康弘药业:基因治疗创新产品KH631眼用注射液获药物临床试验批准

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 KH631 eye injection, aimed at treating Diabetic Macular Edema (DME) [1] Group 1 - KH631 eye injection is an innovative gene therapy product independently developed by Hongji Biotechnology, classified as a Class 1 biological product for treatment [1] - The product received clinical trial approval from the National Medical Products Administration on November 15, 2022, and from the U.S. Food and Drug Administration on November 22, 2022, for conducting clinical trials on Neovascular (Wet) Age-related Macular Degeneration (nAMD) in the United States [1] - KH631 is based on a proprietary Adeno-Associated Virus (AAV) delivery system, featuring characteristics in tissue specificity, immunogenicity, expression controllability, and infection efficiency, demonstrating sustained efficacy in preclinical disease models [1]