Haisco(SZ:002653) Zhi Tong Cai Jing·2025-10-09 10:51Core Viewpoint - Company Haisco (002653.SZ) has received a notice from the National Medical Products Administration regarding the acceptance of its clinical trial application for the drug "HSK36357 capsules," which is a new small molecule drug with independent intellectual property rights developed by the company [1] Group 1: Drug Development - HSK36357 has shown significant analgesic effects in non-clinical studies and can enhance the contraction force of skeletal muscles in Duchenne Muscular Dystrophy (DMD) model mice, improving muscle recovery after fatigue [1] - The drug is intended for the treatment of muscular dystrophies, including Becker Muscular Dystrophy and Duchenne Muscular Dystrophy [1] - HSK36357 has already been approved for clinical trials for the indication of "peripheral neuropathic pain," and the current acceptance is for the clinical trial application for muscular dystrophies [1] Group 2: Regulatory Classification - According to the National Medical Products Administration's announcement on the classification and application requirements for chemical drug registration (2020 No. 44), HSK36357 is classified as a Class 1 chemical drug [1]