ARS Pharmaceuticals (NASDAQ:SPRY) said China’s drug regulator has approved neffy 2 mg, an epinephrine nasal spray, for the emergency treatment of Type 1 allergic reactions in adults and children weighing at least 30 kilograms, marking the first epinephrine product authorized for community use in the country.
The approval was granted by the National Medical Products Administration, the company said.
ARS has licensed commercialization rights in China to Pediatrix Therapeutics, where the product will be marketed under the trade name 优敏速®.
Commercial availability is expected in the spring of 2026.
Under the terms of the agreement, ARS will receive a $4 million final regulatory milestone and is eligible for up to $80 million in additional sales-based milestones, as well as royalties in the low double digits.
ARS will manufacture and supply neffy to Pediatrix at cost of goods.
ARS said the China approval adds to a growing list of regulatory wins for neffy, with approvals and launches already secured in the United States and Europe, approval in Australia, and an expected launch in New Zealand.
The company positions neffy as a needle-free alternative to injectable epinephrine for the treatment of severe allergic reactions.