PUMCH has recently received regulatory approval to commercialize a Class II in vitro diagnostic reagent it independently developed, a chemiluminescent immunoassay kit for detecting allergen-specific IgE antibodies to green ash (Fraxinus pennsylvanica) pollen. The kit was brought to market by Beijing Xiehe Technology Development Co., Ltd. The product is the first in vitro diagnostic reagent originally developed and registered for in-house hospital use to successfully transition to full commercial registration, and the first medical device to achieve regulatory approval through a pathway with clinical assessment based on real-world data. The product fills a gap in precision in vitro diagnostics for green ash pollen allergy in China, offering patients who suffer from spring pollen allergy a more targeted diagnostic option.
Contrary to popular understanding, it's not the showy, colorful flowers that trigger pollen allergies: the real culprits are wind-pollinated plants whose pollen can travel hundreds of kilometers on a breeze. Every year between March and May, Beijing enters the peak flowering season for trees such as Chinese juniper (Juniperus chinensis L.), green ash (Fraxinus pennsylvanica), and Asian white birch (Betula platyphylla Sukaczev), bringing with it a surge in spring pollen allergy cases. While Chinese juniper pollen has received more attention, green ash pollen has largely flown under the radar, yet its allergenic impact is striking. Airborne allergenic pollen monitoring data from PUMCH in 2025 shows that ash genus pollen accounts for 14% of total spring pollen counts, ranking second only to cypress family pollen. Outpatient testing data paints an even more striking picture: the positivity rate for green ash pollen-specific IgE antibodies — the specific diagnostic marker for this allergy — reached 47.7%, actually surpassing that of Chinese juniper pollen. Data from Beijing Children's Hospital further confirms this trend, with skin prick test positivity for green ash pollen running as high as 45.8% among pediatric patients aged 6 to 11.
Given its potent allergenic property, green ash pollen has become a growing priority in the prevention and management of spring pollen allergies. The combination of “early prevention + precision diagnosis + targeted treatment or allergen immunotherapy” is the most effective strategy for relieving the relentless sneezing, itchy eyes, runny nose, and nasal irritation that allergy sufferers endure each spring. While well-established in vitro diagnostic tools exist for Chinese juniper pollen allergy, no comparable precision diagnostic tool for green ash pollen has been available till now.
Zhou Junxiong, head of PUMCH's Allergen Preparation Laboratory, noted that the hospital has nearly 70 years of experience in pollen allergen and allergen immunotherapy research. As one of the first hospitals in China to pilot self-developed in vitro diagnostic reagents for clinical use, PUMCH completed the registration of its in-house green ash pollen-specific IgE antibody detection kit in 2024. The kit was introduced into clinical practice in March 2025, the peak of the green ash pollen season. Patient demand has been substantial: by the end of the in-house use phase, approximately 7,000 real-world cases had already been documented. The product performs quantitative detection of green ash pollen-specific IgE antibodies in small serum samples, supporting the diagnosis of Type I hypersensitivity reactions and enabling clinicians to make more informed, precision treatment decisions.
▲A lab technician conducting a test
Zhi Yuxiang, Director of PUMCH's Department of Allergy and President of the Allergist Branch of the Chinese Medical Doctor Association, emphasized that the product's development and successful commercialization reflect a rigorous process of clinical application and real-world data accumulation. Now on the market, the kit can directly guide preventive and therapeutic decisions for pollen allergy patients, improving diagnostic precision. Paired with the hospital's pollen allergen immunotherapy extracts which have been widely used in clinical settings, it creates a fully integrated "diagnosis + treatment" clinical ecosystem, offering patients a seamless, end-to-end solution and delivering on PUMCH's commitment to translating scientific innovation into tangible public health benefits.
The speed and efficiency of this product's path to market owes much to the active support of the Beijing Municipal Medical Products Administration. Gao Fei, Director of the Medical Device Registration Division of the agency, noted that the agency designated the product as a priority project under its "Spring Rain Initiative," providing targeted policy guidance and technical support at every stage. The agency also pioneered a new review and approval mechanism that, for the first time, formally opens the door for real-world data to support medical device registration in China, significantly shortening the approval timeline without compromising product safety or quality. The case has become a prime example of Beijing's broader push to reform medical device review and approval processes in service of clinical and public health needs.