Core Viewpoint - Chengdu Kanghong Pharmaceutical Group Co., Ltd.'s subsidiary, Chengdu Hongji Biotechnology Co., Ltd., has received approval from the National Medical Products Administration for its KH631 eye injection for the treatment of Diabetic Macular Edema (DME) [1] Group 1 - The approved indication for KH631 is specifically for Diabetic Macular Edema (DME) [1]

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].

Group 1 - Kanghong Pharmaceutical's subsidiary Chengdu Hongji Biotechnology Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of KH631 eye injection, aimed at treating diabetic macular edema (DME) [1] Group 2 - Nepean Mining Machine has received approval from the China Securities Regulatory Commission for the registration of a convertible bond issuance to unspecified investors [2] - Tianqi Co., Ltd.'s controlling shareholder Huang Weixing has released 4 million shares from pledge, which represents 0.99% of the company's total share capital [2] - Huang Weixing and his concerted parties have a total of 8.9848 million pledged shares maturing in the next six months, accounting for 2.23% of the total share capital, and 29.59 million shares maturing within a year, representing 7.36% of the total share capital [2]

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]