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补充申请批准通知书的公告

Core Viewpoint - Chengdu Kanghong Pharmaceutical Group Co., Ltd. announced that its wholly-owned subsidiary, Chengdu Kanghong Biotechnology Co., Ltd., received the approval notice for the supplementary application of clinical trials for the drug Kangbaxip (Kangbaxip Eye Injection) from the National Medical Products Administration [1][2]. Group 1: Drug Information - Drug Name: Kangbaxip Eye Injection [3] - Dosage Form: Injection [3] - Indications: Treatment for neovascular (wet) age-related macular degeneration (nAMD) and vision loss due to macular edema secondary to retinal vein occlusion (RVO), including branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO) [1][3]. Group 2: Product Overview - Kangbaxip Eye Injection is a Class 1 biopharmaceutical innovation drug developed independently by Kanghong Biotechnology, possessing complete intellectual property rights [3]. - The product effectively binds to VEGF in blood and tissues, blocking the signaling pathways that promote neovascularization and growth [3]. - This clinical trial aims to explore the application of high-dose Kangbaxip Eye Injection, potentially improving patient compliance and reducing medical burdens [3]. Group 3: Impact on the Company - The uncertainty surrounding the drug's development, clinical trials, review, and approval processes necessitates cautious decision-making by investors [4].