Core Viewpoint - Fosun Pharma'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, which are indicated for the treatment of high-risk non-metastatic castration-resistant prostate cancer (NM-CRPC) and symptomatic or asymptomatic metastatic castration-resistant prostate cancer (CRPC) in adult patients who have failed androgen deprivation therapy (ADT) [1] Group 1 - Enzalutamide is an androgen receptor inhibitor that acts on the androgen receptor signaling pathway, competitively inhibiting the binding of androgens to androgen receptors, thereby suppressing androgen receptor nuclear translocation and the interaction between androgen receptors and DNA [1] - The primary metabolite of Enzalutamide, N-desmethyl-Enzalutamide, exhibits similar in vitro activity to Enzalutamide [1] - Enzalutamide has been shown to inhibit the proliferation of prostate cancer cells and induce apoptosis in vitro, and it can reduce tumor volume in mouse models of prostate cancer xenografts [1]

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]

格隆汇10月30日丨福森药业(01652.HK)公告，集团全资附属公司嘉亨(珠海横琴)医药科技有限公司研发 的"恩扎卢胺软胶囊"，上市申请已获得中华人民共和国国家药品监督管理局批准，批准用于以下疾病的 治疗：有高危转移风险的非转移性去势抵抗性前列腺癌(NM-CRPC)成年患者；雄激素剥夺治疗(ADT)失 败后无症状或有轻微症状且未接受化疗的转移性去势抵抗性前列腺癌(CRPC)成年患者。 前列腺癌是常见的泌尿系统恶性肿瘤，位居全球男性癌症发病率的第2位和癌症死亡率的第5位。我国前 列腺癌的发病率低于西方国家，但近年来呈现上升的趋势。 恩扎卢胺是一种雄激素受体抑制剂，作用于雄激素受体信号通路，可竞争性抑制雄激素与雄激素受体结 合，进而抑制雄激素受体核移位以及雄激素受体与DNA的相互作用。恩扎卢胺主要代谢物N-去甲基–恩 扎卢胺的体外活性与恩扎卢胺相似。恩扎卢胺在体外可抑制前列腺癌细胞增殖并诱导前列腺癌细胞死 亡，且在小鼠前列腺癌移植瘤模型中可降低肿瘤体积。 恩扎卢胺2012年在美国上市，2013年在欧盟上市。2019年在中国批准上市。主要用于去势抵抗性前列腺 癌和转移性去势敏感性前列腺癌的治疗。 ...