Milestone's Etripamil Gains First China Approval, Triggers $2M…

Event summary

China’s NMPA approved Milestone’s etripamil nasal spray for PSVT, marking its first regulatory approval outside the U.S.
Everest Medicines will commercialize the drug in Greater China, with Milestone eligible for up to $98M in future milestones and 18% royalties.
The approval was based on positive Phase 3 data showing etripamil’s superiority over placebo in converting PSVT to sinus rhythm within 30 minutes.
Etripamil is already FDA-approved in the U.S. as CARDAMYST for PSVT and is in late-stage development for atrial fibrillation.

The big picture

This approval solidifies Milestone’s position as a player in cardiovascular innovation, with China representing a significant growth opportunity. The deal structure with Everest Medicines provides Milestone with substantial upside while outsourcing commercial risk. The success of etripamil in China could serve as a blueprint for other biopharmaceutical companies targeting both U.S. and Asian markets.

What we're watching

Commercial Execution: Whether Everest Medicines can effectively launch etripamil in a competitive Chinese market with 3-6 million potential PSVT patients.
Regulatory Momentum: The pace at which Milestone can secure additional international approvals for etripamil beyond China and the U.S.
Pipeline Progress: How Milestone’s ongoing Phase 3 trial for atrial fibrillation could expand etripamil’s therapeutic applications.