Sanofi SA (SNY.US) Announces Approval of Second-Generation Cardiac Myosin Inhibitor in China

Stock News12-17 21:16

Sanofi SA (SNY.US) announced on December 17 that its second-generation cardiac myosin inhibitor (CMI), Aficamten (brand name: Xin Shu Ping in China), has received approval from the National Medical Products Administration (NMPA) for commercial launch. The drug is indicated for adult patients with obstructive hypertrophic cardiomyopathy (HCM) classified as New York Heart Association (NYHA) Class II-III to improve exercise capacity and symptoms.

Aficamten is a small-molecule cardiac myosin inhibitor originally developed by Cytokinetics. The drug features comprehensive chemical optimization to enhance its therapeutic index and pharmacokinetic profile. It works by reducing the number of active myosin force-generating cross-bridges during each cardiac cycle, thereby inhibiting excessive myocardial contraction associated with HCM. Additionally, its pharmacological properties allow for a shorter half-life of just 3-4 days, enabling optimal dosing within 8 weeks.

In 2020, Cytokinetics granted exclusive development and commercialization rights for Aficamten in Greater China to Ji Xing Pharmaceuticals. In 2024, Sanofi acquired these exclusive rights from Ji Xing.

Aficamten is considered a potential "best-in-class" therapy for HCM. This approval marks Aficamten as an innovative drug achieving "global first launch" in China, with regulatory clearance ahead of the U.S., EU, and other global markets.

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