▎医药观澜/报道

2021年2月8日， 全球领先的开放式生物制药技术平台公司药明生物（WuXi Biologics, 2269.HK）祝贺合作伙伴Vir Biotechnology（以下简称Vir）乙肝中和抗体VIR-3434临床I期试验获得积极数据。

VIR-3434是一款中和乙肝病毒的单克隆抗体，能抑制全部10种亚型的乙肝病毒进入肝细胞，并减少血液中的病毒体和亚病毒颗粒。初步临床数据来自8名志愿者（6人接受了药物，2人接受了安慰剂），在单次接受6mg的VIR-3434注射的8天后，有6位志愿者的血清乙肝病毒的表面抗原平均减少1.3 log10 IU/mL。

借助卓越的一体化生物技术平台，药明生物赋能Vir公司解决了VIR-3434研发过程中的CMC技术挑战，助力其成功完成新药临床试验申请（IND）并顺利开展临床试验。Vir公司和药明生物的紧密合作极大地加快了VIR-3434的研发进程，为产品早日上市，惠及数百万乙肝患者带来了希望。

“依据临床前研究的结果，我们预计要在更高的剂量中才能看到同样幅度的乙肝病毒表面抗原下降，在I期临床试验中仅用6mg的剂量取得这一结果完全超出预期，”Vir公司首席执行官George A. Scangos博士表示，“在VIR-3434实现乙肝功能性治愈的征途中，合作伙伴药明生物团队具有的丰富行业经验和强大技术洞见，是至关重要的一环，感谢他们为该创新药物做出的积极贡献。”

药明生物首席执行官陈智胜博士表示，“祝贺Vir公司VIR-3434项目I期临床试验取得里程碑，我们非常荣幸赋能Vir公司将具有潜力的候选药物转化为安全有效的治疗方案，以解决传染病领域高度未满足的医疗需求。我们将继续通过健全强大的全球供应链网络加速赋能Vir公司推进VIR-3434临床试验，以全球高质量标准助力这一创新药物早日上市，造福广大病患。”

关于药明生物

药明生物（股票代码：2269.HK）作为一家香港上市公司，是全球领先的开放式、一体化生物制药能力和技术赋能平台。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。截至2020年6月30日，在药明生物平台上研发的综合项目达286个，包括141个处于临床前研究阶段，125个在临床早期（I期，II期）阶段，19个在后期临床（III期）以及1个在商业化生产阶段。预计到2023年后，公司在中国、爱尔兰、美国、德国和新加坡规划的生物制药生产基地合计产能将超过30万升，这将有力确保公司通过健全强大的全球供应链网络为客户提供符合全球质量标准的生物药。如需更多信息，请访问：www.wuxibiologics.com

WuXi Biologics Congratulates Vir Biotechnology on Positive Data from Phase 1 Trial of VIR-3434 for Chronic Hepatitis B Virus Infection

SHANGHAI

February 8, 2021

WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms,congratulates its partner Vir Biotechnology (Nasdaq: VIR) on initial topline data from the ongoing trial of VIR-3434 in patients with chronic hepatitis B virus (HBV) infection.

VIR-3434 is a subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. Data from the first blinded cohort of eight patients, two of whom received placebo and six of whom received a single dose of 6 mg of VIR-3434, showed that six of eight patients achieved a mean reduction of 1.3 log10 IU/mL in serum hepatitis B virus surface antigen (HBsAg) by day eight, the day when nadir was achieved in most patients.

Through its integrated biologics technology platform, WuXi Biologics helped Vir address the technical challenges of Vir-3434 CMC development and successfully delivered clinical materials for an Investigational New Drug (IND) application and clinical trial. The partnership between Vir and WuXi Biologics has accelerated the timely delivery of new, investigational therapies for the treatment of a serious chronic infectious disease that affects millions of people worldwide.

"Extrapolating from our preclinical data, we expected it might require much higher doses of VIR-3434 to achieve this level of HBsAg knockdown. To have achieved it with a dose of 6 mg is unexpected." said George A. Scangos, Ph.D., CEO of Vir Biotechnology. "The technical expertise and capabilities of the WuXi Biologics team have been important to our efforts to advance new therapies that have the potential to deliver a functional cure for HBV, and we appreciate their ongoing commitment to addressing patient needs."

"Congratulations to Vir on this exciting progress," said Dr. Chris Chen, CEO of WuXi Biologics, "We are honored to enable Vir to turn promising candidates into potential tangible treatments to fulfill the unmet medical needs in the field of infectious disease.WuXi Biologics will continue to deliver high quality biologics through our robust global supply chain network to expedite clinical development of this program to benefit patients worldwide.”


About WuXi Biologics

WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company's history and achievements demonstrate its commitment to providing a truly one-stop service offering and strong value proposition to its global clients. As of June 30, 2020, there were a total of 286 integrated projects, including 141 projects in pre-clinical development stage, 125 projects in early-phase (phase I and II) clinical development, 19 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany, and Singapore exceeding 300,000 liters after 2023, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network. For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

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注：本文旨在介绍医药健康研究进展，不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。