Hengrui Pharma's subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has recently seen its drug candidate HRS-5346, intended for the treatment of elevated lipoprotein(a) levels, included in the Breakthrough Therapy Designation list by the Center for Drug Evaluation of the National Medical Products Administration.

Elevated lipoprotein(a) [Lp(a)] is one of the most common single-gene lipid disorders worldwide and represents a typical form of lipoprotein abnormality. In China, the prevalence of Lp(a) levels exceeding 30 mg/dL and 50 mg/dL among adults is 18.67% and 8.41%, respectively. Elevated Lp(a) has been confirmed as an independent risk factor for atherosclerotic cardiovascular diseases, including coronary heart disease, ischemic stroke, peripheral vascular disease, and calcific aortic valve stenosis. Lipid-lowering therapies targeting Lp(a) represent a promising new direction for cardiovascular disease prevention and treatment. However, no approved drugs currently target the reduction of Lp(a), and related therapies remain in the clinical research stage.

HRS-5346 is an orally administered small-molecule Lp(a) inhibitor independently developed by Hengrui Pharma. It works by blocking the initial non-covalent binding between apolipoprotein(a) [apo(a)] and apolipoprotein B100 (ApoB100), thereby inhibiting disulfide bond formation and the assembly of Lp(a), leading to reduced Lp(a) levels. Study results indicate that HRS-5346 effectively lowers Lp(a) with a favorable safety profile.

In March 2025, the company granted Merck & Co., Inc. the exclusive global rights to HRS-5346 outside Greater China.

The Breakthrough Therapy Drug Program is designed to encourage the research and development of drugs with significant clinical advantages. According to guidelines issued by the Center for Drug Evaluation, drugs eligible for this designation are those intended to prevent or treat serious or life-threatening conditions for which no effective treatment exists, or which demonstrate clear clinical benefits over existing therapies. Drugs included in the program receive prioritized resources for communication and guidance to accelerate their development.