GRAND PHARMA (00512) announced that through its collaboration with Youer Pharma, the group has recently secured the drug registration certificate from China's National Medical Products Administration (NMPA) for Neffy® (Youmin Su®), the world's first adrenaline nasal spray indicated for the emergency treatment of Type I allergic reactions (including anaphylaxis) in adults and pediatric patients weighing 30kg and above (2mg dosage form). The group holds exclusive commercialization rights for the product within cooperative channels in mainland China, as well as non-exclusive commercialization rights in the Hong Kong Special Administrative Region, and plans to achieve localized production within 24 months following the product's approval.
As the first non-injectable treatment for Type I allergic reactions (including anaphylaxis) approved by the U.S. Food and Drug Administration (FDA), Youmin Su® innovatively adopts nasal spray administration. It is not only easy to use but also compact and portable, enabling quick administration by the patient themselves or others nearby during an acute allergic reaction. With a shelf life of up to 30 months, the product can significantly reduce waste caused by expiration and effectively alleviate patients' economic and medication burdens.
Key clinical study data shows that subjects treated with Youmin Su® achieved adrenaline blood concentrations comparable to those using approved adrenaline injections; additionally, Youmin Su® has been proven to have a rapid onset of action and significant symptom relief in allergic reaction patients within a short time. The product is available in two dosages: the 2mg formulation was approved for marketing in the U.S. and EU in August 2024; the 1mg formulation received U.S. approval in March 2025; and both 1mg and 2mg dosages were approved in Japan in September 2025.
Allergic reactions are classified into four types based on immune mechanisms. Among them, Type I allergic reaction (also known as immediate hypersensitivity) is characterized by rapid onset, typically manifesting symptoms within minutes to hours after allergen exposure. Within Type I allergic reactions, anaphylaxis is the most life-threatening condition—a systemic hypersensitivity syndrome affecting multiple organ systems. Its clinical symptoms vary in severity, ranging from mild skin manifestations to rapid deterioration and even death within minutes, making it one of the most acute and severe forms of allergic disease.
Statistics show that the annual incidence of anaphylaxis worldwide is approximately 50 to 112 cases per 100,000 person-years, with this figure rising annually, and the lifetime prevalence ranging from 0.3% to 5.1%. Given the extremely rapid progression of anaphylaxis, which can affect the respiratory and/or circulatory systems, immediate medical intervention is crucial for improving patients' survival outcomes.
Currently, mainstream clinical guidelines and expert consensus on anaphylaxis both domestically and internationally clearly identify adrenaline as the first-line emergency treatment, recommending immediate administration upon diagnosis or high suspicion of anaphylaxis. Prior to Youmin Su®'s approval, all globally approved adrenaline medications were injectable formulations, including hospital-only adrenaline injections and auto-injectors for out-of-hospital self-administration. However, the Chinese market currently only has adrenaline injections approved, with their limited usage scenarios and insufficient convenience severely restricting the practical application of adrenaline drugs in patients with anaphylaxis.
Data indicates that in China, only 25% of patients with anaphylaxis receive adrenaline treatment during an attack, and even in severe cases, this proportion is merely 34%. The group's引进的 globally innovative adrenaline nasal spray Youmin Su® is the first FDA-approved non-injectable treatment for Type I allergic reactions in 35 years, expected to significantly improve the accessibility of adrenaline treatments for Chinese anaphylaxis patients and fill the market gap for out-of-hospital emergency drugs for anaphylaxis.
Following the product's launch, the group will leverage its rich department resources and mature channel system accumulated in the emergency care field to accelerate academic promotion and market education, driving rapid sales growth. With its unique portability and user-friendly operation, Youmin Su® is expected to quickly penetrate diverse out-of-hospital scenarios such as homes, schools, and travel, emerging as a new growth engine for the group's cardiovascular emergency segment.
The cardiovascular emergency segment is one of the key strategic focus areas in the group's pharmaceutical technology sector, encompassing both emergency rescue and chronic disease management. In emergency rescue, the group, as a "National Essential Medicine Production Base", "National Strategic Reserve Emergency Medicine Manufacturer", and "National Small-Volume (Shortage) Drug Centralized Production Base Construction Unit", boasts over 30 drug varieties, with 14 included in China's National Emergency Rescue Drug List and 16 in the Shortage Drug List, placing its product pipeline among the industry's leaders. Its products extensively cover three major emergency scenarios: in-hospital emergency, pre-hospital emergency, and community emergency, continuously providing multi-scenario, diversified, safe, and effective product combinations for domestic cardiovascular emergency patients.
In chronic disease management, the group's core products such as Nengqilang, Limeitong® Eplerenone Tablets, and Hexinshuang/Hebeishuang have long maintained leading positions in their respective niche markets. Currently, the cardiovascular emergency segment has over 20 pipeline products, driven by both independent innovative R&D and breakthroughs in high-difficulty generic technologies, continuously布局 and developing clinically needed products in cardiovascular emergency and chronic disease treatment.
The group has always attached great importance to the R&D of innovative products and advanced technologies, with patient needs as the core orientation and technological innovation as the development engine. Addressing unmet clinical needs, it continues to increase investment in global innovative products and advanced technologies, constantly enriching and improving its product pipeline and industrial layout. Adopting the strategy of "Global Operation Layout, Dual-Cycle Development", the group has built a new pattern of domestic and international dual-cycle interactive development and mutual promotion, giving full play to its industrial advantages and R&D capabilities to accelerate the launch of technologically innovative products, providing more advanced and diversified treatment options for global patients.
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