ARS Pharma Secures China Approval For neffy 2 mg, The Country’s First Ready-To-Use Nasal Epinephrine For Anaphylaxis; Launch Set For Spring 2026

ARS Pharmaceuticals, Inc., a commercial-stage biopharmaceutical company focused on helping at-risk patients and their caregivers better manage severe allergic reactions that can lead to anaphylaxis, has announced that China’s National Medical Products Administration (NMPA) has approved neffy 2 mg, an epinephrine nasal spray. This approval covers the emergency treatment of Type 1 allergic reactions, including anaphylaxis, in adults and children who weigh 30 kilograms or more. In China, the product will be sold under the trade name 优敏速®, which translates to “Excellent Allergy (treatment) Fast.” The company, together with Pediatrix Therapeutics, plans to submit an application in the coming months for the 1 mg dose of neffy intended for children weighing more than 15 kilograms and less than 30 kilograms.

At present, China does not have any approved community-use epinephrine products, including auto-injectors. This highlights a significant unmet need, as food allergies affect an estimated 4 to 8.2 percent of the Chinese population, which translates to roughly 50 to 100 million people at risk of experiencing severe allergic reactions. For chronic spontaneous urticaria, a condition that ARS Pharma is also developing treatments for and currently progressing through Phase 2b development, approximately 6.5 million people in China are estimated to be diagnosed and receiving treatment with antihistamines or biologics.

According to Richard Lowenthal, Co-founder, President and CEO of ARS Pharmaceuticals, the approval of neffy in China marks an important advancement for patients and caregivers dealing with severe allergic reactions. Until now, individuals experiencing symptoms in community settings had no option to self-administer epinephrine and were forced to rely solely on emergency medical assistance. Lowenthal explained that neffy, as the first community-use epinephrine product available in China, has the potential to change the way severe allergies are treated by enabling earlier intervention at the first sign of symptoms. He added that this approval may improve preparedness, confidence, and overall outcomes for patients and families throughout China, and he expressed the company’s commitment to working with Pediatrix Therapeutics to ensure timely availability.

Neffy’s design offers important practical advantages. As a needle-free nasal spray, it removes the hesitation many people feel toward injections, making it easier and quicker to administer during emergencies. The device is portable, simple to use, and capable of withstanding temperature excursions up to 122 degrees Fahrenheit (50 degrees Celsius). Additionally, if the product is accidentally frozen, it can still be used once thawed without compromising the device or the medication inside.

In 2021, ARS Pharmaceuticals entered into an exclusive licensing agreement with Pediatrix Therapeutics, granting Pediatrix the rights to commercialize neffy in China for severe allergic reactions and certain other conditions, including chronic spontaneous urticaria. Under the terms of this partnership, ARS Pharma will receive a final regulatory milestone payment of 4 million dollars and is eligible for up to 80 million dollars in sales-based milestone payments, along with tiered royalties in the low double digits on annual net sales. ARS Pharma will manage the manufacturing and supply of neffy for the Chinese market, and the company expects the product to be available in China by the spring of 2026.

The approval in China adds to a series of recent global regulatory achievements for neffy. In Australia, the Therapeutics Goods Administration (TGA) approved neffy through ARS Pharma’s partnership with CSL Seqirus. The approval covers both the 1 mg and 2 mg doses for adults and children who weigh 15 kilograms or more. Approval in New Zealand is anticipated by the end of 2025. Neffy is also commercially available in the United States, where it is approved for the emergency treatment of allergic reactions, including anaphylaxis, for adults and children aged four years and older who weigh at least 15 kilograms. 

Earlier this year, ARS Pharma’s European partner, ALK, introduced EURneffy in several European countries and in the United Kingdom. Pediatrix Therapeutics, ARS Pharma’s partner for the Chinese market, is a biotechnology company focused on pediatrics. The company is dedicated to delivering high-quality, child-friendly, and affordable therapeutics and healthcare products. Founded in 2021 by Eight Roads, F-Prime Capital, and Creacion Ventures, Pediatrix Therapeutics operates from offices in Shanghai and Beijing.