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 therapeutic biological product [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 for Neovascular (Wet) Age-related Macular Degeneration (nAMD) in the United States [1] - The product is based on a proprietary Adeno-Associated Virus (AAV) delivery system, featuring characteristics in tissue specificity, immunogenicity, controllable expression, and infection efficiency, demonstrating sustained efficacy in preclinical disease models [1]

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]

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]

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 - The drug KH631 is classified as a Class 1 therapeutic biological product and has received approval to conduct clinical trials for DME [1] - The approval numbers for the drug are CXSL2500874 and CXSL2500875 [1] - KH631 is an innovative gene therapy product developed by Hongji Biotechnology, which has also received approval from the U.S. Food and Drug Administration to conduct clinical trials for neovascular (wet) age-related macular degeneration (nAMD) [1] Group 2 - The product utilizes a proprietary 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 for KH631 [1]

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]

证券代码：002773 证券简称：康弘药业 公告编号：2026-001 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 本公司及董事会全体成员保证信息披露内容的真实、准确和完 整，没有虚假记载、误导性陈述或重大遗漏。 近日，成都康弘药业集团股份有限公司（以下简称"公司"）子 公司成都弘基生物科技有限公司（以下简称"弘基生物"）收到国家 药品监督管理局签发的《药物临床试验批准通知书》。现将相关情况 公告如下： 一． 药品基本信息 药品名称：KH631 眼用注射液 适应症：本品适用于治疗糖尿病黄斑水肿（DME） 注册分类：治疗用生物制品 1 类 受理号：CXSL2500874、CXSL2500875 审批结论：同意开展本品适用于治疗糖尿病黄斑水肿（DME）的 临床试验。 二． 产品简介 KH631 眼用注射液是弘基生物自主研发的基因治疗创新产品，属 于治疗用生物制品 1 类，分别于 2022 年 11 月 15 日获得中国药品监 督管理局药物临床试验批准通知书，美国时间 2022 年 11 月 22 日收 到 U.S.Food and Drug Administration（美国食品药品 ...

一、募集资金基本情况 1、首次公开发行股票募集资金基本情况 经中国证券监督管理委员会（以下简称"中国证监会"）"证监 许可[2015]1198号文"核准，成都康弘药业集团股份有限公司（以下 简称"公司"）公开发行人民币普通股股票4,560.00万股，每股发行 价为13.62元，扣除证券公司承销费、保荐费等费用后实际募集资金 净额为人民币57,624.77万元。上述募集资金已于2015年6月23日全部 到位，经信永中和会计师事务所（特殊普通合伙）审验，并出具了 XYZH/2015CDA50084号《验资报告》。 2、公开发行可转换公司债券募集资金基本情况 经中国证监会（证监许可[2019]2572号）核准，公司公开发行了 1,630.00万张可转换公司债券，每张面值100元，发行总额163,000.00 万元，扣除证券公司承销费、保荐费等费用后实际募集资金净额为人 民币160,935.70万元。上述募集资金已于2020年3月11日全部到位， 经信永中和会计师事务所（特殊普通合伙）审验，并出具了 XYZH/2020CDA50024号《验资报告》。 证券代码：002773 证券简称：康弘药业 公告编号：2025-0 ...

Group 1 - The company, Chengdu Kanghong Pharmaceutical Group Co., Ltd., announced that its wholly-owned subsidiary, Chengdu Kanghong Biotechnology Co., Ltd., received a clinical trial supplement application approval notice from the National Medical Products Administration for the drug Kangbaisipu Eye Injection [1][2] - Kangbaisipu Eye Injection is a Class 1 innovative biological drug independently developed by the company, which effectively binds to VEGF in blood and tissues, blocking the signaling pathways that promote neovascularization [2] - The approval allows for the exploration of high-dose Kangbaisipu Eye Injection in clinical applications, which is expected to improve patient compliance and reduce medical burdens [2]

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].

Core Viewpoint - Kanghong Pharmaceutical's subsidiary has been approved to conduct clinical trials for a high-dose version of Conbercept eye injection, a first-class biopharmaceutical innovation developed by Kanghong Biotech [1] Group 1: Product Information - Conbercept eye injection is a self-developed innovative drug by Kanghong Biotech, designed for injection [1] - The indications for Conbercept include neovascular (wet) age-related macular degeneration (nAMD) and vision impairment caused by macular edema due to retinal vein occlusion (RVO) [1] Group 2: Regulatory Approval - The National Medical Products Administration has approved the high-dose version of Conbercept for clinical trials, with acceptance numbers CXSB2500193 and CXSB2500194 [1]