Jiangsu Hengrui Pharmaceuticals (01276): HRS-5346 tablets have been included in the list of breakthrough therapies by the drug approval center.

Jiangsu Hengrui Pharmaceuticals (01276) announced that recently, the HRS-5346 tablets of its subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. has been included in the list of breakthrough therapeutic drug varieties by the Drug Evaluation Center of the National Medical Products Administration. Elevated Lipoprotein(a) [Lp(a)] levels are the most common monogenic lipid disorder globally, and it is a typical manifestation of lipid disorder. The prevalence of Lp(a) levels >30mg/dl and >50mg/dl in Chinese 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 stenosis. Targeting Lp(a) for lipid-lowering therapy is one of the important breakthrough directions for the prevention and treatment of cardiovascular diseases. HRS-5346 is an oral small molecule inhibitor of Lp(a), and as per the search, there are currently no similar products approved for market both domestically and internationally. Up to now, the accumulated research and development investment for the HRS-5346 tablets project is approximately 76.30 million yuan (unaudited). According to the "Announcement of the National Medical Products Administration on the Release of Three Documents including (No.82, 2020)", the Drug Evaluation Center prioritizes resources for drugs included in the breakthrough therapeutic drug program, facilitates communication, provides guidance, and promotes drug development. Drug development can be influenced by various factors such as technology, approval, policies, etc., and uncertainties and risks exist in terms of evaluation policies and future market competition for drugs.