Core Viewpoint - The approval of Neffy, the world's first non-injection epinephrine nasal spray for emergency treatment of severe allergic reactions, marks a significant advancement in the treatment options available for patients in China, filling a critical gap in out-of-hospital emergency care [1][2]. Group 1: Product Approval and Market Impact - The product Neffy has received a drug registration certificate from the National Medical Products Administration, making it the first non-injection epinephrine product approved for severe allergic reactions in China [1]. - The company plans to achieve localized production of Neffy within 24 months post-approval, aiming to accelerate market penetration and reshape the epinephrine drug market in China [1]. - Neffy is expected to enhance the accessibility and convenience of epinephrine administration, which is crucial for patients experiencing severe allergic reactions [2]. Group 2: Innovation and Usage - Neffy utilizes an innovative nasal spray delivery method, making it easy to carry and administer, which is essential for timely treatment in emergency situations [2]. - The product has a shelf life of 30 months, reducing waste from expired medications and alleviating economic burdens on patients [2]. - The introduction of Neffy is anticipated to gradually change the reliance on injection-based epinephrine administration in China, improving public awareness and response capabilities regarding severe allergic reactions [2]. Group 3: Product Line Expansion - The successful launch of the 2mg Neffy is a key outcome of the company's "self-research + introduction" product strategy, with plans for a 1mg version aimed at children weighing 15kg-30kg [3]. - The 1mg product has already been approved in the US and Japan, and the company intends to submit a market application for it in China, expanding treatment options for a broader range of allergic patients [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