SND006系生诺医药自主研发、享有全球权益的双特异性抗体，拟用于治疗炎症性肠病（IBD）等自身 免疫性疾病，目前已完成体外功能验证研究。生诺医药计划2026年向中国国家药品监督管理局 （NMPA）和美国食品药品监督管理局（FDA）提交新药临床试验申请（IND）。 1月29日，药明生物与生诺医药共同宣布，双方就创新双特异性抗体SND006的工艺开发和生产达成战略 合作。根据双方签署的协议，生诺医药将借助药明生物在生物药开发和生产领域积累的丰富经验和规模 化生产能力，推进SND006的临床前药学研究和临床样品制备，加速临床申报进程。 （药明生物公众号） ...

Core Viewpoint - WuXi Biologics and Sinorda Biomedicine have announced a strategic collaboration to develop and manufacture SND006, a novel bispecific antibody aimed at treating inflammatory bowel disease (IBD) and other autoimmune diseases [1][2]. Company Overview - WuXi Biologics is a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) that provides end-to-end solutions for biologics from concept to commercialization [4]. - The company employs over 12,000 skilled professionals across multiple countries, including China, the United States, Ireland, Germany, and Singapore [5]. - As of December 31, 2025, WuXi Biologics is supporting 945 integrated client projects, with 74 in Phase III and 25 in commercial manufacturing [5]. Collaboration Details - Under the agreement, Sinorda Biomedicine will utilize WuXi Biologics' expertise in biologics development to advance SND006's preclinical studies and clinical supply, expediting the Investigational New Drug (IND) application process [2]. - Sinorda Biomedicine has completed in vitro functional validation studies for SND006 and plans to submit IND applications to the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA) in 2026 [2]. Future Prospects - The collaboration aims to expand further into Sinorda Biomedicine's pipeline, which includes multiple integrated projects from molecule discovery to clinical manufacturing [2]. - Both companies believe that this partnership will accelerate the IND filings of innovative biologics, addressing unmet medical needs in autoimmune diseases [3]. Sinorda Biomedicine Overview - Established in 2010, Sinorda Biomedicine focuses on the R&D and industrialization of innovative drugs for digestive tract diseases, tumor immunity, and autoimmune diseases [8][9]. - The company has successfully commercialized its self-developed drug for gastric acid-related diseases and has ongoing clinical research for solid tumor treatments [10].