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成都
2025年6月9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）与维瑾生物科技公司（Virogen Biotechnology Inc.），今日达成战略合作，维瑾生物将委托药明生物为其全球创新药物VG712提供原液及制剂生产的技术转移、工艺验证和商业化生产服务，共同加速该药物的上市进程。
VG712是一款全球首创的CD3免疫毒素融合蛋白，通过清除患者体内免疫功能异常的T细胞群，重启正常免疫功能，为肿瘤、自身免疫性疾病等领域的患者带来突破性的治疗方案。药明生物将依托其一体化微生物发酵技术平台、领先的原液及制剂生产能力以及全球统一的质量标准，为 VG712 提供从技术转移到商业化生产的全链条赋能。VG712目前正处于上市前关键临床研究阶段，并已获得美国食品药品监督管理局（FDA）的快速审评资格，预计将于2027年到2028年间提交产品上市申请。
陈智胜博士
首席执行官
药明生物
很高兴与维瑾生物就这款突破性创新药的商业化生产达成战略合作。药明生物通过一体化微生物发酵技术平台赋能复杂药物分子研发和生产的实力再次获得客户认可。随着成都微生物商业化生产基地启动建设，我们的全球化生产网络再度扩容，将为包括维瑾生物在内的众多合作伙伴提供更高效的服务和敏捷的产能响应。此外，我们也将在产品的开发过程中，为维瑾生物带来更多的战略赋能，期待在免疫治疗领域实现新的突破，为全球患者带来更多希望。
陈粟先生
创始人
维瑾生物
与药明生物的合作对维瑾生物具有里程碑意义。药明生物在创新药物的开发经验和商业化能力上的全球领先地位，为维瑾生物VG712的快速上市提供坚实保障。未来，期待与药明生物持续深耕合作，共同在免疫治疗领域，为患者带来更具临床价值的创新疗法。
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12000名员工。通过药明生物的专业服务团队，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2024年12月底，药明生物帮助客户研发和生产的综合项目高达817个，其中包括21个商业化生产项目（不包括新冠项目）。
药明生物以可持续发展为长期业务增长的基石。公司持续推动绿色创新技术，为全球合作伙伴提供先进的端到端绿色CRDMO解决方案，同时在ESG方面不断取得卓越成就。秉承创造共享价值的理念，公司携手利益相关方构建可持续发展生态，通过负责任运营模式推动社会价值与生态效益双提升，实现全价值链的协同赋能。更多信息，请访问：www.wuxibiologics.com
关于维瑾生物
维瑾生物是一家处于临床阶段的生物技术公司，团队积淀了深厚的专业知识和丰富的国际化产品开发经验。公司的核心项目VG712由免疫毒素先驱David Neville博士在美国国立卫生研究院（NIH）发明。不同于传统免疫毒素或ADC药物，VG712能迅速清除体内T细胞且作用短暂，同时巧妙地规避了细胞因子风暴的触发，可实现人体细胞免疫功能的重启。通过这一独特机理，已经在前期的临床研究中，治愈了多名晚期肿瘤患者，并取得了美国FDA的快速审评资格。维瑾生物拥有VG712的全球独家开发权与销售权，已完成用于全球临床试验药物的生产，正全面布局包括肿瘤和器官排异等重大领域的多项临床研究。
如需更多信息，请访问www.virogenbio.com
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WuXi Biologics and Virogen Biotechnology Establish Commercial Manufacturing Partnership
Chengdu
June 9, 2025
WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced a strategic collaboration with Virogen Biotechnology Inc. (Virogen). Under the agreement, WuXi Biologics will provide comprehensive services, including technology transfer, process validation, and commercial manufacturing of both drug substance (DS) and drug product (DP) for VG712, Virogen's lead clinical-stage asset. The partnership is expected to accelerate VG712's path to global market approval.
VG712 is a first-in-class anti-CD3 immunotoxin designed to restore immune function through rapid depletion of the patient's existing T cell pool—a novel therapeutic strategy known as immunological reset. By targeting T cell dysregulation, which lies at the core of cancers, autoimmune diseases, and other conditions, this groundbreaking approach allows the immune system to regenerate from a clean slate and regain its innate ability to control disease, offering the new hope for sustained remission and, in some cases, a clinical cure. Leveraging its end-to-end microbial fermentation platform, industry-leading DS and DP manufacturing capabilities, and world-class quality systems, WuXi Biologics will enable Virogen to advance VG712 from late-stage development to commercial-scale production. VG712 has received Fast Track designation from the U.S. Food and Drug Administration (FDA), and a pivotal Phase II trial is currently underway. A Biologics License Application (BLA) submission is targeted between 2027 and 2028, aiming to address significant unmet medical needs.
Dr. Chris Chen
Chief Executive Officer
WuXi Biologics
We are delighted to partner with Virogen on this groundbreaking therapy which further demonstrates our capabilities in enabling the Research, Development, and Manufacturing of complex molecules through our integrated microbial fermentation platform. The construction of our Chengdu microbial manufacturing site marks a significant expansion of our global network, allowing us to deliver more agile, efficient, and scalable solutions to our partners. In addition, we can bring more strategic resources to Virogen throughout its development journey. Together, we aspire to drive new breakthroughs in immunotherapy and bring renewed hope to patients worldwide.
Mr. Su Chen
Founder
Virogen
This collaboration marks a major milestone for Virogen. WuXi Biologics' strong track record in translating innovative science into commercial therapies makes it an ideal partner as we prepare for VG712's global launch. We remain committed to delivering transformative treatments in immunotherapy that can truly save lives.
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, 2024, WuXi Biologics is supporting 817 integrated client projects, including 21 in commercial manufacturing (excluding COVID CMO projects).
WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives green technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while consistently achieving excellence in Environment, Social and Governance (ESG). Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts and promote responsible practices that empower the entire value chain.
For more information about WuXi Biologics, please visit: www.wuxibiologics.com
About
Virogen
Virogen is a clinical stage biotechnology company with expertise in both US and Asia. Its leading development program is VG712, invented at NIH by a pioneer in immunotoxin, Dr. David Neville. Unlike earlier generation immunotoxins, VG712 induces a rapid and transient T cell depletion without triggering cytokine response. By targeting CD3 receptors, VG712 is effective against all T cell subtypes. Virogen owns the global rights to develop and commercialize this novel fusion protein and has completed the CMC development of drug products for global clinical trials.
For more information visit virogenbio.com.
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