Yixi Mass Spectrometry Files IPO Prospectus: Pioneering Single-Platform Multi-Omics Clinical Diagnostics with China's First TOF Mass Spectrometer

Recently, Hexin Instruments was listed on the STAR Market. Its opening price on the first day of trading was RMB 92.11 per share, with a market capitalization of RMB 6.5 billion.

Hexin Instruments focuses on the field of environmental monitoring, specializing in the monitoring of PM2.5, VOCs, and O3 in the atmosphere. In recent years, with the rising popularity of the clinical mass spectrometry industry and increasingly mature market education, Hexin Instruments has begun to exert efforts in the healthcare sector, and its time-of-flight mass spectrometer obtained registration certification in 2020.

Ma Qingwei, founder of Bioyong Technologies Inc., has been deeply engaged in the clinical mass spectrometry industry for nearly 20 years, witnessing its transformation from a barren landscape to a vibrant and rapidly growing sector. Ma was profoundly moved by the listing of Hexin Instruments. He stated, “As the first domestically produced mass spectrometry company to go public, Hexin Instruments’ successful listing holds significant meaning for both the mass spectrometry instrument sector and the clinical mass spectrometry industry. I am confident that the future prospects for Chinese-made mass spectrometers and the clinical mass spectrometry industry are promising.”

Bioyong Mass Spectrometry was established in 2003 and has a history of 18 years, serving as an early planner and pioneer in clinical mass spectrometry. Under its umbrellaClin-ToF is the first time-of-flight mass spectrometry system approved in China, capable of simultaneous microbial identification and nucleic acid detection. Its Clin-ICP-QMS is the first inductively coupled plasma mass spectrometer for trace element analysis approved in China.

Currently, Bioyong'sThe equipment and reagents have been deployed in over 60 renowned medical institutions and testing centers across China, including Peking Union Medical College Hospital, the PLA General Hospital (301 Hospital), Zhongshan Hospital, the Chinese Center for Disease Control and Prevention, and BGI Genomics., with impressive revenue and market share figures.

Bioyong Mass Spectrometry has grown alongside the global clinical mass spectrometry industry, evolving from its inception to its current strength. What is the current state of the clinical mass spectrometry sector both in China and abroad? How has Bioyong Mass Spectrometry secured a first-mover advantage in the domestic clinical mass spectrometry market? To address these questions, VCBeat conducted an exclusive interview with Ma Qingwei, founder of Bioyong Mass Spectrometry.

It is widely acknowledged within the industry that 2018 marked the “Year One” of clinical mass spectrometry in China. Why was Bioyong Technologies established as early as 2003? In response to this question, Ma Qingwei stated, “Bioyong has never confined its focus to the domestic market; instead, it has closely followed global trends in clinical mass spectrometry, adopting a forward-looking approach to its technological and product strategic planning.”

In 2002, John B. Fenn and Koichi Tanaka were awarded the Nobel Prize in Chemistry for their respective inventions of electrospray ionization (ESI) and matrix-assisted laser desorption/ionization (MALDI), which made it possible to analyze biological macromolecules by mass spectrometry.

Influenced by the Nobel Prize in Chemistry, time-of-flight mass spectrometry gained immense global popularity in 2003, with companies such as GE, Waters, PerkinElmer, and ABI actively developing TOF-MS products.Bioyong Mass Spectrometry was born amidst this global surge in time-of-flight mass spectrometry R&D.

“At that time, time-of-flight mass spectrometry was primarily applied in scientific research for proteomics analysis. In 2007, the growth prospects for time-of-flight mass spectrometry in the research sector were viewed unfavorably, and the industry entered a downturn. ABI, then the leading global brand in time-of-flight mass spectrometry, shut down its U.S. manufacturing facility. GE, PerkinElmer, and Waters also suspended their product development efforts,” said Ma Qingwei.

Unlike overseas enterprises,Bioyong Technologies has firmly believed in the clinical application potential of time-of-flight mass spectrometry since 2003.In 2006, Ma Qingwei published an article titled “MALDI-TOF MS Ushers in a New Era of Molecular Diagnostics,” highlighting the broad clinical prospects of time-of-flight mass spectrometry.

After experiencing a downturn in 2007, many companies have also shifted their focus to the clinical sector, ushering in a period of robust growth for the clinical mass spectrometry industry.

In 2012, the global field of clinical mass spectrometry achieved breakthrough progress, with microbial mass spectrometry detection systems developed by bioMérieux and Bruker successively receiving FDA clearance. In 2014, the FDA approved time-of-flight mass spectrometry systems for genetic testing. The clinical value of time-of-flight mass spectrometry was thus truly recognized, leading to its rapid adoption in clinical practice.

From winning the Nobel Prize in 2002 to gaining widespread recognition in the U.S. clinical sector, time-of-flight mass spectrometry took more than a decade. During this period, although Bioyong Technologies was located on the other side of the globe, it closely monitored overseas developments, particularly in the U.S. clinical mass spectrometry market, kept pace with international companies, and accelerated the research, development, and regulatory registration of its time-of-flight mass spectrometers.

In 2014, the company’s self-developed Clin-ToF time-of-flight mass spectrometer was approved for microbial identification., only one year after bioMérieux, isChina's First Approved Time-of-Flight Mass Spectrometer，In 2016, Clin-ToF was approved for nucleic acid testing, enabling simultaneous microbial identification and nucleic acid detection.

Following the approval of Clin-ToF in 2014, Bioyong Technologies secured a RMB 36 million investment from SoftBank SAIF Partners. From 2018 to the present, Ma Qingwei has been delighted to witness the clinical mass spectrometry industry in China enter a golden period of development. The 18 years of dedication by Bioyong Technologies have also begun to bear fruit. Today, Bioyong Technologies has emerged as a leading enterprise in this promising sector, successively receiving support from the Chongde Hongxin Fund, Hanfu Capital, and the Beijing Yizhuang Leading Talent Entrepreneurship Development Fund. Its instruments and reagents are now deployed in more than 60 hospitals and institutions.

It is understood that, at present, mass spectrometers from companies such as Bruker and bioMérieux can only perform microbial identification and are incapable of genetic testing, whereas Agena’s mass spectrometers are limited to genetic testing.

“Time-of-flight mass spectrometry is inherently expensive and cannot be used simultaneously for microbial identification and nucleic acid detection, further limiting its clinical application,” said Ma Qingwei.

“The most critical aspect of product development is focusing on clinical needs. The clinical utilization of microbial mass spectrometry is relatively low, with many hospitals processing only 20–30 samples per day, and each test can be completed in just over 10 minutes. Instruments purchased for millions of yuan remain idle for the majority of the day, resulting in very low economic efficiency.”Achieving simultaneous detection of microbes and nucleic acids to improve instrument utilization is an urgent clinical need.”

Bioyong Technologies Inc. developedClin-ToF is the world’s first time-of-flight mass spectrometer capable of simultaneously performing microbial identification and nucleic acid detection, pioneering single-instrument multi-omics testing.

In the field of microbial mass spectrometry, in 2012, Bioyong Technologies Inc. undertook a major national special project of the Ministry of Science and Technology. Led by the Academy of Military Medical Sciences, Bioyong Technologies Inc., together with the Institute of Microbiology of the Chinese Academy of Sciences, the Chinese Center for Disease Control and Prevention, and more than ten top-tier domestic medical institutions, spent six years jointly establishingA microbial mass spectrometry database based on the Chinese population, comprising over 412 genera, 2,372 species, and 11,581 strains.In 2016, Bioyong Technologies Inc. participated in the formulation of China’s first expert consensus on clinical microbial mass spectrometry.

In the field of nucleic acid mass spectrometry, Clin-ToF has been widely applied in pharmacogenomic testing, genetic testing, and epidemiological surveillance. In 2016, Bioyong Technologies Inc. undertook a key national R&D program focused on the development of an integrated innovation technology platform combining microfluidic chips with nucleic acid mass spectrometry. In 2018, the company participated in the formulation of China’s first expert consensus on the application of nucleic acid mass spectrometry.

Furthermore, targeting the trace element testing market, Bioyong Technologies Inc.'s Clin-ICP-QMS received approval in 2019 and isThe First Approved Mass Spectrometer for Trace Elements in China.

Currently, Yixin Mass Spectrometry possessesOver 60 patented inventions and more than 100 published papers, equipment and reagents have been deployed at Peking Union Medical College Hospital, the 301 Hospital, Zhongshan Hospital, the Chinese Center for Disease Control and Prevention, BGI Genomics, and others.Over 60 renowned medical institutions and testing centers in China, with Grade A tertiary hospitals accounting for 80% of the client base.Among domestically produced products of the same category, Bioyong Technologies Inc. holds a commanding lead in market share.

Disease research has evolved from genomics to multi-omics, as the value of multi-omics data—including genomics, metabolomics, proteomics, and ionomics—in enabling precise diagnosis and treatment of diseases gains recognition.The growth and expansion of clinical mass spectrometry has become an irreversible trend.

In the United States, clinical mass spectrometry accounts for 15% of the clinical testing market, whereas in China it accounts for only 1%. The Chinese clinical mass spectrometry market is currently in a phase of rapid growth, with a market growth rate exceeding 10%, and the potential addressable market size surpasses RMB 100 billion.

Ma Qingwei stated, “Although the growth rate of China’s clinical mass spectrometry market has been slower than I anticipated, the market’s vitality has exceeded my expectations, with an increasing number of companies entering the clinical mass spectrometry field.”Within the next 5–10 years, clinical mass spectrometry will surpass immunoassay and molecular diagnostics to become the leading technology in terms of market share within the in vitro diagnostics (IVD) sector.“More than 100 companies will actively participate in the clinical mass spectrometry field, fostering a vibrant and diverse industry landscape.”

However, despite the immense potential of the clinical mass spectrometry industry, high costs and technological immaturity remain unavoidable challenges. “In this context, companies must exercise patience and possess a deep understanding of the clinical market. We hope that more expert consensus statements and industry standards will be introduced in the future to facilitate the rapid and standardized development of the sector.”