Core Viewpoint - Fosen Pharmaceutical's subsidiary, Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd., has received approval from the National Medical Products Administration of China for the listing application of Enzalutamide soft capsules, indicating a significant advancement in the treatment options for specific prostate cancer patients [1] Group 1: Product Approval - The approved indication for Enzalutamide includes treatment for high-risk non-metastatic castration-resistant prostate cancer (NM-CRPC) in adult patients [1] - It is also approved for asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (CRPC) in adult patients who have failed androgen deprivation therapy (ADT) and have not received chemotherapy [1] Group 2: Mechanism of Action - Enzalutamide acts as an androgen receptor inhibitor, targeting the androgen receptor signaling pathway by competitively inhibiting the binding of androgens to the androgen receptor [1] - The drug suppresses androgen receptor nuclear translocation and the interaction between the androgen receptor and DNA [1] - The primary metabolite, N-desmethyl-Enzalutamide, exhibits similar in vitro activity to Enzalutamide [1] Group 3: Efficacy - In vitro studies show that Enzalutamide can inhibit the proliferation of prostate cancer cells and induce apoptosis in these cells [1] - In mouse models of prostate cancer xenografts, Enzalutamide has been shown to reduce tumor volume [1]
福森药业(01652)：“恩扎卢胺软胶囊”获批上市