Neffy®, the world’s first adrenaline nasal spray that the Group obtained through its collaboration with Pediatrix Therapeutics for emergency treatment of type I allergic reactions (including severe allergic reactions) in adults and children weighing over 30kg or more (2mg specification), has obtained drug registration certificate issued by the National Medical Products Administration of the People’s Republic of China (NMPA) recently. The Group holds exclusive commercialization rights in Mainland China through cooperative channels and the non-exclusive commercialization rights in Hong Kong Special Administrative Region for the product, and plans to achieve localized production within 24 months of product approval.
Neffy® is the first non-injectable treatment product approved by the United States Food and Drug Administration (“FDA”) for the treatment of type I allergic reactions (including severe allergic reactions). It uses an innovative nasal spray delivery method, which is convenient to use, compact and easy to carry, and can be administered by the patient or others in the event of an allergic reaction. The product has a shelf life of up to 30 months, which can significantly reduce waste caused by expired medicines, and alleviate the economic and medication burden on patients. Its pivotal clinical study results show that subjects treated with Neffy® or approved adrenaline injection products had comparable blood concentrations of adrenaline, and Neffy® has been shown to have a rapid onset of action and provide short-term symptom relief in patients with allergic reactions. Neffy® is available in two specifications: the 2mg strength was approved for commercialization in the United States and the European Union in August 2024; the 1mg specification was approved for commercialization in the United States in March 2025. The 1mg and 2mg specifications were approved for commercialization in Japan in September 2025.
Allergic reactions can be classified into four types based on their immune mechanisms. Among
them, type I allergic reaction (also known as immediate-type hypersensitivity reaction) is
characterized by a rapid reaction, usually occurring within minutes to hours after exposure to
the allergen. Severe allergic reactions are the most critical type of type I allergic reaction which
affect multiple systems throughout the body as a hypersensitivity syndrome. Its clinical
symptoms vary in severity and can progress rapidly from the mildest skin symptoms within
minutes, even leading to death. Thus, it is one of the most acute and severe allergic diseases.
Statistics show that the global incidence of severe allergic reactions is approximately 50-112 per
100,000 people per year, and the incidence is increasing annually, with a lifetime prevalence of
approximately 0.3%-5.1%. Because severe allergic reactions progress very rapidly and can
affect the respiratory and/or circulatory systems, immediate medical intervention is crucial for
the patient’s survival.
Current mainstream clinical guidelines and expert consensus on severe allergic reactions both
domestically and internationally clearly state that adrenaline is the recognized first-line
emergency drug for severe allergic reactions, and recommend that adrenaline treatment should
be given as soon as possible when a severe allergic reaction is diagnosed or highly suspected.
Prior to the approval of Neffy®, all approved adrenaline drugs were administered via injection
globally, including adrenaline injections for in-hospital use only and adrenaline auto-injection
pens for out-of-hospital self-administration. However, only adrenaline injection has been
approved for commercialization in the Chinese market. Restrictions on usage scenarios and ease
of administration have limited the practical application of adrenaline in patients with severe
allergic reactions. Statistics show that only 25% of severe allergic reactions in China are treated
with adrenaline during an attack, and even in severe cases, the proportion using adrenaline is
only 34%.
