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Hengrui Pharmaceutical (600276.SH): HRS-5346 tablets obtained drug clinical trial approval notice

Zhitongcaijing·11/09/2026 09:09:12
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Zhitong Finance App News, Hengrui Pharmaceutical (600276.SH) issued an announcement. Recently, the company's subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received approval from the State Drug Administration to issue a “Pharmaceutical Clinical Trial Approval Notice” for HRS-5346 tablets, agreeing to carry out phase III clinical trials of this product. Application indications: Reduce the risk of major adverse cardiovascular events in adult patients with confirmed atherosclerotic cardiovascular disease with elevated lipoprotein (a) or increased risk of first-time cardiovascular events.

HRS-5346 is an Lp (a) oral small molecule inhibitor, showing the potential to prevent the risk of atherosclerotic cardiovascular disease by effectively reducing Lp (a). Oral administration is also expected to provide greater convenience for patients. According to inquiries, there are currently no similar drugs approved for marketing at home or abroad. Up to now, the total R&D investment for HRS-5346 film-related projects is approximately RMB 86.2 million (unaudited).