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恒瑞医药(01276):注射用醋酸亮丙瑞林微球获批开展临床试验
智通财经网· 2025-12-19 12:01
Core Viewpoint - Heng Rui Medicine (01276) has received approval from the National Medical Products Administration for clinical trials of injectable acetic acid leuprolide microspheres, which will be conducted shortly [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 domestically [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 has not been launched domestically [1] Group 2: Financial Investment - The total research and development investment for the injectable acetic acid leuprolide microspheres project has reached approximately 24.68 million yuan [1]
恒瑞医药(600276.SH):获得关于注射用醋酸亮丙瑞林微球的临床试验批准通知书
Ge Long Hui A P P· 2025-12-19 09:40
Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of injectable acetic acid leuprolide microspheres, which will be conducted shortly [1] Group 1: Product Information - Acetic acid leuprolide is a GnRH analog used 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] - The formulation and dosage of the injectable acetic acid leuprolide microspheres differ from the already marketed injectable leuprolide microspheres in China, classifying it as a generic version of an overseas product that is not yet available domestically [1] Group 2: R&D Investment - The cumulative research and development investment for the injectable acetic acid leuprolide microspheres project has reached approximately 24.68 million yuan [1]