China Approves Landmark Needle-Free Anaphylaxis Rescue Nasal Spray

SAN DIEGO, CA – December 29, 2025 – In a landmark decision for public health, China's National Medical Products Administration (NMPA) has approved neffy, the first and only epinephrine product designed for community use to treat life-threatening allergic reactions, including anaphylaxis. The approval grants millions of people in China access to an emergency treatment that can be self-administered outside of a hospital setting for the very first time.

The needle-free nasal spray, developed by ARS Pharmaceuticals, Inc., will be marketed in China by Pediatrix Therapeutics under the trade name 优敏速® (meaning “Excellent Allergy Treatment Fast”). This regulatory milestone paves the way for its availability, anticipated in the spring of 2026, for adults and children weighing 30 kilograms (approximately 66 pounds) or more.

Addressing a Critical Unmet Need in China

Until now, the estimated 50 to 100 million people in China living with food allergies and at risk for severe reactions had no approved option for immediate, self-administered epinephrine. Anaphylaxis is a severe, rapidly progressing allergic reaction that can be fatal within minutes if left untreated. Exposure to allergens like certain foods, insect stings, or medications can trigger a cascade of symptoms, including difficulty breathing, a drop in blood pressure, and swelling of the throat. The standard of care globally is the immediate administration of epinephrine.

Without access to community-use products like the auto-injectors common in Western countries, the only recourse for individuals experiencing anaphylaxis in China has been to seek immediate emergency medical services, a delay that can have dire consequences. The approval of neffy is set to fundamentally change this paradigm.

“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. “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.”

The current approval is for the 2 mg dose. ARS Pharma and its Chinese partner, Pediatrix Therapeutics, have stated they intend to file for approval of a 1 mg dose for smaller children (weighing between 15 kg and 30 kg) in the coming months, further expanding access to this critical medication.

A Needle-Free Revolution in Allergy Care

While epinephrine auto-injectors have been a lifeline in other parts of the world for decades, their use is not without significant challenges. Well-documented issues such as needle-phobia, concerns about injury, lack of portability, and the complexity of use often lead to hesitation or failure to administer the drug during a crisis.

neffy was designed specifically to overcome these barriers. As a small, pre-filled nasal spray, it requires no assembly and can be administered quickly and easily by patients or caregivers. This needle-free design is not only less intimidating but also eliminates the risk of accidental needle sticks.

Furthermore, the device boasts a robust design profile that makes it practical for everyday life. It is compact, easy to carry, and can withstand temperature excursions up to 50°C (122°F). In a notable advantage over many auto-injectors, if neffy is accidentally frozen, it remains effective and can be used once it thaws, without damage to the device or the medication. This resilience provides peace of mind for families who need to have the rescue medication on hand at all times, whether at school, on vacation, or during daily activities.

The Strategic Partnership Bringing neffy to Market

The introduction of neffy into the Chinese market is the result of a strategic licensing agreement established in 2021 between the San Diego-based ARS Pharma and Pediatrix Therapeutics, a Chinese biotechnology company focused on pediatric health. Under the agreement, Pediatrix holds the exclusive rights to commercialize the nasal spray in China for anaphylaxis and other potential indications, such as chronic spontaneous urticaria.

With this NMPA approval, ARS Pharma is set to receive a final regulatory milestone payment of $4 million. The deal also includes the potential for up to $80 million in sales-based milestones and tiered royalties in the low double digits on annual net sales in China. ARS Pharma will manage the manufacturing and supply of the product to Pediatrix at cost.

This partnership combines ARS Pharma's innovative drug-delivery technology with Pediatrix's deep market knowledge and focus on bringing high-quality, child-friendly healthcare products to families across China. The collaboration is poised to establish a new standard of care for allergy emergencies in the country.

A Growing Global Footprint

The approval in China is the latest in a series of regulatory successes for neffy, underscoring its growing acceptance as a vital alternative to injectable epinephrine worldwide. Earlier in 2025, the product was approved in Australia by the Therapeutic Goods Administration (TGA) for both 1 mg and 2 mg doses in adults and children weighing 15 kg or more, in partnership with CSL Seqirus. An approval in New Zealand is anticipated by the end of 2025.

In the United States, neffy is commercially available for adults and children aged 4 and older weighing at least 15 kg (33 lbs). In Europe and the United Kingdom, ARS Pharma’s partner ALK successfully launched the product under the trade name EURneffy earlier this year.

This expanding global footprint demonstrates a widespread recognition of the need for more accessible and user-friendly emergency allergy treatments. By providing a reliable, easy-to-use, and needle-free option, neffy is empowering patients and caregivers around the world to act decisively and confidently at the first signs of a severe allergic reaction, potentially saving lives and reducing the burden on emergency healthcare systems. The upcoming launch in China marks a pivotal next chapter in this global health story.