China’s first epinephrine auto-injection pen approved

On the evening of January 29, 2023, Yuanda Pharmaceutical (00512) announced that another innovative product has achieved initial results - Jext® prefilled epinephrine auto-injection pen for the treatment of severe allergic reactions has been approved by the Guangdong Provincial Drug Administration of China. It was officially approved by the Bureau and obtained approval for importing drugs from Hong Kong and Macao that are urgently needed for clinical use in the Guangdong-Hong Kong-Macao Greater Bay Area.

The Jext® prefilled epinephrine auto-injection pen was approved in the Greater Bay Area this time. It not only fills the gap in my country's domestic market, but also provides an innovative and effective self-treatment method for patients with a history of severe allergies, which can improve the survival of patients. Probability and improving the quality of life of patients have far-reaching significance.

Authoritative guidelines recommend that patients with a history of severe allergic reactions stock up on epinephrine auto-injection pens to achieve early self-treatment.

Severe allergic reaction is a severe, life-threatening, systemic allergic reaction. Its main clinical feature is the rapid development of life-threatening respiratory and circulatory system problems. According to the "World Allergy Organization (WAO) Guidelines for Severe Anaphylaxis (2020)", the global incidence of severe allergic reactions is about 50-112/per 100,000 people/year, and the incidence rate is increasing year by year, and the lifetime prevalence is about 0.3 %-5.1%. In some cases of severe, life-threatening allergic reactions, the disease progresses very rapidly, with the median time from symptom onset to severe allergic reaction being only 5-30 minutes. Therefore, immediate medical intervention is crucial for patient survival benefit.

"World Allergy Organization (WAO) Guidelines for Severe Anaphylaxis 2020", "China First Aid Guidelines for Severe Anaphylaxis (2019)", American Academy of Allergy, Asthma and Immunology (AAAAI), European Academy of Allergy and Clinical Immunology (EAACI) and other guidelines Or organizations have clearly pointed out that intramuscular epinephrine is currently recognized as the first-line treatment for severe allergic reactions, and recommend that patients with a history of severe allergic reactions need to stock up on epinephrine auto-injection pens to achieve early self-treatment.

Yuanda Pharmaceutical's Jext® prefilled epinephrine auto-injection pen provides a better way of drug delivery and has become a must-have medicine for patients with a history of severe allergic reactions abroad. As the first-line drug for community treatment of severe allergic reactions recommended by EAACI, epinephrine auto-injection pen has obvious advantages such as rapid administration and low operating error rate compared with other treatment methods. Compared with ordinary syringes, the use of automatic injection pens reduces the administration time by 70 seconds on average and reduces administration errors. It can be used by oneself or administered by others when symptoms occur. It is convenient to use and highly safe.

Jext® prefilled epinephrine auto-injection pen has been approved for marketing in 21 countries and regions including Spain, the United Kingdom, France, Germany and South Korea. It has been on the market for more than 10 years worldwide and has been fully proven in terms of safety and effectiveness. verification.

It is worth noting that the epinephrine injection currently used in my country is mainly in the form of ampoules, and there is no epinephrine automatic injection pen product on the market. Patients need to rely on the arrival of medical staff to obtain drug treatment, which greatly delays the golden treatment of patients with severe allergic reactions. Treatment time. The Jext® prefilled epinephrine auto-injection pen was approved in the Greater Bay Area, filling a gap in my country's domestic market and bringing innovative clinically urgent products to the benefit of patients in the Greater Bay Area. It is also an important step in the layout of Yuanda Pharmaceutical's innovative products. milestone.

The cardiovascular and cerebrovascular emergency field has a complete layout, focusing on three major emergency scenarios

It is reported that Yuanda Pharmaceutical has made a systematic layout in the epinephrine series products. In addition to automatic injection pens, it also includes ampoules, pre-filled seals and other forms, which can meet the objective needs of different application scenarios. From the perspective of pipeline layout, the cardiovascular and cerebrovascular emergency segment to which related products belong is also one of Yuanda Pharmaceutical's key layout directions in the field of pharmaceutical technology.

As a "National Basic Drug Production Base", "National War Readiness Reserve Emergency Drug Manufacturing Enterprise", and "National Small Variety Drug (Shortage Drugs) Centralized Production Base Construction Unit", Yuanda's cardiovascular and cerebrovascular emergency segment has a total of 24 varieties, of which 14 16 varieties have been included in the National Emergency Drug Catalog, covering 6 categories, 16 varieties have been included in the Shortage Drug Catalog, covering 6 categories, and the number of product pipelines ranks among the top in the industry.

Currently, there are more than 20 products under development in the cardiovascular and cerebrovascular emergency sector of Yuanda Pharmaceutical. The Jext® prefilled epinephrine auto-injection pen has been approved in the Guangdong-Hong Kong-Macao Greater Bay Area, which will further accelerate the promotion of high-barrier products in the company's first-aid sector and improve The company's competitiveness and professional authority in the first aid field have laid the foundation for the subsequent domestic launch of this product.

Yuanda Pharmaceutical stated that the company attaches great importance to the research and development of innovative products and advanced technologies. In the future, it will continue to focus on the three major emergency scenarios of in-hospital emergency, pre-hospital emergency and social emergency, lay out and develop urgently needed emergency products for clinical use, and provide patients around the world with more advanced and more Such treatment options.