CSPC gains clinical trial approval for innovative RNA drug SYH2061 injection

CSPC Pharmaceutical Group Limited's SYH2061 Injection, a double-stranded small interfering RNA (siRNA) drug, has received clinical trial approval in China from the National Medical Products Administration. This Class 1 new chemical drug was independently developed by the group.

SYH2061 is an siRNA drug designed for liver-targeted delivery, specifically targeting complement component C5 via subcutaneous administration to reduce C5 levels. It is the first independently developed, ultra-long-lasting siRNA drug of its kind to enter clinical trials in China and is indicated for treating IgA nephropathy and other complement-mediated diseases.

Preclinical studies demonstrated SYH2061's superior pharmacological activity, extended efficacy, strong safety profile, and high patient adherence compared to similar siRNA products, highlighting its promising clinical development value. The announcement was made in Hong Kong on 24 October 2025.