CSPC Pharmaceutical Group Limited (the “Group”) announced that its independently developed SYH2061 Injection, a double-stranded small interfering RNA (siRNA) drug, has obtained clinical trial approval in China from the National Medical Products Administration. The product, a Class 1 new chemical drug, uses N-acetylgalactosamine (GalNAc) conjugation for liver-targeted delivery and reduces complement component C5 levels through subcutaneous administration.

According to the announcement, the product delivers a sustained gene-silencing effect and represents the first locally developed ultra-long-lasting siRNA drug targeting C5 to enter clinical trials in China. It is intended for the treatment of IgA nephropathy and other complement-mediated diseases. Preclinical studies demonstrated strong pharmacological activity, long-lasting therapeutic effects, and a favorable safety profile, suggesting significant potential for clinical development value.