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德谷门冬双胰岛素注射液(CA508注射液)
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智飞生物控股子公司德谷门冬双胰岛素注射液完成Ⅲ期临床试验
Jin Rong Jie· 2025-12-31 02:17
Core Viewpoint - Chongqing Zhifei Biological Products Co., Ltd.'s subsidiary, Chongqing Chanan Biopharmaceutical Co., Ltd., has successfully completed the phase III clinical trial for CA508 injection, a dual insulin product for treating type 2 diabetes, demonstrating efficacy and safety comparable to the original drug [1][2]. Product Development Progress and Market Path - Following the completion of the phase III clinical trial, Chongqing Chanan Biopharmaceutical Co., Ltd. will submit a drug production registration application to the National Medical Products Administration, which must pass technical review and clinical site inspection before market approval [2]. - The successful development of CA508 injection signifies a significant breakthrough for Chongqing Chanan Biopharmaceutical Co., Ltd. in the diabetes treatment sector, with broad clinical application prospects [2]. Impact on Company Business Layout - Chongqing Zhifei Biological Products Co., Ltd. indicated that CA508 injection will not have a major short-term impact on overall company performance, but successful market approval could strengthen the company's treatment segment within its integrated "prevention & treatment" business layout [3]. - The strategic extension into therapeutic drugs, particularly in diabetes treatment, reflects the company's commitment to diversifying beyond its traditional vaccine business, laying a solid product foundation for long-term development [3].
智飞生物:子公司德谷门冬双胰岛素注射液在有效性和安全性上与原研药诺和佳相当
Xin Lang Cai Jing· 2025-12-29 13:11
Core Viewpoint - The announcement indicates that Zhifei Biological's subsidiary, Chongqing Chen'an Biological Pharmaceutical Co., Ltd., has completed the Phase III clinical trial summary report for the insulin injection CA508, demonstrating comparable efficacy and safety to the original drug, NovoRapid® [1] Group 1: Clinical Trial Results - The CA508 insulin injection has shown effectiveness and safety comparable to the original NovoRapid® insulin injection [1] - The clinical trial design meets the requirements outlined in the "Guidelines for Clinical Trials of Diabetes Drugs and Biological Products" regarding efficacy and safety evaluation [1] Group 2: Market Context - As of the announcement date, there is only one other domestic company that has received approval for a similar insulin injection product [1]