China's NMPA Grants Neffy Approval: ARS Pharmaceuticals Expands into Asia's Massive Allergic Reaction Market

ARS Pharmaceuticals Inc. (SPRY) has achieved a major regulatory milestone with China’s NMPA greenlighting neffy—a breakthrough needle-free epinephrine nasal spray designed for emergency treatment of Type I allergic reactions. The approval covers both adults and children weighing 30 kg or more, positioning ARS Pharmaceuticals to tap into one of the world’s largest untreated patient populations.

Market Expansion and Product Availability

Pediatrix Therapeutics, holding exclusive distribution rights in China, plans to launch neffy in spring 2026. This marks a significant step in ARS Pharmaceuticals’ global strategy, as the product now boasts regulatory approvals across five major markets: the U.S., EU, UK, Japan, and Australia. The needle-free delivery mechanism represents a critical advancement in anaphylaxis management, addressing a persistent challenge—delays in epinephrine administration during allergic emergencies.

Commercial Momentum and Financial Performance

The commercial traction is undeniable. During Q3 2025, neffy generated $31.3 million in net product revenue, a dramatic leap from $0.57 million in the corresponding quarter last year. This 54-fold year-over-year increase underscores strong market adoption and validates the commercial potential of needle-free epinephrine solutions.

Why China Represents a Game-Changer for ARS Pharmaceuticals

China’s healthcare landscape presents an exceptional opportunity for neffy. The country’s massive population faces significant anaphylaxis risk yet lacks widely available community-use epinephrine products. This gap creates substantial room for ARS Pharmaceuticals to capture market share and establish neffy as a standard-of-care treatment.

Stock Performance and Investor Outlook

SPRY shares are trading at $11.45, up 0.62%, within a 52-week range of $6.66 to $18.90. The China approval, combined with robust Q3 revenue performance, positions ARS Pharmaceuticals for potential continued growth as the company scales its presence across different types of ARS therapeutic applications in emerging markets.