As Cytokinetics’ aficamten awaits approval decisions from regulators in the U.S. and China, Sanofi has picked up China rights to the cardiovascular candidate.
The rights will be transferred from Corxel Pharmaceuticals, which had offered Cytokinetics up to $200 million in biobucks for regional rights to aficamten in 2020.
French drugmaker Sanofi will now hold exclusive rights to develop and commercialize the cardiac myosin inhibitor for obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China, according to a Dec. 20 release.
Back in June 2020, Shanghai-based Corxel—at the time known as Ji Xing—gained aficamten rights in China across indications tied to excessive heart contractility. Then, earlier this month, Corxel shared that a new drug application for aficamten tablets had been accepted by China regulatory authorities under priority review in obstructive hypertrophic cardiomyopathy (oHCM).
Now, Sanofi is taking over the China rights for an undisclosed sum, with Cytokinetics eligible to receive up to $150 million in milestone payments from Sanofi, plus royalties. The California-based biotech is also able to receive additional undisclosed payments in connection with the deal between Sanofi and Corxel.
Meanwhile, aficamten awaits approval decisions from both the European Medicines Agency and the FDA in oHCM, with a U.S. decision expected by Sept. 26, 2025. The candidate has secured an FDA breakthrough designation and offers the potential to rival Bristol Myers Squibb’s approved heart disease drug Camzyos.
In December 2023, Cytokinetics shared phase 3 data from a SEQUOIA-HCM trial, which found aficamten was better than placebo at improving the exercise capacity of patients with oHCM.
Cytokinetics also compared how aficamten fared on the primary endpoint that underpinned Camzyos’ FDA approval. The exploratory analysis showed that 42% of people on aficamten met the composite exercise capacity and symptom endpoint, compared with 14% of their counterparts on placebo. In the Camzyos trial, 37% of patients on the study drug met (PDF) the response criteria, versus 17% on placebo. The placebo-adjusted difference was bigger in the aficamten trial (28%) than in the Camzyos study (19%).
As Cytokinetics preps for the possible commercialization of aficamten, the biotech is also running clinical trials for the candidate in HCM.
Sanofi isn’t the first Big Pharma to invest in aficamten. Just this November, Bayer put down 50 million euros upfront for licensing rights to the asset in Japan. Under the collaboration, Bayer plans to run a phase 3 study of the drug in Japanese patients with obstructive HCM, while Cytokinetics will expand a global aficamten study into the country.
As for Sanofi, the transfer of rights follows a string of movement in China. Earlier this month, the company said it's establishing a $1 billion manufacturing site in the country, its largest investment in China to date. The new production base will be Sanofi’s fourth in the country and is intended to bolster local end-to-end insulin production.