ARS Pharma's neffy Nasal Spray Gains Landmark Approval in China

BEIJING, China – December 29, 2025 – ARS Pharmaceuticals has secured a monumental regulatory victory with the approval of its neffy (epinephrine nasal spray) by China's National Medical Products Administration (NMPA). The approval marks a pivotal moment for public health in the nation, introducing the first and only community-use epinephrine product for the emergency treatment of severe allergic reactions, including anaphylaxis, for adults and children weighing 30 kg or more. This needle-free solution is set to address a critical unmet need in a country where millions live with the risk of anaphylaxis without access to out-of-hospital emergency treatments.

A New Lifeline for Millions at Risk

The significance of neffy's approval cannot be overstated for China's public health landscape. An estimated 50 to 100 million people in the country are affected by food allergies, placing them at risk for life-threatening anaphylactic reactions. Before this approval, no epinephrine auto-injectors were available for use outside of a hospital setting, leaving a vast population vulnerable. Individuals experiencing a severe allergic reaction in a community setting—at school, work, or home—faced potentially catastrophic delays in receiving the first-line, life-saving treatment of epinephrine.

This gap in care created immense anxiety for patients and caregivers. The Chinese food allergy diagnostics and therapeutics market, valued at over $377 million in 2024, is projected to more than double to nearly $731 million by 2030, underscoring the growing awareness and scale of the issue. The introduction of neffy, to be marketed under the trade name 优敏速 (Excellent Allergy treatment Fast), directly confronts this challenge by empowering individuals and their families with an accessible, easy-to-use emergency device. The needle-free design is particularly crucial, as it helps overcome common barriers like needle phobia and hesitation, which can prevent or delay administration of traditional auto-injectors.

Strategic Partnership Unlocks a Vast Market

The commercial rollout of neffy in China is being managed through an exclusive licensing agreement with Pediatrix Therapeutics, a specialized Chinese biotechnology company. Co-founded in 2021 by prominent life science investors including Eight Roads, F-Prime Capital, and Creacion Ventures, Pediatrix is dedicated to bringing high-quality pediatric therapies to the Chinese market. The company has already demonstrated its capability in this niche, notably through a partnership to commercialize a portfolio of ADHD medications from Tris Pharma.

This strategic alliance is crucial for navigating China's complex pharmaceutical market. Pediatrix's established presence and focus on pediatrics provide ARS Pharma with a strong local partner to ensure a successful launch, which is anticipated by the spring of 2026. The financial terms of the agreement highlight the significant commercial potential, with ARS Pharma set to receive a $4 million regulatory milestone payment, up to $80 million in future sales-based milestones, and low double-digit tiered royalties on net sales. This structure provides ARS Pharma with substantial upside as neffy penetrates a market with no direct competitors in the community-use space.

Navigating the commercial landscape will involve leveraging policies like China's "Dual-Channel" system, which aims to improve patient access to innovative drugs through both hospital and retail DTP (Direct-to-Patient) pharmacies. Given neffy's community-use design, this policy could be instrumental in ensuring broad availability beyond traditional hospital formularies.

Beyond the Needle: Redefining Emergency Allergy Care

The core innovation of neffy lies in its delivery system. As a pre-filled, single-dose nasal spray, it eliminates the need for a needle, a feature that offers profound advantages for both patients and caregivers. The fear and complexity associated with traditional auto-injectors are significant barriers to their effective use during a high-stress emergency. Neffy's simple, intuitive design—akin to a standard nasal spray—is intended to promote confidence and swift action when every second counts.

Furthermore, the product's portability and stability profile add to its practical benefits. Unlike some auto-injectors that have strict temperature storage requirements, neffy is stable at temperatures up to 122°F (50°C), making it more convenient to carry in a pocket, purse, or backpack. This user-centric design philosophy is aimed at increasing treatment adherence and ensuring that a life-saving dose of epinephrine is always within reach.

ARS Pharma is also working to expand its offerings, with plans to file for approval of a 1 mg dose for children weighing between 15 kg and 30 kg in the coming months, further broadening its potential impact within the pediatric population.

A Proven Model of Global Expansion

The approval in China is the latest in a series of global regulatory and commercial successes for ARS Pharmaceuticals, underscoring the strong international demand for a needle-free epinephrine alternative. The company's flagship product was first approved in the United States in August 2024 and has demonstrated remarkable market traction. U.S. net revenues for neffy grew from $7.3 million in its partial launch quarter in 2024 to an impressive $31.3 million in the third quarter of 2025, driven by expanding insurance coverage and strong commercial execution.

This momentum is mirrored worldwide. Neffy, under the brand name EURneffy, received marketing authorization in the European Union in August 2024 and the United Kingdom in July 2025, with a successful launch in Germany in June 2025 by European partner ALK. Approvals have also been secured in other major markets, including Japan in September 2025 and Australia in December 2025, with launches planned in collaboration with local partners Alfresa Pharma and CSL Seqirus, respectively. With filings also under review in Canada and expected in New Zealand, ARS Pharma has built a robust global footprint through a strategic partnership model.

This track record of navigating diverse regulatory systems and achieving commercial success in highly developed markets provides a strong blueprint for the product's launch in China. As Pediatrix Therapeutics prepares for the 2026 rollout, the global performance of neffy signals a promising future for anaphylaxis care in the world's most populous nation.