By Fineline Cube 
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that its Category 1 biologic product recaticimab (SHR-1209) has been approved by the National Medical Products Administration (NMPA). The PCSK9-targeted monoclonal antibody (mAb) can now be used in combination with statins or statins plus other lipid-lowering therapies for adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia. This approval is significant for patients who still cannot achieve their low-density lipoprotein cholesterol (LDL-C) target despite receiving moderate or higher doses of statin therapy, on the basis of dietary control. Recaticimab can also be used as a monotherapy for non-familial hypercholesterolemia and mixed dyslipidemia to reduce levels of LDL-C, total cholesterol (TC), and apolipoprotein B (ApoB).
Mechanism of Action and Patient Benefits
Recaticimab works by inhibiting the binding of PCSK9 to the low-density lipoprotein receptor (LDLR), thereby increasing the number of LDLR available to clear LDL from the blood and reducing LDL-C levels. A key advantage of recaticimab is its 8-week administration interval, which is more convenient compared to other PCSK9 mAbs that require injections every 2, 4, or 6 weeks. This longer interval improves patient compliance and offers flexible monthly and bi-monthly medication plans.
Market Landscape
The global market for PCSK9 inhibitors already includes several commercially available options, such as Amgen’s Repatha (evolocumab), Sanofi’s Praluent (alirocumab), Innovent Bio’s tafolecimab, Junshi Bio’s ongericimab, and Akeso Bio’s ebronucimab. The approval of recaticimab adds to this competitive landscape, offering healthcare providers and patients another effective option for managing hypercholesterolemia and dyslipidemia.
Future Prospects
The approval of recaticimab by the NMPA is a significant step forward for Hengrui Pharmaceuticals, as it expands the company’s presence in the cardiovascular disease treatment market. With its unique dosing schedule and proven efficacy, recaticimab is poised to make a meaningful impact on the management of hypercholesterolemia and related conditions, improving patient outcomes and quality of life.-Fineline Info & Tech