Corxel Pharmaceuticals (CORXEL) has signed a definitive agreement with Sanofi, whereby Sanofi will acquire CORXEL’s exclusive rights to develop and commercialize aficamten in Greater China for an undisclosed amount.

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,” added Mou.

“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. 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,” added Peter Fong, Board Executive Director of CORXEL, Partner and President of RTW Investments, LP.

"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. 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,” said Wayne Shi, Country President of Sanofi Greater China.