JW Jungwoo Pharmaceutical, 'Technology Export' Gout Treatment Receives Clinical Phase 1 Approval in China

[Asia Economy Reporter Cho Hyun-ui] JW Pharmaceutical announced on the 2nd that its gout treatment drug 'URC102' has received approval for a Phase 1 clinical trial plan from the China National Medical Products Administration (NMPA).

URC102 is a compound that JW Pharmaceutical licensed out last year to China-based Simcere Pharmaceutical (hereafter Simcere). It is a new drug candidate effective for 'underexcretion-type' gout, where uric acid is not properly excreted, and has a mechanism that promotes uric acid excretion. In August, Simcere submitted the clinical trial plan for URC102 to the Chinese NMPA.

With this approval, Simcere will evaluate safety, tolerability, and other factors in 40 Chinese subjects at the Shanghai Public Health Clinical Center.

JW Pharmaceutical demonstrated high safety and a reduction in blood uric acid levels in a Phase 2a clinical trial of URC102 conducted on 140 Korean gout patients. The subsequent Phase 2b trial completed subject dosing last month and is currently in the clinical data collection stage. The Phase 2b trial results report is expected to be released early next year.

At the time of the URC102 licensing contract with Simcere, JW Pharmaceutical received an upfront payment of 5 million USD (approximately 5.5 billion KRW). Subsequently, milestone payments for clinical development, approval, and commercialization will be received sequentially up to a maximum of 65 million USD (approximately 72 billion KRW). The total contract value is 70 million USD (approximately 77.5 billion KRW). Royalties based on sales are separate.

Simcere holds exclusive rights for development and commercialization of URC102 in the Chinese market (including Hong Kong and Macau), while JW Pharmaceutical retains rights for all countries outside China.

This content was produced with the assistance of AI translation services.