Everest Medicines has received approval from China’s National Medical Products Administration for CARDAMYST, or etripamil, for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia to sinus rhythm in adults.
The approval marks Everest Medicines’ first innovative therapy in the cardiovascular field and further expands the company’s cardiovascular, kidney and metabolic disease portfolio.
CARDAMYST is a rapid-acting calcium channel blocker delivered through a portable nasal spray and designed for as-needed self-administration outside healthcare settings.
Everest Medicines said it is currently the only self-administered treatment in China for adults with PSVT capable of rapidly treating acute episodes.
Treatment effects were observed as early as five minutes after administration, with nearly two-thirds of patients converting to sinus rhythm within 30 minutes in clinical studies.
The company is positioning CARDAMYST as an alternative to the traditional model of acute PSVT care, which has relied largely on hospital-based emergency treatment.
PSVT is characterised by sudden episodes of rapid, regular heart rhythm and affects an estimated 3 million to 6 million people in China.
Symptoms can include severe palpitations, shortness of breath, chest discomfort, dizziness and distress, with episodes sometimes lasting several hours.
“The approval of CARDAMYST addresses a critical unmet need by introducing the first innovative therapy that enables patients to self-administer treatment for acute PSVT episodes in China,” said Professor Changsheng Ma, Principal Investigator of the Phase III JX02002 study and Director of Cardiology at Beijing Anzhen Hospital.
The approval was supported by the global Phase III RAPID study and China Phase III JX02002 trial.
In the RAPID study, 64% of participants who self-administered etripamil converted from supraventricular tachycardia to sinus rhythm within 30 minutes, compared with 31% receiving placebo.
The study met its primary endpoint with a hazard ratio of 2.62.
In the China JX02002 study, patients receiving etripamil were also significantly more likely to achieve conversion to sinus rhythm within 30 minutes compared with placebo, with a hazard ratio of 3.002.
CARDAMYST was approved by the US Food and Drug Administration in December 2025.
The therapy is also in Phase III development for atrial fibrillation with rapid ventricular response, supported by positive Phase II findings.
Everest Medicines estimates that CARDAMYST could potentially benefit more than 12 million patients in China across PSVT and AFib-RVR.
“The approval of CARDAMYST marks an important milestone, introducing the first out-of-hospital, patient-administered treatment option for acute PSVT episodes in China,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines.
The company plans to accelerate commercial launch preparations in China while continuing clinical development in additional cardiovascular indications.
