Chromai Files IPO Prospectus: A Pioneer in UHPLC Technology Offering Integrated Solutions for Precision Medicine and General Testing

Since 2015, the wave of precision medicine has rapidly swept across the globe. China’s continuous advancements in precision medicine have fostered a close intersection between clinical laboratory testing and high-end, sophisticated scientific instruments, leading to a rapid expansion in the clinical application of liquid chromatography.

“The era of precision medicine is marked by three key pillars: genomics, proteomics, and personalized medication. Among these, personalized medication urgently requires the implementation of therapeutic drug monitoring (TDM) and the detection of commonly encountered nutritional and metabolic substances in clinical practice. This represents an emerging market with significant potential. Liquid chromatography, offering advantages such as faster speed, higher analytical efficiency, high sensitivity, high specificity, and the capability for multi-analyte simultaneous detection, is a critical technology for enabling personalized medication,” said Zhang Xin, Co-founder and CEO of Chromai, in an interview with VCBeat.

As can be seen,In the context of precision medicine, liquid chromatography plays a pivotal role in clinical laboratory testing.

Currently, liquid chromatography has become the recommended method in expert consensus for various applications, including therapeutic drug monitoring and vitamin testing. With broad prospects, the field is experiencing rapid growth. Meanwhile, China’s liquid chromatography market has long been dominated by imported brands, presenting significant opportunities for domestic substitution.

Chromai specializes in intelligent scientific instruments, analytical testing, and precision medicine. With core ultra-high-performance liquid chromatography (UHPLC) technology, it offers end-to-end solutions including fully automated IVD two-dimensional liquid chromatography systems, fully automated biological sample pretreatment platforms, and reagents and consumables, thereby filling the gap in China’s independent innovation in the UHPLC field.

China's annual imports of analytical instruments amount to approximately $100 billion, second only to petroleum and semiconductors. Among these, liquid chromatography is the largest single product category in the analytical instrument market. It is widely used in general testing fields such as pharmaceuticals, food, biology, agriculture, forestry, animal husbandry, and veterinary medicine, as well as in clinical medical areas including vitamin analysis and therapeutic drug monitoring. The annual market size for equipment and consumables in this sector reaches tens of billions of dollars.

For decades, China's liquid chromatographs have been heavily reliant on imports, especiallyUltra-high-performance liquid chromatography (UHPLC) systems are essentially monopolized by imported brands such as Waters, Thermo Fisher Scientific, and Agilent., Chinese brands are even harder to find in the international market. According to data provided by Chromai, China's annual incremental demand for liquid chromatography systems is approximately 25,000 units, of which nearly 20,000 are imported instruments.accounting for nearly 90% of the market share.

In this case,Breaking the import monopoly on ultra-high-performance liquid chromatography (UHPLC) systems and resolving the bottleneck issues in core technologies have become top priorities.Since 2018, policies have vigorously encouraged the domestic substitution of scientific instruments, with liquid chromatography becoming a key focus area. Chromai was established in response to this trend of domestic substitution, committed to becoming a leader in domestically produced ultra-high-performance liquid chromatography (UHPLC). Its mission is to fundamentally break import monopolies, enhance efficiency, reduce costs, and create value for customers.

The Chromai team boasts an average of over 10 years of experience in the scientific instrumentation and analytical testing industry. Zhang Xin, Co-founder and CEO of the company, previously served as General Manager of the Life Sciences and Chemical Analysis Division at China’s largest manufacturer and service provider of electronic test and measurement equipment. As one of the drafters of the national standards for liquid chromatography, he has led multiple national development special projects and possesses over 15 years of global marketing and management operations experience. The company’s CTO and Chairman has been engaged in technical research, product development, and project management in the fields of chemical analysis and life sciences for over 20 years. He has successfully developed dozens of products for several publicly listed companies, holds numerous patents, has presided over multiple national-level projects, and is a technological leader in China’s liquid chromatography sector. Another Co-founder and Vice President brings nearly 20 years of industry experience, with expertise in chromatography, spectroscopy, and automated sample preparation technologies, as well as extensive and proven experience in supply chain management, production operations, and mass manufacturing.

Notably, the three founders of Chromai have worked together for many years,Created multiple firsts in China, such as China’s first quasi-ultra-high-efficiency liquid chromatography system, the earliest in China to fully master ultra-high-performance liquid chromatography (UHPLC) technology and receive national-level special support, China’s first independently developed liquid chromatography system with an automated sampler configuration, and China’s first independently developed database and network-based liquid chromatography workstation. The company’s founding team has deep expertise in the field of liquid chromatography, with highly complementary professional skills. It is a rare team in China capable of achieving technological breakthroughs from 0 to 1 and realizing industrial transformation from 1 to 10 in the liquid chromatography sector.

Currently, the liquid chromatography market is undergoing a technological upgrade from high-performance liquid chromatography (HPLC) to ultra-high-performance liquid chromatography (UHPLC).

Ultra-high-performance liquid chromatography (UHPLC) has achieved significant leaps in analytical efficiency, separation speed, sensitivity, resolution, and scalability, reducing detection time from 30–40 minutes to just 5 minutes. In simple terms, UHPLC has delivered a paradigm-shifting advantage over high-performance liquid chromatography (HPLC) across multiple dimensions, including detection time and precision. Zhang Xin stated bluntly:“The transition from high-performance liquid chromatography to ultra-high-performance liquid chromatography is an inevitable trend.”

China has made certain progress in the domestic production of high-performance liquid chromatography (HPLC) systems, but has yet to achieve a breakthrough in the domestic production of ultra-high-performance liquid chromatography (UHPLC) systems.

“Ultra-high performance liquid chromatography (UHPLC) involves multiple disciplines, including mechanics, structural engineering, electronics, optics, software engineering, automation, and embedded systems, placing extremely high technical demands on development teams. Furthermore, UHPLC technology requires substantial capital investment and has a lengthy cycle for independent R&D; it took Waters Corporation nearly seven years to upgrade from high-performance liquid chromatography (HPLC) to UHPLC. Therefore, for many years, few enterprises in China have dared to undertake the challenge of independently developing UHPLC technology,” stated Zhang Xin.

As early as 2012, when the domestic market was predominantly focused on high-performance liquid chromatography (HPLC), the founding team of Chromai pioneered the research and development of ultra-high-performance liquid chromatography (UHPLC) technology, making itA domestic leader and an enterprise that has fully mastered the key core technologies of ultra-high-performance liquid chromatography through forward engineering.

In the field of general testing, liquid chromatography holds significant promise in industries such as pharmaceuticals and food safety.In 2019, the China Food and Drug Administration (CFDA) issued the Guiding Principles for Capacity Building of Drug Inspection and Testing Institutions, which classified liquid chromatography systems as Class A equipment required for comprehensive capacity building, thereby designating them as mandatory instruments. The 2020 edition of the Chinese Pharmacopoeia formally incorporated ultra-high-performance liquid chromatography (UHPLC) methods.

In the field of general-purpose testing, Chromai has deployed a range of products including intelligent ultra-high-performance liquid chromatography (UHPLC) systems, ultra-high-pressure infusion pumps, fully automatic samplers, and UV/diode array detectors. Chromai remains committed to breaking the monopoly of imported instruments, enabling a broad spectrum of industry users to access UHPLC-level liquid chromatography at lower costs. This helps customers continuously reduce costs and improve efficiency, making complex analyses simpler and more user-friendly.

Clinical diagnostics is a potential blue-ocean market for liquid chromatography, with a growth rate approaching 30%.In the field of clinical laboratory testing, Chromai has deployed a fully automated 2D ultra-high-performance liquid chromatography (UHPLC) system for in vitro diagnostics (IVD), an automated sample pretreatment platform, and supporting reagents and consumables. Leveraging deep insights into scientific instrument development and clinical needs, Chromai has established a one-stop, fully automated solution encompassing both instruments and consumables. In the future, it will launch an integrated, fully automated, online diagnostic system, making liquid chromatography truly simple and user-friendly at the clinical testing level, thereby enhancing its clinical significance and meeting the demands of precision medicine.

Regarding the recently surging popularity of clinical mass spectrometry, Zhang Xin stated that it represents the current “ultimate” testing solution, offering superior accuracy compared to other technologies. However, it faces numerous challenges, including high costs for hospital adoption and operation, complex procedures, and substantial space requirements. Consequently, liquid chromatography-tandem mass spectrometry (LC-MS/MS) is largely confined to top-tier Grade 3A hospitals with ample funding, sufficiently large sample volumes, and dedicated professional operators, making it difficult to extend its reach to lower-tier institutions such as Grade 2 or 3 hospitals and specialized facilities.

Liquid chromatography can complement liquid chromatography-tandem mass spectrometry technology,Chromai’s IVD two-dimensional liquid chromatography system significantly reduces costs. By leveraging two-dimensional separation technology and proprietary technical solutions, it greatly enhances the limit of detection (LOD) and sensitivity, achieving performance comparable to liquid chromatography-tandem mass spectrometry (LC-MS/MS). Both methods effectively meet the LOD requirements for clinical testing, thereby catering to the clinical needs of more small and medium-sized hospitals. Furthermore, built on an ultra-high-performance foundation, the system substantially shortens separation time and greatly improves analytical efficiency.

Currently, Chromai has established stable mass-production capabilities for ultra-high-performance liquid chromatography (UHPLC) systems and has obtained five medical device registration certificates. Zhang Xin stated, “2022 marked the inaugural year for Chromai’s comprehensive strategic layout and scaled mass production in China. The company has established in-depth collaborations with institutions such as the Shanxi Provincial Center for Precision Medicine Diagnosis and Treatment, Peking Union Medical College Hospital, Fuwai Central China Cardiovascular Hospital, and Bethune International Peace Hospital.”

Moving forward, Chromai will continue to innovate by leveraging ultra-high-performance liquid chromatography (UHPLC) technology to establish a simultaneous presence in both general testing and clinical diagnostics. By breaking the monopoly held by imported products, the company aims to continuously enhance analytical efficiency and reduce costs, thereby creating UHPLC products with international competitiveness and exceptional value. Furthermore, Chromai plans to expand into overseas markets, disrupt the established global market landscape, and bring global recognition to Chinese innovation.