长春高新技术产业（集团）股份有限公司关于子公司注射用GenSci136 境内生产药品注册临床试验申请获得受理的公告

Core Viewpoint - The company, Changchun High-tech Industry (Group) Co., Ltd., announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received a clinical trial application acceptance notice from the National Medical Products Administration for the domestically produced drug, GenSci136, intended for the treatment of generalized myasthenia gravis (gMG) [1][4]. Group 1: Drug Information - Product Name: GenSci136, an injectable drug developed by Jinsai Pharmaceutical [1] - Application: Acceptance of clinical trial application for domestic production [1] - Indication: Treatment of generalized myasthenia gravis [1][2] Group 2: Disease Background - gMG is an autoimmune disease characterized by neuromuscular transmission disorders, with a global prevalence of approximately 12.4 per 100,000 people and an incidence rate in China of about 0.68 per 100,000 [2] - Traditional treatments include cholinesterase inhibitors, corticosteroids, and immunosuppressants, but about 20% of patients do not respond well to these therapies [2] Group 3: Drug Mechanism and Research - GenSci136 features a novel drug structure and dual-target mechanism, designed to enhance its blocking activity and prolong its half-life in the body [3] - Non-clinical pharmacology, pharmacokinetics, and toxicology studies indicate that GenSci136 has good efficacy and safety, potentially offering a better treatment option for patients with gMG in China [3] Group 4: Company Impact - Successful progress of the clinical trial application could help the company expand its business structure, optimize product offerings, and enhance its core competitiveness [4]