EVEREST MED Wins NMPA Approval for CARDAMYST Nasal Spray, First Self-Administered Treatment for Adult PSVT in China

Bulletin Express09-03 20:22

Hong Kong, 3 September 2026 — Everest Medicines Limited (EVEREST MED) has obtained National Medical Products Administration (NMPA) clearance for its New Drug Application (NDA) for CARDAMYST (etripamil) nasal spray, authorizing use in China to convert acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.

CARDAMYST is now the first self-administered, fast-acting, non-injectable therapy available to Chinese PSVT patients, addressing an urgent clinical gap previously managed primarily through emergency-room intervention. The approval marks EVEREST MED’s inaugural entry into the cardiovascular arena and advances the company’s commercialization roadmap.

Regulatory endorsement is underpinned by two Phase III studies: • RAPID Trial (global): 64 % of patients self-treating with etripamil (n=99) converted to sinus rhythm within 30 minutes versus 31 % on placebo (n=85), yielding a hazard ratio of 2.62 (95 % CI: 1.66–4.15; p < 0.001). Results were published in The Lancet in 2023. • JX02002 Trial (China): Among 84 evaluable patients per arm, etripamil produced a hazard ratio of 3.002 (p = 0.0005) for 30-minute conversion compared with placebo.

PSVT affects an estimated 3–6 million people in China—equivalent to 2.3 to 4 per 1,000 individuals—and is characterized by sudden, debilitating episodes of rapid heart rate. CARDAMYST’s rapid onset, with treatment effects seen as early as five minutes and nearly two-thirds of patients converting within 30 minutes, offers a portable, at-home alternative that could reduce emergency care dependence.

The NMPA decision follows the U.S. Food and Drug Administration’s December 2025 approval of CARDAMYST, where it became the first such self-administered nasal spray for PSVT in over three decades. EVEREST MED’s latest regulatory success extends its cardiovascular pipeline and reinforces its capacity to introduce innovative therapies to the Chinese market.

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