China's National Medical Products Administration (NMPA) has approved Cardamyst (etripamil) nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) in adults — the molecule's first regulatory clearance outside the US, where the US FDA approved it in December 2025. Commercialization in Greater China will be led by Everest Medicines, which holds an exclusive license from Montreal-based Milestone Pharmaceuticals (Nasdaq: MIST). The approval triggers a USD 2 million milestone payment to Milestone, which remains eligible for up to USD 98 million in further commercial and development milestones plus tiered royalties of up to 18% on Greater China sales.
Cardamyst is a self-administered intranasal calcium channel blocker indicated for acute conversion of symptomatic PSVT episodes to sinus rhythm in adults, without requiring immediate medical oversight. The nasal route allows patients to treat episodes outside a clinical setting on demand.
The NMPA decision drew on data from two Phase III studies: the global pivotal RAPID trial and the China-specific JX02002 study. JX02002 met its primary endpoint, with etripamil demonstrating statistically significant superiority over placebo in converting PSVT to sinus rhythm within 30 minutes of dosing (hazard ratio 3.002 [95% CI: 1.578–5.711]; p = 0.0005). Treatment-emergent adverse events were comparable between arms, and no serious adverse events were reported within 24 hours post-dose across Phase III studies.