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- 药明生物和合全药业将成为Tubulis的CDMO合作伙伴
中国, 上海
2020年12月2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）、药明康德子公司合全药业与总部位于德国慕尼黑的蛋白质-药物偶联开发商Tubulis公司今天宣布，三方建立战略合作伙伴关系，共同加速Tubulis新一代抗体偶联药物（Antibody-Drug Conjugates, ADC）的开发，直至新药临床实验申请（IND）。Tubulis开发了一种双平台方法来生成具有独特匹配性和疾病特异性的抗体偶联药物，能够将选择性抗体与有效载荷（payload）相结合，该方法已在临床前研究中显示出高度稳定性和有效性。此次与药明生物及合全药业达成合作，将支持Tubulis生产工艺扩大至全球临床标准。TUB-010是此次合作管线中的首个项目，它是一种高度匹配、高度稳定和高效的蛋白偶联物药物，用于治疗淋巴瘤。
根据合作协议，药明生物和合全药业将成为Tubulis的CDMO（合作研究开发生产）合作伙伴，提供 ADC产品中间体的规模放大、工艺开发和GMP 生产服务，其中合全药业专注于连接体（linker）和有效载荷（payload），药明生物专注于单克隆抗体（mAb）和Tubulis专有Tub-tag®技术中使用的酶。药明生物随后将进行工艺开发和生物偶联，并以GMP标准生产偶联原液和制剂，灌装用于临床前毒理研究，同时供应用于临床评价的产品批次。此次合作的财务细节未披露。
Tubulis首席执行官Dominik Schumacher博士表示：“作为全球领先的创新技术平台，药明生物和合全药业具备一流的技术水平和能力，将为我们ADC的技术开发和生产赋能。对于Tubulis独特的多用途和可定制的ADC技术平台来说，与在ADC药物领域具有丰富开发和生产经验的CDMO合作，尤其能在高质量服务基础上建立长期合作关系非常重要。我们正在加速将首个ADC候选药物推向临床阶段，很高兴能达成此次合作，这将使我们的产品线更加成熟。”
药明生物首席执行官陈智胜博士表示：“一体化的技术平台、坚实的专业知识及符合全球高质量标准的厂房，正是Tubulis选择与药明生物合作的原因。此次合作再次验证了药明生物作为全球一体化生物制药能力和技术赋能平台的价值。研发和生产TUB-010这样的生物偶联物非常复杂，需要高水平的专业知识和强大的供应链整合能力。我们将利用卓越的生物技术平台，具有丰富ADC药物研发生产经验的团队以及行业领先的项目执行能力，加速将TUB-010推向临床研究阶段。”
合全药业首席执行官陈民章博士表示：“很高兴Tubulis选择与我们合作，来助力将这种新型药物推向临床，以造福全球患者。相信合全药业在高活原料药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ADC连接体（linker）和有效载荷（payload）的开发生产提供最强有力的保障。我们与药明生物在ADC药物开发方面有着紧密联系，并积累了合作经验，共同致力于为合作伙伴提供一站式服务，这也将确保我们能携手高效研发和生产TUB-010。”
Tubulis近期已完成1070万欧元的A轮融资，用于扩大抗体偶联药物的治疗潜力，并推进其独特的多功能和可定制的ADC技术平台开发。该公司利用两项专有技术来解决目前获批的ADC药物面临的主要瓶颈——稳定性及有效载荷驱动的毒性。通过P5偶联，Tubulis采用半胱氨酸的偶联方法能够生成高度稳定的抗体偶联药物，其具有绝佳的连接体稳定性和化学柔韧性，能够快速识别先导物。第二项技术是具有人源性特征的Tub-tag®平台，能够通过调节抗体为有效载荷提供十分有益的微环境，从而大幅提升ADC药物的稳定性。通过适应症定制 ADC，Tubulis将开发创新化合物来治疗癌症及其他疾病。
关于Tubulis
Tubulis通过将专有的新型技术与疾病特异性生物学相结合，开发独特匹配的蛋白-药物偶联物。我们的目标是扩大抗体-药物偶联物（ADC）的治疗潜力，引领新一代ADC药物浪潮，并进一步提升治疗效果。采用公司特有的ADC开发方法，Tubulis将开发多种不受适应症限制的偶联药物。更多信息请访问www.tubulis.com或者在LinkedIn和Twitter上关注我们。
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28万升，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。
Tubulis Forms Strategic Partnership with WuXi Biologics and WuXi STA to Advance New Generation of Antibody-Drug Conjugates towards Clinical Evaluation
- WuXi Biologics and WuXi STA to become Contract Development and Manufacturing Organization (CDMO) partners for Tubulis
SHANGHAI and MUNICH, GERMANY
December 2, 2020
Tubulis, WuXi STA and WuXi Biologics today announced a strategic collaboration to manufacture and advance Tubulis' next generation antibody-drug conjugates (ADCs) towards IND-enabling studies. Tubulis has developed a dual platform approach to generate uniquely matched and disease-specific ADCs that combine selective antibodies with effective payloads. This approach has demonstrated superior stability and efficacy in preclinical studies. The partnership with WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms and STA Pharmaceutical, a WuXi AppTec Company, (WuXi STA), will support the scale-up of the manufacturing process to a global clinical standard. The first program from Tubulis' pipeline the companies will collaborate on is TUB-010, a uniquely matched, highly stable and efficient protein-drug conjugate designed to treat patients with lymphoma.
Under the terms of the agreement, WuXi Biologics and WuXi STA will become the Contract Development and Manufacturing Organization (CDMO) partners for Tubulis. WuXi Biologics and WuXi STA will perform scale-up, process development and GMP manufacturing for the ADC product intermediates, with WuXi STA focused on the linker and payload and WuXi Biologics on the monoclonal antibody (mAb) and the enzyme used in Tubulis' proprietary Tub-tag® technology. WuXi Biologics subsequently will conduct process development and GMP bioconjugation to produce the drug substance and the final drug product formulation and fill for final preclinical toxicology studies. WuXi Biologics will also supply product batches for clinical evaluation. Financial details of the collaboration were not disclosed.
"As leaders in manufacturing for innovative technology platforms, WuXi Biologics and WuXi STA provide world-class capabilities for the development and production of our ADCs," said Dr. Dominik Schumacher, CEO of Tubulis. "For our uniquely versatile and customizable ADC technology portfolio, it was important to partner with CDMOs that have extensive experience with ADCs and offer the opportunity for a long-term partnership at the highest quality level. We are rapidly moving towards the clinic with our first ADC candidate and are excited to have entered this partnership, which will enable the further maturation of our pipeline."
"Tubulis requires single-source technology platforms, scientific expertise and state-of-the-art facilities set to the highest global quality standards. This is why we are thrilled to be selected for this project," remarked Dr. Chris Chen, CEO of WuXi Biologics. "This collaboration is a perfect illustration of the value that WuXi Biologics provides to innovative companies worldwide. Bioconjugates like TUB-010 are highly complex and require high levels of expertise and integration across the entire supply chain. We will leverage our advanced development platforms, large scientific teams dedicated to ADCs and industry-leading development timelines to bring TUB-010 towards the clinic."
"We are honored that Tubulis selected our organization to help bring this novel therapeutic towards the clinic with the goal of benefiting patients worldwide," commented Dr. Minzhang Chen, CEO of WuXi STA. "I am confident that WuXi STA's leading capability and capacity for high potency API, along with our high quality standards in meeting global regulatory requirements, will provide the strongest support for ADC linker and payload development and manufacturing. Our strong connection and past experience working with WuXi Biologics on ADC therapeutics, and our shared commitment to providing seamless project management and one-stop services, will ensure that together we can develop and manufacture TUB-010 efficiently."
Tubulis recently completed a €10.7 million Series A to expand the therapeutic potential of ADCs and to advance its uniquely versatile and customizable ADC technology portfolio. The company utilizes two proprietary technologies to tackle limitations of currently approved ADCs, which include stability and payload-driven toxicity. With the P5 conjugation, Tubulis employs a cysteine-selective conjugation that enables the generation of ultra-stable ADCs with unprecedented linker stability and chemical flexibility, enabling rapid lead identification. The second technology, the human-derived Tub-tag® platform, modulates the antibody to provide a highly beneficial microenvironment for the payload, thereby adding a significant amount of stability to the ADC. By tailoring the ADCs to the respective indication, Tubulis develops innovative compounds to treat cancer and beyond.
About Tubulis
Tubulis generates uniquely matched protein-drug conjugates by combining proprietary novel technologies with disease-specific biology. Our goal is to expand the therapeutic potential of antibody-drug conjugates (ADCs), ushering in a new era and delivering better outcomes for patients. Employing the company’s proprietary ADC development approach, Tubulis will advance a variety of conjugates that are unlimited by indication. For more information, visit www.tubulis.com or follow us on LinkedIn and Twitter.
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 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
