The world's first adrenaline nasal spray to treat severe allergic reactions introduced by Yuanda Pharmaceutical (00512) was issued a drug registration certificate

Zhitong Financial App News, Yuanda Pharmaceutical (00512) announced that recently, through cooperation with Yuer Pharmaceutical, the Group obtained the world's first adrenaline nasal spray for emergency treatment of adults and children of 30 kg and above (2mg specification) type I allergic reactions (including severe allergic reactions), obtained a drug registration certificate from the China National Drug Administration (China Drug Administration). The Group has exclusive commercial rights for this product within cooperation channels in mainland China and exclusive non-commercial rights in the Hong Kong Special Administrative Region of China. It also plans to achieve localized production within 24 months after the product is approved.

YouSensitive® is the first non-injectable treatment product approved by the US Food and Drug Administration (FDA) for type I allergic reactions (including severe allergic reactions). It uses an innovative nasal spray method, is easy to use, compact and easy to carry, and can be administered by the patient himself or others as soon as possible in the event of an emergency with an allergic reaction. The product has a shelf life of up to 30 months, which can significantly reduce waste due to drug expiration and reduce the financial and medication burden on patients. Results of key clinical studies have shown that subjects treated with U-Sensitive® or approved adrenaline injection products had comparable levels of adrenaline in their bodies, and it has been proven that Usensitive® has a rapid effect and relief of symptoms in patients with allergic reactions in a short time. Usensitive® has two specifications. Among them, 2mg products were approved for sale in the US and EU in August 2024; 1mg products were approved for sale in the US in March 2025. The 1mg and 2mg specification products were approved for sale in Japan in September 2025.

Allergic reactions can be divided into four types according to immune mechanisms. Among them, the main characteristic of type I anaphylaxis (also known as rapid hypersensitivity reaction) is a rapid response, which usually occurs within a few minutes to a few hours after exposure to the allergen. Among type I allergic reactions, severe anaphylaxis is the most critical condition. It is a hypersensitivity syndrome involving multiple systems throughout the body. The clinical symptoms vary in severity, and can progress rapidly from the mildest skin symptoms within a few minutes, and even lead to death. Therefore, it is one of the most rapid and serious cases of allergic diseases. According to statistics, the global incidence of severe allergic reactions is about 50,112 per 100,000 people per year, and the incidence rate is increasing year by year, while the lifetime prevalence rate is about 0.3%-5.1%. Since severe anaphylaxis progresses rapidly and may affect the respiratory and/or circulatory systems, early medical intervention is critical to the patient's survival benefit.

Currently, mainstream clinical guidelines or expert consensus for severe allergic reactions at home and abroad clearly state that adrenaline is the first aid drug for severe allergic reactions, and it is recommended that adrenaline be treated as soon as possible when diagnosing or highly suspected severe allergic reactions. Prior to the approval for marketing of U-Sensitive Speed®, globally approved adrenaline drugs were administered in the form of injections, including adrenaline injections for in-hospital use only and self-administered adrenaline pens outside the hospital. However, currently only adrenaline injections have been approved for sale in the Chinese market. Scenario restrictions and ease of use have affected the actual application of adrenaline drugs in patients with severe allergic reactions. According to statistics, only 25% of severe allergic reactions in China were treated with adrenaline during the attack, and even in severe cases, only 34% were treated with adrenaline.

The innovative global adrenaline nasal spray introduced by the Group is a non-injectable treatment product for type I allergic reactions approved by the FDA for the first time in 35 years. It is expected to improve the accessibility of adrenaline treatment products to patients with severe allergic reactions in China and fill the gap in the use of emergency medicine for severe allergic reactions outside of hospitals. After the product is launched, the Group will fully rely on the rich department resources and mature channel system accumulated in the field of first aid to accelerate its academic promotion and market education, and help the product to be released quickly. With its unique portability and ease of operation, Usensitive® is expected to rapidly penetrate various outpatient scenarios such as homes, schools, and travel, and become a new growth engine for the Group's cardiovascular first aid sector.

The cardiovascular emergency sector is one of the Group's key layout directions in the field of pharmaceutical science and technology, taking into account the two major directions of first aid and chronic disease management. In the direction of first aid, as a “national basic drug production base”, “national combat preparation reserve first aid drug manufacturer”, and “national small-variety drug (shortage drug) centralized production base construction unit”, the Group has more than 30 varieties, of which 14 varieties are included in China's national emergency drug catalogue, 16 varieties are included in the shortage drug catalogue, and the number of product pipelines is among the highest in the industry. The products cover the three major emergency scenarios of in-hospital first aid, pre-hospital first aid, and social first aid. Effective product mix. In the direction of chronic disease management, core products such as Nengqilang, Limeitong® eplerone tablets, and Hexinshuang/Hebeishuang continue to lead the market segment. Currently, the cardiovascular emergency sector is developing more than 20 products. Through a combination of independent innovation and research and breakthroughs in difficult imitation technology, it continues to lay out and develop clinically urgently needed cardiovascular first aid and chronic disease treatment products.

The Group has always attached great importance to research and development of innovative products and advanced technology, with patient needs as the core, scientific and technological innovation, increasing investment in innovative global products and advanced technology, enriching and improving product pipelines and industrial layout in response to unmet clinical needs, adopting a “global operation layout, dual cycle business development” strategy to form a new pattern of domestic and international dual cycle linkage development and mutual promotion, giving full play to the Group's industrial advantages and R&D strength, and quickly launch innovative scientific and technological products to provide patients around the world with more advanced and diverse treatment plans.