康弘药业：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: Drug Information - Drug Name: KH631 Eye Injection [1] - Dosage Form: Injection [1] - Indication: Treatment of Diabetic Macular Edema (DME) [1] - Registration Classification: Class 1 therapeutic biological product [1] - Acceptance Numbers: CXSL2500874, CXSL2500875 [1] - Approval Conclusion: Authorized to conduct clinical trials for the treatment of DME [1] Group 2: Product Development - KH631 Eye Injection is an innovative gene therapy product independently developed by Hongji Biotechnology [1] - The product received clinical trial approval from the China 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 in the U.S. for neovascular (wet) age-related macular degeneration (nAMD) [1] - The product is based on an adeno-associated virus (AAV) delivery system with unique features in tissue specificity, immunogenicity, expression controllability, and infection efficiency, showing sustained efficacy in preclinical disease models [1]