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恒瑞医药:注射用醋酸亮丙瑞林微球获批开展临床试验
Zhi Tong Cai Jing· 2025-12-19 12:04
Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for clinical trials of injectable acetic acid leuprolide microspheres, which will be conducted soon [1] Group 1: Product Information - Acetic acid leuprolide is a GnRH analog used for the treatment of prostate cancer [1] - The original research product LEUPLIN Pro was developed by Takeda Pharmaceutical Company and was approved for market in Japan in November 2015, but has not yet been launched in China [1] - The dosage and administration of the injectable acetic acid leuprolide microspheres differ from the already marketed injectable leuprolide microspheres in China, making it a generic version of an overseas product that is not yet available domestically [1] Group 2: Financial Investment - The cumulative R&D investment for the injectable acetic acid leuprolide microspheres project has reached approximately 24.68 million yuan [1]
恒瑞医药注射用醋酸亮丙瑞林微球临床试验获批
Bei Jing Shang Bao· 2025-12-19 11:57
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of its injectable leuprolide acetate microspheres for prostate cancer treatment [1] Group 1: Company Announcement - Heng Rui Medicine's subsidiary, Shanghai Heng Rui Medicine Co., Ltd., has been granted a clinical trial approval notice for leuprolide acetate microspheres [1] - The drug is a GnRH analog intended for the treatment of prostate cancer [1] - The original product, LEUPLIN Pro, was developed by Takeda Pharmaceutical Company and was approved for market in Japan in November 2015, but has not yet been launched in China [1] Group 2: Product Details - The formulation and dosage of leuprolide acetate microspheres differ from the already marketed injectable leuprolide in China [1] - The product is classified as a generic version of an overseas drug that has been approved but not yet launched domestically [1]