FUSEN PHARM (01652) has announced that the new drug application for "Dydrogesterone Tablets" (brand name: Yun Mei Yan), developed by its wholly-owned subsidiary Jahen (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd., has been approved by the China National Medical Products Administration. The tablets are approved for treating diseases and/or symptoms caused by endogenous progesterone deficiency. Dydrogesterone Tablets are an orally absorbable progestin used to treat conditions such as dysmenorrhea, endometriosis, secondary amenorrhea, irregular menstrual cycles, dysfunctional uterine bleeding, premenstrual syndrome, threatened or habitual miscarriage, and infertility due to luteal phase deficiency. They are also indicated for luteal phase support in assisted reproductive technology. Dydrogesterone is a synthetic progestin with a structure and function closest to natural progesterone. Compared to natural progesterone, it offers higher bioavailability, lower dosing frequency, and improved liver safety. Unlike traditional synthetic progestins, it has no estrogenic, androgenic, or corticoid effects and does not increase the risk of breast cancer. Dydrogesterone Tablets are classified as a Category B drug under China's National Healthcare Security Administration and are recommended by authoritative guidelines including China's "Guidelines for Diagnosis and Treatment of Endometriosis," "Guidelines for Diagnosis and Treatment of Amenorrhea," and "Clinical Practice Guidelines for Progesterone in Pregnancy Maintenance and Luteal Support," making them widely used in various gynecological and obstetric conditions. According to data from Menet, the total sales of dydrogesterone tablets in Chinese urban and county-level public hospitals and urban retail pharmacies are projected to reach approximately RMB 2.5 billion by 2025. The approval of Dydrogesterone Tablets represents another significant product for the Group, further enriching its product portfolio. This milestone marks an important breakthrough in the company's pipeline within the gynecology/reproductive health sector and will provide patients with more treatment options.