October 18, 2024, Shanghai, China - Jixing Pharmaceuticals (hereinafter referred to as "Jixing"), a biotechnology company committed to bringing innovative science and drugs to patients suffering from serious life-threatening cardiometabolic diseases, today Announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration has officially accepted the new drug marketing application for Aficamten tablets for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Aficamten is a new generation of selective small molecule cardiac myosin inhibitor under development. Its treatment of oHCM has been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) and the China National Medical Products Administration.

This new drug marketing application is based on the positive results of the pivotal global Phase 3 clinical study SEQUOIA-HCM. A total of 282 patients with obstructive HCM were enrolled in SEQUOIA-HCM. The study results showed that treatment with Aficamten significantly improved patients' exercise capacity compared with placebo, and the treatment effect was consistent across all prespecified subgroups that reflected the patients' baseline characteristics and treatment strategies, including those receiving or patients not receiving beta-blockers as background therapy. Statistically significant and clinically meaningful improvements were also observed in all 10 prespecified secondary endpoints.

In July 2020, Jixing signed an exclusive license agreement with Cytokinetics, a late-stage clinical biopharmaceutical company headquartered in California, for the development and commercialization of Aficamten, a new generation cardiac myosin inhibitor, in Greater China. In December 2023, Cytokinetics announced positive results from SEQUOIA-HCM in patients with symptomatic obstructive hypertrophic cardiomyopathy. In March 2024, Jixing announced that the Center for Drug Evaluation of the National Medical Products Administration approved the clinical trial application (CTA) of the ACACIA-HCM Chinese cohort, which is a trial of Aficamten in the treatment of 3 patients with non-obstructive hypertrophic cardiomyopathy (nHCM). phase clinical trials.

About Aficamten. As an investigational, selective small molecule cardiac myosin inhibitor, Aficamten uses comprehensive chemical optimization to improve the drug's therapeutic index and pharmacokinetic characteristics, reducing active myosin force-producing cross-bridges in each cardiac cycle. A new generation of cardiac myosin inhibitors, thereby inhibiting the excessive myocardial contraction associated with hypertrophic cardiomyopathy (HCM). In preclinical models, Aficamten reduces myocardial contractility by directly binding to cardiac myosin at a unique and selective allosteric binding site, thereby preventing myosin from entering a force-producing state.

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