Haisco(SZ:002653) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-08-17 22:36Group 1 - The company has received a "Notice of Acceptance" from the National Medical Products Administration regarding its clinical trial application for HSK39297 tablets, which are intended for the treatment of age-related macular degeneration (AMD) and generalized myasthenia gravis (gMG) [1][2] - AMD is a degenerative disease affecting the macula, with a global prevalence of approximately 8.7%, and it is estimated that nearly 300 million people will be affected by 2040 [2] - HSK39297 is a novel small molecule drug with independent intellectual property rights, showing clear targets, confirmed efficacy, and good safety, indicating a high benefit/risk ratio for clinical application [3] Group 2 - The drug has previously submitted IND applications for complement-mediated primary or secondary glomerular diseases and complement-mediated hemolytic diseases, with ongoing clinical studies for IgA nephropathy and paroxysmal nocturnal hemoglobinuria [3] - The current acceptance pertains specifically to clinical trials for AMD and gMG, addressing the clinical drug shortage faced by patients [3][4]