Zhejiang University-Alumni Couple Leads Overseas-Focused POCT Firm Anxu Bio to Shanghai STAR Market Debut

Another alumni couple has joined the ranks of listed companies in the healthcare sector today.

On November 18, 2021, Hangzhou Autosun Biotechnology Co., Ltd. (hereinafter referred to as “Autosun Biotech”) was officially listed on the STAR Market of the Shanghai Stock Exchange. The initial public offering (IPO) price was RMB 78.28 per share, with 15.3334 million new shares publicly issued, raising a total of RMB 1.2 billion. It is reported that the proceeds from this IPO will be primarily allocated to the following areas:

An analysis of the use of proceeds from the company’s fundraising reveals that the majority of funds raised by Autobio Diagnostics will be allocated to the mass production of its medical devices, in vitro diagnostics (IVD), and related products, with the aim of achieving an annual production capacity of 300 million units. The remaining funds will be directed toward research and development, facility upgrades, and supplemental working capital.

Axsom Biotech, established in 2008, specializes in the research and development, manufacturing, and sales of POCT reagents and instruments. The company operates five major technology platforms: immunochromatography, dry chemistry, biological raw materials, chemiluminescence, and precision diagnostics. Its business covers eight key POCT areas: drug testing, infectious disease testing, chronic disease testing, pregnancy testing, tumor marker testing, cardiac marker testing, biochemical testing, and allergen testing.

It is worth mentioning that Aoxu Biology'sCore business is mainly laid out inSea, with domestic business volume accounting for less than 10%, the company's products are exported to many countries including the United States, Germany, the United Kingdom, Canada, Russia, Mexico, Thailand, Indonesia, and Poland, and have becomeA select few Chinese in vitro diagnostic (IVD) product suppliers capable of competing with multinational IVD industry giants in the international POCT marketone of.

Previously, the company was cited by the National Medical Products Administration (NMPA) for issues with its clinical data. In March this year, its corresponding product, the “HIV Antibody/Hepatitis C Virus Antibody/Hepatitis B Virus Surface Antigen/Treponema pallidum Antibody Combined Test Kit (Immunochromatography),” was notified of registration rejection. This inevitably raised market concerns about whether Anxu Biotech’s IPO process would be affected. However, several months later, the company demonstrated its capabilities through action and successfully listed on the STAR Market today.

Ling Shisheng, the founder of AllTest Biotech, holds a Bachelor’s degree in Genetics and a Master of Science from Zhejiang University. He previously served as a researcher at the College of Life Sciences of Hangzhou University, R&D Director at ACON Biotech, and Executive Vice President of Medicon Biotechnology. On July 4, 2008, Mr. Ling established Hangzhou AllTest Technology Co., Ltd. (which was restructured into AllTest Biotech on August 28, 2019) and served as its General Manager. The R&D activities of AllTest Biotech are primarily led by Mr. Ling, while his spouse, Ms. Jiang Xueying, serves as the Company’s Deputy General Manager.

Ms. Jiang Xueying also graduated from Zhejiang University with a degree in Law and later obtained a Master of Laws from Shanghai University of Finance and Economics. Prior to joining Autobio Diagnostics, Ms. Jiang primarily worked as a judge and in other related professional roles. After joining Autobio Diagnostics, she mainly assisted her husband, Mr. Ling Shisheng, in formulating the company’s strategic development plans, operational plans, and business development plans, effectively establishing what is commonly referred to as a “family-run business.”

This “husband-and-wife” company operated for 13 years from its establishment to its IPO, with actual controlling rights consistently held by the Ling Shisheng couple. According to Anxu Biotechnology’s prospectus, during the 13 years of the company’s development, it never conducted any public fundraising. Apart from Ma Huaxiang, a natural person shareholder who holds 15.5% equity in the company, the remaining shares are basically indirectly or directly controlled by the Ling Shisheng couple. Before the IPO, Mr. Ling Shisheng directly held 33.50% of the company’s shares, and Ms. Jiang Xueying directly held 2.67%. The two jointly held another 35.83% through Aixu Holdings and 7.52% through Chuangsheng Investment, resulting in a combined stake of 79.52% in the company.

Currently, Anxu Biology holds seven wholly-owned subsidiaries with mutually supportive operations, aligning with the company’s diverse business segments and needs. This structure enables a comprehensive layout spanning from upstream core raw materials for POCT to downstream product distribution, alongside a strategic plan that has expanded from overseas sales into the domestic market. Anxu Biology continues to strengthen R&D in cutting-edge technologies within the POCT industry, consistently optimize manufacturing processes, diversify its product portfolio, enhance its capacity for in-house production of biological raw materials, and increase R&D investment, all aimed at expanding its market share both domestically and internationally.

Anxu Biotech, with technological innovation as its core competitiveness, has successively establishedImmunochromatography, Dry Biochemistry, Biological Raw Materials, Chemiluminescence, Precision TestingSeveral major platforms. Among them,, biological raw materials, immunochromatographic platforms, and dry biochemistryPlatformRelatively mature, with related technologies already industrialized;Chemiluminescence and Precision Testing PlatformWe are comprehensively laying out our strategic framework, with certain reserves of relevant technologies and products already in place, and will gradually achieve industrialization.

Immunochromatography PlatformThis was the first technical platform established at the inception of Anxu Biology. It is a rapid detection technology that combines chromatography with immunoreaction. The principle involves immobilizing specific antibodies in a defined zone on a nitrocellulose membrane. When one end of the dry nitrocellulose membrane is immersed in a sample (urine or serum), the sample migrates along the membrane via capillary action. Upon reaching the antibody-immobilized zone, the corresponding antigens in the sample bind specifically to the antibodies. By using colloidal gold or enzyme-based immunolabeling, this binding event produces a visible color change, thereby enabling specific immunodiagnosis.

Immunochromatography is characterized by its convenience, speed, and accuracy, and is widely used in fields such as POCT clinical testing, food safety testing, and forensic testing. The immunochromatographic technologies primarily employed by Anxu Biotechnology focus on two directions:Colloidal Gold Immunochromatography TechnologyandFluorescence Immunochromatography Assay, and has developed over 200 colloidal gold-based products and nearly 60 fluorescent immunochromatographic assay products. The product portfolio covers series for drug testing, infectious disease testing, pregnancy testing, tumor marker testing, and cardiac marker testing.

Aoxu Biotech's Platform Technology

Since 2015, Assure Tech has continued to expand on its immunochromatography technology platform.Dry Biochemistry Technology Platform, this platform is based on biosensor technology and can be subdivided intoPhotochemical Analysis TechniquesandElectrochemical Analysis TechnologyPhotochemical analysis technology primarily determines reactant concentrations based on photochemical principles and is mainly applied in the detection of blood lipids, hemoglobin, and other analytes; electrochemical analysis technology primarily determines reactant concentrations based on electrochemical principles and is mainly applied in the detection of blood glucose, uric acid, and other analytes.

Leveraging its dry chemistry biochemistry technology platform, Aoxu Bio has expanded its testing portfolio to include series for chronic disease detection and allergen testing. Meanwhile, the company has made initial strides in integrating diagnostic reagents with testing instruments, successfully developing point-of-care testing (POCT) devices such as hemoglobin analyzers, lipid profile analyzers, and blood glucose meters.

In 2017, Anxu Biotech continued to expand its POCT technology platform, establishingChemiluminescenceandPrecision TestingTwo Major Technology Platforms. The Chemiluminescence Technology Platform, withMagnetic Bead Separation TechnologyandEnzyme-Enhanced Chemiluminescence TechnologyCentered on HRP- and ALP-based enzyme-linked chemiluminescence and integrated with magnetic separation technology, this method involves conjugating active substances such as antigens or antibodies to functional groups on the surface of magnetic beads. During detection, the analyte is incubated under specified conditions with the antigen- or antibody-coated magnetic beads to facilitate antigen-antibody binding. An external magnetic field is then applied to induce magnetic aggregation of the beads, enabling washing and the separation of bound from unbound fractions. Finally, substrate and initiator reagents are added, and the emitted light signal is detected using a photomultiplier tube.

Precision Testing Technology Platform withMolecular Diagnostics TechnologyandMass Spectrometry Detection Technologyas the core, to detect and analyze target substances in samples. Molecular diagnostic techniques extract nucleic acids from samples and then apply fluorescent PCR or isothermal amplification to detect and analyze target genes; mass spectrometry utilizes the mass-to-charge ratio of ions for analysis, thereby enabling qualitative and quantitative detection of analytes.

Axsens' Biological Raw Materials Platform

Since its establishment, Autobio has adhered to the in-house production of core POCT raw materials, striving to integrate the upstream supply chain and gradually transition from imports to domestic alternatives, thereby providing robust support for the company’s business operations.

Currently, the company has mastered technologies for recombinant antigen production via genetic engineering, synthetic antigen technology, polyclonal antibody preparation, and monoclonal antibody preparation, forming a portfolio that includes syntheticAntigens, Recombinant Antigens, Monoclonal Antibodies, Polyclonal Antibodies, and Other Biological MaterialsThe company offers five major product categories, covering drug testing, infectious disease testing, pregnancy testing, tumor marker testing, cardiac biomarker testing, and chronic disease testing. It achieves in-house production of antigen and antibody raw materials required for nearly 100 reagent products, accounting for more than half of the company’s demand for biological raw materials. This has laid a solid foundation for the continuous innovative development and stable production of the company’s products.

Leveraging the aforementioned major technology platforms, Axsom Bio primarily focuses its POCT applications on five key areas: drug testing, infectious disease testing, pregnancy testing, tumor testing, and cardiac marker testing. These also represent the first five application scenarios covered by Axsom Bio’s immunochromatography platform.

Anxu Biotech's Core Areas in POCT Business Layout and Its Representative In-House Antigen and Antibody Raw Materials

According to the prospectus of Anxu Biology, the company’s POCT business has its most extensive layout in the fields of drug testing and infectious disease testing. Drug-testing POCT products are primarily used for the rapid detection of drug use, such as marijuana, cocaine, and heroin, typically by analyzing samples like urine or saliva from users. These products are characterized by their rapid results, ease of use and portability, and high accuracy. They are widely applicable in screening programs at drug rehabilitation centers, hospitals, military recruitment stations, customs and border control checkpoints, road traffic safety inspections for high-risk populations, as well as in physical examinations for special industries and pre-employment health checks. Meanwhile, infectious disease POCT products can significantly enhance infectious disease monitoring capabilities, assist physicians in making timely and accurate diagnoses and treatment decisions, and reduce the likelihood of disease transmission within the population.

Anxu Biotech's POCT Core Business Revenue (Unit: 10,000 Yuan)

As the company's core testing business, drug POCT and infectious disease POCT have also generated substantial revenue, with drug and infectious disease testing accounting for more than 90% of the company's total revenue.Generated nearly RMB 1.2 billion in revenue for the company in 2020。

However, it is not difficult to observe that 2020 marked a watershed year in the diversification of Axsom Biotech’s core business segments. Prior to 2020, the company’s POCT (Point-of-Care Testing) business was predominantly driven by drug abuse testing, which accounted for over 70% of revenue, while infectious disease testing constituted a smaller share, at just over 10%. Starting in 2020, however, infectious disease testing became the primary revenue contributor for Axsom Biotech. This shift is closely tied to the fact that the company’s main sales markets are in Europe and the United States.

North America is the primary market for drug testing product series, with substantial demand for point-of-care testing (POCT) reagents from hospitals and testing institutions, judicial authorities, employers, and households. Centered in Europe and North America, Aoxu Biology has continuously expanded its market reach to other continents. Notably, revenue from drug testing reagent sales in the North American market accounted for a significant proportion of the company’s total drug testing reagent sales during the same periods, reaching 58.27%, 58.23%, 58.98%, and 63.88%, respectively.

 Top Five Customers of Anxu Biotechnology

Among them, the German customer NAL VON MINDEN GMBH generated RMB 630 million and RMB 280 million in sales revenue (drugs of abuse + infectious diseases) for Anxu Biotech in 2020 and January–June 2021, respectively, ranking as the largest customer during these periods. This significantly increased the company’s sales concentration, with the proportion of revenue from its largest customer rising rapidly from 16.09% in 2018 and 16.03% in 2019 to 52.35% in 2020 and 55.85% in January–June 2021.

In 2020, the COVID-19 pandemic erupted globally, leading to a surge in overseas demand for COVID-19 testing reagents within a short period. AllTest Biotech actively responded to this international demand by sequentially developing, launching production of, and achieving large-scale sales of its COVID-19 antibody and antigen testing reagents. Following the outbreak of the pandemic, AllTest Biotech’s COVID-19 testing business became a sustained source of revenue growth for the company. The company’s developedSARS-CoV-2 Test Kit (Immunochromatographic Assay) Has Been Sold to Overseas Markets Since March 2020, with cumulative sales revenue reaching RMB 990 million by the end of 2020, driving the company’s total operating revenue to RMB 1.2 billion in 2020.

However, Axsun Biotechnology’s COVID-19 test kits primarily consist of antigen tests, supplemented by antibody tests. Among these, the antibody test kits have obtained certifications in the United States, Canada, and the European Union, while the antigen test kits have secured certifications in Canada and the European Union. In China, however, the mainstream method for COVID-19 testing is nucleic acid testing, which is not covered by Axsun Biotechnology’s COVID-19 testing portfolio.Neither its antibody tests nor antigen tests have obtained product registration certification in China.. Therefore, the core business of Anxu Biotechnology is primarily focused on overseas markets, with its domestic market share accounting for less than 10%.

According to the World Drug Report 2019 released by the World Health Organization, the severity and complexity of the global drug situation are increasing. The number of drug users in 2019 was 30% higher than in 2009, and governments worldwide have implemented drug control measures to curb the spread of illicit substances. Therefore, on a global scale, rapid drug testing is becoming a prominent trend in the context of international drug control, indicating broad future prospects for the market of point-of-care testing (POCT) products for drugs.

As Aoxu Biotech’s flagship product line, its drug POCT solutions currently cover testing for more than 20 conventional drugs of abuse, as well as over 20 novel psychoactive substances including synthetic cannabinoids, kratom, trazodone, lysergic acid diethylamide (LSD), tilidine, pregabalin, zolpidem, and zaleplon. The testing modalities encompass saliva, urine, whole blood, hair, and powder analysis, positioning the company among the global leaders in terms of product variety.According to Trimark statistics, the global market size for POCT drug testing was $830 million in 2018. Based on this figure, Aoxu Biology’s global market share for drug testing products in that year was calculated at 2.07%.

Aoxu Biology is a corporate member of the China Narcotics Control Association. However, its drug testing reagents are primarily targeted at the North American and European markets. The company obtained multiple registration certificates for urine cup-based drug testing reagents in the United States and Canada in 2017 and 2018, respectively. Currently, Aoxu Biology is intensifying its R&D efforts on drug testing reagents and expanding its sales presence in North America.

The growing demand for drug testing reagents in North America will drive the continuous growth of Aoxu Biology’s sales revenue from such products. Meanwhile, the company’s mature biological raw material platform ensures a stable supply of materials for its POCT reagents, enabling an integrated industry chain that spans from upstream core raw materials to diagnostic reagents. This integration helps maintain competitive advantages and offers significant potential for future growth.