ARS Pharmaceuticals announced that the National Medical Products Administration (NMPA) has approved its neffy 2 mg intranasal epinephrine spray for adults and children weighing 30 kg or more. The approval makes neffy the first and only community‑use epinephrine product available in China, a market that previously had no auto‑injector or nasal spray options for anaphylaxis.
The decision unlocks a potential customer base of 50 to 100 million people in China who are at risk for severe allergic reactions. ARS will manufacture and supply neffy to its exclusive licensing partner, Pediatrix Therapeutics, at cost of goods, and the product is slated for launch in spring 2026 under the trade name 优敏速®.
The approval also positions ARS to pursue additional indications in China, including chronic spontaneous urticaria (CSU). A Phase 2b study of neffy for CSU is ongoing, with topline data expected in mid‑2026, potentially expanding the product’s market beyond anaphylaxis.
Financially, ARS will receive a $4 million regulatory milestone payment and is eligible for up to $80 million in sales milestones, plus tiered royalties in the low double‑digits. These payments represent a significant new revenue stream for the company, complementing its existing approvals in the United States, Europe, the United Kingdom, Australia, and anticipated approvals in New Zealand and Canada.
CEO Richard Lowenthal said, “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.” The announcement underscores ARS’s strategy to expand its global footprint and capitalize on unmet medical needs in emerging markets.
The approval also gives ARS a competitive edge in China, where needle‑free delivery and ease of use differentiate neffy from the auto‑injectors that are currently unavailable for community use. By entering this market first, ARS positions itself to capture early market share and establish a strong brand presence ahead of potential future entrants.
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