CORXEL and Sanofi Announce an Agreement for Aficamten in Greater China Markets
• Sanofi will acquire CORXEL’s exclusive rights to develop and commercialize aficamten in Greater China
• The NDA for aficamten for the treatment of obstructive hypertrophic cardiomyopathy (oHCM) has been accepted by the China NMPA and U.S. FDA
SHANGHAI, December 20, 2024 – Corxel Pharmaceuticals (CORXEL), a leading biotech company committed to bringing innovative science and medicines to underserved patients with cardiometabolic diseases around the world, and Sanofi, today announced that the companies have entered into a definitive agreement, whereby Sanofi will acquire CORXEL’s exclusive rights to develop and commercialize aficamten in Greater China for an undisclosed amount. The transaction is expected to close in 2024.
Aficamten is an investigational, next-in-class selective small molecule cardiac myosin inhibitor discovered and developed globally by Cytokinetics. It received Breakthrough Therapy Designation for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) from the U.S. Food & Drug Administration (FDA) as well as Breakthrough Therapy Designation by the National Medical Products Administration (NMPA) of the PRC. In October 2024, the Center for Drug Evaluation (CDE) of the NMPA of the PRC accepted the New Drug Application (NDA) for aficamten tablets for the treatment of oHCM and designated it for priority review. In December 2024, Cytokinetics announced that the U.S. FDA accepted the company’s NDA for aficamten for the treatment of oHCM with a PDUFA date of September 26, 2025. In addition, aficamten is currently being evaluated in ACACIA-HCM, a pivotal phase 3 clinical trial in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
“In a short span of four years, CORXEL worked closely with Cytokinetics to conduct the Phase 1 to Phase 3 clinical development of aficamten as a potential treatment for oHCM in China, which has culminated in its NDA acceptance by China NMPA”, said Sandy Mou, Board Executive Director and Chief Executive Officer of CORXEL. “Our agreement with Sanofi is consistent with CORXEL’s corporate mission to develop and deliver innovative medicines to underserved patients with cardiometabolic diseases. Sanofi is a leading multinational pharmaceutical company with an outstanding cardiovascular commercial franchise and a strong track record of success in China. We are confident that, under the continuation of the program by Sanofi, many HCM patients in China can benefit from aficamten. “
“Today’s agreement with Sanofi is a major milestone for CORXEL and proves its strong capability to select leading innovative drug candidates of high significance for patients”, added Peter Fong, Board Executive Director of CORXEL, Partner and President of RTW Investments, LP. “Since its establishment, CORXEL has achieved tremendous success in the clinical development of innovative medicines. The agreement with Sanofi will not only ensure a fast and broad market access of aficamten for HCM patients in Greater China, but also allow CORXEL to grow further and focus on developing innovative medicines for cardiometabolic diseases globally, as we increase our focus on worldwide markets.”
"Building on Sanofi's strong heritage in cardiometabolic diseases, we see a significant opportunity to impact the health of Chinese patients by partnering with CORXEL, a leading biotech company,” said Wayne Shi, Country President of Sanofi Greater China. “This strategic partnership also demonstrates Sanofi's commitment to playing a more active role in the Chinese healthcare ecosystem, offering more innovative treatments for the large Chinese population with joint efforts of other leading companies.”
Additional information
Aficamten is an investigational selective, small molecule cardiac myosin inhibitor discovered by Cytokinetics 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 (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 (HCM).
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.
CORXEL, formerly named Ji Xing Pharmaceuticals, is a leading biotech company headquartered in US and China focused on developing innovative cardiometabolic therapies globally. Backed by RTW Investments, CORXEL was founded in 2019 and has been committed to bringing innovative science and medicines to underserved patients. With a strong and further developing asset pipeline for cardiometabolic diseases, industry leading talent, and patient-centric focus, CORXEL is dedicated to deliver a meaningful and lasting impact on patients around the world.
The portfolio of CORXEL consists of 2 assets with global rights and 2 assets with Greater China rights in late-stage clinical development. The portfolio with global rights covers JX09 for hypertension and JX10 for acute ischemic stroke (AIS), while the portfolio with Greater China rights includes etripamil and LNZ100.
For further information about CORXEL, please visit www.corxelbio.com
Sanofi is an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. In 1982, Sanofi opened an office in China as one of the first multinational corporations to support China’s opening up and reform. We have 12 offices with diverse models, 3 production sites and 4 R&D sites in China. Sanofi China has a diversified business that ranges from pharmaceuticals and human vaccines to consumer healthcare. As a multinational in China, Sanofi is committed to introducing innovative medicines and vaccines faster in China and transforming the practice of medicine to serve the broadest base of the Chinese people, and never stops questing to make life better for patients, partners, communities, and our own people.
For more information, please visit http://www.sanofi.cn or subscribe to the Sanofi China official WeChat account: SanofiChina (赛诺菲中国).
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
