In July 2025, the innovative achievement "18 hydroxycortisol, 18 oxycortisol, and 18 hydroxycorticosterone detection reagents (liquid chromatography-mass spectrometry)" independently developed by Professor Guo Wei's team from the Laboratory Department and Professor Li Xiaoying's team from the Endocrinology Department of Zhongshan Hospital Fudan University, and developed by Dunwill Medical as a commissioned preparation enterprise, was officially registered with the Shanghai Drug Administration. As the first medical institution in China to be approved for hormone mass spectrometry detection, this product has independently developed an in vitro diagnostic reagent (HDT), successfully filling the gap in related fields in China and providing key technical support for the classification and detection of primary aldosteronism (PA).

The classification and diagnosis of primary aldosteronism (PA) have long faced clinical challenges: the sensitivity (78%) and specificity (75%) of adrenal CT examination are limited, and there is a certain risk of misdiagnosis and missed diagnosis; As the "gold standard", AVS technology is limited by its invasiveness and high cost, and is not suitable as a screening method for patients. Based on the detection methods of 18 hydroxycortisol, 18 oxycortisol, and 18 hydroxycorticosterone, and the innovative use of liquid chromatography-mass spectrometry technology, the positive expected value can reach 97%, which can be used for the auxiliary diagnosis of aldosteronism in patients with primary aldosteronism, helping clinical practice to select appropriate treatment plans for patients.

Dunwill Medical relies on its profound accumulation in the field of integrated omics transformation research, fully leveraging the advantages of multi-platform integration and the industrial transformation experience of original diagnostic products. In response to major clinical needs and core pain points, it adopts the "Medical-R&D-Manufacturer" collaborative innovation model of medical institutions leading technology research and development, enterprises ensuring production and product quality, effectively connecting the entire chain transformation path from laboratory to clinical products. Based on this model, the company has developed multiple original clinical grade IVD products with independent intellectual property rights, continuously providing innovative solutions for clinical diagnosis. Among them, the "Human Cholangiocarcinoma 5 Gene Mutation Detection Kit" independently developed by Academician Fan Jia's team from Zhongshan Hospital affiliated with Fudan University and Dunwill Medical was approved in April this year, becoming the world's first HDT product for molecular diagnosis of cholangiocarcinoma. This breakthrough not only fills the gap in the field of molecular diagnosis of cholangiocarcinoma, but also marks a leap from "following" to "leading" in the field of precision medicine for cancer in China.

The successful registration of the hormone mass spectrometry detection HDT reagent is another successful practice of collaborative innovation between medical enterprises. Dunwill Medical will also continue to optimize its mass spectrometry detection products and expand their application in precision diagnosis and treatment of endocrine diseases. 

Looking ahead to the future, Dunwill Medical will continue to work with clinical experts, driven by innovation, to deepen the clinical application layout of mass spectrometry technology, improve the full chain capacity building from biomarker discovery to mass spectrometry detection standardization and large-scale production, and jointly promote the high-quality development of precision diagnosis and treatment.