neffy® (epinephrine nasal spray) Approved in China as the First and Only Community Use Epinephrine Product for the Treatment of Allergic Reactions (anaphylaxis)

Core Viewpoint - The approval of neffy, an epinephrine nasal spray, in China marks a significant advancement in the treatment of severe allergic reactions, providing a community-use option for patients and caregivers [3][4]. Group 1: Product Approval and Market Potential - Neffy is the first epinephrine product approved for use outside of a hospital setting in China for adults and children weighing over 30 kg, with availability expected in spring 2026 [1][4]. - Approximately 4.0% to 8.2% of the Chinese population, estimated at 50 to 100 million people, is affected by food allergies and at risk for severe allergic reactions [2]. - The approval in China follows recent approvals in Australia and the U.S., indicating a growing international market for neffy [5][6]. Group 2: Company Collaboration and Financial Aspects - ARS Pharmaceuticals has an exclusive licensing agreement with Pediatrix Therapeutics to commercialize neffy in China, which includes a final regulatory milestone payment of $4 million and potential sales milestones up to $80 million [4]. - ARS Pharma will manufacture and supply neffy to Pediatrix at cost, indicating a strategic partnership aimed at enhancing market penetration in China [4]. Group 3: Product Features and Benefits - Neffy's needle-free design is intended to reduce barriers to timely treatment, making it easier to carry and use in everyday life, with temperature stability up to 122°F (50°C) [3]. - The product aims to improve preparedness and outcomes for patients experiencing severe allergic reactions, addressing the limitations of traditional epinephrine auto-injectors [3][17].