Jiangsu Hengrui Pharmaceuticals (600276.SH): HRS-5346 tablets receive drug clinical trial approval notice

Jiangsu Hengrui Pharmaceuticals (600276.SH) announced that recently, its subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received the Drug Clinical Trial Approval Notice for HRS-5346 tablets approved and issued by the National Medical Products Administration, agreeing to conduct a Phase III clinical trial of this product. Proposed indication: to reduce the risk of major adverse cardiovascular events in adult patients with confirmed atherosclerotic cardiovascular disease accompanied by elevated lipoprotein(a) or at increased risk of a first cardiovascular event. HRS-5346 is an oral small-molecule inhibitor of Lp(a), showing potential to prevent the risk of atherosclerotic cardiovascular disease by effectively lowering Lp(a); oral administration is also expected to offer greater convenience to patients. According to searches, no similar drugs have been approved for marketing domestically or internationally to date. As of now, cumulative R&D investment in HRS-5346 tablet-related projects is approximately RMB86.2 million (unaudited).