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上海,
2024年1月17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）宣布其具有自主知识产权、高灵活性、高可开发性的双特异性抗体技术平台WuXiBodyTM获得了美国专利商标局授权。这也标志着该平台已在美国、日本和中国三个国家获得专利授权。
自2018年在全球亮相以来，WuXiBodyTM已经获得了广泛认可。该平台突破了双抗CMC的技术瓶颈，有效克服了双抗开发过程中的挑战，具有高表达量、高稳定性、高溶解性，易于纯化等优势。相比于现有的一些双抗技术平台，WuXiBodyTM还能够为每个项目节约6到18个月的研发时间，显著降低生产成本。
WuXiBodyTM平台几乎可将所有抗体序列用以构建双抗，还有望降低免疫原性风险及延长其体内半衰期。其兼具独特的灵活性，可以构建各种不同的价数（如二价、三价或四价双抗），并且与不同的Fc结构域兼容，以满足不同项目的生物学特性需求。
陈智胜
博士
药明生物首席执行官
我们为WuXiBodyTM平台获得美国专利授权而自豪，这不仅进一步验证了我们在全球双抗技术平台领域的领导地位，也是我们研究与发现服务发展历程中的重要里程碑——更多的药明生物合作伙伴能够借助这一创新双抗技术平台，探索不同的生物学机制和研发前沿疗法。我们也将继续投资新一代技术，打造创新生物药解决方案，赋能广大合作伙伴，造福全球患者。
截至2023年12月31日，WuXiBodyTM共达成45个对外授权项目，其中4个处于I期临床开发阶段。预计到2024年，共有2个WuXiBodyTM项目新药临床试验申请（IND）获得批准，这也将进一步证明WuXiBodyTM领先技术平台的价值。
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）服务公司。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12000名员工。通过药明生物人的专业服务团队，以及先进技术和精深洞见，公司为客户提供高效经济的生物药解决方案。截至2023年12月底，药明生物帮助客户研发和生产的综合项目高达698个，其中包括24个商业化生产项目。
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
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WuXi Biologics Granted U.S. Patent for Proprietary Bispecific Antibody Technology Platform WuXiBody™
Shanghai,
January 17, 2024
WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that a patent for WuXiBody™ – a proprietary, highly flexible engineering platform that greatly enhances the developability characteristics of bispecifics – was granted by the U.S. Patent and Trademark Office. This also marks that WuXiBody™ has been granted patents in the U.S., Japan and China.
WuXiBody™ has been widely adopted globally since its launch in 2018. It can effectively break through the CMC barriers for the development of many bispecific antibodies with high expression yield, high stability, good solubility, and easy purification to homogeneity. Additionally, it can shorten the process by 6-18 months and significantly reduce manufacturing costs compared to many other current bispecific platforms.
The WuXiBody™ platform enables almost any mAb sequence pairs to be assembled into bispecific constructs that are expected to have low immunogenicity risk and a long in vivo half-life. It offers unique structural flexibility, which makes it convenient for building various formats with different combinations of valencies (1+1, 1+2, 2+2), and is also compatible with different Fc domains to meet the requirements of different target biologies.
Dr. Chris Chen
CEO
WuXi Biologics
We're proud that our WuXiBody™ platform was granted the U.S. patent, further validating our global leadership in bispecific technologies and capabilities. It is a great milestone for our Discovery business, which will enable more partners to pursue different biology and therapeutic approaches via this novel bispecific antibody platform. We will continue to invest in next-generation technologies to provide new biologics solutions for our global partners and benefit patients worldwide.
As of December 31, 2023, there are 45 out-licensed WuXiBody™ projects in various stages -- four of which are in Phase Ⅰ clinical development. Further demonstrating the value of WuXiBody™'s state-of-the-art technology, investigational New Drug (IND) applications of two WuXiBody™ projects are expected be approved in 2024.
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 12,000 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. As of December 31, 2023, WuXi Biologics is supporting 698 integrated client projects, including 24 in commercial manufacturing.
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.
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注：本信息不构成药明生物的信息披露或投资建议
