CSPC Pharmaceutical Group (01093.HK): Phase II Clinical Trial of SYH2070 Injection for Mixed Dyslipidemia Officially Launched at First Center in China

Zhitong Finance APP News: CSPC (01093) announced that the Phase II clinical trial of SYH2070 injection, developed by the Group for the treatment of mixed hyperlipidemia, has officially commenced at the first site in China.

Current treatment regimens for mixed hyperlipidemia require the combination of multiple drugs, and there remains an unmet clinical need for therapies that can simultaneously lower triglycerides (TG) and low-density lipoprotein cholesterol (LDL-C). This product is a small interfering RNA (siRNA) drug independently developed by the Group, featuring N-acetylgalactosamine (GalNAc) conjugation and targeting angiopoietin-like protein 3 (ANGPTL3) messenger RNA (mRNA) in hepatocytes. The product sustainably and specifically silences ANGPTL3 mRNA, inhibits ANGPTL3 protein expression, thereby enhancing lipoprotein lipase (LPL) activity and suppressing endothelial lipase (EL) activity, reducing the conversion of very-low-density lipoprotein (VLDL) to low-density lipoprotein (LDL). This achieves the goal of simultaneously, durably, and stably lowering TG and LDL-C levels, while significantly improving patient compliance through extended dosing intervals.

Previously, the Group obtained the "Notice of Approval for Drug Clinical Trials" (Acceptance No.: 2025LP02566) from the National Medical Products Administration (NMPA) of China in September 2025, and has completed the Phase I clinical trial and initiated the current Phase II clinical trial. This Phase II clinical trial aims to evaluate the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of the product compared with placebo in subjects with mixed hyperlipidemia receiving lipid-lowering therapy. A total of 240 subjects are planned to be enrolled. Currently, subject recruitment and screening are actively progressing.