Zhitong Finance App News, Fussen Pharmaceutical (01652) announced that “enzalutamide softgels” developed by Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of the Group, have submitted a marketing application to the China National Drug Administration and have been accepted. Enzalutamide softgels are used to treat the following diseases: This product is suitable for adult patients with non-metastatic castration-resistant prostate cancer (NM-CRPC) with a high risk of metastatic metastatic metastasis resistant prostate cancer (CRPC); treatment of adult patients with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or have mild symptoms after failure of androgen deprivation therapy (ADT) and have not received chemotherapy.

According to reports, enzalutamide is an androgen receptor inhibitor. It acts on the androgen receptor signaling pathway and can competitively inhibit androgen receptor binding to androgen receptors, thereby inhibiting androgen receptor nuclear shift and the interaction between androgen receptors and DNA. N-demethyl-enzalutamide, the main metabolite of enzalutamide, has in vitro activity similar to enzalutamide. In vitro enzalutamide can inhibit the proliferation of prostate cancer cells and induce their death, and can reduce tumor size in mouse prostate cancer transplant models.

Enzalutamide was marketed in the US in 2012 and in the European Union in 2013. The listing was approved in China in 2019. It is mainly used to treat castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.

The “enzalumide softgels” developed by the company are declared according to the 4 types of chemicals. The prescription is basically the same as the original reference formulation, and the quality of the product is strictly controlled. Through pharmaceutical and clinical (BE) research, the quality and efficacy are consistent with the original reference formulation to ensure the safety of patients. “Enzalutamide softgels” provide a very favorable risk-benefit ratio in terms of laboratory test results and clinical symptoms in the treatment of adult patients with non-metastatic castration-resistant prostate cancer (NM-CRPC) with a high risk of metastatic metastasis and adult patients with asymptomatic or mild symptoms after failure of androgen deprivation treatment (ADT) and did not receive chemotherapy.

According to the announcement, “enzalumide softgels” are another important product of the Group, further enriching the Group's product pipeline in the field of anti-tumor treatment. Once launched, the product will provide more treatment options for adult prostate cancer patients.