Youcare Pharmaceutical Group Co. Ltd. AFDA approval for YKYY033 injection advances its clinical development, a positive regulatory milestone for the company.

Youcare Pharmaceutical announced that its subsidiary Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. recently received a letter from the US FDA agreeing to the clinical trial application for YKYY033 injection for the prevention and treatment of arterial and venous thrombosis. YKYY033 is a double-stranded siRNA drug conjugated with a GalNAc ligand that silences the mRNA transcribed from the coagulation factor XI gene through RNA interference, inhibiting the production of FXI protein. Preclinical studies have shown good safety and tolerability, and it has demonstrated significant antithrombotic efficacy in multiple animal models without increasing bleeding risk. The product received clinical trial approval from the NMPA for multiple anticoagulation-related indications in June and July 2026, and Phase I clinical trials are progressing steadily.
Youcare Pharmaceutical Group Co. Ltd. AFDA approval for YKYY033 injection advances its clinical development, a positive regulatory milestone for the company.