Yuanda Pharmaceutical (00512) won the world's first nasal adrenaline product, Yousensitive®, to break injection dependency or become the only out-of-hospital first aid product in China
The Zhitong Finance App learned that it will spread good news again! Hong Kong Stock Technology's innovative pharmaceutical company Yuanda Pharmaceutical (00512) recently reported positive news. On December 23, the company once again announced that it reached a product cooperation agreement with Yuer Pharmaceuticals (Shanghai) Co., Ltd. (Yuer Pharmaceuticals), and Yuanda Pharmaceuticals obtained the world's first epinephrine nasal spray Neffy® (Neffy®) for emergency treatment of type I allergic reactions (including severe allergic reactions) within the cooperation channel in mainland China and non-exclusive commercial rights in Hong Kong SAR, China. This cooperation covers 2 mg and 1 mg specifications, which are suitable for adults, children over 30 kg, and children aged 15-30 kg, respectively. In December 2024, Uminsu® submitted a marketing application to the State Drug Administration and was accepted.
Notably, Usensitive® uses an innovative nasal spray method and is the first non-injection treatment product approved by the US FDA for type I allergic reactions (including severe allergic reactions). The cooperation is led by Yuanda Pharmaceutical (Beijing) Co., Ltd., a subsidiary of Yuanda Pharmaceutical in Changping District, Beijing, and plans to achieve localized production within 24 months after the product is approved. This will further consolidate Yuanda Pharmaceutical's leading position in the field of cardiovascular and cerebrovascular first aid, while also demonstrating Yuanda Pharmaceutical's strategic determination to continue to lay out innovative global products and consolidate the core competitive advantage of the industry.
Easy medication administration to solve the pain points of first aid, and YouSensitive Speed® is expected to fill gaps in out-of-hospital scenarios
According to reports, allergic reactions can be divided into four types according to the immune mechanism. Among them, the main characteristic of type I allergic reactions (also known as rapid-onset hypersensitivity reactions) 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 acute and serious cases of allergic diseases. Studies have shown that the median time of death from severe anaphylaxis is only 5-30 minutes.
Due to the rapid progression of severe allergic reactions, respiratory and/or circulatory systems may be affected. Therefore, medical intervention as soon as possible is essential for the survival benefits of patients. However, in actual clinical scenarios, patients need to be admitted to the hospital before receiving targeted treatment, which will undoubtedly delay precious treatment time.
Under these circumstances, how to optimize the first aid process for severe allergic reactions has become an important issue that needs to be solved urgently, and promoting out-of-hospital coverage of the therapeutic drug, adrenaline, is becoming one of the answers to this problem. Currently, adrenaline is the first aid drug for severe allergic reactions that are clearly recommended by mainstream clinical guidelines for severe allergic reactions at home and abroad or by expert consensus. Multiple studies have confirmed that early use of adrenaline can significantly reduce hospitalization, mortality, and the incidence of bipolar reactions, and speed up recovery.
For a long time, adrenaline has mainly been administered in the form of injections, including adrenaline injections used only in hospitals and automatic adrenaline injection pens that can be administered by oneself outside the hospital. Currently, only adrenaline injections have been approved for marketing in the Chinese market. This injectable administration method requires that the recipient has a certain degree of medical operation expertise, which limits the use scenarios and ease of use of adrenaline to a certain extent. This also affects 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.
Yuanda Pharmaceuticals' current layout of U-Sensitive Speed® has brought new hope for solving this dilemma. Uominsult® is a non-injectable treatment product for type I allergic reactions approved by the FDA for the first time in 35 years. It uses an innovative nasal spray method, is easy to use, compact and easy to carry, and can be administered by the patient or others as soon as possible in the event of an emergency with an allergic reaction. At the same time, the product has a shelf life of up to 30 months, which can significantly reduce waste caused by drug expiration and reduce patients' financial and medication burden. Key clinical study results showed that subjects treated with U-Sensitive® or approved adrenaline injectable products had comparable blood concentrations of adrenaline; furthermore, “PharmacoKinetics/Pharmacodynamics of epinephrine after single and repeat administration of neffy, EpiPen, and manual intramuscular According to literature such as “injection”, the effect of improving pharmacodynamics (PD) indicators such as pulse rate (PR) and systolic pressure (SBP) is significantly better than the standard conventional intramuscular adrenaline injection regimen, and the effect of 2 doses is better. It has been proven that this product has a rapid effect and relieves symptoms in a short period of time in patients with allergic reactions. Significant clinical advantages are expected to help U-Sensitive® quickly fill gaps in the out-of-hospital market.
In August 2024, the 2mg standard product of Uminsu® was approved for marketing in the US and the European Union, and a marketing application was submitted and accepted to the National Drug Administration in December 2024; the 1mg standard product was approved for listing in the US in March 2025. The 1mg and 2mg specification products were approved for sale in Japan in September 2025. In regions where it has already been marketed, Usensitive® quickly gained wide recognition from patients, healthcare workers and the public due to its easy operation and rapid administration. In the second quarter of 2025, its US sales reached US$12.8 million, an increase of about 180%. Global revenue is expected to reach US$54 million in 2025 and is expected to approach US$500 million in 2028.
In the future, after being successfully marketed in China, with its unique portability and ease of operation, it is expected to quickly penetrate various out-of-hospital scenarios such as homes, schools, and travel, improving the accessibility of adrenaline treatment products to patients with severe allergic reactions in China, and filling the gap in the use of emergency medicine for severe allergic reactions in out-of-hospital scenarios. At the same time, Yuanda Pharmaceutical relies on a mature channel system accumulated in the field of first aid, which will also help the rapid release of products and provide a new growth engine for the company's cardiovascular emergency sector.
In-depth insight into clinical needs and consolidate the competitive advantage of cardiovascular and cerebrovascular first aid
Yuanda Pharmaceutical's deep involvement in first aid also reflects the company's deep insight into the life and health needs of patients with severe allergic reactions. According to the data, 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%. In China, the incidence of severe allergic reactions reached 839/100,000 people per year. According to data from the Hong Kong Special Administrative Region of China from 2010 to 2019, the incidence of severe allergic reactions among people under 18 was 9.76 to 100,000 people per year, and is increasing year by year. Corresponding to this is the growing market size. According to Frost & Sullivan data, China's allergic disease drug market is expected to reach 9.6 billion US dollars in 2025 and 16.2 billion US dollars in 2030, of which the adrenaline market will reach 1.1 billion US dollars in 2025.
This time, Yuanda Pharmaceutical's layout will further improve the company's differentiated layout in the field of cardiovascular and cerebrovascular first aid. In terms of adrenaline products, the company currently has various forms of products such as pre-fillers and nasal sprays, which can fully meet the needs of patients in various scenarios. The introduction of Usensitive® in the form of a nasal spray will further lower the threshold of use and save valuable first aid time for patients with severe allergies.
In addition to severe allergies, the company has also established a more complete product matrix for the broader cardiovascular first aid market. As a “national basic drug production base”, “national combat reserve emergency medicine manufacturer”, and “national small-variety drug (shortage drug) centralized production base construction unit”, Yuanda Pharmaceutical has more than 30 varieties, 14 of which 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, and continues to provide domestic cardiovascular emergency patients with multiple scenarios, multiple choices, safe and effective product combinations.
In the cardiovascular emergency sector, Yuanda Pharmaceutical is also actively expanding its product line around chronic disease management. The core products include Nengqilang, Limeitong® eplerone tablets, and Hexinshuang/Hebeishuang, etc., and continues to lead the market segment. Furthermore, the company continues to lay out and develop clinically urgently needed cardiovascular first aid and chronic disease treatment products through a combination of independent innovation and research and breakthroughs in difficult imitation technology. Currently, Yuanda Pharmaceutical's cardiovascular and cerebrovascular emergency division has a reserve of more than 20 products.
Taken together, Yuanda Pharmaceutical has formed a significant market competitive advantage in the field of cardiovascular and cerebrovascular first aid with its rich product layout. The current layout of Excellent Sensitivity® will help the company penetrate deeply into the three major emergency scenarios in hospitals, outside the hospital, and lay a solid foundation for its long-term leading position in the field of cardiovascular and cerebrovascular disease treatment, especially in the field of adrenaline. It is expected that while meeting urgent clinical needs and improving patient treatment results, it will further consolidate and expand its market share, bring stronger growth impetus to the company, and continue to contribute to industry development and patient health.