Youcare Pharmaceutical Group Co.,Ltd. (688658.SH) announced that its subsidiary, Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd., has recently received notification from the U.S. Food and Drug Administration (FDA) approving the clinical trial application for YKYY033 Injection, intended for the prevention and treatment of arterial and venous thrombosis.

The product had previously obtained multiple anticoagulant-related clinical trial approvals from China's National Medical Products Administration (NMPA) in June and July 2026, with Phase I clinical studies progressing steadily.

This successful clearance from the U.S. FDA marks the official qualification of the product for overseas clinical development. Leveraging the approved, comprehensive matrix of indications for thrombosis prevention and treatment across all scenarios, the company will pursue differentiated clinical exploration for multiple indications, precisely aligning with global mainstream anticoagulation treatment guidelines and clinical standards. This initiative aims to fill the market gap for both domestically and globally high-safety, long-acting nucleic acid-based anticoagulant drugs.