天宇股份：全资子公司阿帕他胺原料药通过CDE审评

Core Viewpoint - Tianyu Co., Ltd. announced that its wholly-owned subsidiary, Jingsheng Pharmaceutical, has recently passed the CDE review for the active pharmaceutical ingredient (API) Apalutamide, which is used for the treatment of prostate cancer [1] Group 1: Regulatory Approval - The API Apalutamide has a packaging specification of 25 kg per barrel and is registered under the number Y20240000773 [1] - The company submitted the registration application in 2024, which has been accepted [1] - The API must obtain a "compliant" public notice from the Zhejiang Provincial Drug Administration for GMP conformity inspection before it can be marketed domestically [1] Group 2: Market Competition - As of the announcement date, there are 10 other manufacturers in China that have passed the technical review for the same API [1] - Jingsheng Pharmaceutical is currently preparing to apply for the GMP conformity inspection, indicating that the timeline for market entry remains uncertain [1]