三生国健药业（上海）股份有限公司关于自愿披露公司获得《药物临床试验批准通知书》的公告

Core Viewpoint - Recently, Sangon Biotech (Shanghai) Co., Ltd. received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration, allowing the company to conduct Phase I clinical trials for SSGJ-627 injection for ulcerative colitis (UC) [2][3]. Group 1: Drug Information - SSGJ-627 injection is an innovative recombinant anti-TL1A humanized monoclonal antibody developed by the company, with independent intellectual property rights [3]. - TL1A is a member of the tumor necrosis factor superfamily, primarily expressed by endothelial cells, and plays a crucial role in mucosal immune response, allergies, and autoimmune diseases [3]. - The drug has received Phase I clinical trial approvals in both China and the United States, making it the first domestically developed TL1A antibody to obtain an IND approval [3]. - Preclinical studies have shown that SSGJ-627 has high affinity and specificity for TL1A, demonstrating significant efficacy in various animal models, along with good safety and tolerability [3].