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中国, 上海
2021年2月1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）、全球领先的新药研发生产CDMO企业合全药业与专注于肿瘤创新疗法研发及商业化的领先创新生物制药公司德琪医药有限公司（简称“德琪医药”，6996.HK）今天宣布，三方达成战略合作，共同加速德琪医药创新抗体偶联药物（Antibody-Drug Conjugates, ADC）的研发生产。这也是自2020年10月药明生物与德琪医药针对双特异性抗体达成CDMO合作后，双方进一步扩大战略合作，第二次在GMP生产方面建立合作。
通过此次战略合作，药明生物与合全药业将为德琪医药ADC药物开发提供产品中间体的规模放大、工艺开发和GMP生产服务。其中，德琪医药专注于抗体偶联药物的核心要素——单克隆抗体的研发，合全药业专注于连接体（linker）和有效载荷（payload）的GMP生产，药明生物专注于单克隆抗体（mAb）、生物偶联和成品冻干工艺开发，并以GMP标准生产偶联原液和冻干制剂。三方将充分发挥各自优势和资源，实现ADC药物领域的合作共赢。
德琪医药创始人、董事长兼首席执行官梅建明博士表示：“很高兴德琪与药明生物、合全药业建立的高效稳定的合作关系。我们一直注重自主研发体系的搭建，通过建立德琪新药研发中心，全面布局早期研发项目；我们立足联合与互补的战略，通过临床团队、注册团队和早期研发团队的整合，更高效地推进药物研发项目。相信合全药业及药明生物在ADC药物领域的深厚积淀将与德琪的创新理念相结合，形成更强大的技术合力，加速ADC药物临床研究及应用，早日造福病患。”
合全药业首席执行官陈民章博士表示：“非常高兴与德琪医药进一步扩大合作的范围与深度，相信合全药业在高活原料药方面和涉及ADC等新型药物分子的偶联化学方面的领先能力和规模优势，以及符合全球标准的质量体系，将为德琪医药ADC药物项目提供强有力的支撑。合全药业将继续提升新型药物分子从临床前至商业化的一体化CMC能力，赋能更多全球合作伙伴，惠及更多病患。”
药明生物首席执行官陈智胜博士表示：“我们非常高兴与德琪医药扩大战略合作，通过药明生物卓越的生物技术平台、充足的产能以及高质量标准，加速德琪医药创新ADC药物推进至临床试验阶段。药明生物将持续在ADC药物领域夯实能力和规模建设，赋能全球合作伙伴拥抱新一代生物药浪潮，早日造福广大患者。”
关于德琪医药
德琪医药有限公司（简称“德琪医药”，香港联交所股票代码：6996.HK）是一家专注于创新抗肿瘤药物的亚太地区临床阶段生物制药公司，旨在为中国、亚太地区及全球各地的患者提供最前沿的抗肿瘤创新疗法。自成立以来，德琪医药已建立起拥有12款临床及临床前创新药物的丰富产品管线，并在亚太地区取得12个临床试验批件。德琪人以“医者无疆，创新永续”为愿景，力争通过对同类首款/同类最优疗法的专研与市场化，解决亚太乃至全球患者未满足的临床需求。欲了解更多，请访问：www.antengene.com。
关于合全药业
合全药业是在中美两地均有运营的药明康德子公司，服务于生命科学行业，拥有卓越的化学创新药研发和生产的能力和技术平台。作为全球新药合作研究开发生产领域（CDMO）的领军企业，合全药业致力于为全球合作伙伴提供从临床前到商业化，高效、灵活、高质量的一站式CMC（化学、生产和控制）解决方案。更多信息，请访问公司网站：www.STApharma.com.cn。
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, WuXi STA and Antengene Announce Collaboration to Advance Antibody-Drug Conjugate Candidate into Clinical Stage
SHANGHAI
February 1, 2021
WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, STA Pharmaceutical Co., Ltd., ("WuXi STA"), a leading Contract Development and Manufacturing Organization, and Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), today announced a strategic collaboration to accelerate the development and manufacturing of antibody-drug conjugate (ADC) drug candidates in Antengen's pipeline. This is the second partnership between Antengene and WuXi Biologics for the GMP manufacturing services following the announcement of a bispecific antibody CDMO service collaboration in October 2020.
Through this collaboration, WuXi Biologics and WuXi STA will provide services for the process development, scale-up, and GMP manufacturing of ADC drug intermediates. Antengene will focus on the discovery and development of monoclonal antibody, the core element of the ADC drug development. WuXi STA will focus on the GMP manufacturing of linkers and payloads while WuXi Biologics will provide process development for monoclonal antibody and the biological conjugation as well as the subsequent GMP manufacture. All three parties will work closely to leverage the resources and technological capabilities, with the goal to accelerating the development of ADCs for the benefit of patients.
Dr. Jay Mei, Founder, Chairman and CEO of Antengene, commented, "We are pleased to form a long-term strategic partnership with WuXi STA and WuXi Biologics. It has long been Antengene's strategic imperative to establish our own in-house discovery capabilities, and we started our early discovery programs through the Antengene New Drug Discovery Center. Through strategic alliances and further integrating our clinical development, regulatory, and early discovery teams, we are rapidly advancing our in-house discovery programs. We believe that this collaboration will allow us to build an even stronger capabilities in ADC field by combining deep expertise from the three companies. I am confident that together we can bring our ADC pipeline forward much faster that will ultimately bring benefit to patients in need."
Dr. Minzhang Chen, CEO of WuXi STA, commented: "We are delighted to strengthen our strategic cooperation with Antengene. I am confident that WuXi STA's leading capability and capacity for high potency API and conjugation chemistry for novel molecular modalities such as ADCs, along with our high quality standards in meeting global regulatory requirements, will provide the strongest support for ADC linker and payload development and manufacturing. We will continue to leverage our 'end-to-end' novel molecular modality platform to empower more partners to accelerate their development pathway to market for the benefit of global patients."
Dr. Chris Chen, CEO of WuXi Biologics, said: "We are glad to expand our strategic collaboration with Antengene to advance its ADC program into clinical stage, leveraging our integrated biologics platforms, unparalleled capacity and world-class quality system. WuXi Biologics will continue to increase capabilities and capacities to enable global partners as they develop next-generation biologics such as ADCs for the benefit of patients worldwide."
About Antengene
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage Asia-Pacific biopharmaceutical company focused on innovative oncology medicines. Antengene aims to provide the most advanced anti-cancer drugs to patients in China, the Asia Pacific Region and around the world. Since its establishment, Antengene has built a pipeline of 12 clinical and pre-clinical stage assets and obtained 12 investigational new drug approvals in Asia Pacific. The vision of Antengene is to "Treat Patients Beyond Borders". Antengene aims to address significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics. For more information, please visit: www.antengene.com.
About WuXi STA
STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec (WuXi STA), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Control) requirements from preclinical to commercial uses. For more information, please visit: http://www.STApharma.com and follow us on LinkedIn.
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 280,000 liters after 2023, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on 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
