The Chinese National Medical Products Administration (NMPA) has approved a 2 mg dose of ARS Pharmaceuticals’s neffy epinephrine nasal spray for the treatment of anaphylaxis in patients who weigh 30 kg or more, the company said. According to ARS Pharma, Chinese biotech Pediatrix Therapeutics, which acquired the Chinese rights to neffy in 2021, expects to launch the nasal spray within the next few months. The company also said that submission of a marketing application for a 1 mg dose for use in children who weigh between 15 and 30 kg in China is expected soon.
The epinephrine nasal spray has been approved In the US and in Europe since August 2024. The Japanese PMDA approved both the 1 and 2 mg doses in September 2025, and ARS reports that the Australian TGA has also recently approved both doses. In Europe, and in the UK, where the MHRA approved the nasal spray in July 2025, the product is known as EURneffy.
ARS Pharma President and CEO Richard Lowenthal commented, “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. As the first community use epinephrine product available in the Chinese market, neffy has the potential to transform how severe allergies are treated, enabling earlier epinephrine use at the first signs of symptoms and reducing barriers that can delay care. We believe this innovation can meaningfully improve preparedness, confidence, and outcomes for patients and families across China and we look forward to working with the Pediatrix Therapeutics team to make neffy available promptly.”
Read the ARS Pharma press release
