Ji Xing Pharmaceuticals (Jixing) and Cytokinetics Inc (CYTK, NASDAQ: CYTK) have achieved a significant milestone with the acceptance of their market filing for aficamten by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. Aficamten, a next-generation cardiac myosin inhibitor, is under development for the treatment of hypertrophic cardiomyopathy (HCM).
In July 2020, Cytokinetics entered into a licensing agreement granting Jixing exclusive rights to develop and commercialize aficamten in Greater China. The drug has been granted breakthrough therapy designation (BTD) for the treatment of obstructive hypertrophic cardiomyopathy (oHCM) by the CDE in 2022. The Phase III SEQUOIA-HCM study demonstrated that aficamten significantly improves peak oxygen consumption and cardiac function in patients with oHCM.
Furthermore, a Phase III study (MAPLE-HCM) comparing aficamten to metoprolol for first-line oHCM treatment was initiated in China. In March 2024, aficamten received clearance for a Phase III study in non-obstructive hypertrophic cardiomyopathy (nHCM) in China, expanding its potential patient reach.- Flcube.com
