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]

Core Viewpoint - Fosen Pharmaceutical's subsidiary has received approval from the National Medical Products Administration of China for the marketing application of Enzalutamide soft capsules, targeting specific types of prostate cancer [1] Company Summary - Fosen Pharmaceutical's subsidiary, Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd., has developed Enzalutamide soft capsules [1] - The approved indications include treatment for high-risk non-metastatic castration-resistant prostate cancer (NM-CRPC) in adult patients and asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (CRPC) in adults who have not received chemotherapy after androgen deprivation therapy (ADT) failure [1] Industry Summary - Prostate cancer is the second most common malignancy among men globally and the fifth leading cause of cancer-related deaths [1] - The incidence of prostate cancer in China is lower than in Western countries but has been increasing in recent years [1] - Enzalutamide is an androgen receptor inhibitor that competes with androgens for binding to androgen receptors, inhibiting their nuclear translocation and interaction with DNA [1] - Enzalutamide has shown efficacy in inhibiting prostate cancer cell proliferation and inducing cell death in vitro, and it has reduced tumor volume in mouse models of prostate cancer [1] - Enzalutamide was first launched in the United States in 2012, followed by the European Union in 2013, and was approved for use in China in 2019 [1]