Group 1 - The company, Yuan Da Pharmaceutical, has received a drug registration certificate from the National Medical Products Administration of China for Neffy® (优敏速®), the world's first nasal spray epinephrine for emergency treatment of type I allergic reactions in adults and children weighing 30 kg and above [1] - The company holds exclusive commercialization rights for the product in mainland China and non-exclusive rights in Hong Kong, with plans for localized production within 24 months after approval [1] Group 2 - Neffy® is the first non-injection treatment for type I allergic reactions approved by the FDA, featuring an innovative nasal spray delivery method that is convenient and portable for emergency use [2] - The product has a shelf life of up to 30 months, which helps reduce waste from expired medications and alleviates the economic burden on patients [2] - Clinical studies show that Neffy® achieves comparable blood epinephrine levels to approved injection products and provides rapid symptom relief for allergic reaction patients [2] - The 2 mg version of Neffy® is expected to be approved for sale in the US and EU by August 2024, while the 1 mg version will be approved in the US by March 2025, and both versions are set for approval in Japan by September 2025 [2]
远大医药(00512.HK)：集团引进的全球首款用于治疗严重过敏反应的肾上腺素鼻喷雾剂获颁发药品注册证书