Everest Medicines Announces China NMPA Approval of CARDAMYST® for the Conversion of Acute Symptomatic Episodes of Paroxysmal Supraventricular Tachycardia (PSVT) to Sinus Rhythm in Adults
SHANGHAI, Sept. 3, 2026 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that China's National Medical Products Administration (NMPA) has approved CARDAMYST® (etripamil) for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. As Everest's first innovative therapy approved in the cardiovascular field, CARDAMYST further expands the Company's cardiovascular portfolio. The approval marks another important milestone in the execution of Everest's commercialization strategy and reinforces the Company's capability to bring innovative therapies to patients in China.
CARDAMYST (etripamil) nasal spray is a novel, rapid-acting calcium channel blocker administered as needed via a convenient, portable nasal spray. It offers rapid onset of action, favorable tolerability, and the potential for at-home self-administration, enhancing patient accessibility. CARDAMYST is currently the only self-administered treatment for adults with PSVT to rapidly treat episodes. Treatment effects observed as early as five minutes after administration, with nearly two-thirds of patients achieving conversion to sinus rhythm within 30 minutes, reducing the need for emergency medical interventions and filling a critical gap in out-of-hospital, self-administered treatment options for acute symptomatic episodes of PSVT in China.
The approval of CARDAMYST was supported by the global pivotal Phase III RAPID trial and the Phase III JX02002 study in China. Both studies met their primary endpoints. The RAPID trial achieved its primary endpoint with 64% of participants who self-administered etripamil (N=99) converting from supraventricular tachycardia (SVT) to sinus rhythm within 30 minutes compared to 31% on placebo (N=85) (HR = 2.62; p<0.001). The study results were published in The Lancet in 2023. In the JX02002 study, among participants with PSVT episodes (N=84), a greater number of patients receiving etripamil achieved conversion to sinus rhythm within 30 minutes, compared with placebo (N=84) (hazard ratio [HR] = 3.002; p=0.0005). In December 2025, CARDAMYST was approved by the U.S. Food and Drug Administration (FDA), becoming the first and only self-administered nasal spray in more than 30 years capable of converting paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
PSVT is a type of tachyarrhythmia characterized by the sudden onset and termination of episodes of rapid, regular heart rhythm. The heart rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing patients to limit their daily activities. There are currently no approved self-administered, fast-acting, non-injectable therapies for acute PSVT, leaving patients with limited treatment options beyond emergency care. Approximately 2.3 to 4 per 1,000 individuals are affected by PSVT, representing an estimated 3 to 6 million patients in China.
"PSVT episodes are often sudden and unpredictable and can significantly impact patients' quality of life. The management of acute PSVT episodes in China has long relied primarily on hospital-based emergency care, highlighting the need for an on-demand treatment option that patients can self-administer outside of healthcare settings," said Professor Changsheng Ma, M.D., Principal Investigator of the Phase III JX02002 study, Director of Cardiology Department at Beijing Anzhen Hospital, and President of the Chinese Society of Cardiology, Chinese Medical Association, "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. Both the global pivotal Phase III RAPID trial and the China Phase III JX02002 study demonstrated its rapid onset, robust efficacy, and favorable safety profile. In the RAPID trial, CARDAMYST achieved a conversion rate of 64% within 30 minutes. Its efficacy in Chinese patients was further confirmed in the JX02002 study, conducted across 48 leading clinical centers in China. CARDAMYST was generally well tolerated, with predominantly mild adverse events, and significantly reduced the need for emergency department visits. We believe this innovative therapy has the potential to transform the treatment paradigm for acute PSVT episodes by enabling timely, patient-initiated treatment, reducing the need for emergency medical intervention, and ultimately improving patients' quality of life."
"The approval of CARDAMYST marks an important milestone, introducing the first out-of-hospital, patient-administered treatment option for acute PSVT episodes in China. This innovative therapy has the potential to shift the management of acute PSVT episodes beyond hospital-based emergency care and help ease the burden on healthcare systems. Patients with PSVT often require emergency medical care during episodes, leaving them with the anxiety and uncertainty associated with unpredictable recurrences," said Mr. Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "As the only innovative therapy currently available that enables patients to self-administer treatment for PSVT episodes outside of healthcare settings, CARDAMYST offers a new on-demand treatment option. With treatment effects observed as early as five minutes after administration, CARDAMYST enables patients to manage episodes outside of a healthcare setting, giving them greater control over their condition and potentially reshaping the treatment paradigm for PSVT in China. Leveraging our proven commercialization capabilities, we look forward to accelerating the launch of CARDAMYST in China to address the significant unmet needs of patients with PSVT and realize its long-term clinical and societal value."
CARDAMYST is also in Phase III clinical development for atrial fibrillation with rapid ventricular response (AFib-RVR), with positive Phase II results supporting its advancement. CARDAMYST has the potential to benefit more than 12 million patients in China, including those with PSVT and AFib-RVR.
About CARDAMYST® (etripamil) Nasal Spray
Etripamil is a novel calcium channel blocker developed by Milestone Pharmaceuticals Inc. (Nasdaq: MIST). It is designed as a rapid-response therapy for episodic cardiovascular conditions. As a self-administered nasal spray, etripamil has the potential to shift treatment from emergency department-based care to a patient-managed setting. In May 2021, JIXING (now CORXEL) and Milestone entered into an exclusive license agreement for the development and commercialization of investigational drug etripamil for PSVT and other cardiovascular indications in Greater China ("Milestone License Agreement").
In March 2026, Everest Medicines entered into an asset purchase agreement with CORXEL Pharmaceuticals to acquire the rights to develop, commercialize, and manufacture CARDAMYST in Greater China.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative pharmaceutical products that address critical unmet medical needs for patients in global markets. The management team of Everest Medicines has deep expertise and an extensive track record both in China and with leading global pharmaceutical companies.
The Company's therapeutic areas of focus include autoimmune, ophthalmology, critical care, and CKM (cardiovascular, kidney, and metabolic) diseases. Everest Medicines has developed a fully integrated commercialization platform that combines omnichannel commercial capabilities with end-to-end product lifecycle management. Leveraging its proprietary mRNA platform, the Company is advancing its existing pipeline, including mRNA in vivo CAR-T and mRNA cancer vaccines, while selectively expanding into additional high-value therapeutic areas with blockbuster potential, and accelerating its global expansion. For more information, please visit the Company's website: www.everestmedicines.com.
source: Everest Medicines