Genting Xinyao (01952) was approved, the first innovative cardiovascular drug Starbital®, and the first and only innovative treatment for PSVT emergency self-help for adults entered China
Zhitong Finance App learned that on September 3, Genting Xinyao (01952), an innovative Hong Kong pharmaceutical company, announced that China's National Drug Administration (NMPA) has approved a new drug marketing license application (NDA) for the treatment of acute episodes of paroxysmal supraventricular tachycardia (PSVT) in adults, which reverted to sinus heart rhythm. As Genting Xinyao's first approved innovative drug in the field of cardiovascular diseases, the approval of Starbital® further enriched the company's innovative product portfolio.
According to information, Starbital ® was approved by the US Food and Drug Administration (FDA) in December 2025, becoming the first and only innovative therapy approved for the treatment of PSVT acute attacks in adults in more than 30 years. This approval also marks the official entry of this innovative treatment plan into the Chinese market.
PSVT is a type of rapid arrhythmia characterized by sudden onset. The heart rate increases significantly during the attack. Patients often experience symptoms such as palpitations, chest tightness, and dizziness. In severe cases, it can be accompanied by obvious anxiety and fear. However, for a long time, treatment for acute attacks of PSVT has mainly relied on emergency treatment by medical institutions. Treatment options for rapid termination of attacks that can be used independently outside the hospital are limited, and patients' emergency treatment needs have not been fully met.
Starbital ® is a novel, fast-acting calcium ion channel blocker. It has the characteristics of rapid effect and convenient administration. It is currently the only drug that PSVT patients can self-administer when symptoms occur and quickly stop the attack. Starbital ® can be effective as early as 5 minutes after administration. Nearly two-thirds of patients can recover sinus rhythm within 30 minutes. The median turnaround time is 17.2 minutes, significantly reducing the need for additional emergency medical intervention and filling the “emergency self-help” gap for Chinese PSVT patients during acute attacks.
This approval is mainly based on data results obtained from key global Phase III RAPID clinical studies and China Phase III JX02002 clinical research studies. The RAPID study showed that 64% of patients in the Starbital ® group returned to sinus rhythm within 30 minutes, while 31% of patients in the placebo group had a median recovery time of 17.2 minutes, and the placebo group was 53.5 minutes, confirming that it had rapid recovery effects and good safety. The relevant findings were published in the “Lancet” magazine in 2023. In the Chinese Phase III JX02002 study, compared with placebo, the Starbital® group had significant efficacy in converting PSVT to sinus rhythm. Both studies reached primary endpoints and were generally well tolerated.
Professor Ma Changsheng, chief investigator of the Phase III clinical study in China, director of the Cardiology Center at Beijing Anzhen Hospital affiliated to Capital Medical University, and chairman of the Cardiovascular Branch of the Chinese Medical Association, said, “PSVT attacks are often sudden and difficult to predict. Severe panic and palpitations are accompanied by intense anxiety, which has a lasting impact on patients' quality of life and mental health. The approval of Starbital ® has filled the gap where PSVT patients have no self-treatment for acute attacks outside of hospital, and brought the first innovative treatment option for PSVT patients in China that can be used on their own outside of hospital, giving patients the ability to intervene in a timely manner and independently control their lives during a seizure.
Global and Chinese phase III clinical studies have confirmed that Starbital® works quickly, has accurate efficacy, and is safe. In the global phase III RAPID study, the 30-minute turnaround rate reached 64%; while the Chinese Phase III JX02002 study jointly conducted by 48 authoritative clinical centers across the country further verified its remarkable efficacy in Chinese patients. At the same time, Starbital® is generally well tolerated, has few adverse reactions, and can significantly reduce the frequency of emergency visits.”
Luo Yongqing, CEO of Genting Xinyao, said, “The approval of Starbital® marks Genting Xinyao's significant progress in innovative treatments for cardiovascular diseases. In China, about 2.3 to 4 out of every 1,000 people have PSVT. The total number of patients is estimated to be between 3 and 6 million, and there is a significant unmet clinical need. As the only innovative treatment that can currently be used by patients for acute attacks of PSVT outside the hospital, Starbital® provides patients with a new treatment option for 'immediate use (on-demand)' emergency self-help. It works as fast as 5 minutes after administration and stops the attack quickly, thus achieving active management and greater controllability of the condition, while significantly reducing the emergency treatment rate. In the future, Genting Xinyao will rely on an excellent commercial operation platform for innovative drugs to accelerate the commercialization process of Starbital® in China, meet the huge unmet clinical needs of PSVT patients, and fully unleash its long-term clinical and social value.”
In addition to PSVT indications, Genting Xinyao is also advancing the development of an indication for Starbital® for atrial fibrillation (AFib-RVR) with rapid ventricular rate response. At present, relevant phase II clinical studies have achieved positive results, and plans are to further advance phase III clinical studies. If relevant indications are further approved in the future, the potential scope of clinical application of Starbital® is expected to expand further.
As Genting Xinyao's first innovative product in the cardiovascular field, the approval of Starbital® further enriches the company's commercial product portfolio. In recent years, Genting Xinyao has continued to strengthen commercialization capacity building. The company's “A2MS (Access, Medicine, Marketing, Sales) commercial operation system” has been further upgraded and upgraded, not only to achieve capacity improvement and scale growth, but also to the full product life cycle and omni-channel requirements, covering grade hospitals, broad markets, retail pharmacies and online businesses, supporting the market introduction and commercialization of innovative products such as Starbital®.