Awan Medical: Setting the Standard for Clinical Mass Spectrometry as a Three-Time National High-Tech Enterprise
Leveraging its high specificity, high sensitivity, and multi-analyte detection capabilities, clinical mass spectrometry has emerged as one of the most dynamic new technologies in the field of in vitro diagnostics (IVD). As one of the most promising technologies in the IVD sector, clinical mass spectrometry is playing an increasingly important role in a variety of clinical applications, including newborn screening for inherited metabolic disorders, vitamin testing, therapeutic drug monitoring, hormone assays, microbial identification, pharmacogenomic analysis, and trace element detection, andHaving entered a phase of rapid growth, it has maintained an average annual growth rate of over 35%. The market potential for clinical mass spectrometry in China is expected to exceed RMB 10 billion in the next five years.
In recent years, as clinical mass spectrometry has become a significant growth driver in the field of precision diagnosis and treatment, companies within the industry have continued to invest in technological innovation and product development, attracting unprecedented attention from the capital market. According to data from VCBeat Research Institute, there were 15 financing events in China’s clinical mass spectrometry sector in 2022, with total funding exceeding RMB 640 million. In addition to the intensive investment activities by institutional investors in the clinical mass spectrometry market, 51 clinical mass spectrometry products received approval from the National Medical Products Administration (NMPA) in China in 2022, indicating an acceleration in regulatory compliance within this field.
Technological breakthroughs have opened up vast application possibilities. The more critical issue, however, lies in how to better integrate technology with applications, facilitate the translation of research findings into clinical practice, and standardize and universalize application services.Shenzhen Aiwan Medical, which has been recognized as a National High-Tech Enterprise for three consecutive times, answered this question with nine years of accumulation and clinical translation.Since its founding in 2014, Aiwan Medicine has solidified its technological expertise by deeply integrating mass spectrometry and sequencing technologies, building a bridge for “omics data-driven innovative precision diagnosis and treatment” between scientific research and clinical practice.
Aiwan Medicine Has Been Recognized as a National High-Tech Enterprise for Three Consecutive Times
On November 28, Aiwan Medicine held a pre-launch event for its clinical mass spectrometry products alongside its housewarming ceremony. During the event, Aiwan Medicine and Shimadzu (China) signed a strategic cooperation agreement to deepen their partnership. The two parties also unveiled their joint demonstration laboratory and Aiwan Medicine’s clinical mass spectrometry products, working together to achieve innovative breakthroughs ranging from instrument platforms and methodology development to integrated clinical solutions.
iWan Medicine Signs Strategic Cooperation Agreement with Shimadzu (China)
Shimadzu (China) President Koki Aoyama (left) and Aiwan Medical Chairman Yang Jiangtao (right)
In the exhibition hall, Aoyama Koseki, Chairman and General Manager of Shimadzu (China), stopped in front of a photograph. “What is this photo about?” “This is a group photo taken in Wuhan in November at the Clinical Laboratory Committee of the Chinese Hospital Association. I was the only corporate representative present,” replied Yang Jiangtao, Founder and CEO of Aiwan Medicine. “I am here in the photo.”
This is a group photo of the 6th Committee of the Clinical Laboratory Professional Committee of the Chinese Hospital Association. Among the 199 members, Yang Jiangtao was the sole corporate representative.The invitation from the “National Team of Clinical Laboratory Medicine” stems from Aiwan Medical’s years of deep expertise in mass spectrometry applications and its constructive contributions to the field of clinical laboratory testing.
Yang Jiangtao, Chairman of Aiwan Medicine, and Shimadzu (China) Representatives Visit the Exhibition Hall
Aiwan Medicine and Shimadzu (China) Representatives Jointly Unveil the New Instrument
In 2003, Yang Jiangtao graduated with a master’s degree in chemometrics from Hunan University and joined Shimadzu Corporation in Japan, where he worked for 13 years. During his tenure, he held various positions, including Technical Supervisor, Marketing Department Manager, and Regional Sales Manager. Having spent extensive time on the front lines, Yang recognized the gap between mass spectrometry technology and its clinical applications, which led him to resign and embark on an entrepreneurial journey.
Starting with a team of four, Yang Jiangtao led his group to immerse themselves in the research and development of mass spectrometry applications, diligently working in the laboratory for two years. In 2016, Aiwan Medical established an exclusive strategic partnership with Shimadzu in clinical gas chromatography-mass spectrometry (GC-MS), launched its first city-level scientific research collaboration, and obtained a Medical Institution Practice License, thereby initiating its layout in medical laboratory services. The company was subsequently recognized as a National High-Tech Enterprise, established Academician and Expert Workstations at both the Guangdong Provincial and municipal levels, and was designated as a Shenzhen High-Tech Enterprise.
The first clinical application entry point of Aiwan Medicine is positioned at"High-Risk Screening and Auxiliary Diagnosis of Neonatal Inherited Metabolic Disorders"Inborn Errors of Metabolism (IEM) are diseases caused by genetic defects or gene mutations in certain enzymes or receptors essential for maintaining normal bodily metabolism. Most IEMs are monogenic disorders, encompassing a wide variety of congenital metabolic defects involving amino acids, organic acids, fatty acids, and other substrates. These conditions typically manifest during the neonatal period and lack specific clinical presentations. Once typical abnormalities appear, the resulting physical and intellectual impairments are irreversible, with high rates of mortality and disability.
According to the China Birth Defects Prevention Report (2012), the overall incidence of birth defects in China is approximately 5.6%. Each year, there are about 900,000 new cases of birth defects, including approximately 300,000 infants with inherited metabolic disorders. Targeted screening and early diagnosis of specific inherited metabolic diseases in newborns can facilitate timely treatment before the onset of clinical symptoms.
Behind the “High-Risk Screening and Auxiliary Diagnostic System for Neonatal Inherited Metabolic Disorders” is Aiwan Medicine’s independently developed, exclusive clinical application: detection of 135 organic acids in urine.In 2022, Yang Jiangtao published the "Expert Consensus on the Detection of Multiple Organic Acids in Urine by Gas Chromatography-Mass Spectrometry" as the first author.
Leveraging its proprietary methodology, Aiwan Medical has launched the A-Clin 2040NX GC-MS system and a range of derivatized organic acid detection kits, establishing a comprehensive “hardware + applications + standards” solution. Furthermore, through an exclusive partnership with the National Center for Clinical Laboratories (NCCL) under the National Health Commission, Aiwan Medical co-developed the national standard NCCL-E-25 “GC-MS Detection of Urinary Organic Acids for Neonatal Inherited Metabolic Disorders” and the associated external quality assessment program.Currently, Aiwan Medical has covered five National Regional Children's Medical Centers, more than ten provincial-level Maternal and Child Health Hospitals, and over twenty Newborn Disease Screening Centers, among others. It serves nearly 70 hospital-type clients across China, with a developed market share exceeding 90% nationwide.
In addition, Aiwan Medicine has also launchedWorld’s First Metabolic Assessment/Risk Prediction for Urinary Calculi, employing GC-MS technology for semi-quantitative analysis of over 100 urinary organic acid risk factors and 13 classic risk factors in the reconstituted solution of fresh urine live filter paper discs, to predict disease risk. This approach addresses the pain point of requiring 24-hour urine collection for metabolic assessment of urolithiasis, enabling detection using morning urine samples; a nationwide multicenter cohort study has currently been initiated.
“Closely following clinical needs and continuously seeking new application points and breakthroughs for technology is precisely the development path of Aiwan Medicine, as well as the secret to its recognition as a National High-Tech Enterprise for three consecutive years.”
As its medical testing business continues to expand, the Aiwan team has deeply integrated high-throughput gene sequencing technology with clinical mass spectrometry technology, combining applications in metabolomics and genomics to provide comprehensive solutions for precise disease diagnosis and treatment. It has been recognized as the Guangdong Provincial Engineering Technology Center for Genetic Testing of Hereditary Diseases and the Shenzhen Engineering Research Center for Precision Medicine in Rare Disease Metabolomics.
At the press conference, Yang Jiangtao stated, “I will make it a point to communicate more with clinicians, because they tell me what they need, rather than just what I can offer.”
Representatives from Media, R&D, and Marketing Discuss Omics Data Innovation for Precision Diagnosis and Treatment
Taking spinal muscular atrophy (SMA), a rare disease, as an example, the first therapeutic drug, nusinersen, was included in China’s National Reimbursement Drug List (NRDL) in 2021, followed by Evrysdi in 2023. Yang Jiangtao stated, “No small patient population should be left behind. Rare diseases will progress through the stages of having no available treatments, to having accessible therapies, to having insurance coverage, and finally to having multiple treatment options. As new opportunities emerge on the treatment front, screening and diagnostic capabilities must keep pace.”
In 2022, Aiwan Medical entered the SMA kit market, offering an in vitro diagnostic test for detecting copy number variations of exon 7 in the SMN1 gene from genomic DNA extracted from human peripheral whole blood samples. The test can identify homozygous deletions, heterozygous deletions, and normal genotypes, supporting SMA screening and auxiliary diagnosis. Currently, external quality assessment programs for SMA testing have been implemented across 35 newborn screening centers nationwide. In January 2023, Aiwan Medical, in collaboration with the National Center for Clinical Laboratories under the National Health Commission and Peking University First Hospital, launched a large-scale, multicenter cohort project focused on neonatal SMA screening and interventional treatment in China.
Yang Jiangtao (6th from the left, front row) participated in the seminar and progress report meeting on the Chinese SMA newborn screening and intervention model project
Proposals to include spinal muscular atrophy (SMA) in newborn disease screening and improve the birth defect prevention and control system were also presented at this year’s Two Sessions.
Pilot programs have also been launched simultaneously, with multiple regions—including Dongguan and Huizhou in Guangdong, Hohhot in Inner Mongolia, Yuncheng in Shanxi, and Loudi in Hunan—initiating multicenter projects for newborn screening of spinal muscular atrophy (SMA).
It is evident that every step of Aiwan Medicine’s growth has been deeply intertwined with the industry, empowering the sector through its own advancement. However, translating a scientific discovery into clinical application is far from straightforward. “Aiwan Medicine is not focused on routine clinical examinations. This means that ordinary patients find it difficult to understand this test, and it cannot be simply represented by common indicators such as those in a complete blood count. Instead, it requires professional database analysis, data reporting, and interpretation by qualified physicians,” said Gu Qingquan, Director of the Marketing Management Department at Aiwan Medicine. “To promote these applications, the first priority is to educate clinicians.”
At this conference, Aiwan Medicine and Professor Yang Yanling jointly released the monograph *Diagnosis and Treatment of Common Inherited Metabolic Disorders: From Chemical Analysis to Clinical Practice*. Reportedly, this monograph centers on clinical cases and practical experience, covering 48 common inherited metabolic disorders across four major categories. Its content encompasses genetic mechanisms, clinical manifestations, case studies, and frontline diagnostic and therapeutic expertise.
Book Launch for "Diagnosis and Treatment of Common Inherited Metabolic Disorders: From Chemical Analysis to Clinical Practice"
During the conference, Aiwan Medicine also organized roundtable discussions on “How New Media Brings Opportunities to the Development of the In Vitro Diagnostics Industry” and “Omics Data Innovates Precision Diagnosis and Treatment,” inviting a group of practitioners and media professionals, including Hu Jiaxiang, Marketing Director of Shimadzu (China); Li Guangyu, Founder of IVD Network; Pan Liuyang, Founder of Translational Medicine Network; Xing Ge from Medical Industry Observation; and Zhang Honghua from IVD Information.
Media Representatives Hold Roundtable Discussion with Shimadzu China and Aiwan Medical
Beyond clinical promotion and co-creation with media, Aiwan Medicine empowers industry development from multiple angles by starting with numerous subtle initiatives: co-sponsoring the Journal of Rare Diseases and Uncommon Conditions, with Yang Jiangtao serving as Executive Editor-in-Chief; Yang Jiangtao’s tenure as a member of the first and second committees of the Chinese People’s Political Consultative Conference (CPPCC) in Guangming District, Shenzhen; establishing scholarships at Hunan University, Xuzhou Medical University, and Central South University of Forestry and Technology to support the cultivation of talents in medicine and related fields, while providing opportunities for innovation and entrepreneurship. This multi-faceted engagement embodies Aiwan Medicine’s original aspiration to build a “Harbor of Love.”
At the conclusion of the conference, Yang Jiangtao stated, “The numerous testing solutions launched by Aiwan Medicine are designed to offer the public the possibility of a better life. Guided by this objective, we identify many pain points in clinical practice and leverage omics tools combined with data mining to discover new methods, and even find the keys to unlocking the mysteries of disease. This reflects our continuous efforts to harness technological advancements, translate promising discoveries into clinical applications, generate greater value, and contribute our share to combating disease and advancing human health.”