FUSEN PHARM (01652) announced that its wholly-owned subsidiary, Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd., has received approval from China's National Medical Products Administration for the market launch of "Enzalutamide Soft Capsule." The drug is approved for the treatment of the following conditions: adult patients with non-metastatic castration-resistant prostate cancer (NM-CRPC) at high risk of metastasis, and adult patients with metastatic castration-resistant prostate cancer (CRPC) who have failed androgen deprivation therapy (ADT) and are asymptomatic or mildly symptomatic without prior chemotherapy.

Enzalutamide is an androgen receptor inhibitor that targets the androgen receptor signaling pathway. It competitively inhibits the binding of androgens to the receptor, thereby suppressing androgen receptor nuclear translocation and its interaction with DNA. The primary metabolite of enzalutamide, N-desmethyl enzalutamide, exhibits similar in vitro activity to enzalutamide. In preclinical studies, enzalutamide has demonstrated the ability to inhibit prostate cancer cell proliferation, induce cancer cell death, and reduce tumor volume in mouse xenograft models of prostate cancer.