CSPC Pharma Initiates Phase II Trial in China for SYH2070 Injection in Mixed Hyperlipidemia

Stock News
Jul 07

CSPC PHARMA has announced the official commencement of a Phase II clinical trial for its investigational SYH2070 injection in the treatment of mixed hyperlipidemia at the first site in China.

Current treatment regimens for mixed hyperlipidemia typically require the use of multiple medications in combination, and there remains a significant unmet clinical need for therapies that can simultaneously reduce both triglycerides (TG) and low-density lipoprotein cholesterol (LDL-C).

The product, SYH2070, is a novel, self-developed small interfering RNA (siRNA) drug. It utilizes an N-Acetylgalactosamine (GalNAc) conjugate to target and silence the messenger RNA (mRNA) of Angiopoietin-like protein 3 (ANGPTL3) within liver cells. This mechanism persistently and specifically inhibits the expression of the ANGPTL3 protein.

By silencing ANGPTL3, the drug enhances the activity of lipoprotein lipase (LPL) and suppresses endothelial lipase (EL) activity. This action reduces the conversion of very-low-density lipoprotein (VLDL) to low-density lipoprotein (LDL), thereby achieving a sustained and stable reduction in both TG and LDL-C levels. Furthermore, the treatment regimen features an extended dosing interval, which is expected to significantly improve patient compliance.

The company previously received a clinical trial approval notification from China's National Medical Products Administration for this drug in September 2025 and has already completed a Phase I clinical trial, paving the way for this current Phase II study.

The primary objectives of this Phase II trial are to evaluate the product's efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity compared to a placebo in subjects with mixed hyperlipidemia who are already receiving lipid-lowering therapy.

The trial is designed to enroll 240 participants. At present, patient recruitment and screening activities are actively progressing.

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