Jiangsu Hengrui Medicine Co LtdNMPA approved Recaticimab Injection for a Phase III trial in intracranial atherosclerotic stenosis, advancing its self-developed anti-PCSK9 antibody pipeline.

Hengrui Medicine announced that its subsidiary Guangdong Hengrui has received the Drug Clinical Trial Approval Notice for Recaticimab Injection issued by the National Medical Products Administration, approving the product to proceed with a Phase III clinical trial. The indication sought is for adult patients with intracranial atherosclerotic stenosis, to reduce the risk of stroke recurrence. Recaticimab Injection is a self-developed anti-PCSK9 monoclonal antibody that inhibits the binding of PCSK9 to LDL receptors, increasing the number of LDL receptors available to clear low-density lipoprotein from the blood, thereby lowering LDL cholesterol levels. The announcement shows that the product was approved for marketing in China in 2025 for adult patients with hypercholesterolemia and mixed dyslipidemia. Cumulative R&D investment in this project is approximately 422 million yuan.
Jiangsu Hengrui Medicine Co LtdNMPA approved Recaticimab Injection for a Phase III trial in intracranial atherosclerotic stenosis, advancing its self-developed anti-PCSK9 antibody pipeline.