药明生物与GSK就多款创新TCE双抗/多抗达成许可协议

新闻亮点

· GSK将获得基于药明生物专利技术平台开发的一款处于临床前阶段的T细胞接合器（TCE）双特异性抗体的独家许可权，并可基于该平台选择至多三款其他TCE双特异性/多特异性抗体

· 药明生物将获得4000万美元首付款和基于净销售额的分级销售提成

中国，上海

2023年1月5日

全球领先的合同研究、开发和生产（CRDMO）服务公司药明生物（WuXi Biologics, 2269.HK）宣布与葛兰素史克（LSE/NYSE: GSK）达成许可协议，GSK将获得基于药明生物专利技术平台开发的至多四款TCE双特异性/多特异性抗体的独家权利。

根据协议，GSK将获得一款处于临床前阶段的双特异性抗体和其他至多三款处于早期发现阶段的TCE抗体的全球独家研究、开发、生产和商业化权利。该款双抗分别靶向肿瘤细胞表面的肿瘤相关抗原（TAA）和T细胞表面抗原CD3，通过与肿瘤细胞及T细胞结合，特异性激活T细胞，从而杀伤肿瘤细胞，产生抗肿瘤活性。药明生物将获得4000万美元首付款和最高达14.6亿美元的四款TCE抗体的研究、开发、注册和商业化里程碑付款。药明生物也有资格获得基于净销售额的分级销售提成。

陈智胜博士

药明生物首席执行官 

此次与GSK达成许可协议不仅再次证明了药明生物潜在同类最优（Best-in-Class）的CD3抗体技术平台和领先的双抗技术平台WuXiBody^®，也凸显了公司独特CRDMO商业模式中‘R’（研究服务）的优势。这一合作也体现了我们以强大执行力为支点，为全球客户提供高质量开放式生物技术平台所做出的不懈努力。我们期待赋能GSK早日将这些潜力疗法惠及病患，为更多全球患者带来新的治疗希望。

John Lepore

GSK研究高级副总裁

此次与药明生物达成许可协议将为GSK引进潜在同类最优（Best-in-Class）的TCE抗体，进一步扩充公司肿瘤靶向药物产品组合。这些优化后的抗体不仅表现出强大的抗肿瘤疗效，还具有卓越的安全性，有望满足巨大的未满足医疗需求，为多个癌种的肿瘤患者提供潜在治疗方案。

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WuXiBody^®是药明生物具有自主知识产权的双特异性抗体技术平台。该平台突破了绝大多数双特异性抗体平台技术瓶颈，具有表达量高、稳定性高、溶解度好、易于纯化等优势，并且能够为每个项目节约6到18个月研发时间以及显著降低双特异性抗体生产成本。WuXiBody^®平台几乎可将所有抗体序列用以构建双特异性抗体，并且有望降低免疫原性风险及延长其体内半衰期。WuXiBody^®平台还兼具独特的灵活性，可以构建各种不同的价数（如二价、三价或四价双特异性抗体），以满足不同项目的生物学特性需求。

除了WuXiBody^®，药明生物还开发了一套领先、完善的双特异性/多特异性抗体技术平台，包括基于VHH单域抗体的SDArBody^TM、基于工程化稳定的单链抗体（scFv）的SkyBody^TM，以及与Ligand公司合作通过OmniFlic^®生成基于共同轻链的双特异性抗体。通过WuXiBody^®在内的所有生物药发现技术平台强强联合，药明生物能够赋能各种双特异性和多特异性抗体开发，满足客户各种不同项目的生物学需求，其中典型赋能案例包括与GSK达成许可协议的项目。

关于药明生物

药明生物（股票代码：2269.HK）是一家全球领先的合同研究、开发和生产（CRDMO）公司。公司通过开放式、一体化生物制药能力和技术赋能平台，提供全方位的端到端服务，帮助合作伙伴发现、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。

药明生物在中国、美国、爱尔兰、德国和新加坡拥有超过10000名员工。凭借这些员工组成的专业服务团队，以及卓越的技术和洞见，公司为客户提供高效经济的生物药解决方案。

药明生物将环境、社会和治理（ESG）视为业务发展和企业精神的重要组成部分，并致力于成为全球生物药CRDMO领域的ESG领导者，例如应用更绿色环保的新一代生物制药技术和能源等引领行业发展。公司成立了由首席执行官领导的ESG委员会，全面落实ESG战略并践行可持续性发展承诺。

更多信息，请访问：www.wuxibiologics.com

WuXi Biologics and GSK Enter into License Agreement on Multiple Novel Bi- & Multi-specific T Cell Engagers

Highlights

·  WuXi Biologics will provide an exclusive license to GSK for one preclinical bi-specific T cell engaging (TCE) antibody and the option of three additional bi-/multi-specific TCE antibodies developed using WuXi Biologics' proprietary technology platforms

·  WuXi Biologics will receive an upfront payment of $40 million and tiered royalties on net sales

Shanghai, China 

January 5, 2023 

WuXi Biologics ("WuXi Bio") (2269. HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced a license agreement with GSK plc (LSE/NYSE: GSK) under which GSK will have exclusive licenses for up to four bi- & multi-specific TCE antibodies developed using WuXi Biologics' proprietary technology platforms.

Under the terms of the agreement, GSK will be granted an exclusive global license for the research, development, manufacturing, and commercialization of a pre-clinical bispecific antibody that crosslinks tumor cells and T cells by targeting a tumor-associated antigen (TAA) on tumor cells and CD3 expression on T cells and up to three additional pre-clinical TCE antibodies currently at an earlier discovery stage. WuXi Biologics will receive a $40 million upfront payment and up to $1.46 billion in additional payments for research, development, regulatory and commercial milestones across the four TCE antibodies. WuXi Biologics is also eligible to receive tiered royalties on net sales.

Dr. Chris Chen   

CEO of WuXi Biologics

This license agreement with GSK represents an important validation of our potential best-in-class CD3 platform and WuXiBody^® platform, the 'R' in our CRDMO business model. This also demonstrates our efforts in offering global open-access technology platforms with premier quality and excellent execution. We are looking forward to enabling GSK to bring these potentially life-saving therapeutics to more patients worldwide. 

John Lepore   

Senior Vice President, 

Head of Research GSK

This agreement with WuXi Biologics builds on our oncology portfolio of tumor cell targeting agents by providing GSK with access to potential best-in-class T-cell engaging antibodies that have been optimized for effective tumor killing with a desirable safety profile, offering the potential to address significant unmet medical need in patients with multiple tumor types.

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WuXiBody^® is a leading proprietary bispecific antibody platform developed by WuXi Biologics. It can effectively break through the discovery and CMC barriers for the development of many bispecific antibodies with high expression yield, high stability, good solubility, and easy purification to homogeneity, expedite the process by 6-18 months and significantly reduce manufacturing costs, a limitation still faced by many other current bispecific platforms. WuXiBody^® platform enables almost any mAb sequence pairs to be assembled into bispecific constructs, which are expected to have low immunogenicity risk and longer in vivo half-life. WuXiBody^® platform also has a unique structural flexibility, which makes it convenient to build various formats with different combinations of valencies (1+1, 1+2, 2+2) to meet the requirements of different target biology. 

In addition to WuXiBody^®, WuXi Biologics also developed a suite of proprietary bispecific and multispecific antibody platforms including VHH antibody-based SDArBody^TM, stabilized scFv-based SkyBody^TM, and have access to OmniFlic^® rats to generate common light chain-based bispecific antibody through collaboration with Ligand. These platforms together with the flagship platform, WuXiBody^®, enable WuXi Biologics to make various bispecific and multi-specific antibodies to meet various biology needs of the company's clients, including to support development of assets in the GSK license agreement.  

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.

With over 10,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. 

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com

注：本信息不构成药明生物的信息披露或投资建议