Core Insights - The announcement from the Hong Kong-listed company, Yuan Da Pharmaceutical Group, reveals that its product Neffy® (优敏速®), a nasal spray for emergency treatment of type I allergic reactions, has received drug registration certification from the National Medical Products Administration of China [1] Group 1: Product Development and Market Impact - Neffy® is the first non-injection epinephrine product approved in China for severe allergic reactions, filling a gap in emergency medication for severe allergy patients outside of hospital settings [1] - The company plans to achieve localized production of Neffy® within 24 months post-approval, aiming for accelerated market penetration in China [1] - The introduction of Neffy® is expected to reshape the epinephrine drug market in China, leveraging Yuan Da Pharmaceutical's strong commercialization system in the emergency field [1] Group 2: Clinical Significance and Usage - Epinephrine plays a crucial role in emergency responses, particularly for life-threatening allergic reactions, and is recommended by clinical guidelines for severe allergic reactions [1] - The timely and convenient administration of epinephrine is critical for patients with severe allergies, as the median time to death can be as short as 5 to 30 minutes [2] - Neffy® utilizes an innovative nasal spray delivery method, making it easy to carry and use, which can significantly improve the success rate of emergency treatments for severe allergic reactions [2] Group 3: Future Product Strategy - The successful launch of the 2mg Neffy® is a key achievement under the company's "self-research + introduction" product strategy [3] - In addition to the 2mg formulation, the company is also developing a 1mg version for children weighing 15kg to 30kg, which has already been approved in the US and Japan [3] - This strategy aims to provide a comprehensive range of medication options for different age groups within the severe allergy patient population [3]
远大医药肾上腺素鼻喷药优敏速®获批 加速填补国内院外急救空白