Daewon Pharmaceutical and Tium Bio Receive Domestic Phase 2 Approval for Uterine Fibroid New Drug

[Asia Economy Reporter Cho Hyun-ui] Daewon Pharmaceutical announced on the 26th that its new drug candidate for endometriosis and uterine fibroids, 'DW-4902' (Tium Bio name TU2670), which is being jointly developed with Tium Bio, has received approval from the Ministry of Food and Drug Safety for a domestic Phase 2 clinical trial plan.

This clinical trial will evaluate the efficacy and safety in patients with uterine fibroids.

DW-4902 blocks the signal of gonadotropin-releasing hormone (GnRH) secreted from the hypothalamus, thereby inhibiting the secretion of follicle-stimulating hormone (FSH) and luteinizing hormone (LH). It also suppresses female hormones in the ovaries to help treat endometriosis and uterine fibroids.

As it is being developed as a once-daily oral medication, it offers greater convenience in drug administration compared to existing injectable formulations. So far, there are no oral drugs in the GnRH antagonist class available domestically.

Tium Bio transferred the candidate substance technology to Daewon Pharmaceutical in February last year. Daewon Pharmaceutical is responsible for domestic development, production, and commercialization. Daewon Pharmaceutical is conducting clinical trials targeting uterine fibroid patients domestically, while Tium Bio is conducting clinical trials targeting endometriosis patients in five overseas countries including Russia, Ukraine, and Italy.

A Daewon Pharmaceutical official said, "The number of patients with endometriosis and uterine fibroids, which can cause menstrual pain, infertility, difficulty conceiving, and miscarriage, is steadily increasing. We will contribute to improving women's quality of life by developing convenient and safe new drugs."