China's NMPA approves Milestone's etripamil nasal spray for PSVT
The approval, Milestone's first outside the United States, triggers a $2.0 million milestone payment and hands commercialization in Greater China to Everest Medicines.
Milestone Pharmaceuticals said on September 3, 2026 that China's National Medical Products Administration has cleared etripamil nasal spray to treat paroxysmal supraventricular tachycardia (PSVT) in adults. In the United States, the same drug is sold as CARDAMYST nasal spray, a self-administered treatment for adults with PSVT.1
The NMPA decision is the first time etripamil has won regulatory clearance anywhere outside the United States, and it triggers a $2.0 million milestone payment to Milestone.1 Everest Medicines holds an exclusive license from Milestone covering development of etripamil nasal spray across Greater China, defined here as Mainland China, Hong Kong, Macau and Taiwan.1 Under that license deal, Milestone stands to collect as much as $98.0 million in commercial and development milestones plus royalties on Greater China sales that scale up to 18%.1
The Chinese approval rests on two data sets: the global Phase 3 RAPID trial and a China-based Phase 3 study called JX02002.1 JX02002 hit its primary endpoint, showing etripamil converted PSVT to sinus rhythm within 30 minutes far more often than placebo, with a hazard ratio of 3.002 (95% CI: 1.578, 5.711; p = 0.0005).1 Across the Phase 3 program, treatment-emergent adverse events were similar between etripamil and placebo arms, and no serious adverse events turned up within 24 hours of dosing.1
PSVT affects an estimated three to six million people in China and about two million in the United States.1 Everest Medicines will lead the drug's commercial rollout in the region.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.