Genting Xinyao (01952): The marketing application for a new drug for treating acute episodes of paroxysmal supraventricular tachycardia in adults converted to sinus rhythm was approved in China

Zhitong Finance App News, Genting Xinyao (01952) issued an announcement. China's National Drug Administration (NMPA) has approved the new drug marketing license application for Starbital® (etripamil nasal spray) to treat acute episodes of paroxysmal supraventricular tachycardia (PSVT) in adults, which reverted to sinus rhythm.

This approval is based on data results obtained from the Starbital® Global Key Phase III RAPID Clinical Study and the China Phase III JX02002 Clinical Research Institute. Both studies reached the primary endpoints anticipated by the programme. Among them, in the critical phase III RAPID clinical study, 64% of participants judged to have had PSVT episodes (N=99) switched from supraventricular tachycardia to sinus rhythm within 30 minutes of administration after self-administration, while the placebo group (N=85) was 31% (HR = 2.62; 95% CI: 1.66—4.15; p<0.001). The relevant findings were published in the “Lancet” magazine in 2023. In the Chinese phase III JX02002 clinical study, participants who were determined to have had PSVT episodes (N=84) used Starbital® on their own. Compared with the placebo administration group (N=84), PSVT had significant efficacy in converting to sinus rhythm (HR = 3.002; p=0.0005). In all phase III clinical studies, nebital® was generally well tolerated, and no serious adverse events (SAEs) were observed within 24 hours of administration. Previously, 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 acute attacks of PSVT in adults in more than 30 years.

As the company's first approved innovative drug in the field of cardiovascular disease, Starbital® has further enriched the company's innovative product portfolio. This approval is another important milestone in the continued implementation of the company's innovative product commercialization strategy, fully demonstrating the company's ability to continuously integrate global innovation resources, accelerate the transformation of innovation achievements, and efficiently promote commercialization.