CSPC Pharmaceutical Group Limited ‘s chemical 1-class new drug, a double-stranded small interfering RNA drug, has received approval for clinical trials from the FDA
November 25, 2025
Source: drugdu
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On November 24th, CSPC (01093) released an announcement stating that the group's independently developed chemical Class 1 new drug, the double-stranded small interfering RNA drug (SYH2061 injection), has been approved by the US Food and Drug Administration (FDA) and can now conduct clinical trials in the United States. Additionally, this product was approved by the China National Medical Products Administration in October 2025 to conduct clinical trials in China.
SYH2061 injection is a siRNA drug that achieves liver-targeted delivery through the conjugation of acetylated galactosamine (GalNAc). It aims to target the complement protein C5 (C5) and effectively reduce its level. Preclinical studies have shown that this product outperforms other similar siRNA products in terms of drug activity and drug efficacy persistence, and has high clinical development value. It is suitable for the treatment of IgA nephropathy and other complement-mediated related diseases.
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