Home Calibra Medical Files for IPO to Advance Clinical Mass Spectrometry-Based Precision Diagnostics in China

Calibra Medical Files for IPO to Advance Clinical Mass Spectrometry-Based Precision Diagnostics in China

Mar 09, 2021 08:00 CST Updated 08:00

In 2012, the then Director of Applied Technologies and Support at SCIEX, a mass spectrometry instrument company under Danaher Corporation, a globally renowned medical group,Liu HuafenLittle did she imagine that her initial business engagement with Dian Diagnostics back then would mark the beginning of her journey to found Gloria Spectrum.

 

SCIEX is a globally renowned provider of comprehensive mass spectrometry solutions, while Dian Diagnostics is a leading third-party medical diagnostic institution in China. The collaboration between these two industry giants stems from a niche market—mass spectrometry. Years ago, Dian Diagnostics foresaw the significant potential of China’s mass spectrometry testing market. Its Chairman, Chen Haibin, repeatedly invited Liu Huafen to join Dian Diagnostics with the aim of aligning China’s precise mass spectrometry diagnostic technologies with international standards, spearheading the company’s entry into the mass spectrometry market, narrowing the gap with global counterparts, and ultimately benefiting the health and well-being of the Chinese population. This original aspiration resonated perfectly with Liu Huafen’s own vision and ambitions.


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Ms. Liu Huafen, Founder of Gloria Spectrum

 

Liu Huafen candidly remarked, “Entrepreneurship was once a parallel line in my life plan, but it has now become a significant intersection beyond my original plans.” She resolutely chose to return to China to start her business, driven by both a personal aspiration and a sense of mission.

 

Years of living overseas allowed Liu Huafen, a veteran in the mass spectrometry field, to clearly witness the significant gap between China and Europe/the United States in the clinical application of mass spectrometry technology. “The clinical adoption of mass spectrometry technology in China has long struggled to gain momentum. I sincerely hope to leverage my expertise to contribute to advancing the development of mass spectrometry in clinical practice and precision medicine in my home country,” Liu Huafen remarked.

 

In March 2017, immediately after completing her defense in Washington on the global standardization of promoted allergen detection methods for the AOAC INTERNATIONAL, Liu Huafen promptly returned to China to lead Hangzhou Gloria Spectrum Precise Medical Testing Technology Co., Ltd. (hereinafter referred to as “Gloria Spectrum”) in its official launch.

 

In the same year, Gloria Spectrum secured RMB 50 million in angel investment from Dian Diagnostics, and its central laboratories in Hangzhou and Shanghai, as well as its metabolomics laboratory, were successively established. Liu Huafen told VCBeat that the original intention behind founding Gloria Spectrum was to genuinely promote the application of core mass spectrometry technology in precision medicine in China, to cultivate a team of professionals in the field of mass spectrometry through this platform, and to establish an industry benchmark for the clinical application of mass spectrometry technology in China. The company hopes that these future pillars will serve as seeds driving the development of the clinical multi-omics precision diagnostics industry in China and even globally, thereby fulfilling its mission of achieving healthy living through innovative diagnostics.

 

Two Rounds of Financing Worth Hundreds of Millions in One Year: Kaluopu Officially Embarks on Independent Development


Following the establishment of Gloria Spectrum, the enthusiasm in the clinical mass spectrometry market and the favor shown by capital markets toward this sector have both exceeded expectations.

 

In 2018, merely one year after its establishment, Gloria Spectrum achieved an annual revenue exceeding RMB 30 million. Leveraging the strong backing of a “giant” as well as its own robust technical and R&D capabilities, Gloria Spectrum’s comprehensive clinical mass spectrometry solutions have been deployed in dozens of tertiary healthcare institutions across China and in multiple laboratories of Dian Diagnostics, with an annual testing volume surpassing one million cases.

 

Its impressive achievements have also attracted a rush of capital.From 2020 to 2021, within just one year, Gloria Spectrum successively completed two rounds of financing, Series A and Series B, each amounting to hundreds of millions of RMB., exclusively invested by Boyuan Capital, and led by Hillhouse Ventures with participation from Defu Capital and Sinopharm Capital.

 

Meanwhile, the plan for Gloria Spectrum to spin off from Dian Diagnostics and list independently has become increasingly clear. Liu Huafen joked, “Rather than calling it a spin-off, it is more accurate to say that Gloria Spectrum has ‘grown out’ of Dian Diagnostics. With the development of the mass spectrometry industry and the continuous increase in customer demand, combined with Mr. Haibin’s comprehensive considerations from an enterprise-level perspective, we hope that Gloria Spectrum’s advanced technology, quality management system, and cutting-edge products can collaborate with more customers and be applied to broader scenarios. Therefore, through joint deliberation, we believe that Gloria Spectrum’s independent development will better serve the entire industry.”

 

Independently developed, Gloria Spectrum focuses more on providing customers with comprehensive clinical mass spectrometry solutions. Driven by multi-omics biomarker discovery and leveraging mass spectrometry as its core platform, the company advances the identification of key biomarkers and facilitates their translation into commercial products. Centering on three major application areas—clinical diagnostics, multi-omics research, and biomarker discovery and translation—and guided by end-to-end technologies spanning from multi-omics to clinical applications, the company delivers integrated clinical mass spectrometry solutions encompassing “products + services + management.”

 

Through dedicated R&D and innovative applications, Gloria Spectrum has independently developed clinical solutions in areas including precision chronic disease management, precision endocrine and metabolic diagnostics, precision medication guidance, precision maternal and child health management, and precision nutritional assessment.Over 300 Laboratory Test Items

 

Mass Spectrometry Testing: The Gold Standard for Small Molecule Analysis in Biological Samples


Gloria Spectrum originated from mass spectrometry. Why is mass spectrometry regarded as the gold standard for small-molecule analysis in biological samples? Moreover,The Cornerstone of the Precision Medicine Industry

 

Mass spectrometry is an analytical technique that ionizes molecules in a sample and then separates and quantifies them at the molecular level based on their mass-to-charge ratio (m/z) under the influence of an electric field. This technique began to be adopted for industrial applications in the late 1980s, with its initial widespread use in new drug development and scientific research. It offers analytical advantages such as rapid analysis, high resolution, high sensitivity, and high specificity.

 

Liu Huafen explained, “Unlike traditional immunoassays that detect the conjugates formed by antigen-antibody reactions, mass spectrometry directly analyzes the chemical properties—such as molecular weight and structure—of the biomarker compounds themselves in the sample, yielding more reliable results. In theory, if the instrumentation and methodology are robust, a given compound in a specific sample should have a single, definitive concentration value, independent of the methodological approach or reaction system.”

 

Gloria Spectrum's Soft Power in Mass Spectrometry Testing

 

However, due to the high barriers associated with mass spectrometry technology, domestic production currently relies primarily on imported brands, and the application of clinical mass spectrometry in China remains in its early stages. Many users, despite having purchased expensive instruments, produce unreliable test results owing to a lack of expertise in methodology and quality control. This situation has begun to change with the entry of Gloria Spectrum. Adhering to high North American standards, Gloria Spectrum has established a first-class mass spectrometry application platform in China. The platform’s full-spectrum scanning capability enables the analysis of thousands of indicators from a 100-microliter sample, allowing for comprehensive, multi-pathway interpretation.

 

During the 2020 COVID-19 pandemic, the team at Gloria Spectrum led the cohort design and metabolomics analysis for the progression from mild to severe COVID-19. As co-first authors and co-corresponding authors, they collaborated with partners to publish the world’s first protein-metabolite multi-omics study on COVID-19 in Cell, providing critical evidence for anticoagulant and immunosuppressive pharmacotherapies.

 

Multi-parameter analysis can even enable precise prediction before the onset of disease. Liu Huafen cited an example: “For instance, when individuals are under significant stress, the endocrine system mounts a stress response. Mass spectrometry can analyze various pathways involved in this stress response, thereby accurately determining whether the patient is experiencing chronic or acute stress. This means that mass spectrometry testing can achieve precise diagnosis and thus facilitate disease prevention, even before physiological changes become apparent in the human body.”

 

In addition to disease prevention, mass spectrometry technology is widely applied in clinical testing and research, multi-omics, pharmaceutical CROs, and forensic toxicology. Currently, Kaluipu primarily focuses on the clinical translation of biomarkers identified through small-molecule multi-omics mass spectrometry analysis, ultimately applying its products to guide precise clinical diagnosis and treatment.


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The development and translation of biomarkers require strict quality system control, which is precisely the type of system lacking in research institutions. “Only through rigorous quality systems and standardization can data reliability and significance be ensured; this isOneSecond“Moreover, the results obtained from mass spectrometry also require professionals with biochemistry expertise to extract valuable information. Currently, China has an abundance of R (Research) talent, but there is a scarcity of truly experienced D (Development) professionals. Expertise in product development, along with a deep understanding of customer needs and the industry chain, can only be acquired through years of accumulation,” said Liu Huafen, speaking to VCBeat about Gloria Spectrum’s soft power.

 

III.“Even after these differentiated compounds have been identified, their productization is a long-term development process. It is not merely about developing simple detection methods by combining several compounds; rather, it involves the integration of an entire industry chain to provide a holistic solution. This includes a deep understanding of clinical significance and needs, reagent productization, development of related sample processing consumables, methodology, and quality management systems, as well as strategies for promotion after late-stage product development. All of this requires extensive experience and accumulation in the industry, which are precisely the strengths and advantages of Gloria Spectrum.”

 

Meanwhile, multiple projects on Gloria Spectrum’s mass spectrometry platform have achieved comprehensive automation.Fastest: 0.7 minutesThis enables biological sample analysis, significantly improving testing efficiency.Let the platformWhile the average daily sample volume increased more than tenfold, staffing levels were reduced by over half.

 

Gloria Spectrum's strength has also been recognized by the industry in recent years, even though the companyExceeded revenue targets beyond expectations amid the 2020 pandemic turmoil. Compared with several domestic competitors in mass spectrometry testing, Kalapu, a new entrant, is undoubtedly a dark horse.