HENGRUI PHARMA (01276.HK) gets clinical trial approvals for HRS-5346 tablets and SHR-1139 injection

NewTimeSpace News: On November 9, 2026, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (01276.HK/600276.SH) announced that two of its subsidiaries had recently received drug clinical trial approval notices issued by the National Medical Products Administration (NMPA) for HRS-5346 tablets and SHR-1139 injection, both of which will enter clinical trials in the near future.

HRS-5346 tablets were filed by subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. under acceptance number CXHL2600979, which was accepted on August 10, 2026. The NMPA has agreed to the conduct of a Phase III clinical trial for the indicated use of reducing the risk of major adverse cardiovascular events in adult patients with confirmed atherosclerotic cardiovascular disease and elevated lipoprotein(a), or at increased risk of a first cardiovascular event. HRS-5346 is an oral small-molecule Lp(a) inhibitor that has shown potential to prevent atherosclerotic cardiovascular disease risk by effectively lowering Lp(a), with oral administration expected to offer greater convenience for patients. No similar drug has been approved for marketing in China or overseas, and cumulative R&D investment in the project amounts to about RMB 86.2 million (unaudited).

SHR-1139 injection was filed by subsidiary Guangdong Hengrui Pharmaceutical Co., Ltd. under acceptance number CXSL2600876, which was accepted on August 17, 2026. The NMPA has agreed to the conduct of a clinical trial for palmoplantar pustulosis. SHR-1139 is a self-developed bispecific antibody targeting both IL-23p19 and IL-36R, blocking two pathways simultaneously and potentially providing more comprehensive and sustained inflammation control. No similar drug has been approved for marketing in China or overseas, and cumulative R&D investment in the project amounts to about RMB 162.7 million (unaudited). The company cautioned that the drugs must still complete clinical trials and obtain NMPA review and approval before they can be manufactured and marketed.