康弘药业(002773.SZ)：KH631眼用注射液获批药物临床试验

Core Viewpoint - Kanghong Pharmaceutical (002773.SZ) announced that its subsidiary Chengdu Hongji Biotechnology Co., Ltd. received the Clinical Trial Approval Notice from the National Medical Products Administration for the drug KH631, an eye injection for the treatment of diabetic macular edema (DME) [1] Group 1 - The drug KH631 is classified as a Class 1 therapeutic biological product and has received approval to conduct clinical trials for DME [1] - The approval numbers for the drug are CXSL2500874 and CXSL2500875 [1] - KH631 is an innovative gene therapy product developed by Hongji Biotechnology, which has also received approval from the U.S. Food and Drug Administration to conduct clinical trials for neovascular (wet) age-related macular degeneration (nAMD) [1] Group 2 - The product utilizes a proprietary adeno-associated virus (AAV) delivery system, which features specificity for tissues, low immunogenicity, controllable expression, and high infection efficiency [1] - Preclinical disease models have demonstrated sustained efficacy for KH631 [1]