1. SPRY's neffy approved in China for community use in severe allergies. 2. Availability in China expected by spring 2026, expanding market access. 3. China's food allergy prevalence is high, impacting millions potentially benefiting SPRY. 4. neffy has unique advantages over auto-injectors, enhancing compliance and usage. 5. Sales milestones and royalties linked to neffy sales could enhance SPRY's revenue.
FAQ
Why Very Bullish?
The approval of neffy in China expands SPRY's market significantly, positioning it well against competitors. Historical instances, such as the launch of EpiPen, illustrate how new entrants can capture market share and drive stock prices upward.
How important is it?
The global market for epinephrine products is growing, and SPRY's entry into China positions it strongly amid high demand for allergy treatments. The anticipated revenues from royalties and milestone payments present a compelling case for investor interest.
Why Long Term?
With a successful launch and growing demand, SPRY could see prolonged revenue growth from neffy. Past pharmaceutical products have shown sustained market expansions following initial approvals in large populations.
Approval of neffy® Marks a Significant Milestone in Allergy Treatment in China
SAN DIEGO, Dec. 29, 2025 (GLOBE NEWSWIRE) — ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) announced that its epinephrine nasal spray, neffy®, has become the first community-use epinephrine product approved for adults and children (weighing over 30 kg) in China for the emergency treatment of severe allergic reactions, specifically anaphylaxis. This groundbreaking decision by the National Medical Products Administration (NMPA) in China is expected to enhance access to life-saving treatment for millions of at-risk patients.
Details of neffy's Approval and Market Launch
neffy, known in China under the trade name 优敏速® (meaning "Excellent Allergy Fast"), is anticipated to be available in the spring of 2026. The approval also sets the stage for ARS Pharma and its partner, Pediatrix Therapeutics, to file for the 1 mg dosage of neffy for children weighing between 15 kg and 30 kg in the near future.
Currently, no community-use epinephrine products, such as auto-injectors, are approved in China. This is significant as food allergies affect approximately 4.0% to 8.2% of the population in China, equating to about 50 to 100 million individuals, who are at risk of severe allergic reactions.
Implications of neffy’s Approval
Richard Lowenthal, Co-founder, President, and CEO of ARS Pharma, stated, “The approval of neffy in China represents a significant advancement for the millions of patients and caregivers managing severe allergic reactions. Until now, they only had the option to seek emergency medical help without the ability to self-administer epinephrine.”
As neffy is the first of its kind in the Chinese market, it holds the potential to transform the treatment landscape for severe allergies. The product is designed to enable earlier epi use at the first signs of allergic symptoms, which could significantly improve preparedness and health outcomes for families across China.
Features and Benefits of neffy
- Needle-free design for easier use
- Portable and simple to carry
- Temperature stability up to 122°F (50°C)
- Can be used after accidental freezing
These features aim to reduce barriers to timely treatment and align more naturally with the daily lives of patients.
Financial and Regulatory Context
ARS Pharma entered into an exclusive licensing agreement with Pediatrix Therapeutics in 2021, which allows them to commercialize neffy® in China for treating anaphylaxis and other conditions like chronic spontaneous urticaria. ARS Pharma expects to receive $4 million upon final regulatory approval and could earn up to $80 million in sales milestones, in addition to tiered royalties based on annual net sales.
The recent approval in China follows the successful receipt of marketing authorization for neffy in Australia, where both 1 mg and 2 mg doses have been approved for emergency allergic reactions.
As a key player in the biopharmaceutical industry, ARS Pharma continues to pave the way for transformative healthcare solutions, with neffy® being part of its broader commitment to reduce risks associated with severe allergies.
About ARS Pharma and neffy®
ARS Pharmaceuticals is a biopharmaceutical company focused on developing innovative solutions for severe allergic reactions. neffy is already available in the U.S., approved for emergency treatment in adults and children aged 4 years and older who weigh at least 33 pounds (15 kg).
For further inquiries regarding potential side effects or usage instructions, patients and healthcare professionals can contact ARS Pharmaceuticals Operations at 1-877-MY-NEFFY (877-696-3339) or visit www.fda.gov/medwatch.
Conclusion
The introduction of neffy® into the Chinese market marks a notable advancement in the treatment of allergic reactions, enhancing the capabilities of patients and caregivers to manage anaphylaxis effectively. As the stock symbol indicates, ARS Pharmaceuticals (SPRY) is on track for significant growth and impact in the biopharmaceutical realm.