CSPC Pharma's SYH2070 injection approved for US clinical trials

CSPC Pharmaceutical Group Limited announced that its independently developed Class 1 new chemical drug, SYH2070 Injection, a double-stranded small interfering RNA (siRNA) drug, has secured approval from the U.S. Food and Drug Administration (FDA) to initiate clinical trials in the U.S. This follows approval obtained in September 2025 from China's National Medical Products Administration for clinical trials within China.

The product, an siRNA drug, utilizes N-acetylgalactosamine (GalNAc) conjugation for liver-targeted delivery and targets Angiopoietin-like 3 (ANGPTL3) via subcutaneous administration to reduce ANGPTL3 levels. It is designed to treat hypertriglyceridemia or mixed hyperlipidemia and aims to reduce elevated residual cholesterol levels, exhibiting a sustained gene silencing effect.

Preclinical studies indicated that SYH2070 Injection demonstrated superior pharmacological activity, longer efficacy duration compared to similar siRNA products, a favorable safety profile, and high patient adherence, underscoring its potential clinical development value.