CSPC PHARMA (01093) announced that its self-developed Class 1 chemical new drug, the dual-chain small interfering RNA drug (SYH2061 Injection), has received approval from the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States. The product had also obtained approval from China's National Medical Products Administration in October 2025 to proceed with clinical trials in China.

SYH2061 is an siRNA drug that achieves liver-targeted delivery through GalNAc (N-acetylgalactosamine) conjugation. Administered subcutaneously, it targets complement protein C5, effectively reducing C5 levels. Through optimized sequencing and chemical modification strategies, the drug demonstrates prolonged gene silencing effects. It is the first ultra-long-acting C5-lowering siRNA drug independently developed in China to enter clinical trials, intended for treating IgA nephropathy and other complement-mediated diseases.

Preclinical studies indicate that SYH2061 outperforms similar siRNA products in both drug activity and sustained efficacy. It exhibits long-lasting therapeutic effects, favorable safety profiles, and high patient compliance, highlighting its significant clinical development potential.