成都康弘药业集团股份有限公司 关于子公司收到药物临床试验批准通知书的公告

Core Viewpoint - Chengdu Kanghong Pharmaceutical Group Co., Ltd. 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, which is intended for the treatment of Diabetic Macular Edema (DME) [1][4]. Group 1: Drug Information - The drug KH631 is an eye injection developed by Hongji Biotechnology, classified as a Class 1 therapeutic biological product [2]. - The drug has received clinical trial approval in China on November 15, 2022, and in the United States on November 22, 2022, for the treatment of Neovascular (Wet) Age-related Macular Degeneration (nAMD) [2]. - KH631 utilizes a proprietary Adeno-Associated Virus (AAV) delivery system, showcasing unique characteristics in tissue specificity, immunogenicity, controllable expression, and infection efficiency, with demonstrated sustained efficacy in preclinical disease models [2]. Group 2: Impact on the Company - The company acknowledges that the drug development process, including clinical trials, reviews, and approvals, carries inherent uncertainties, urging investors to make cautious decisions and be aware of investment risks [3].