FUSEN PHARM (01652): "Diqupregnol tablets" approved for market listing

FUSEN PHARM (01652) announced that its wholly-owned subsidiary, Jiaheng (Zhuhai Hengqin) Medical Technology Co., Ltd., has received approval from the China National Medical Products Administration for the market application of "Diqu Progesterone Tablets" (trademark: Yunmeiyan). It is approved for the treatment of diseases and/or symptoms caused by endogenous progesterone deficiency. "Diqu Progesterone Tablets" is an orally absorbable progestogen used to treat diseases and/or symptoms caused by endogenous progesterone deficiency, such as dysmenorrhea, endometriosis, secondary amenorrhea, irregular menstrual cycles, dysfunctional uterine bleeding, premenstrual syndrome, threatened miscarriage or habitual miscarriage, and infertility due to luteal insufficiency. It can also be used to provide luteal support in assisted reproductive technologies. Diqu progesterone is a synthetic progestogen with a structure and function closest to natural progesterone. Compared with natural progesterone progesterone, it has higher bioavailability, lower dosing frequency, and better hepatic safety. Compared with traditional synthetic progestogens, it has no estrogen, androgen, or corticosteroid effects, and does not increase the risk of breast cancer. "Diqu Progesterone Tablets" is a Class B variety in the National Medical Care Bureau, recommended by authoritative guidelines such as the Chinese Guidelines for the Diagnosis and Treatment of Endometriosis, the Guidelines for the Diagnosis and Treatment of Amenorrhea, and the Clinical Practice Guidelines for Progestogen Maintenance of Pregnancy and Luteal Support, widely used in various gynecological diseases. According to Meinee data, the total sales of Diqu Progesterone Tablets in urban and county public hospitals and urban pharmacies in China in 2025 is about RMB 2.5 billion. "Diqu Progesterone Tablets" is another important product of the group, further enriching the company's product line. The approval of this product signifies a significant breakthrough in the company's pipeline in the field of gynecology/reproduction, providing more treatment options for patients.