Core Viewpoint - The approval of Neffy® (优敏速®), China's first non-injection epinephrine product for emergency treatment of type I allergic reactions, marks a significant advancement in the market for severe allergic reactions, providing a more convenient option for patients [1][4]. Group 1: Product Approval and Market Impact - Neffy® has received a drug registration certificate from the National Medical Products Administration, filling a gap in emergency medication for severe allergic reactions outside of hospital settings [1]. - The product is expected to accelerate market penetration in China, reshaping the epinephrine drug market landscape due to its innovative delivery method [1][3]. - The approval reflects the company's keen market opportunity recognition and plans for localized production within 24 months post-approval [1]. Group 2: Clinical Significance and Usage Statistics - Epinephrine is crucial for emergency responses, particularly in cases of anaphylaxis, and is recommended by clinical guidelines for severe allergic reactions [1]. - In China, only 25% of severe allergic reactions receive epinephrine treatment, highlighting a significant unmet market need [2]. - The incidence of severe allergic reactions in China is reported at 8.39 per 100,000 person-years, with a global incidence rate of approximately 50-112 per 100,000 person-years [2]. Group 3: Product Advantages and Future Projections - Neffy® offers advantages such as portability, ease of use, and a 30-month shelf life, which can reduce waste and economic burden on patients [3]. - Clinical studies indicate that Neffy® achieves comparable blood concentration levels of epinephrine to traditional injection methods, with superior pharmacodynamic effects [3]. - The product is projected to generate $54 million in global revenue by 2025 and approach $500 million by 2028, positioning it as a new growth driver for the company's cardiovascular emergency segment [4].
填补国内空白！远大医药：全球首款肾上腺素鼻喷剂优敏速®国内获批上市