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2021年5月27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）和临床阶段生物制药公司OncoC4今日宣布，双方就OncoC4的全部研发管线建立了独家CDMO合作伙伴关系。OncoC4的研发管线包括新一代CTLA-4抗体ONC-392，目前该抗体正在美国和中国进行I期临床试验。
根据协议，药明生物将作为独家CDMO合作伙伴提供一体化研发和生产服务，满足OncoC4的生物药从早期研究、临床前至商业化阶段的需求。OncoC4将充分利用药明生物在细胞株、制剂等工艺开发，以及生物药原液和制剂生产领域的技术能力和经验，加速产品开发进程。
此外，OncoC4还进一步与药明生物扩大合作至双特异性抗体领域。根据协议，OncoC4获得授权使用WuXiBody®技术平台发现和开发双抗药物；除首付款外，药明生物还将获得WuXiBody®平台双抗药物的开发和商业化里程碑付款，以及产品上市后的净销售提成。
早在2017年，药明生物就为OncoC4（前身为昂科免疫OncoImmune）ONC-392提供了一体化CMC服务，双方建立了紧密稳固的合作关系。此次达成新协议也标志着药明生物与OncoC4的合作伙伴关系再次迈上新台阶。
OncoC4创始人、董事长兼首席执行官刘阳博士表示：“我们很高兴与药明生物签订长期合作协议，深化双方战略合作伙伴关系。OncoC4研发管线包括靶向先天性和适应性免疫检查点的癌症治疗双特异性抗体和抗体偶联药物，我们相信药明生物的卓越技术和强劲产能，将有效确保这些创新药物的研发和生产，助力公司为全球患者提供同类最优（best-in-class）和同类首创（first-in-class）药物。”
药明生物首席执行官陈智胜博士表示：“我们非常荣幸成为OncoC4独家CDMO合作伙伴，为其全部研发管线提供服务，这也是我们‘跟随分子’和‘赢得分子’双轮战略的又一成功力证。此次深化合作也再次证明了药明生物出色的质量体系和优异的执行力获得合作伙伴高度认可。我们期待继续赋能OncoC4，加快其产品上市进程，提升创新生物药的可及性，早日惠及更多全球病患。”
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关于OncoC4
OncoC4一家私有的、处于临床阶段的生物制药公司，总部位于美国马里兰州罗克维尔市，致力于发现和开发治疗癌症的创新生物药。OncoC4是2020年12月OncoImmune公司被默沙东宣布收购后拆分成立的新公司，保留了除CD24Fc之外的资产，并获得了默沙东的注资以促进其同类最优（best-in-class）和同类首创（first-in-class）的肿瘤免疫管线研发。
作为OncoC4的主要临床候选药物，ONC-392是新一代抗CTLA-4抗体，能够抑制癌症治疗中的免疫治疗相关不良反应。ONC-392的I期临床试验首次人体试验于2020年启动，目前正在招募患者以评估ONC-392作为单药疗法治疗晚期实体瘤以及与抗PD-(L)1标准疗法联合治疗非小细胞肺癌（PRESERVE-001, NCT04140526）的安全性、有效性及药代动力学。
OncoC4研发管线代表着业界新兴的治疗模式，治疗靶点不仅包括CTLA-4和PD-L1等适应性免疫检查点，也包括OncoC4创始人发现的先天免疫检查点CD24-Siglec 10。OncoC4的技术平台包括人源化抗体、双特异性抗体和抗体偶联药物等。如需更多信息，请访问www.oncoc4.com。
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2021年3月22日，在药明生物平台上研发的综合项目达361个，包括190个处于临床前研究阶段，137个在临床早期（I期，II期）阶段，32个在后期临床（III期）以及2个在商业化生产阶段。预计到2024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达到43万升，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。
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，并成立了由首席执行官领导的ESG委员会，在提升运营效率的同时践行可持续性发展承诺。如需更多信息，请浏览：www.wuxibiologics.com。
WuXi Biologics and OncoC4 Establish Exclusive CDMO Partnership
SHANGHAI, China and Rockville, Maryland USA
May 27, 2021
WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, and OncoC4, Inc., a privately-held, clinical-stage biopharmaceutical company, today announced that the companies have entered into an exclusive contract development and manufacturing partnership for OncoC4's full pipeline of biologics including its late-stage project, ONC-392, a next generation CTLA-4 antibody which is under phase I clinical trials in the U.S. and China.
Per the agreement, WuXi Biologics, as the exclusive CDMO partner will provide biologics development and cGMP manufacturing services for OncoC4's products from early R&D and preclinical activities to post commercialization. OncoC4 will leverage WuXi Biologics' process development and manufacturing capabilities and expertise in cell line development, formulation development as well as drug substance and drug product manufacture.
The two companies expand the strategic collaboration by using the proprietary WuXiBody® bispecific antibody platform to research and develop certain bispecific antibodies. Under the terms of the agreement, OncoC4 has rights to use the WuXiBody® platform to research and develop bispecific antibodies. For any potential bispecific antibody products commercialized from the WuXiBody® platform, in addition to an upfront payment, WuXi Biologics will receive development and commercialization milestones as well as tiered royalties on net sales of such bispecific antibody.
These new agreements build on the companies' successful multi-year relationship. Since 2017, WuXi Biologics has been providing services to OncoC4 (formerly known as OncoImmune), including comprehensive and integrated CMC services for the ONC-392 clinical program.
Dr. Yang Liu, Chairman, CEO and Founder of OncoC4, commented, "This long-term supply agreement is another significant step forward in our relationship with WuXi Biologics. It allows OncoC4 to leverage world-class manufacturing capacity to meet the challenges associated with the production of our best-in-class and first-in-class biologics, that include bispecific antibodies and antibody-drug conjugates that target innate and adaptive immune checkpoints for cancer treatment."
Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are honored to be OncoC4's exclusive CDMO partner for its full therapeutic pipeline, which is another great example of our follow and win the molecule strategy. This partnership is a strong validation of our premier quality and project execution excellence. We are looking forward to enabling OncoC4 to make innovative life-saving biologics more available and affordable to patients across the globe."
About OncoC4
Based in Rockville, Maryland, OncoC4 is a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for cancer treatment. OncoC4 is a spinout of OncoImmune that was acquired by Merck in December 2020. As part of the acquisition of OncoImmune by Merck, OncoC4 retains the original assets except for the CD24Fc and was infused with additional funds from Merck to invigorate the product development pipeline focusing on best-in-class and first-in-class immunotherapies for oncology.
OncoC4's lead clinical candidate is ONC-392, a next generation anti-CTLA-4 antibody capable of uncoupling the cancer therapeutic effects from immunotherapy-related adverse effects. A first-in-human Phase I clinical trial for ONC-392 was initiated in 2020 and is currently enrolling cancer patients to assess the safety, pharmacokinetics, and efficacy of ONC-392 as a single agent in advanced solid tumors and in combination with anti-PD(L)1 standard of care in Non- Small Cell Lung Cancer (PRESERVE-001, NCT04140526).
OncoC4's new products represent new paradigms of therapeutic targeting of not only adaptive immune checkpoints including CTLA-4 and PD-L1, but also innate immune checkpoint CD24-Siglec 10, which was discovered by OncoC4 founders. Technology platforms include humanized antibodies, bispecific antibody and antibody-drug conjugates. For more details, please visit www.oncoc4.com.
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 March 22, 2021, there were a total of 361 integrated projects, including 190 projects in pre-clinical development stage, 137 projects in early-phase (phase I and II) clinical development, 32 projects in late-phase (phase III) development and 2 projects in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany, and Singapore around 430,000 liters after 2024, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network.
WuXi Biologics views Environmental, Social, and Governance (ESG) as an integral component of its ethos and business strategy and has established an ESG committee led by the CEO to increase the efficiency while advancing 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
