康弘药业:子公司KH631眼用注射液获临床试验批准
Core Viewpoint - Kanghong Pharmaceutical's subsidiary, Hongji Biotech, has received approval from the National Medical Products Administration to conduct clinical trials for KH631 eye injection, aimed at treating diabetic macular edema (DME) [1] Group 1: Product Development - KH631 eye injection is an innovative gene therapy product independently developed by Hongji Biotech, classified as a Class 1 therapeutic biological product [1] - The product utilizes a self-owned intellectual property 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 of KH631 [1]