FUSEN PHARM: "Enzalutamide Soft Capsules" Approved for Market Launch

Zhitong
2025.10.30 14:01
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FUSEN PHARM announced that its wholly-owned subsidiary Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd. has developed "Enzalutamide Soft Capsules," which have been approved for marketing by the National Medical Products Administration of China. This drug is used for the treatment of high-risk non-metastatic castration-resistant prostate cancer (NM-CRPC) and metastatic castration-resistant prostate cancer (CRPC) after failure of androgen deprivation therapy. Enzalutamide is an androgen receptor inhibitor that can inhibit the proliferation of prostate cancer cells and induce cell death

According to the Zhitong Finance APP, FUSEN PHARM (01652) announced that its wholly-owned 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." The approval is for the treatment of the following diseases: adult patients with non-metastatic castration-resistant prostate cancer (NM-CRPC) at high risk of metastatic progression; adult patients with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or have mild symptoms and have not received chemotherapy after failure of androgen deprivation therapy (ADT).

Enzalutamide is an androgen receptor inhibitor that acts on the androgen receptor signaling pathway, competitively inhibiting the binding of androgens to androgen receptors, thereby inhibiting androgen receptor nuclear translocation and the interaction between androgen receptors and DNA. The in vitro activity of the main metabolite of enzalutamide, N-desmethyl–enzalutamide, is similar to that of enzalutamide. Enzalutamide can inhibit the proliferation of prostate cancer cells in vitro and induce prostate cancer cell death, and it can reduce tumor volume in mouse models of prostate cancer xenografts