"Xiehe-made" Fills the Spring Pollen Testing Gap! China's First Self-made Reagent by a Medical Institution Achieves Transformation in Beijing

In March, Beijing is full of spring vitality, but for people allergic to pollen, it means the return of a miserable season with itchy noses, sneezing, and swollen eyes.

Pollen Monitoring Data from Peking Union Medical College Hospital in 2025 Shows Fraxinus Pollen Accounts for 14% of Total Spring Pollen, Ranking Second after Cupressaceae Pollen; Relevant Outpatient Test Data Indicates a 47.7% Positive Detection Rate of Specific IgE Antibodies for Fraxinus Excelsior Pollen Allergy, Even Higher than that of Juniperus Chinensis Pollen.

However, compared with the mature diagnostic methods for Juniperus chinensis, the precise in vitro diagnosis for Fraxinus americana has been in a blank state.

Recently, the second-class in vitro diagnostic reagent independently developed by Peking Union Medical College Hospital and commercially transformed by Beijing Peking Union Technology Development Co., Ltd. —— the Fraxinus excelsior pollen allergen-specific IgE antibody detection kit (chemiluminescence immunoassay) —— has been approved for marketing. Zhou Junxiong, head of the Allergen Preparation Department at Peking Union Medical College Hospital, stated: "This product is unique in China with no equivalent domestically produced alternatives, created to meet clinical usage needs."

Gao Fei, Director of the Medical Device Registration Department of the Beijing Municipal Medical Products Administration, further stated that the transformation and market launch of self-made reagents by medical institutions is a core manifestation of medical device innovation "originating from clinical practice and serving clinical practice."

This product is not only the first in vitro diagnostic reagent independently developed and used by medical institutions in China to be converted from an in-hospital filing to a registered listing, but also the first medical device product in China to complete clinical evaluation and gain approval for marketing using real-world data, successfully establishing a regulatory pathway for the registration and conversion of self-made reagents.

The launch of this product stems from an urgent clinical need.

Fraxinus americana, as a street or courtyard tree species, has been widely introduced and cultivated across China. Its flowering period is from March to April each year, and it ranks among the top three in the list of spring pollen allergens in many cities. As a major area affected by pollen allergies in the north, the urban areas of Beijing can detect up to 5,000 allergenic pollen grains per cubic meter of air.

As one of the first hospitals in China to carry out the pilot program for the self-development and use of in vitro diagnostic reagents by medical institutions, Peking Union Medical College Hospital completed the registration of the R&D project for the Fraxinus pollen allergen-specific IgE antibody detection kit in 2024. It was put into clinical use during the peak Fraxinus pollen season in March 2025.

It is reported that the product uses micro-quantitative detection of serum-specific Fraxinus excelsior pollen allergen IgE antibodies to assist in diagnosing Type I hypersensitivity reactions, supporting clinical precision treatment decisions.

The clinical demand from patients is very high. Beijing Union Medical College Hospital alone has accumulated approximately 7,000 real-world cases during the self-made reagent phase. After the kit receives approval for marketing, it will be widely applied in hospitals across China.

Zhou Junxiong stated that this year's plan is to promote it to other hospitals with allergy specialty departments, conduct post-marketing clinical evaluations, and adopt prospective research methods based on strict criteria to further assess its clinical performance.

Zhi Yuxiang, Director of the Allergy Department at Peking Union Medical College Hospital and President of the Allergy Physicians Branch of the Chinese Medical Doctor Association, further stated that the research, development, and commercialization of this product have undergone a complete process of clinical practice and data accumulation. After its market launch, it can precisely guide the prevention and treatment of pollen allergies and improve the accuracy of clinical diagnosis.

At the same time, this product, together with the hospital's existing desensitization treatment preparations, forms a "diagnosis + treatment" synergistic system, allowing doctors to formulate an integrated plan of "advance prevention + precise diagnosis + targeted treatment/desensitization treatment" based on pollen forecasts and patients' specific allergens. For example, after confirming an ash tree pollen allergy, patients can specifically take protective measures from late March to mid-April and receive targeted desensitization treatment, thereby avoiding blind medication.

Since Beijing was approved to carry out the pilot program for self-made reagents in medical institutions in 2022, it has been making efforts across the entire chain by improving systems, providing precise guidance, strengthening supervision, and promoting registration transformation, fully pushing for the implementation of the pilot program. The pilot results have accurately addressed clinical challenges, forming the "Beijing Experience" that stimulates clinical innovation, ensures product safety, and serves public health.

To accelerate the transformation of scientific achievements, the Beijing Municipal Drug Administration included the Fraxinus pollen detection kit in the "Spring Rain Action" as a key cultivation project, providing comprehensive policy guidance and technical support. By innovating the evaluation and approval mechanism, the pioneering application of real-world data in product registration transformation was achieved, promoting the product to complete registration transformation in a shorter cycle and with higher efficiency.

As the product has been approved, its amplification effect is gradually becoming apparent. According to reports, Beijing Union Medical College Hospital has more than ten allergy-related products under development. This achievement has illuminated a feasible path for the development of more in-hospital self-made reagents with market potential, providing a reference model for the research, development, and market launch of similar products across China. It will help promote the development of in vitro diagnostic reagents towards localization, scale, and independent innovation in China.

Zhou Junxiong stated that for in-house reagent projects involving rare diseases or the exploration of cutting-edge new technologies, due to the small patient population, lack of profit-driven motivation for enterprises, but genuine clinical demand, such projects will mostly serve clinical needs in the form of hospital-prepared reagents. However, projects with large clinical usage volumes, no similar products available on the market, and industrialization potential will be encouraged to undergo commercial transformation. Furthermore, from the perspective of the entire lifecycle management of in-house reagents, some projects will gradually be discontinued if they exhibit insufficient usage, excessively high operation and maintenance costs, overly high risks, or lack comparative advantage in clinical diagnostic value.

Beijing Municipal Medical Products Administration stated that it will continue to deepen the reform of the review and approval system, providing early-stage services for the registration of more clinical innovation R&D transformations. At the same time, it will strengthen quality supervision after product transformation and market entry, allowing more innovative achievements originating from clinical practice to be quickly implemented through policy guidance and full-chain services.