China Approves Neffy as First Community-Use Epinephrine Product for Severe Allergic Reactions
核心洞察
China's NMPA has approved neffy, the first and only needle-free epinephrine nasal spray (搜索) for emergency treatment of Type I allergic reactions (搜索) in adults and children weighing 30 kg or more.
The approval marks a significant milestone as neffy becomes the first epinephrine product approved for community use outside hospital settings in China, addressing an unmet medical need for 50-100 million people at risk.
Pediatrix Therapeutics (搜索), which holds exclusive licensing rights from ARS Pharma, expects neffy to be commercially available in China by spring 2026 under the trade name 优敏速®.
China's National Medical Products Administration (搜索) (NMPA) has granted approval for neffy 2 mg (epinephrine nasal spray (搜索)) for the emergency treatment of Type I allergic reactions (搜索) (anaphylaxis (搜索)) in adults and children who weigh 30 kg or more. This approval establishes neffy as the first and only community-use epinephrine product available in China, where no approved epinephrine auto-injectors currently exist for out-of-hospital use.
The approval addresses a significant unmet medical need in China, where approximately 4.0% to 8.2% of the population—about 50 to 100 million people—is estimated to be affected by food allergies (搜索) and at risk for severe allergic reactions. Until now, patients experiencing severe allergic reactions had no option for self-administered epinephrine treatment in community settings and could only seek emergency medical help.
Commercial Partnership and Market Launch
Pediatrix Therapeutics (搜索), which secured an exclusive licensing agreement with ARS Pharmaceuticals in 2021, will market neffy in China under the trade name 优敏速® (meaning "Excellent Allergy treatment Fast"). The company expects the product to be available in spring 2026. ARS Pharma and Pediatrix Therapeutics anticipate filing for approval of neffy 1 mg dose for children greater than 15 kg and less than 30 kg in the coming months.
Under the licensing agreement, ARS Pharma will receive a final regulatory milestone of $4 million and is eligible to receive up to $80 million in sales milestones, as well as tiered royalties in the low double digits on annual net sales. ARS Pharma will be responsible for manufacturing and supplying neffy to Pediatrix Therapeutics (搜索) in China at cost of goods.
Clinical Advantages and Design Features
Richard Lowenthal, Co-founder, President and CEO of ARS Pharma, emphasized the transformative potential of the approval: "As the first community use epinephrine product available in the Chinese market, neffy has the potential to transform how severe allergies are treated, enabling earlier epinephrine use at the first signs of symptoms and reducing barriers that can delay care."
Neffy's needle-free design addresses several barriers to timely epinephrine administration that have been well-documented with traditional auto-injectors, including fear of needles, lack of portability, needle-related safety concerns, lack of reliability, and device complexity. The nasal spray is designed to be easy to carry, simple to use, and maintains stability with temperature excursions up to 122°F (50°C). If accidentally frozen, the device can be used once thawed without damage to the product or device.
Global Market Expansion
The China approval represents a significant expansion of neffy's global reach. The product is already commercially available in the United States for emergency treatment of allergic reactions, including anaphylaxis (搜索), in adults and children aged 4 years and older who weigh at least 33 pounds (15 kg). Neffy has also received approval in the European Union, United Kingdom, Japan, and Australia.
Recent financial results demonstrate strong commercial momentum, with neffy generating $31.3 million in net product revenue for the third quarter of 2025, compared to $0.57 million in the year-ago quarter. The regulatory clearance in China follows recent approval in Australia, where both 1 mg and 2 mg doses were concurrently approved by the Therapeutics Goods Administration (TGA). Approval in New Zealand is expected by the end of 2025.
Broader Therapeutic Potential
Beyond severe allergic reactions, the Chinese market presents additional opportunities for neffy. For chronic spontaneous urticaria (搜索) (CSU), which is currently in Phase 2b development by ARS Pharma, an estimated 6.5 million people are diagnosed and treated with antihistamines or biologics in China today. The exclusive licensing agreement with Pediatrix Therapeutics (搜索) covers both severe allergic reactions and certain other diseases such as chronic spontaneous urticaria.
The approval in China reinforces neffy's position as a needle-free alternative that may help reduce delays in epinephrine administration, addressing a major barrier in managing severe allergic reactions globally. With its simple design and improved accessibility, neffy has the potential to meaningfully improve preparedness, confidence, and outcomes for patients and families managing severe allergies.