The approval of neffy provides the first community-use option for patients at risk of anaphylaxis in China.
RT’s Three Key Takeaways:
- Community Access: The National Medical Products Administration approved the first epinephrine product for use outside of hospital settings in China for adults and children weighing at least 30 kg.
- Market Need: Approximately 50 million to 100 million people in China are estimated to have food allergies and are at risk for anaphylaxis without current access to community-use epinephrine products like auto-injectors.
- Nasal Delivery: The needle-free spray is designed for ease of use and portability, withstanding temperatures up to 122°F and remaining functional after thawing if accidentally frozen.
The National Medical Products Administration (NMPA) in China granted approval for neffy 2 mg (epinephrine nasal spray) for the emergency treatment of Type 1 allergic reactions, including anaphylaxis, in adults and children weighing 30 kg or more, according to ARS Pharmaceuticals Inc.
The product is the first community-use epinephrine option approved in the country, where no epinephrine auto-injectors are currently available. Pediatrix Therapeutics, which holds the license to market the spray in China under the trade name 优敏速, expects the treatment to be available in the spring of 2026. ARS Pharmaceuticals and Pediatrix Therapeutics also plan to file for approval of a 1 mg dose for children weighing between 15 kg and 30 kg in the coming months, the company stated.
Between 4.0% and 8.2% of the Chinese population, or approximately 50 million to 100 million people, are estimated to be at risk for severe allergic reactions due to food allergies, according to the news release. Additionally, about 6.5 million people in China are estimated to be diagnosed with chronic spontaneous urticaria, a condition for which the nasal spray is currently in clinical development.
“The approval of neffy in China represents a significant advancement for the millions of patients and caregivers managing severe allergic reactions whose only option until now was to seek emergency medical help without the option to self-administer epinephrine in a community setting,” said Richard Lowenthal, co-founder, president and CEO of ARS Pharma, in a news release.
Lowenthal added that the product “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.”
The needle-free device is designed to be portable and simple to use. It can withstand temperature excursions up to 122°F and can be used once thawed if accidentally frozen without damage to the product or device, the company reported. These features are intended to reduce barriers to timely treatment and improve preparedness for patients and families.
The regulatory clearance in China follows recent approvals for the product in Australia, Europe, and the UK. In the US, the spray is commercially available for the emergency treatment of allergic reactions in adults and children aged 4 years and older who weigh at least 15 kg. ARS Pharmaceuticals also expects regulatory approval in New Zealand by the end of 2025, according to the news release.
Pediatrix Therapeutics, a healthcare company based in China, will be responsible for the commercialization of the product in the Chinese market. ARS Pharmaceuticals will receive a regulatory milestone payment of $4 million and is eligible for up to $80 million in sales milestones, as well as tiered royalties on annual net sales.
