{"id":39517,"date":"2025-08-18T14:16:57","date_gmt":"2025-08-18T06:16:57","guid":{"rendered":"https:\/\/flcube.com\/?p=39517"},"modified":"2025-08-18T14:16:58","modified_gmt":"2025-08-18T06:16:58","slug":"haiscos-hsk39297-gains-nmpa-approval-for-amd-and-gmg-trials","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=39517","title":{"rendered":"Haisco’s HSK39297 Gains NMPA Approval for AMD and gMG Trials"},"content":{"rendered":"\n

Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653<\/a>) announced that the National Medical Products Administration (NMPA) has accepted two additional Investigational New Drug (IND) applications for HSK39297. The applications target the treatment of age-related macular degeneration (AMD) and generalized myasthenia gravis (gMG).<\/p>\n\n\n\n

Disease Background<\/strong>
AMD is a degenerative disease of the macular region of the retina, primarily affecting middle-aged and elderly individuals. It can lead to the loss of central visual field and vision, severely impacting daily life. Excessive activation of the complement system is a significant factor in its pathogenesis. gMG is an autoimmune disease of the neuromuscular junction, mediated by acetylcholine receptor (AChR) antibodies and involving complement participation. It is characterized by fluctuating skeletal muscle weakness and fatigue, with the pathogenesis involving the activation of the complement cascade by autoantibodies, mainly AChR antibodies.<\/p>\n\n\n\n

HSK39297 Overview<\/strong>
HSK39297 tablets are a Category 1 chemical drug. Previously, IND applications were submitted for primary or secondary glomerular diseases mediated by complement participation (acceptance numbers: CXHL2301085, CXHL2301086) and hemolytic diseases mediated by complement participation (acceptance numbers: CXHL2400057, CXHL2400058). Currently, Phase 2 clinical studies for IgA nephropathy and Phase 3 clinical studies for paroxysmal nocturnal hemoglobinuria are ongoing.-Fineline Info & Tech<\/a><\/p>\n\n\n\n