Sanofi Acquires Rights to Cytokinetics' Aficamten for Hypertrophic Cardiomyopathy in Greater China
核心洞察
Sanofi has acquired exclusive rights from Corxel (搜索) Pharmaceuticals to develop and commercialize aficamten in Greater China for hypertrophic cardiomyopathy (搜索) (HCM).
Cytokinetics (搜索) is eligible to receive up to $150 million in milestone payments and royalties on future sales of aficamten in Greater China from Sanofi.
Aficamten, a next-in-class cardiac myosin (搜索) inhibitor, has received Breakthrough Therapy Designation in China for symptomatic obstructive HCM.
Cytokinetics (搜索), Incorporated announced that Sanofi will acquire exclusive rights to develop and commercialize aficamten from Corxel (搜索) Pharmaceuticals for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (搜索) (HCM) in Greater China.
In 2020, Corxel (搜索) (formerly Ji Xing) acquired the rights to develop and commercialize aficamten in Greater China from Cytokinetics (搜索) in accordance with Cytokinetics’ global registration programs. The Center for Drug Evaluation of the China National Medical Products Administration recently accepted the New Drug Application for aficamten tablets for the treatment of oHCM for Priority Review after Aficamten received Breakthrough Therapy Designation for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (搜索) (oHCM).
Sanofi will now acquire Corxel (搜索)’s rights relating to aficamten in Greater China for an undisclosed amount. Cytokinetics (搜索) remains eligible to receive up to $150 million in development and commercial milestone payments from Sanofi as well as royalties in the low-to-high teens on future sales of aficamten in Greater China. Cytokinetics is now also eligible to receive additional undisclosed payments in connection with the execution of the agreement between Sanofi and Corxel.
Robert I. Blum, Cytokinetics (搜索)’ President and CEO, stated, “We have enjoyed a productive collaboration with Corxel (搜索) and appreciate all they have done to advance aficamten in Greater China. We now look forward to partnering with Sanofi with shared objective to leverage their cardiovascular expertise and expand the reach of aficamten to patients suffering from HCM throughout Greater China.”
About Aficamten
Aficamten is an investigational selective, small molecule cardiac myosin (搜索) inhibitor discovered following an extensive chemical optimization program that was conducted with careful attention to therapeutic index and pharmacokinetic properties and as may translate into next-in-class potential in clinical development. Aficamten was designed to reduce the number of active actin-myosin cross bridges during each cardiac cycle and consequently suppress the myocardial hypercontractility that is associated with hypertrophic cardiomyopathy (搜索) (HCM). In preclinical models, aficamten reduced myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state.
The development program for aficamten is assessing its potential as a treatment that improves exercise capacity and relieves symptoms in patients with HCM as well as its potential long-term effects on cardiac structure and function. Aficamten was evaluated in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), a positive pivotal Phase 3 clinical trial in patients with symptomatic obstructive hypertrophic cardiomyopathy (搜索) (HCM). Aficamten received Breakthrough Therapy Designation for the treatment of symptomatic obstructive HCM from the U.S. Food & Drug Administration (FDA). The FDA recently accepted the company’s New Drug Application (NDA) for aficamten, for the treatment of obstructive hypertrophic cardiomyopathy and assigned the NDA a Prescription Drug User Fee Act target action date of September 26, 2025. Cytokinetics (搜索) also recently submitted a Marketing Authorization Application for aficamten to the European Medicines Agency.
Aficamten is also currently being evaluated in MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, and CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM.
Hypertrophic Cardiomyopathy (HCM)
Hypertrophic cardiomyopathy (搜索) (HCM) is a disease in which the heart muscle (myocardium) becomes abnormally thick (hypertrophied). The thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller and stiffer, and thus the ventricle becomes less able to relax and fill with blood. This ultimately limits the heart’s pumping function, resulting in reduced exercise capacity and symptoms including chest pain, dizziness, shortness of breath, or fainting during physical activity. HCM is the most common monogenic inherited cardiovascular disorder, with approximately 280,000 patients diagnosed, however, there are an estimated 400,000-800,000 additional patients who remain undiagnosed in the U.S. Two-thirds of patients with HCM have obstructive HCM, in which the thickening of the cardiac muscle leads to left ventricular outflow tract obstruction, while one-third have non-obstructive HCM, in which blood flow isn’t impacted, but the heart muscle is still thickened. People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease. People with HCM are at risk for potentially fatal ventricular arrhythmias and it is one of the leading causes of sudden cardiac death in younger people or athletes. A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation.