Fill the domestic gap! GRAND PHARMA (00512) The world's first approved adrenaline nasal spray brand OptiNose has been approved for domestic launch.

The first non-injection adrenaline treatment product in China has been approved for marketing! Recently, GRAND PHARMA (00512) announced that the world's first adrenal adrenaline nasal spray Neffy (Youminsu) for emergency treatment of Type I allergic reactions (including severe allergic reactions) has been issued with a drug registration certificate by the National Medical Products Administration. This is the first non-injection adrenaline product approved for this indication in China, filling the gap in the use of emergency medication for severe allergic reactions outside of hospitals, providing a more convenient product choice for severe allergy patients. The approval of Neffy fully demonstrates GRAND PHARMA's keen grasp of market opportunities. The company also plans to achieve localized production of the product within 24 months of approval. Leveraging GRAND PHARMA's strong commercialization system in the emergency treatment field, the product is expected to accelerate penetration in the domestic market and reshape the market landscape for adrenal adrenaline products in China. The advantage of needle-free administration directly addresses clinical pain points and fills the gap in the market for emergency treatment of severe allergies outside of hospitals. Adrenaline is a hormone secreted by the medulla of the adrenal glands in the human body and can also be artificially synthesized. It plays an important role in the body's emergency response. Clinically, adrenaline can be widely used for rescuing cardiac arrest, treating anaphylactic shock, and other critical conditions. The drug acts quickly, saving valuable emergency time for patients, especially in life-threatening severe allergic reactions where it is irreplaceable and recommended by clinical guidelines or expert consensus on severe allergies domestically and internationally. For patients with severe allergies who have a median time to death of only 5-30 minutes, the timeliness and convenience of administering adrenaline directly affect their life and death. Therefore, ensuring that adrenaline can be quickly accessed and correctly used in actual emergency situations is a key factor in improving the success rate of treating severe allergic reactions. However, there have been certain barriers in the clinical use of adrenaline in China. The core issue lies in the current form of injection administration, which limits its use in different scenarios and convenience of carrying, restricting patients to only use the product in hospitals and affecting the practical application among severe allergy patients. Statistics show that only 25% of severe allergic reactions in China were treated with adrenaline when they occurred, and even in severe cases, only 34% received adrenaline treatment. According to a report by Bain & Company, it is estimated that the market size of adrenaline in China will reach approximately 3.209 billion yuan in 2025. With its significant advantages in portability and efficiency, Neffy is expected to quickly capture the adrenaline market and become an important factor in expanding the market. Neffy uses an innovative nasal spray delivery method, which is convenient, compact, and easy to carry. It can be administered by the patient or others in emergency situations of allergic reactions. Additionally, the product has a shelf life of up to 30 months, significantly reducing wastage due to expired medications and alleviating the economic burden on patients. Clinical research results show that the epinephrine blood concentrations in subjects treated with Neffy or approved adrenaline injection products were equivalent. Furthermore, studies have shown that Neffy had significantly better effects on pharmacodynamic indices such as pulse rate and systolic blood pressure than standard intramuscular adrenaline injection schemes. The product has been proven to have a rapid and effective relief of symptoms in allergic reaction patients. The approval of Neffy in the domestic market will provide a safer, more convenient, and easily operable new treatment option for severe allergy patients. With the introduction and promotion of Neffy, it is expected to gradually change the current practice in China where severe allergic reactions mostly rely on injection administration. This is crucial for enhancing the public's awareness and response capabilities to severe allergic reactions, and has significant and far-reaching implications for improving the overall management of severe allergic reactions in China. GRAND PHARMA will leverage its rich resources in the emergency treatment field and mature channel system to accelerate its academic promotion and market education, helping the product achieve rapid sales growth. It is reported that Neffy achieved sales of $12.8 million in the United States in the second quarter of 2025, which represents a 180% year-on-year increase. It is estimated that the global revenue will reach $54 million in 2025, and nearly $500 million in 2028. With its unique portability and user-friendly design, Neffy is poised to quickly penetrate the domestic emergency care scene and become a new growth engine for GRAND PHARMA's cardiovascular emergency treatment segment, integrating with the company's existing range of adrenaline products in various forms to bring sustained business growth. A comprehensive layout in three major emergency care scenarios to consolidate the leading position in the emergency care field The successful launch of 2mg Neffy is an important achievement for GRAND PHARMA's product layout strategy of "self-research + introduction". In addition to the 2mg Neffy, the company has also introduced a 1mg version of the product for pediatric patients weighing 15-30kg. This version of the product has already been approved for marketing in the United States and Japan, and is expected to apply for approval in the domestic market, further expanding the medication options for pediatric patients of different age groups with severe allergies. As an important emergency product, Neffy will further enhance the market competitiveness of GRAND PHARMA in the cardiovascular emergency treatment field. The company has always seen the cardiovascular emergency treatment segment as one of the key focus areas in pharmaceutical technology, balancing emergency rescue and chronic disease management. In terms of emergency treatment, GRAND PHARMA is designated as a "National Basic Drug Production Base", "National Emergency Drug Production Base for War Preparedness Reserve", and "National Manufacturer for Concentrated Production of Small Variety Drugs (Shortage Drugs)". It has over 30 product varieties, with 14 included in the Chinese National Emergency Rescue Drug List and 16 included in the Shortage Drug List. The product line covers emergency care in hospital, pre-hospital, and community settings, providing a combination of safe and effective products for cardiovascular emergency patients in China. In the cardiovascular emergency treatment segment, GRAND PHARMA is also actively expanding its product line around chronic disease management. Core products like Nengqilang and Limetong Irbesartan Tablets are leading the market continuously. Through a combination of independent innovation research and breakthroughs in high-difficulty generic technologies, the company continues to develop products for clinical needs in cardiovascular emergency treatment and chronic disease management, with over 20 products in the pipeline in the cardiovascular emergency treatment segment. In summary, in terms of fast response capabilities in emergency care scenarios and continued development in chronic disease management, GRAND PHARMA demonstrates strong comprehensive strength, laying the foundation for sustained growth in its core competitiveness and market barriers. The successful approval and subsequent localization production plan of Neffy not only enriches the company's product matrix in the cardiovascular emergency treatment segment, but also solidifies its leading position in the growing market of severe allergic reaction medications. In the future, with the comprehensive deployment of Neffy in the domestic market, GRAND PHARMA's leadership position in the cardiovascular emergency treatment field will be further consolidated and enhanced, providing patients with higher quality medical solutions.