On September 3rd, Hong Kong-listed innovative drug developer EVEREST MED (01952) announced that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for its drug, 星必妥® (Etripamil Nasal Spray), for the acute treatment of paroxysmal supraventricular tachycardia (PSVT) in adults to restore sinus rhythm. As the company's first approved innovative therapy in the cardiovascular disease area, this approval further enriches EVEREST MED's product portfolio.
Notably, 星必妥® had already secured approval from the U.S. Food and Drug Administration (FDA) in December 2023, establishing itself as the first and only novel therapy for acute PSVT episodes in adults in over three decades. The recent approval in China marks the official entry of this innovative treatment into the domestic market.
PSVT is a type of rapid arrhythmia characterized by sudden onset and termination. During an episode, the heart rate increases significantly, often leading to symptoms such as palpitations, chest tightness, and dizziness, which can be accompanied by intense anxiety and fear. Historically, treatment for acute PSVT episodes has primarily relied on emergency medical services, with limited options available for patients to self-administer outside of a hospital setting, leaving a significant unmet need for on-demand relief.
星必妥® is a novel, fast-acting calcium channel blocker designed for rapid onset and convenient administration. It is currently the only medication that PSVT patients can self-administer during an episode to achieve rapid termination. The therapy can begin working within as little as 5 minutes after administration, with nearly two-thirds of patients achieving conversion to sinus rhythm within 30 minutes. The median time to conversion is 17.2 minutes, substantially reducing the need for additional emergency medical intervention and filling a critical void for out-of-hospital self-rescue in China.
The approval is supported by data from the global pivotal Phase III RAPID clinical trial and the Phase III JX02002 study conducted in China. In the RAPID study, 64% of patients in the 星必妥® group achieved conversion to sinus rhythm within 30 minutes, compared to 31% in the placebo group. The median time to conversion was 17.2 minutes in the treatment group versus 53.5 minutes in the placebo group, confirming the therapy's rapid efficacy and favorable safety profile. Results from this study were published in The Lancet in 2023. In the Chinese Phase III JX02002 study, 星必妥® demonstrated statistically superior efficacy over placebo in converting PSVT to sinus rhythm. Both trials met their primary endpoints and showed generally good tolerability.
Professor Ma Changsheng, Chief Investigator of the China Phase III clinical study and Director of the Cardiology Center at Beijing Anzhen Hospital of Capital Medical University, stated: "PSVT episodes are often sudden and unpredictable, with intense palpitations accompanied by strong anxiety, which continuously impacts patients' quality of life and mental health. The approval of 星必妥® fills the gap for out-of-hospital self-rescue, providing Chinese PSVT patients with their first self-administered treatment option. This empowers patients to intervene promptly during an episode and maintain control over their lives. Both the global and Chinese Phase III studies have confirmed that 星必妥® acts rapidly, is effective, and is safe. The global RAPID trial showed a 64% conversion rate at 30 minutes, while the Chinese study, conducted across 48 authoritative clinical centers, further validated its significant efficacy in Chinese patients. Additionally, 星必妥® was generally well-tolerated, with mild adverse reactions, and significantly reduced the frequency of emergency department visits."
Rogers Luo, Chief Executive Officer of EVEREST MED, commented: "The approval of 星必妥® marks a significant milestone for EVEREST MED in the field of cardiovascular innovative treatments. In China, approximately 2.3 to 4 out of every 1,000 people suffer from PSVT, with an estimated total patient population of 3 to 6 million, representing substantial unmet clinical need. As the only innovative therapy currently available for out-of-hospital acute PSVT management, 星必妥® offers patients a novel 'on-demand' self-rescue option. It can begin working within 5 minutes of administration, rapidly terminating episodes and enabling proactive disease management with greater patient control, while significantly reducing emergency visits. Moving forward, EVEREST MED will leverage its exceptional commercialization platform for innovative drugs to accelerate the launch of 星必妥® in China, addressing the immense unmet needs of PSVT patients and unlocking its long-term clinical and societal value."
Beyond the PSVT indication, EVEREST MED is also advancing the development of 星必妥® for the treatment of atrial fibrillation with rapid ventricular rate (AFib-RVR). Phase II clinical studies have yielded positive results, and plans are underway to progress to Phase III trials. If additional indications receive approval in the future, the potential clinical applications of 星必妥® could expand further.
As the company's first innovative product in the cardiovascular field, the approval of 星必妥® further enriches EVEREST MED's commercialized product portfolio. In recent years, the company has continuously strengthened its commercialization capabilities. Its "A2MS" (Access, Medical, Marketing, Sales) commercial operating system has been further upgraded and expanded, extending across the full product lifecycle and all channels, including tier-one hospitals, broader markets, retail pharmacies, and online platforms. This robust infrastructure will support the market introduction and commercial rollout of 星必妥® and other innovative therapies.
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