Cytokinetics has secured the China National Medical Products Administration’s approval for its cardiac myosin inhibitor MYQORZO (aficamten) on December 17, 2025. The approval covers adults with New York Heart Association class II‑III obstructive hypertrophic cardiomyopathy (oHCM) and represents the drug’s first global regulatory win.
The NMPA decision triggers a $7.5 million milestone payment from Sanofi and makes Cytokinetics eligible for up to $142.5 million in future development and commercial milestone payments, as well as royalties on sales in Greater China. Sanofi, which acquired exclusive rights to aficamten in Greater China in December 2024, will lead commercialization efforts in the region.
MYQORZO is a selective cardiac myosin inhibitor that reduces myocardial hypercontractility and was evaluated in the Phase 3 SEQUOIA‑HCM trial. The drug has received Breakthrough Therapy designation from both the U.S. FDA and China’s NMPA, underscoring its potential to address an unmet need in a disease that affects an estimated 280,000 diagnosed patients in the United States.
The China approval is a critical early milestone ahead of the U.S. FDA’s PDUFA target date of December 26, 2025 and the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) positive opinion issued on December 12, 2025. A final European Commission decision is expected in the first quarter of 2026, positioning MYQORZO for a potential global launch in 2026.
Cytokinetics remains in a heavy R&D‑investment phase, reporting a net loss of $306.2 million for Q3 2025 versus $160.5 million in Q3 2024, and revenue of $1.93 million for the same period. The milestone payment provides a much‑needed cash infusion, but the company’s long‑term commercial prospects hinge on securing U.S. and EU approvals and achieving sales growth once the drug is available in those markets.
President and CEO Robert I. Blum said the China approval “confirms the clinical promise of MYQORZO and strengthens our partnership with Sanofi, positioning us for a successful global launch.” Analysts view the approval as a positive signal for the company’s pipeline, noting that MYQORZO could compete with Bristol Myers Squibb’s Camzyos, the first approved cardiac myosin inhibitor for oHCM.
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