing in vitro pseudo-virus testing to confirm the neutralising activity of sotrovimab against the combination of all the Omicron mutations with the intent to provide an update by the end of 2021.<blockquote>葛兰素史克公司和Vir Biotechnology，Inc.今天宣布更新预印本服务器bioRxiv，临床前数据表明，研究中的单克隆抗体sotrovimab保留了针对新奥密克戎新型冠状病毒病毒变异体（B.1.1.529）关键突变[1]的活性，包括在sotrovimab结合位点发现的突变。这些数据是通过对在奥密克戎发现的特定个体突变进行假病毒测试而产生的。迄今为止，sotrovimab已证明对世界卫生组织(WHO)定义的所有受关注和感兴趣的测试变体具有持续的活性。两家公司目前正在完成体外假病毒测试，以确认sotrovimab对所有奥密克戎突变组合的中和活性，并打算在2021年底前提供更新。</blockquote> George Scangos, PhD, Chief Executive Officer of Vir, said:“Sotrovimab was deliberately designed with a mutating virus in mind. By targeting a highly conserved region of the spike protein that is less likely to mutate, we hoped to address both the current SARS-CoV-2 virus and future variants that we expected would be inevitable. This hypothesis has borne out again and again – with its ongoing ability to maintain activity against all tested variants of concern and interest to date, including key mutations found in Omicron, as demonstrated by preclinical data. We have every expectation that this positive trend will continue and are working rapidly to confirm its activity against the full combination sequence of Omicron.”<blockquote>Vir首席执行官George Scangos博士表示：“Sotrovimab在设计时考虑到了一种突变病毒。通过靶向刺突蛋白中不太可能突变的高度保守区域，我们希望解决当前的新型冠状病毒病毒和我们预计不可避免的未来变种。这一假设已经一次又一次地得到证实——正如临床前数据所证明的那样，它能够持续保持针对迄今为止所有受关注和感兴趣的测试变种的活性，包括在奥密克戎发现的关键突变。我们完全预计这种积极趋势将持续下去，并正在迅速努力确认其针对奥密克戎全组合序列的活性。”</blockquote> Dr Hal Barron, Chief Scientific Officer and President R&amp;D, GSK, said:“Since the beginning of the pandemic, we have been working with Vir to combine our scientific expertise and technologies to deliver an enduring treatment option for patients with COVID-19. Though very early, these pre-clinical data support our long-held view on the potential for sotrovimab to maintain its activity as the virus continues to mutate. We are pleased that this treatment option is available to patients in the US and many other countries, and are working to expand access worldwide.”<blockquote>葛兰素史克首席科学官兼研发总裁Hal Barron博士表示：“自大流行开始以来，我们一直与Vir合作，结合我们的科学专业知识和技术，为COVID-19患者提供持久的治疗选择。虽然还为时过早，但这些临床前数据支持了我们长期以来的观点随着病毒的不断变异，sotrovimab有可能保持其活性。我们很高兴美国和许多其他国家的患者可以使用这种治疗方案，并正在努力扩大全球范围。”</blockquote> About sotrovimab<blockquote>关于sotrovimab</blockquote> Sotrovimab is an investigational SARS-CoV-2 neutralising monoclonal antibody. The antibody binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. Sotrovimab, which incorporates Xencor’s Xtend™ technology, has also been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.<blockquote>Sotrovimab是一种在研新型冠状病毒中和单克隆抗体。该抗体与新型冠状病毒上与SARS-CoV-1（导致SARS的病毒）共有的表位结合，表明该表位高度保守，这可能会使耐药性更难产生。Sotrovimab，结合了Xencor的Xtend™技术，也被设计成在肺中实现高浓度，以确保最佳渗透到受新型冠状病毒病影响的气道组织中，并具有延长的半衰期。</blockquote> Updated in vitro data, published in bioRxiv, demonstrate that sotrovimab retains activity against all current tested variants of concern and interest of the SARS-CoV-2 virus as defined by WHO, plus others, including but not limited to Delta (B.1.617.2), Delta Plus (AY.1 or AY.2), Mu (B.1.621) and key mutations of Omicron (B.1.1.529).<blockquote>发表在bioRxiv上的更新体外数据表明，sotrovimab保留了针对世卫组织定义的所有当前测试的受关注和感兴趣的新型冠状病毒病毒变体以及其他变体的活性，包括但不限于Delta(B.1.617.2)、Delta Plus(AY.1或AY.2)、Mu(B.1.621)和奥密克戎病毒的关键突变(B.1.1.529)。</blockquote> About the sotrovimab clinical development programme<blockquote>关于sotrovimab临床开发项目</blockquote> <ul> <li>COMET-ICE: a Phase III, multi-centre, double-blind, placebo-controlled trial investigated an intravenous (IV) infusion of sotrovimab in adults with mild-to-moderate COVID-19 at high risk of progression to severe disease, who are not hospitalised and not requiring oxygen. The final COMET-ICE trial results in the full trial population of 1,057 participants demonstrated a 79% reduction (adjusted relative risk reduction) (p&lt;0.001) in hospitalisation for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial. Interim data were published inThe New England Journal of Medicineon 27 October 2021 and final data were pre-published on 8 November 2021 onmedRxiv.</li> <li>COMET-TAIL: a Phase III, randomised, multi-centre, open-label, non-inferiority trial of intramuscular (IM) versus IV administration of sotrovimab for the early treatment of mild-to-moderate COVID-19 in high-risk non-hospitalised adult and paediatric patients (12 years of age and older). The trial’s primary endpoint was met, and headline data demonstrated that intramuscularly administered sotrovimab was non-inferior and offered similar efficacy to intravenous administration for high-risk populations. The companies plan to submit the complete COMET-TAIL data set to a peer-reviewed journal for publication in the first quarter of 2022.</li> <li>COMET-PEAK: a Phase II, randomised, multi-centre, parallel-group trial evaluating IV and IM administration of sotrovimab in outpatients with mild-to-moderate COVID-19. Data available to date from open-label Part B of the trial (500mg IV vs. 500mg IM) demonstrated equivalence on the virological response between the IM and IV arms. The companies plan to submit the complete COMET-PEAK data set to a peer-reviewed journal for publication in due course.</li> <li>GSK and Vir are also partnering to investigate the use of sotrovimab in uninfected immunocompromised adults to determine whether sotrovimab can prevent symptomatic COVID-19 infection. GSK and Vir are supporting investigator-sponsored studies and fostering scientific collaborations with experienced investigators and networks involved in the continuum of care of immunocompromised patients, to understand the role sotrovimab for prophylaxis could play in this population. Discussions with regulatory authorities regarding the prophylaxis programme will take place in due course.</li> </ul> About global access to sotrovimab<blockquote><ul><li>COMET-ICE：一项III期、多中心、双盲、安慰剂对照试验研究了在进展为严重疾病的高风险、未住院且不需要氧气的轻度至中度新冠肺炎成人中静脉（IV）输注sotrovimab。在1,057名参与者的完整试验人群中，最终COMET-ICE试验结果显示，与安慰剂相比，第29天住院超过24小时或因任何原因死亡的人数减少了79%（调整后的相对风险降低）（p&lt;0.001），达到了试验的主要终点。中期数据发表于新英格兰医学杂志于二零二一年十月二十七日及最终数据于二零二一年十一月八日预先公布medRxiv.</li><li>COMET-TAIL：一项III期、随机、多中心、开放标签、非劣效性试验，在高危非住院成人和儿童患者（12岁及以上）中，肌肉注射（IM）与静脉注射sotrovimab用于早期治疗轻度至中度新冠肺炎。该试验的主要终点达到了，主要数据表明，对于高危人群，肌肉注射sotrovimab并不劣效，并且提供了与静脉注射相似的疗效。两家公司计划将完整的彗尾数据集提交给同行评审期刊，以便于2022年第一季度发表。</li><li>COMET-PEAK：一项II期、随机、多中心、平行组试验，评估轻度至中度新冠肺炎门诊患者静脉注射和肌肉注射sotrovimab。迄今为止，来自试验开放标签B部分的可用数据（500mg IV vs.500mg IM）证明了IM组和IV组之间的病毒学应答等效。两家公司计划将完整的彗星峰值数据集提交给同行评审期刊，以便在适当的时候发表。</li><li>GSK和Vir还合作研究sotrovimab在未感染的免疫功能低下成人中的使用情况，以确定sotrovimab是否可以预防有症状的新冠肺炎感染。GSK和Vir正在支持研究者赞助的研究，并促进与参与免疫功能低下患者连续护理的经验丰富的研究者和网络的科学合作，以了解sotrovimab在该人群中的预防作用。将在适当的时候与监管机构讨论预防计划。</li></ul>关于sotrovimab的全球准入</blockquote> <ul> <li>Sotrovimab is authorised for emergency use in the United States. Xevudy (sotrovimab) received apositive scientific opinionunder Article 5(3) of Regulation 726/2004 from the Committee for Human Medicinal Products (CHMP) in the EU, has been granted a provisional marketing authorisation in Australia, and conditional marketing authorisation in Saudi Arabia. In Japan, it has been approved via the Special Approval for Emergency Pathway. Temporary authorisations for sotrovimab have been granted in a dozen countries.</li> <li>GSK and Vir also recently submitted the Marketing Authorisation Application (MAA) to the European Medicines Agency for Xevudy (sotrovimab) for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at risk of progressing to severe</li> <li>COVID-19.</li> <li>Sotrovimab is supplied in several countries worldwide, including through national agreements in the United States, United Kingdom, Japan, Australia, Canada, Singapore, Switzerland and United Arab Emirates. We have also signed a Joint Procurement Agreement with the European Commission to supply doses of sotrovimab. Additional agreements are yet to be announced due to confidentiality or regulatory requirements.</li> </ul> Sotrovimab in the United States<blockquote><ul><li>Sotrovimab在美国被授权紧急使用。Xevudy(sotrovimab)根据欧盟人类药品委员会(CHMP)第726/2004号法规第5(3)条获得了积极的科学意见，已在澳大利亚获得临时营销授权，在沙特阿拉伯获得有条件营销授权。在日本，它已通过紧急途径的特别批准获得批准。sotrovimab已在十几个国家获得临时授权。</li><li>GSK和Vir最近还向欧洲药品管理局提交了Xevudy（sotrovimab）的上市许可申请（MAA），用于治疗患有冠状病毒疾病2019（COVID-19）的成人和青少年（12岁及以上，体重至少40公斤），这些人不需要补充氧气，并且有进展为严重的风险</li><li>新冠肺炎。</li><li>Sotrovimab在全球多个国家供应，包括通过美国、英国、日本、澳大利亚、加拿大、新加坡、瑞士和阿拉伯联合酋长国的国家协议。我们还与欧盟委员会签署了一项联合采购协议，以供应sotrovimab的剂量。由于保密或监管要求，其他协议尚未公布。</li></ul>Sotrovimab在美国</blockquote> The following is a summary of information for sotrovimab. Healthcare providers in the U.S. should review the Fact Sheets for information about the authorised use of sotrovimab and mandatory requirements of the EUA. Please see theFood and Drug Administration (FDA) Letter of Authorization, fullFact Sheet for Healthcare Providers, and fullFact Sheet for Patients, Parents, and Caregivers.<blockquote>以下是sotrovimab的信息总结。美国的医疗保健提供者应查看情况说明书，了解有关sotrovimab授权使用和EUA强制性要求的信息。请参见食品药品监督管理局（FDA）的授权书、医疗保健提供者的完整情况说明书和患者、父母和护理人员的完整情况说明书。</blockquote> Sotrovimab has been authorized by the U.S. FDA for the emergency use described below. Sotrovimab is not FDA-approved for this use.<blockquote>Sotrovimab已获得美国FDA的紧急使用授权，如下所述。Sotrovimab未被FDA批准用于此用途。</blockquote> Sotrovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of sotrovimab under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.<blockquote>Sotrovimab仅在根据法案第564（b）（1）节，21 U.S.C.360BBB-3（b）（1）宣布存在证明授权紧急使用Sotrovimab的情况期间获得授权，除非授权提前终止或撤销。</blockquote> Authorized Use<blockquote>授权使用</blockquote> The U.S. FDA has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product sotrovimab for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.<blockquote>美国FDA已发布紧急使用授权（EUA），允许紧急使用未经批准的产品sotrovimab，用于治疗成人和儿科患者（12岁及以上，体重至少40公斤）的轻中度冠状病毒疾病2019（COVID-19），这些患者直接新型冠状病毒病毒检测结果呈阳性，并且有进展为严重COVID-19（包括住院或死亡）的高风险。</blockquote> Limitations of Authorized Use<blockquote>授权使用的限制</blockquote> Sotrovimab is not authorized for use in patients:<blockquote>Sotrovimab未被授权用于以下患者：</blockquote> <ul> <li>who are hospitalized due to COVID-19, OR</li> <li>who require oxygen therapy due to COVID-19, OR</li> <li>who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity)</li> </ul> Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID 19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID 19 requiring high flow oxygen or mechanical ventilation.<blockquote><ul><li>因COVID-19住院的人，或</li><li>因COVID-19需要氧疗的人，或</li><li>因新冠肺炎而需要增加基线氧流量的人（因潜在的非新冠肺炎相关合并症而接受慢性氧疗的人）</li></ul>在因COVID 19住院的患者中未观察到sotrovimab治疗的益处。当给予需要高流量氧气或机械通气的COVID 19住院患者时，新型冠状病毒单克隆抗体可能与更差的临床结局相关。</blockquote> Important Safety Information<blockquote>重要安全信息</blockquote> CONTRAINDICATIONS<blockquote>禁忌证</blockquote> Sotrovimab is contraindicated in patients who have a history of anaphylaxis to sotrovimab or to any of the excipients in the formulation.<blockquote>对sotrovimab或制剂中的任何赋形剂有过敏反应史的患者禁用sotrovimab。</blockquote> WARNINGS AND PRECAUTIONS<blockquote>警告和注意事项</blockquote> There are limited clinical data available for sotrovimab. Serious and unexpected adverse events may occur that have not been previously reported with sotrovimab use.<blockquote>sotrovimab的可用临床数据有限。使用sotrovimab可能会发生以前未报告的严重和意外不良事件。</blockquote> Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions<blockquote>超敏反应，包括过敏反应和输液相关反应</blockquote> Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of sotrovimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.<blockquote>服用sotrovimab后观察到严重的超敏反应，包括过敏反应。如果出现临床上显著的超敏反应或过敏反应的体征和症状，立即停止给药并开始适当的药物和/或支持性护理。</blockquote> Infusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of sotrovimab. These reactions may be severe or life threatening.<blockquote>服用sotrovimab时观察到输注期间和输注后24小时内发生的输注相关反应。这些反应可能很严重或危及生命。</blockquote> Signs and symptoms of infusion-related reactions may include: fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vaso-vagal reactions (eg, pre-syncope, syncope), dizziness and diaphoresis.<blockquote>输注相关反应的体征和症状可能包括：发热、呼吸困难、氧饱和度降低、寒战、疲劳、心律失常（如房颤、窦性心动过速、心动过缓）、胸痛或不适、虚弱、精神状态改变、恶心、头痛、支气管痉挛、低血压、高血压、血管水肿、咽喉刺激、皮疹（包括荨麻疹）、瘙痒、肌痛、血管迷走神经反应（如晕厥前、晕厥）、头晕和出汗。</blockquote> Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs.<blockquote>如果发生输注相关反应，考虑减慢或停止输注，并给予适当的药物和/或支持性护理。</blockquote> Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization.<blockquote>在紧急使用授权下使用新型冠状病毒单克隆抗体时，也报告了输注后超过24小时发生的超敏反应。</blockquote> Clinical Worsening After SARS-CoV-2 Monoclonal Antibody Administration<blockquote>新型冠状病毒单克隆抗体给药后临床恶化</blockquote> Clinical worsening of COVID‑19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (eg, atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID‑19.<blockquote>据报道，接受新型冠状病毒单克隆抗体治疗后，COVID-19的临床恶化可能包括发热、缺氧或呼吸困难增加、心律失常（如房颤、心动过速、心动过缓）、疲劳和精神状态改变的体征或症状。其中一些事件需要住院治疗。尚不清楚这些事件是与新型冠状病毒单克隆抗体的使用有关，还是由于COVID-19的进展。</blockquote> Limitations of Benefit and Potential for Risk in Patients with Severe COVID‑19<blockquote>重症COVID-19患者的获益限制和潜在风险</blockquote> Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID‑19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID‑19 requiring high flow oxygen or mechanical ventilation. Therefore, sotrovimab is not authorized for use in patients: who are hospitalized due to COVID‑19, OR who require oxygen therapy due to COVID‑19, OR who require an increase in baseline oxygen flow rate due to COVID‑19 in those on chronic oxygen therapy due to underlying non‑COVID‑19 related comorbidity.<blockquote>在因COVID-19住院的患者中未观察到sotrovimab治疗的益处。当给予需要高流量氧气或机械通气的COVID-19住院患者时，新型冠状病毒单克隆抗体可能与更差的临床结局相关。因此，sotrovimab未被授权用于以下患者：因新冠肺炎住院的患者，或因新冠肺炎需要氧疗的患者，或因新冠肺炎需要增加基线氧流量的患者，以及因潜在的非新冠肺炎相关合并症而接受慢性氧疗的患者。</blockquote> ADVERSE EVENTS<blockquote>不良事件</blockquote> Hypersensitivity adverse reactions have been observed in 2% of patients treated with sotrovimab and 1% with placebo in COMET-ICE.<blockquote>在COMET-ICE中，在2%接受sotrovimab治疗的患者和1%接受安慰剂治疗的患者中观察到超敏反应。</blockquote> The most common treatment-emergent adverse events observed in the sotrovimab treatment group in COMET-ICE were rash (1%) and diarrhea (2%), all of which were Grade 1 (mild) or Grade 2 (moderate). No other treatment-emergent adverse events were reported at a higher rate with sotrovimab compared to placebo.<blockquote>COMET-ICE中sotrovimab治疗组观察到的最常见的治疗后出现的不良事件为皮疹（1%）和腹泻（2%），均为1级（轻度）或2级（中度）。与安慰剂相比，sotrovimab组未报告其他治疗中出现的不良事件发生率更高。</blockquote> USE IN SPECIFIC POPULATIONS<blockquote>用于特定人群</blockquote> Pregnancy<blockquote>妊娠</blockquote> There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome. Sotrovimab should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.<blockquote>没有足够的数据来评估药物相关的重大出生缺陷、流产或不良母体或胎儿结局的风险。只有当潜在益处证明对母亲和胎儿的潜在风险合理时，才应在妊娠期间使用Sotrovimab。</blockquote> Lactation<blockquote>哺乳期</blockquote> There are no available data on the presence of sotrovimab in human milk, the effects on the breastfed infant, or the effects on milk production. Individuals with COVID-19 who are breastfeeding should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.<blockquote>没有关于母乳中sotrovimab的存在、对母乳喂养婴儿的影响或对产奶量的影响的可用数据。正在母乳喂养的新冠肺炎患者应遵循临床指南的做法，以避免婴儿接触新冠肺炎。</blockquote> About the GSK and Vir collaboration<blockquote>关于GSK与Vir的合作</blockquote> In April 2020, GSK and Vir entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.<blockquote>2020年4月，葛兰素史克和Vir达成合作，研究和开发冠状病毒的解决方案，包括导致COVID-19的新型冠状病毒病毒。此次合作使用Vir专有的单克隆抗体平台技术来加速现有的和识别新的抗病毒抗体，这些抗体可用作治疗或预防选择，以帮助应对当前的新冠肺炎疫情和未来的疫情。两家公司将利用GSK在功能基因组学方面的专业知识，并结合其在CRISPR筛选和人工智能方面的能力，以识别靶向细胞宿主基因的抗冠状病毒化合物。他们还将运用他们的综合专业知识来研究新型冠状病毒和其他冠状病毒疫苗。</blockquote> GSK commitment to tackling COVID-19<blockquote>葛兰素史克致力于应对COVID-19</blockquote> GSK’s response to COVID-19 has been one of the broadest in the industry, with potential treatments in addition to our vaccine candidates in development with partner organisations.<blockquote>葛兰素史克对新冠肺炎的反应是业内最广泛的反应之一，除了我们与合作伙伴组织正在开发的候选疫苗之外，还有潜在的治疗方法。</blockquote> GSK is collaborating with several organisations on COVID-19 vaccines by providing access to our adjuvant technology. We are working with Sanofi S.A., Medicago Inc. and SK bioscience Co., Ltd. to develop adjuvanted, protein-based vaccine candidates, and all are now in Phase III clinical trials. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protecting more people in need.<blockquote>葛兰素史克正在与几个组织合作开发新冠肺炎疫苗，提供我们的佐剂技术。我们正在与Sanofi S.A.、Medicago Inc.和SK bioscience Co., Ltd.合作开发基于佐剂的蛋白质候选疫苗，目前均处于III期临床试验。佐剂的使用在大流行中可能特别重要，因为它可以减少每剂所需的疫苗蛋白的量，允许生产更多的疫苗剂量并有助于保护更多有需要的人。</blockquote> GSK is also working with mRNA specialist, CureVac N.V., to jointly develop next-generation, optimised mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine.<blockquote>葛兰素史克还与mRNA专家CureVac N.V.合作，共同开发下一代优化的新冠肺炎mRNA疫苗，有可能在一种疫苗中解决多种新出现的变异。</blockquote> GSK is also exploring treatments for COVID-19 patients, collaborating with Vir Biotechnology to investigate monoclonal antibodies that could be used as therapeutic or preventive options for COVID-19.<blockquote>葛兰素史克还在探索新冠肺炎患者的治疗方法，与Vir Biotechnology合作研究可用作新冠肺炎治疗或预防选择的单克隆抗体。</blockquote> Vir’s commitment to COVID-19<blockquote>Vir对COVID-19的承诺</blockquote> Vir was founded with the mission of addressing the world’s most serious infectious diseases. In 2020, Vir responded rapidly to the COVID-19 pandemic by leveraging our unique scientific insights and industry-leading antibody platform to explore multiple monoclonal antibodies as potential therapeutic or preventive options for COVID-19. Sotrovimab is the first SARS-CoV-2-targeting antibody Vir advanced into the clinic. It was carefully selected for its demonstrated promise in preclinical research, including an anticipated high barrier to resistance and potential ability to both block the virus from entering healthy cells and clear infected cells. Vir is continuing to pursue novel therapeutic and prophylactic solutions to combat SARS-CoV-2 and future coronavirus pandemics, both independently and in collaboration with its partners.<blockquote>Vir成立的使命是解决世界上最严重的传染病。2020年，Vir利用我们独特的科学见解和行业领先的抗体平台，探索多种单克隆抗体作为COVID-19的潜在治疗或预防选择，迅速应对COVID-19大流行。Sotrovimab是第一个挺进临床的新型冠状病毒靶向抗体Vir。它被精心选择是因为它在临床前研究中表现出的前景，包括预期的高耐药性屏障和阻止病毒进入健康细胞和清除受感染细胞的潜在能力。Vir正在继续寻求新的治疗和预防解决方案，以应对新型冠状病毒和未来的冠状病毒大流行，无论是独立还是与其合作伙伴合作。</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>Glaxo says its vaccine retains activity against key Omicron mutations<blockquote>葛兰素史克表示其疫苗保留了针对关键奥密克戎突变的活性</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\">\nGlaxo says its vaccine retains activity against key Omicron mutations<blockquote>葛兰素史克表示其疫苗保留了针对关键奥密克戎突变的活性</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 \n2021-12-02 15:14\n</div>\n</a>\n</h4>\n</header>\n<article>\nGlaxoSmithKline plc&nbsp;and Vir Biotechnology, Inc.&nbsp;today announced an update to bioRxiv, a preprint server, with preclinical data demonstrating that sotrovimab, an investigational monoclonal antibody, retains activity against key mutations[1]&nbsp;of the new Omicron SARS-CoV-2 variant (B.1.1.529), including those found in the binding site of sotrovimab. These data were generated through pseudo-virus testing of specific individual mutations found in Omicron. To date, sotrovimab has demonstrated ongoing activity against all tested variants of concern and interest defined by the World Health Organization (WHO). The companies are now completing in vitro pseudo-virus testing to confirm the neutralising activity of sotrovimab against the combination of all the Omicron mutations with the intent to provide an update by the end of 2021.<blockquote>葛兰素史克公司和Vir Biotechnology，Inc.今天宣布更新预印本服务器bioRxiv，临床前数据表明，研究中的单克隆抗体sotrovimab保留了针对新奥密克戎新型冠状病毒病毒变异体（B.1.1.529）关键突变[1]的活性，包括在sotrovimab结合位点发现的突变。这些数据是通过对在奥密克戎发现的特定个体突变进行假病毒测试而产生的。迄今为止，sotrovimab已证明对世界卫生组织(WHO)定义的所有受关注和感兴趣的测试变体具有持续的活性。两家公司目前正在完成体外假病毒测试，以确认sotrovimab对所有奥密克戎突变组合的中和活性，并打算在2021年底前提供更新。</blockquote> George Scangos, PhD, Chief Executive Officer of Vir, said:“Sotrovimab was deliberately designed with a mutating virus in mind. By targeting a highly conserved region of the spike protein that is less likely to mutate, we hoped to address both the current SARS-CoV-2 virus and future variants that we expected would be inevitable. This hypothesis has borne out again and again – with its ongoing ability to maintain activity against all tested variants of concern and interest to date, including key mutations found in Omicron, as demonstrated by preclinical data. We have every expectation that this positive trend will continue and are working rapidly to confirm its activity against the full combination sequence of Omicron.”<blockquote>Vir首席执行官George Scangos博士表示：“Sotrovimab在设计时考虑到了一种突变病毒。通过靶向刺突蛋白中不太可能突变的高度保守区域，我们希望解决当前的新型冠状病毒病毒和我们预计不可避免的未来变种。这一假设已经一次又一次地得到证实——正如临床前数据所证明的那样，它能够持续保持针对迄今为止所有受关注和感兴趣的测试变种的活性，包括在奥密克戎发现的关键突变。我们完全预计这种积极趋势将持续下去，并正在迅速努力确认其针对奥密克戎全组合序列的活性。”</blockquote> Dr Hal Barron, Chief Scientific Officer and President R&amp;D, GSK, said:“Since the beginning of the pandemic, we have been working with Vir to combine our scientific expertise and technologies to deliver an enduring treatment option for patients with COVID-19. Though very early, these pre-clinical data support our long-held view on the potential for sotrovimab to maintain its activity as the virus continues to mutate. We are pleased that this treatment option is available to patients in the US and many other countries, and are working to expand access worldwide.”<blockquote>葛兰素史克首席科学官兼研发总裁Hal Barron博士表示：“自大流行开始以来，我们一直与Vir合作，结合我们的科学专业知识和技术，为COVID-19患者提供持久的治疗选择。虽然还为时过早，但这些临床前数据支持了我们长期以来的观点随着病毒的不断变异，sotrovimab有可能保持其活性。我们很高兴美国和许多其他国家的患者可以使用这种治疗方案，并正在努力扩大全球范围。”</blockquote> About sotrovimab<blockquote>关于sotrovimab</blockquote> Sotrovimab is an investigational SARS-CoV-2 neutralising monoclonal antibody. The antibody binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. Sotrovimab, which incorporates Xencor’s Xtend™ technology, has also been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.<blockquote>Sotrovimab是一种在研新型冠状病毒中和单克隆抗体。该抗体与新型冠状病毒上与SARS-CoV-1（导致SARS的病毒）共有的表位结合，表明该表位高度保守，这可能会使耐药性更难产生。Sotrovimab，结合了Xencor的Xtend™技术，也被设计成在肺中实现高浓度，以确保最佳渗透到受新型冠状病毒病影响的气道组织中，并具有延长的半衰期。</blockquote> Updated in vitro data, published in bioRxiv, demonstrate that sotrovimab retains activity against all current tested variants of concern and interest of the SARS-CoV-2 virus as defined by WHO, plus others, including but not limited to Delta (B.1.617.2), Delta Plus (AY.1 or AY.2), Mu (B.1.621) and key mutations of Omicron (B.1.1.529).<blockquote>发表在bioRxiv上的更新体外数据表明，sotrovimab保留了针对世卫组织定义的所有当前测试的受关注和感兴趣的新型冠状病毒病毒变体以及其他变体的活性，包括但不限于Delta(B.1.617.2)、Delta Plus(AY.1或AY.2)、Mu(B.1.621)和奥密克戎病毒的关键突变(B.1.1.529)。</blockquote> About the sotrovimab clinical development programme<blockquote>关于sotrovimab临床开发项目</blockquote> <ul> <li>COMET-ICE: a Phase III, multi-centre, double-blind, placebo-controlled trial investigated an intravenous (IV) infusion of sotrovimab in adults with mild-to-moderate COVID-19 at high risk of progression to severe disease, who are not hospitalised and not requiring oxygen. The final COMET-ICE trial results in the full trial population of 1,057 participants demonstrated a 79% reduction (adjusted relative risk reduction) (p&lt;0.001) in hospitalisation for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial. Interim data were published inThe New England Journal of Medicineon 27 October 2021 and final data were pre-published on 8 November 2021 onmedRxiv.</li> <li>COMET-TAIL: a Phase III, randomised, multi-centre, open-label, non-inferiority trial of intramuscular (IM) versus IV administration of sotrovimab for the early treatment of mild-to-moderate COVID-19 in high-risk non-hospitalised adult and paediatric patients (12 years of age and older). The trial’s primary endpoint was met, and headline data demonstrated that intramuscularly administered sotrovimab was non-inferior and offered similar efficacy to intravenous administration for high-risk populations. The companies plan to submit the complete COMET-TAIL data set to a peer-reviewed journal for publication in the first quarter of 2022.</li> <li>COMET-PEAK: a Phase II, randomised, multi-centre, parallel-group trial evaluating IV and IM administration of sotrovimab in outpatients with mild-to-moderate COVID-19. Data available to date from open-label Part B of the trial (500mg IV vs. 500mg IM) demonstrated equivalence on the virological response between the IM and IV arms. The companies plan to submit the complete COMET-PEAK data set to a peer-reviewed journal for publication in due course.</li> <li>GSK and Vir are also partnering to investigate the use of sotrovimab in uninfected immunocompromised adults to determine whether sotrovimab can prevent symptomatic COVID-19 infection. GSK and Vir are supporting investigator-sponsored studies and fostering scientific collaborations with experienced investigators and networks involved in the continuum of care of immunocompromised patients, to understand the role sotrovimab for prophylaxis could play in this population. Discussions with regulatory authorities regarding the prophylaxis programme will take place in due course.</li> </ul> About global access to sotrovimab<blockquote><ul><li>COMET-ICE：一项III期、多中心、双盲、安慰剂对照试验研究了在进展为严重疾病的高风险、未住院且不需要氧气的轻度至中度新冠肺炎成人中静脉（IV）输注sotrovimab。在1,057名参与者的完整试验人群中，最终COMET-ICE试验结果显示，与安慰剂相比，第29天住院超过24小时或因任何原因死亡的人数减少了79%（调整后的相对风险降低）（p&lt;0.001），达到了试验的主要终点。中期数据发表于新英格兰医学杂志于二零二一年十月二十七日及最终数据于二零二一年十一月八日预先公布medRxiv.</li><li>COMET-TAIL：一项III期、随机、多中心、开放标签、非劣效性试验，在高危非住院成人和儿童患者（12岁及以上）中，肌肉注射（IM）与静脉注射sotrovimab用于早期治疗轻度至中度新冠肺炎。该试验的主要终点达到了，主要数据表明，对于高危人群，肌肉注射sotrovimab并不劣效，并且提供了与静脉注射相似的疗效。两家公司计划将完整的彗尾数据集提交给同行评审期刊，以便于2022年第一季度发表。</li><li>COMET-PEAK：一项II期、随机、多中心、平行组试验，评估轻度至中度新冠肺炎门诊患者静脉注射和肌肉注射sotrovimab。迄今为止，来自试验开放标签B部分的可用数据（500mg IV vs.500mg IM）证明了IM组和IV组之间的病毒学应答等效。两家公司计划将完整的彗星峰值数据集提交给同行评审期刊，以便在适当的时候发表。</li><li>GSK和Vir还合作研究sotrovimab在未感染的免疫功能低下成人中的使用情况，以确定sotrovimab是否可以预防有症状的新冠肺炎感染。GSK和Vir正在支持研究者赞助的研究，并促进与参与免疫功能低下患者连续护理的经验丰富的研究者和网络的科学合作，以了解sotrovimab在该人群中的预防作用。将在适当的时候与监管机构讨论预防计划。</li></ul>关于sotrovimab的全球准入</blockquote> <ul> <li>Sotrovimab is authorised for emergency use in the United States. Xevudy (sotrovimab) received apositive scientific opinionunder Article 5(3) of Regulation 726/2004 from the Committee for Human Medicinal Products (CHMP) in the EU, has been granted a provisional marketing authorisation in Australia, and conditional marketing authorisation in Saudi Arabia. In Japan, it has been approved via the Special Approval for Emergency Pathway. Temporary authorisations for sotrovimab have been granted in a dozen countries.</li> <li>GSK and Vir also recently submitted the Marketing Authorisation Application (MAA) to the European Medicines Agency for Xevudy (sotrovimab) for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at risk of progressing to severe</li> <li>COVID-19.</li> <li>Sotrovimab is supplied in several countries worldwide, including through national agreements in the United States, United Kingdom, Japan, Australia, Canada, Singapore, Switzerland and United Arab Emirates. We have also signed a Joint Procurement Agreement with the European Commission to supply doses of sotrovimab. Additional agreements are yet to be announced due to confidentiality or regulatory requirements.</li> </ul> Sotrovimab in the United States<blockquote><ul><li>Sotrovimab在美国被授权紧急使用。Xevudy(sotrovimab)根据欧盟人类药品委员会(CHMP)第726/2004号法规第5(3)条获得了积极的科学意见，已在澳大利亚获得临时营销授权，在沙特阿拉伯获得有条件营销授权。在日本，它已通过紧急途径的特别批准获得批准。sotrovimab已在十几个国家获得临时授权。</li><li>GSK和Vir最近还向欧洲药品管理局提交了Xevudy（sotrovimab）的上市许可申请（MAA），用于治疗患有冠状病毒疾病2019（COVID-19）的成人和青少年（12岁及以上，体重至少40公斤），这些人不需要补充氧气，并且有进展为严重的风险</li><li>新冠肺炎。</li><li>Sotrovimab在全球多个国家供应，包括通过美国、英国、日本、澳大利亚、加拿大、新加坡、瑞士和阿拉伯联合酋长国的国家协议。我们还与欧盟委员会签署了一项联合采购协议，以供应sotrovimab的剂量。由于保密或监管要求，其他协议尚未公布。</li></ul>Sotrovimab在美国</blockquote> The following is a summary of information for sotrovimab. Healthcare providers in the U.S. should review the Fact Sheets for information about the authorised use of sotrovimab and mandatory requirements of the EUA. Please see theFood and Drug Administration (FDA) Letter of Authorization, fullFact Sheet for Healthcare Providers, and fullFact Sheet for Patients, Parents, and Caregivers.<blockquote>以下是sotrovimab的信息总结。美国的医疗保健提供者应查看情况说明书，了解有关sotrovimab授权使用和EUA强制性要求的信息。请参见食品药品监督管理局（FDA）的授权书、医疗保健提供者的完整情况说明书和患者、父母和护理人员的完整情况说明书。</blockquote> Sotrovimab has been authorized by the U.S. FDA for the emergency use described below. Sotrovimab is not FDA-approved for this use.<blockquote>Sotrovimab已获得美国FDA的紧急使用授权，如下所述。Sotrovimab未被FDA批准用于此用途。</blockquote> Sotrovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of sotrovimab under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.<blockquote>Sotrovimab仅在根据法案第564（b）（1）节，21 U.S.C.360BBB-3（b）（1）宣布存在证明授权紧急使用Sotrovimab的情况期间获得授权，除非授权提前终止或撤销。</blockquote> Authorized Use<blockquote>授权使用</blockquote> The U.S. FDA has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product sotrovimab for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.<blockquote>美国FDA已发布紧急使用授权（EUA），允许紧急使用未经批准的产品sotrovimab，用于治疗成人和儿科患者（12岁及以上，体重至少40公斤）的轻中度冠状病毒疾病2019（COVID-19），这些患者直接新型冠状病毒病毒检测结果呈阳性，并且有进展为严重COVID-19（包括住院或死亡）的高风险。</blockquote> Limitations of Authorized Use<blockquote>授权使用的限制</blockquote> Sotrovimab is not authorized for use in patients:<blockquote>Sotrovimab未被授权用于以下患者：</blockquote> <ul> <li>who are hospitalized due to COVID-19, OR</li> <li>who require oxygen therapy due to COVID-19, OR</li> <li>who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity)</li> </ul> Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID 19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID 19 requiring high flow oxygen or mechanical ventilation.<blockquote><ul><li>因COVID-19住院的人，或</li><li>因COVID-19需要氧疗的人，或</li><li>因新冠肺炎而需要增加基线氧流量的人（因潜在的非新冠肺炎相关合并症而接受慢性氧疗的人）</li></ul>在因COVID 19住院的患者中未观察到sotrovimab治疗的益处。当给予需要高流量氧气或机械通气的COVID 19住院患者时，新型冠状病毒单克隆抗体可能与更差的临床结局相关。</blockquote> Important Safety Information<blockquote>重要安全信息</blockquote> CONTRAINDICATIONS<blockquote>禁忌证</blockquote> Sotrovimab is contraindicated in patients who have a history of anaphylaxis to sotrovimab or to any of the excipients in the formulation.<blockquote>对sotrovimab或制剂中的任何赋形剂有过敏反应史的患者禁用sotrovimab。</blockquote> WARNINGS AND PRECAUTIONS<blockquote>警告和注意事项</blockquote> There are limited clinical data available for sotrovimab. Serious and unexpected adverse events may occur that have not been previously reported with sotrovimab use.<blockquote>sotrovimab的可用临床数据有限。使用sotrovimab可能会发生以前未报告的严重和意外不良事件。</blockquote> Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions<blockquote>超敏反应，包括过敏反应和输液相关反应</blockquote> Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of sotrovimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.<blockquote>服用sotrovimab后观察到严重的超敏反应，包括过敏反应。如果出现临床上显著的超敏反应或过敏反应的体征和症状，立即停止给药并开始适当的药物和/或支持性护理。</blockquote> Infusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of sotrovimab. These reactions may be severe or life threatening.<blockquote>服用sotrovimab时观察到输注期间和输注后24小时内发生的输注相关反应。这些反应可能很严重或危及生命。</blockquote> Signs and symptoms of infusion-related reactions may include: fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vaso-vagal reactions (eg, pre-syncope, syncope), dizziness and diaphoresis.<blockquote>输注相关反应的体征和症状可能包括：发热、呼吸困难、氧饱和度降低、寒战、疲劳、心律失常（如房颤、窦性心动过速、心动过缓）、胸痛或不适、虚弱、精神状态改变、恶心、头痛、支气管痉挛、低血压、高血压、血管水肿、咽喉刺激、皮疹（包括荨麻疹）、瘙痒、肌痛、血管迷走神经反应（如晕厥前、晕厥）、头晕和出汗。</blockquote> Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs.<blockquote>如果发生输注相关反应，考虑减慢或停止输注，并给予适当的药物和/或支持性护理。</blockquote> Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization.<blockquote>在紧急使用授权下使用新型冠状病毒单克隆抗体时，也报告了输注后超过24小时发生的超敏反应。</blockquote> Clinical Worsening After SARS-CoV-2 Monoclonal Antibody Administration<blockquote>新型冠状病毒单克隆抗体给药后临床恶化</blockquote> Clinical worsening of COVID‑19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (eg, atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID‑19.<blockquote>据报道，接受新型冠状病毒单克隆抗体治疗后，COVID-19的临床恶化可能包括发热、缺氧或呼吸困难增加、心律失常（如房颤、心动过速、心动过缓）、疲劳和精神状态改变的体征或症状。其中一些事件需要住院治疗。尚不清楚这些事件是与新型冠状病毒单克隆抗体的使用有关，还是由于COVID-19的进展。</blockquote> Limitations of Benefit and Potential for Risk in Patients with Severe COVID‑19<blockquote>重症COVID-19患者的获益限制和潜在风险</blockquote> Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID‑19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID‑19 requiring high flow oxygen or mechanical ventilation. Therefore, sotrovimab is not authorized for use in patients: who are hospitalized due to COVID‑19, OR who require oxygen therapy due to COVID‑19, OR who require an increase in baseline oxygen flow rate due to COVID‑19 in those on chronic oxygen therapy due to underlying non‑COVID‑19 related comorbidity.<blockquote>在因COVID-19住院的患者中未观察到sotrovimab治疗的益处。当给予需要高流量氧气或机械通气的COVID-19住院患者时，新型冠状病毒单克隆抗体可能与更差的临床结局相关。因此，sotrovimab未被授权用于以下患者：因新冠肺炎住院的患者，或因新冠肺炎需要氧疗的患者，或因新冠肺炎需要增加基线氧流量的患者，以及因潜在的非新冠肺炎相关合并症而接受慢性氧疗的患者。</blockquote> ADVERSE EVENTS<blockquote>不良事件</blockquote> Hypersensitivity adverse reactions have been observed in 2% of patients treated with sotrovimab and 1% with placebo in COMET-ICE.<blockquote>在COMET-ICE中，在2%接受sotrovimab治疗的患者和1%接受安慰剂治疗的患者中观察到超敏反应。</blockquote> The most common treatment-emergent adverse events observed in the sotrovimab treatment group in COMET-ICE were rash (1%) and diarrhea (2%), all of which were Grade 1 (mild) or Grade 2 (moderate). No other treatment-emergent adverse events were reported at a higher rate with sotrovimab compared to placebo.<blockquote>COMET-ICE中sotrovimab治疗组观察到的最常见的治疗后出现的不良事件为皮疹（1%）和腹泻（2%），均为1级（轻度）或2级（中度）。与安慰剂相比，sotrovimab组未报告其他治疗中出现的不良事件发生率更高。</blockquote> USE IN SPECIFIC POPULATIONS<blockquote>用于特定人群</blockquote> Pregnancy<blockquote>妊娠</blockquote> There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome. Sotrovimab should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.<blockquote>没有足够的数据来评估药物相关的重大出生缺陷、流产或不良母体或胎儿结局的风险。只有当潜在益处证明对母亲和胎儿的潜在风险合理时，才应在妊娠期间使用Sotrovimab。</blockquote> Lactation<blockquote>哺乳期</blockquote> There are no available data on the presence of sotrovimab in human milk, the effects on the breastfed infant, or the effects on milk production. Individuals with COVID-19 who are breastfeeding should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.<blockquote>没有关于母乳中sotrovimab的存在、对母乳喂养婴儿的影响或对产奶量的影响的可用数据。正在母乳喂养的新冠肺炎患者应遵循临床指南的做法，以避免婴儿接触新冠肺炎。</blockquote> About the GSK and Vir collaboration<blockquote>关于GSK与Vir的合作</blockquote> In April 2020, GSK and Vir entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.<blockquote>2020年4月，葛兰素史克和Vir达成合作，研究和开发冠状病毒的解决方案，包括导致COVID-19的新型冠状病毒病毒。此次合作使用Vir专有的单克隆抗体平台技术来加速现有的和识别新的抗病毒抗体，这些抗体可用作治疗或预防选择，以帮助应对当前的新冠肺炎疫情和未来的疫情。两家公司将利用GSK在功能基因组学方面的专业知识，并结合其在CRISPR筛选和人工智能方面的能力，以识别靶向细胞宿主基因的抗冠状病毒化合物。他们还将运用他们的综合专业知识来研究新型冠状病毒和其他冠状病毒疫苗。</blockquote> GSK commitment to tackling COVID-19<blockquote>葛兰素史克致力于应对COVID-19</blockquote> GSK’s response to COVID-19 has been one of the broadest in the industry, with potential treatments in addition to our vaccine candidates in development with partner organisations.<blockquote>葛兰素史克对新冠肺炎的反应是业内最广泛的反应之一，除了我们与合作伙伴组织正在开发的候选疫苗之外，还有潜在的治疗方法。</blockquote> GSK is collaborating with several organisations on COVID-19 vaccines by providing access to our adjuvant technology. We are working with Sanofi S.A., Medicago Inc. and SK bioscience Co., Ltd. to develop adjuvanted, protein-based vaccine candidates, and all are now in Phase III clinical trials. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protecting more people in need.<blockquote>葛兰素史克正在与几个组织合作开发新冠肺炎疫苗，提供我们的佐剂技术。我们正在与Sanofi S.A.、Medicago Inc.和SK bioscience Co., Ltd.合作开发基于佐剂的蛋白质候选疫苗，目前均处于III期临床试验。佐剂的使用在大流行中可能特别重要，因为它可以减少每剂所需的疫苗蛋白的量，允许生产更多的疫苗剂量并有助于保护更多有需要的人。</blockquote> GSK is also working with mRNA specialist, CureVac N.V., to jointly develop next-generation, optimised mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine.<blockquote>葛兰素史克还与mRNA专家CureVac N.V.合作，共同开发下一代优化的新冠肺炎mRNA疫苗，有可能在一种疫苗中解决多种新出现的变异。</blockquote> GSK is also exploring treatments for COVID-19 patients, collaborating with Vir Biotechnology to investigate monoclonal antibodies that could be used as therapeutic or preventive options for COVID-19.<blockquote>葛兰素史克还在探索新冠肺炎患者的治疗方法，与Vir Biotechnology合作研究可用作新冠肺炎治疗或预防选择的单克隆抗体。</blockquote> Vir’s commitment to COVID-19<blockquote>Vir对COVID-19的承诺</blockquote> Vir was founded with the mission of addressing the world’s most serious infectious diseases. In 2020, Vir responded rapidly to the COVID-19 pandemic by leveraging our unique scientific insights and industry-leading antibody platform to explore multiple monoclonal antibodies as potential therapeutic or preventive options for COVID-19. Sotrovimab is the first SARS-CoV-2-targeting antibody Vir advanced into the clinic. It was carefully selected for its demonstrated promise in preclinical research, including an anticipated high barrier to resistance and potential ability to both block the virus from entering healthy cells and clear infected cells. Vir is continuing to pursue novel therapeutic and prophylactic solutions to combat SARS-CoV-2 and future coronavirus pandemics, both independently and in collaboration with its partners.<blockquote>Vir成立的使命是解决世界上最严重的传染病。2020年，Vir利用我们独特的科学见解和行业领先的抗体平台，探索多种单克隆抗体作为COVID-19的潜在治疗或预防选择，迅速应对COVID-19大流行。Sotrovimab是第一个挺进临床的新型冠状病毒靶向抗体Vir。它被精心选择是因为它在临床前研究中表现出的前景，包括预期的高耐药性屏障和阻止病毒进入健康细胞和清除受感染细胞的潜在能力。Vir正在继续寻求新的治疗和预防解决方案，以应对新型冠状病毒和未来的冠状病毒大流行，无论是独立还是与其合作伙伴合作。</blockquote>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"GSK":"葛兰素史克"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1197973971","content_text":"GlaxoSmithKline plc and Vir Biotechnology, Inc. today announced an update to bioRxiv, a preprint server, with preclinical data demonstrating that sotrovimab, an investigational monoclonal antibody, retains activity against key mutations[1] of the new Omicron SARS-CoV-2 variant (B.1.1.529), including those found in the binding site of sotrovimab. These data were generated through pseudo-virus testing of specific individual mutations found in Omicron. To date, sotrovimab has demonstrated ongoing activity against all tested variants of concern and interest defined by the World Health Organization (WHO). The companies are now completing in vitro pseudo-virus testing to confirm the neutralising activity of sotrovimab against the combination of all the Omicron mutations with the intent to provide an update by the end of 2021.\nGeorge Scangos, PhD, Chief Executive Officer of Vir, said:“Sotrovimab was deliberately designed with a mutating virus in mind. By targeting a highly conserved region of the spike protein that is less likely to mutate, we hoped to address both the current SARS-CoV-2 virus and future variants that we expected would be inevitable. This hypothesis has borne out again and again – with its ongoing ability to maintain activity against all tested variants of concern and interest to date, including key mutations found in Omicron, as demonstrated by preclinical data. We have every expectation that this positive trend will continue and are working rapidly to confirm its activity against the full combination sequence of Omicron.”\nDr Hal Barron, Chief Scientific Officer and President R&D, GSK, said:“Since the beginning of the pandemic, we have been working with Vir to combine our scientific expertise and technologies to deliver an enduring treatment option for patients with COVID-19. Though very early, these pre-clinical data support our long-held view on the potential for sotrovimab to maintain its activity as the virus continues to mutate. We are pleased that this treatment option is available to patients in the US and many other countries, and are working to expand access worldwide.”\nAbout sotrovimab\nSotrovimab is an investigational SARS-CoV-2 neutralising monoclonal antibody. The antibody binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. Sotrovimab, which incorporates Xencor’s Xtend™ technology, has also been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.\nUpdated in vitro data, published in bioRxiv, demonstrate that sotrovimab retains activity against all current tested variants of concern and interest of the SARS-CoV-2 virus as defined by WHO, plus others, including but not limited to Delta (B.1.617.2), Delta Plus (AY.1 or AY.2), Mu (B.1.621) and key mutations of Omicron (B.1.1.529).\nAbout the sotrovimab clinical development programme\n\nCOMET-ICE: a Phase III, multi-centre, double-blind, placebo-controlled trial investigated an intravenous (IV) infusion of sotrovimab in adults with mild-to-moderate COVID-19 at high risk of progression to severe disease, who are not hospitalised and not requiring oxygen. The final COMET-ICE trial results in the full trial population of 1,057 participants demonstrated a 79% reduction (adjusted relative risk reduction) (p<0.001) in hospitalisation for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial. Interim data were published inThe New England Journal of Medicineon 27 October 2021 and final data were pre-published on 8 November 2021 onmedRxiv.\nCOMET-TAIL: a Phase III, randomised, multi-centre, open-label, non-inferiority trial of intramuscular (IM) versus IV administration of sotrovimab for the early treatment of mild-to-moderate COVID-19 in high-risk non-hospitalised adult and paediatric patients (12 years of age and older). The trial’s primary endpoint was met, and headline data demonstrated that intramuscularly administered sotrovimab was non-inferior and offered similar efficacy to intravenous administration for high-risk populations. The companies plan to submit the complete COMET-TAIL data set to a peer-reviewed journal for publication in the first quarter of 2022.\nCOMET-PEAK: a Phase II, randomised, multi-centre, parallel-group trial evaluating IV and IM administration of sotrovimab in outpatients with mild-to-moderate COVID-19. Data available to date from open-label Part B of the trial (500mg IV vs. 500mg IM) demonstrated equivalence on the virological response between the IM and IV arms. The companies plan to submit the complete COMET-PEAK data set to a peer-reviewed journal for publication in due course.\nGSK and Vir are also partnering to investigate the use of sotrovimab in uninfected immunocompromised adults to determine whether sotrovimab can prevent symptomatic COVID-19 infection. GSK and Vir are supporting investigator-sponsored studies and fostering scientific collaborations with experienced investigators and networks involved in the continuum of care of immunocompromised patients, to understand the role sotrovimab for prophylaxis could play in this population. Discussions with regulatory authorities regarding the prophylaxis programme will take place in due course.\n\nAbout global access to sotrovimab\n\nSotrovimab is authorised for emergency use in the United States. Xevudy (sotrovimab) received apositive scientific opinionunder Article 5(3) of Regulation 726/2004 from the Committee for Human Medicinal Products (CHMP) in the EU, has been granted a provisional marketing authorisation in Australia, and conditional marketing authorisation in Saudi Arabia. In Japan, it has been approved via the Special Approval for Emergency Pathway. Temporary authorisations for sotrovimab have been granted in a dozen countries.\nGSK and Vir also recently submitted the Marketing Authorisation Application (MAA) to the European Medicines Agency for Xevudy (sotrovimab) for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at risk of progressing to severe\nCOVID-19.\nSotrovimab is supplied in several countries worldwide, including through national agreements in the United States, United Kingdom, Japan, Australia, Canada, Singapore, Switzerland and United Arab Emirates. We have also signed a Joint Procurement Agreement with the European Commission to supply doses of sotrovimab. Additional agreements are yet to be announced due to confidentiality or regulatory requirements.\n\nSotrovimab in the United States\nThe following is a summary of information for sotrovimab. Healthcare providers in the U.S. should review the Fact Sheets for information about the authorised use of sotrovimab and mandatory requirements of the EUA. Please see theFood and Drug Administration (FDA) Letter of Authorization, fullFact Sheet for Healthcare Providers, and fullFact Sheet for Patients, Parents, and Caregivers.\nSotrovimab has been authorized by the U.S. FDA for the emergency use described below. Sotrovimab is not FDA-approved for this use.\nSotrovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of sotrovimab under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.\nAuthorized Use\nThe U.S. FDA has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product sotrovimab for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.\nLimitations of Authorized Use\nSotrovimab is not authorized for use in patients:\n\nwho are hospitalized due to COVID-19, OR\nwho require oxygen therapy due to COVID-19, OR\nwho require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity)\n\nBenefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID 19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID 19 requiring high flow oxygen or mechanical ventilation.\nImportant Safety Information\nCONTRAINDICATIONS\nSotrovimab is contraindicated in patients who have a history of anaphylaxis to sotrovimab or to any of the excipients in the formulation.\nWARNINGS AND PRECAUTIONS\nThere are limited clinical data available for sotrovimab. Serious and unexpected adverse events may occur that have not been previously reported with sotrovimab use.\nHypersensitivity Including Anaphylaxis and Infusion-Related Reactions\nSerious hypersensitivity reactions, including anaphylaxis, have been observed with administration of sotrovimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.\nInfusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of sotrovimab. These reactions may be severe or life threatening.\nSigns and symptoms of infusion-related reactions may include: fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vaso-vagal reactions (eg, pre-syncope, syncope), dizziness and diaphoresis.\nConsider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs.\nHypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization.\nClinical Worsening After SARS-CoV-2 Monoclonal Antibody Administration\nClinical worsening of COVID‑19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (eg, atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID‑19.\nLimitations of Benefit and Potential for Risk in Patients with Severe COVID‑19\nBenefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID‑19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID‑19 requiring high flow oxygen or mechanical ventilation. Therefore, sotrovimab is not authorized for use in patients: who are hospitalized due to COVID‑19, OR who require oxygen therapy due to COVID‑19, OR who require an increase in baseline oxygen flow rate due to COVID‑19 in those on chronic oxygen therapy due to underlying non‑COVID‑19 related comorbidity.\nADVERSE EVENTS\nHypersensitivity adverse reactions have been observed in 2% of patients treated with sotrovimab and 1% with placebo in COMET-ICE.\nThe most common treatment-emergent adverse events observed in the sotrovimab treatment group in COMET-ICE were rash (1%) and diarrhea (2%), all of which were Grade 1 (mild) or Grade 2 (moderate). No other treatment-emergent adverse events were reported at a higher rate with sotrovimab compared to placebo.\nUSE IN SPECIFIC POPULATIONS\nPregnancy\nThere are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome. Sotrovimab should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.\nLactation\nThere are no available data on the presence of sotrovimab in human milk, the effects on the breastfed infant, or the effects on milk production. Individuals with COVID-19 who are breastfeeding should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.\nAbout the GSK and Vir collaboration\nIn April 2020, GSK and Vir entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.\nGSK commitment to tackling COVID-19\nGSK’s response to COVID-19 has been one of the broadest in the industry, with potential treatments in addition to our vaccine candidates in development with partner organisations.\nGSK is collaborating with several organisations on COVID-19 vaccines by providing access to our adjuvant technology. We are working with Sanofi S.A., Medicago Inc. and SK bioscience Co., Ltd. to develop adjuvanted, protein-based vaccine candidates, and all are now in Phase III clinical trials. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protecting more people in need.\nGSK is also working with mRNA specialist, CureVac N.V., to jointly develop next-generation, optimised mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine.\nGSK is also exploring treatments for COVID-19 patients, collaborating with Vir Biotechnology to investigate monoclonal antibodies that could be used as therapeutic or preventive options for COVID-19.\nVir’s commitment to COVID-19\nVir was founded with the mission of addressing the world’s most serious infectious diseases. In 2020, Vir responded rapidly to the COVID-19 pandemic by leveraging our unique scientific insights and industry-leading antibody platform to explore multiple monoclonal antibodies as potential therapeutic or preventive options for COVID-19. Sotrovimab is the first SARS-CoV-2-targeting antibody Vir advanced into the clinic. It was carefully selected for its demonstrated promise in preclinical research, including an anticipated high barrier to resistance and potential ability to both block the virus from entering healthy cells and clear infected cells. Vir is continuing to pursue novel therapeutic and prophylactic solutions to combat SARS-CoV-2 and future coronavirus pandemics, both independently and in collaboration with its partners.","news_type":1,"symbols_score_info":{"GSK":0.9}},"isVote":1,"tweetType":1,"viewCount":751,"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":11,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/603520446"}