Fill the domestic gap! Yuanda Pharmaceutical (00512), the world's first approved adrenaline nasal spray, Yousensitive®, was approved for marketing in China

China's first non-injectable adrenaline treatment product approved for sale!

^{The Zhitong Finance App learned that recently, Yuanda Pharmaceutical (00512) announced that the world's first epinephrine nasal spray for emergency treatment of type I allergic reactions (including severe allergic reactions), has recently been issued a drug registration certificate by the State Drug Administration.} This is the first non-injectable adrenaline product approved for this indication in China. It will fill the gap in the use of emergency medicine for severe allergic reactions in China in out-of-hospital scenarios and bring more convenient product choices to patients with severe allergies in China.

The approval of YouMinsu ^{® fully reflects Yuanda Pharmaceuticals' keen grasp of market opportunities. The company also plans to achieve localized} production within 24 months after the product is approved. In the future, relying on Yuanda Pharmaceutical's strong commercialization system in the field of first aid, this product is expected to accelerate penetration in the domestic market and reshape the adrenaline drug market pattern in China.

The needleless advantage directly hits clinical pain points and fills the gap in the emergency market outside the hospital for severe allergies

Adrenaline is a hormone secreted by the adrenal medulla of the human body. It can also be artificially synthesized and plays an important role in the body's emergency response. Clinically, adrenaline can be widely used to rescue critical conditions such as cardiac arrest and anaphylactic shock. The drug works quickly and can save patients valuable first aid time. In particular, it has an irreplaceable effect on conditions such as severe life-threatening allergic reactions. It is the first aid drug for severe allergic reactions, and has been clearly recommended by mainstream clinical guidelines or expert consensus for severe allergic reactions at home and abroad.

For patients with severe allergies with a median time of death of only 5-30 minutes, the timeliness and convenience of adrenaline administration directly affects the survival of patients. Therefore, in actual first aid scenarios, how to ensure that adrenaline can be obtained quickly and used correctly has become a key step in improving the success rate of treating severe allergic reactions.

However, for a long time, there have been certain barriers to the use of adrenaline in China. The core problem is that the current form of injectable administration limits its usage scenarios and ease of carrying, so patients can only use this product in hospitals, which affects the actual application of patients with severe allergies. 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.

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, with a lifetime prevalence rate of about 0.3%-5.1%; in China, the incidence rate of severe allergic reactions is 8.39/100,000 people per year. Behind the misalignment between patient needs and actual applications, there is an unmet market space. According to the Bayesian Advisory Report, China's adrenaline market is estimated to be around 3.209 billion yuan in 2025.

^{With significant product advantages such as portability and efficiency, YouSensitivity® is expected to quickly seize the adrenaline market and become one of the important factors driving the further expansion of this market.} According to Yuanda Pharmaceutical's announcement, Yousensitive ^® uses an innovative nasal spray administration method, which is easy to use, compact and easy to carry, and can be administered by the patient himself or another person 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.

This time, YouSensitive ^® has been approved for marketing in China, and will provide a new treatment option that is safer, more convenient, and easier to operate for the majority of patients with severe allergies. Furthermore, with the introduction and promotion of Sensitive Rapid ^®, it is expected to gradually change the current situation of long-term reliance on injectable administration in the field of emergency treatment for severe allergic reactions in China, raise the public's level of awareness and response ability to respond to severe allergic reactions, and have an important practical significance and profound impact on promoting the improvement of the overall treatment level of severe allergic reactions in China.

At the same time, Yuanda Pharmaceutical will fully rely on the rich department resources and mature channel system it has accumulated in the field of first aid to accelerate its academic promotion and market education, and help the rapid release of products. ^{According to reports, in the second quarter of 2025, the US sales volume of U-Sensitive Speed® reached 12.8 million US dollars, an increase of about 180% over the previous year.} Global revenue is expected to reach US$54 million in 2025 and approach US$500 million in 2028. With its unique portability and ease of operation, the product is expected to rapidly penetrate China's out-of-hospital first aid scene in the future, and become a new growth engine for Yuanda Pharmaceutical's cardiovascular and cerebrovascular emergency sector. It forms a product matrix with the company's existing prepackaged and other forms of adrenaline, bringing continuous performance growth to the company.

Comprehensive layout of the three emergency scenarios to consolidate the leading position in the field of first aid

The successful launch of 2mg Usensitive ^® is an important achievement under Yuanda Pharmaceuticals' “self-development+introduction” product layout strategy. In addition to the 2mg standard YouSensitive Speed ^®, the company also has a 1mg product, which can be used for 15-30kg children. Products of this scale have now been approved for marketing in the US and Japan, and are also expected to submit marketing applications in the domestic market in the future to further improve medication choices for children of all ages and provide coverage for a wider range of people with severe allergies.

^{As an important first aid product, U-Sensitive® will also further deepen the market competitiveness of Yuanda Pharmaceutical in the field of cardiovascular and cerebrovascular first aid.} According to reports, the company has always regarded the cardiovascular and cerebrovascular emergency sector as one of the key layout directions in the field of pharmaceutical technology, and has taken into account the two major directions of emergency rescue and chronic disease management in this field. In the direction of first aid, Yuanda Pharmaceutical, 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”, 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 at the top of 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 and cerebrovascular emergency patients with multiple scenarios, multiple choices and safety An effective combination of products.

^{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, whether in terms of rapid product response in emergency situations or continuous deep cultivation in the field of chronic disease management, Yuanda Pharmaceutical has shown strong comprehensive strength, which will also establish the company's core competitiveness and market barriers for sustainable development.

The successful approval of YouMinsu ^® and subsequent localized production plans not only enriched the company's product matrix in the cardiovascular emergency sector, but also laid a solid foundation for its leading position in the growing drug market for severe allergic reactions. In the future, with the full expansion of Youminsu ^® in the domestic market, Yuanda Pharmaceutical's leading position in the field of cardiovascular and cerebrovascular first aid will be further consolidated and enhanced, and it will continue to provide patients with better medical solutions.