On January 29, 2023, Yuanda Pharmaceutical (stock code: 00512) disclosed that its innovative product, Jext®, a prefilled epinephrine auto-injection pen designed for treating severe allergic reactions, has successfully secured approval from the Guangdong Provincial Drug Administration for importation and urgent clinical use in the Guangdong-Hong Kong-Macao Greater Bay Area. This marks a significant breakthrough as it addresses a gap in China's domestic market and introduces an innovative self-administration option for patients prone to severe allergic episodes, thereby enhancing their chances of survival and improving their quality of life.
Global statistics indicate that severe allergic reactions (anaphylaxis) have an incidence rate ranging from approximately 50 to 112 cases per 100,000 people annually, with a rising trend. Given the swift progression of symptoms – often reaching critical stages within minutes – prompt access to epinephrine is vital. Leading international guidelines, including those from the World Allergy Organization (WAO), the China First Aid Guidelines, AAAAI, and EAACI, emphasize the importance of having epinephrine auto-injectors readily available for immediate self-administration in cases of severe allergic reactions.
Jext® stands out for its efficient delivery mechanism, significantly cutting down administration time and minimizing errors compared to traditional syringes. Its user-friendly design allows for easy self-use or administration by others during emergencies. Having gained approval in 21 countries, including Europe and Asia, Jext® boasts over a decade of proven safety and efficacy records.
Until now, epinephrine in China has largely been available in ampoule form, lacking an auto-injection option. The introduction of Jext® in the Greater Bay Area thus bridges a critical gap, providing patients quicker access to life-saving medication during acute allergic episodes. Yuanda Pharmaceutical, recognized as a national base for essential drug production and strategic reserve, has a comprehensive portfolio in the cardiovascular and cerebrovascular emergency domain, including various formats of epinephrine products tailored to diverse scenarios.
With more than 20 products under development in this area, the approval of Jext® in the Greater Bay Area not only strengthens Yuanda Pharmaceutical's position in the emergency response market but also paves the way for a potential nationwide rollout. The company underscores its commitment to innovation, stating its intention to continue focusing on developing and advancing emergency care solutions for in-hospital, pre-hospital, and community settings, ultimately aiming to offer more sophisticated and effective treatment options to patients globally.