HENGRUI PHARMA (01276.HK): Recaticimab Cleared for Clinical Trials, Phase III Study Planned in Stroke Recurrence
- The acceptance number is CXSL2600655 and the NMPA accepted the application on 17 June 2026; the drug was approved for marketing in China in 2025 for hypercholesterolaemia and mixed dyslipidaemia.
- Recaticimab for injection is a PCSK9 monoclonal antibody independently developed by the Company that inhibits the binding of PCSK9 to LDLR, increasing the number of LDLRs available to clear LDL from the blood and thereby lowering LDL-C levels.
- Global sales of comparable products totalled approximately USD 3.987 billion in 2025; cumulative R&D investment in the project is approximately RMB 422.2 million (unaudited).
NewTimeSpace (newtimespace.com) News: On 15 September 2026, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (stock code: 01276) published an overseas regulatory announcement setting out an announcement published on the website of the Shanghai Stock Exchange. The Company's subsidiary Guangdong Hengrui Pharmaceuticals Co., Ltd. received a Drug Clinical Trial Approval Notice issued by the National Medical Products Administration approving a Phase III clinical trial of recaticimab for injection.
The indication applied for is adult patients with intracranial atherosclerotic stenosis, to reduce the risk of stroke recurrence. The acceptance number is CXSL2600655 and the NMPA accepted the application on 17 June 2026. The announcement stated that, after obtaining a clinical trial approval notice, the drug still has to undergo clinical trials and pass NMPA review and approval before it can be manufactured and marketed.
Recaticimab for injection is a PCSK9 monoclonal antibody independently developed by the Company that inhibits the binding of PCSK9 to the low-density lipoprotein receptor (LDLR), increasing the number of LDLRs available to clear low-density lipoprotein from the blood and thereby lowering LDL-C levels. The drug was approved for marketing in China in 2025 for adult patients with hypercholesterolaemia and mixed dyslipidaemia.
Comparable drugs are already approved worldwide, including Amgen's evolocumab, Sanofi's alirocumab, Innovent's tafolecimab, Junshi Biosciences' ongericimab and Akeso's ebronucimab. According to the EvaluatePharma database, global sales of such comparable products totalled approximately USD 3.987 billion in 2025. Cumulative R&D investment in the recaticimab for injection project is approximately RMB 422.2 million (unaudited).
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