Guangzhou Kangrun Bio: Becoming a Leader in Sex Hormone and Autoantibody Testing Amid Import Substitution Trends

In 2003, Huang Wenxi, founder of Guangzhou Kangrun Biotech, traveled abroad for an inspection and learned about AMH (Anti-Müllerian Hormone), a landmark test in female endocrine assessment.

AMH can more accurately assess the status of ovarian reserve, reflect subtle changes in the ovaries at an earlier stage, and is the most direct and ideal indicator for evaluating ovarian function. Overseas AMH testing programs were launched earlier; in 1990, IOT released the world’s first commercial AMH kit.

At that time, AMH testing technology was not yet available in China, making it difficult to accurately assess ovarian reserve function using conventional methods such as routine sex hormone assays and ultrasound. There was a significant gap in the domestic market for ovarian reserve assessment.

With a clinical background, Huang Wenxi keenly recognized the broad prospects of AMH testing and quickly decided to collaborate with a foreign company, introducing AMH test kits in 2003.

After introducing AMH assay reagents, Guangzhou Kangrun Biotech promoted the AMH test kits as research-use-only reagents to strengthen market education from 2003 to 2013, while actively advancing their regulatory registration and approval process in China.

July 11, 2013Fu Xiaoyang, Marketing Director of Guangzhou Kangrun Biotech, still has a vivid memory of this date. On this day,Guangzhou Kangrun Biotech’s AMH Test Kit Successfully Approved for Market Launch in China, officially adopted for clinical laboratory testing, bringing new clinical tools for the assessment of ovarian reserve. Guangzhou Kangrun Biotech has also successfully entered the field of female endocrine testing in China as the first company to obtain approval for an AMH assay.

Currently, AMH testing is the flagship offering of Guangzhou Kangrun Biotech Co., Ltd., which has consistently remained a leader in the AMH testing niche. Furthermore, the company has successively established platforms for immunoblotting multiplex assays, indirect immunofluorescence, and chemiluminescence development. Its product portfolio covers sex hormones, thyroid function, autoantibodies, Epstein-Barr virus antibodies, and respiratory pathogens. The company is currently striving to position itself as a leader in the two specialized sectors of sex hormone testing and autoantibody testing.

Recently, VCBeat conducted an exclusive interview with Fu Xiaoyang, Marketing Director of Guangzhou Kangrun Biotech.

Sex Hormone TestingSex hormones, secreted by the gonads—one of the most important endocrine glands in the human body—promote the development of accessory sexual organs and the maturation of reproductive function. They play a crucial role in maintaining normal pregnancy, placental development, and preparation for lactation. Nearly all gynecological endocrine disorders involve hormone testing. Its clinical applications are extensive, and it holds significant importance in the diagnosis and treatment of disorders related to sex hormone imbalances, gynecological diseases, and female infertility.

Fu Xiaoyang stated, “The market size for sex hormone testing in China ranges from RMB 6 billion to RMB 8 billion, while AMH, as a relatively new sex hormone test item, has a market size between RMB 300 million and RMB 500 million.. In the long term, as AMH testing becomes widely applied in fields such as assisted reproduction and gynecological endocrinology,The market size of AMH in China will exceed RMB 1 billion.”

As the first company to introduce AMH test kits into China, Guangzhou Kangrun Biotech has developed rapidly in the AMH testing sector.

In 2013, Guangzhou Kangrun Biotech’s AMH assay kit became the first to receive approval in China., solidifying the company's leading position in the AMH testing sector. The product has been rapidly deployed and applied in multiple top-tier hospitals within China's assisted reproductive technology (ART) field, successfully penetrating the markets of assisted reproduction and gynecological endocrinology.

In 2019, the AMH assay kit (chemiluminescence method) developed by Guangzhou Kangrun Biotech was approved.Compared with the previously used enzyme immunoassay,AMH testing based on chemiluminescence is more convenient and rapid, suitable for high-throughput screening in large hospitals as well as for low-volume specimens in smaller hospitals., closely aligned with the iterative trends of in vitro diagnostic technologies and clinical laboratory testing needs.

In addition, Guangzhou Kangrun Biotech and Peking University Third Hospital jointly launchedFemale Ovarian Reserve Function Assessment Software—“Female Youthfulness”, comprehensively calculated based on female age, AMH, and follicle-stimulating hormone (FSH) levels, to score and grade ovarian reserve function, predict the age of menopause, and guide health care during the perimenopausal period.

Now, Guangzhou Kangrun Biotech has establishedComprehensive Solution for Full Panel Sex Hormone Testing.From AMH to comprehensive reproductive endocrine hormone panels, thyroid function tests, and antiphospholipid syndrome-related markers, the offerings meet the needs of multiple departments, including reproductive centers, obstetrics and gynecology, and internal medicine.

As can be seen, the domestic market for sex hormone testing products, including AMH test kits, features a wide variety of offerings and numerous manufacturers; however, the market remains monopolized by imported products. Fu Xiaoyang stated, “Although products are emerging in rapid succession,The persistent lack of high-quality domestic products has made it difficult for local companies to gain a competitive edge against importers.”

Guangzhou Kangrun Biotech deeply understands clinical needs, providing precise and stable test results for AMH and sex hormones. The AMH product pioneeredLiquid Quality Control Materials, more closely resembling clinical specimens, enabling precise quality assessment and quality control. In addition, the company has jointly established with multiple entitiesReference Range for AMH Testing in the Chinese Population.Leveraging its numerous unique advantages in the sex hormone testing sector, Guangzhou Kangrun Biotech has successfully carved out a niche amidst a crowded field of manufacturers.

As early as 2006, Guangzhou Kangrun Biotech strategically entered the niche segment of autoantibody testing, an area with strong clinical demand.

“Autoantibody testing is a niche sector, widely perceived to have a market size in the range of RMB 1 billion. However, from a clinical perspective, autoimmune diseases are characterized by the presence of multiple autoantibodies in patients and rely heavily on laboratory diagnostics, underscoring the critical role of autoantibody testing in clinical diagnosis and treatment,” said Fu Xiaoyang.

At the end of 2019, the General Office of the National Health Commission issued the Guidelines for the Construction and Management of Rheumatology and Immunology Departments in General Hospitals (Trial). The Guidelines stipulate that tertiary general hospitals with the necessary conditions should, in principle, establish independent rheumatology and immunology departments, and encourage secondary general hospitals and other types of medical institutions with the requisite capabilities to do the same. Furthermore, relevant hospitals are required to possess the capacity to perform routine diagnostic tests for rheumatic and immune diseases, including the detection of related autoantibodies.

The introduction of this guideline has released significant positive momentum for the domestic autoantibody testing market, ushering in a period of rapid development for the autoantibody testing sector.

Guangzhou Kangrun BiotechPossesses the most comprehensive product portfolio for autoantibody testing in China,It encompasses multiple methodologies, including indirect immunofluorescence, immunoblotting, enzyme-linked immunosorbent assay (ELISA), and chemiluminescence.It provides the most highly automated, standardized, and intelligent platform for autoantibody detection, as well as the most comprehensive range of autoantibody quality control products in China, offering standardized solutions to clinical laboratories.Meet the diverse and precise testing needs of clinical practice.

Automation, standardization, and intelligence are the major development trends in China's clinical laboratory sector in recent years.In addition to diagnostic reagents, Guangzhou Kangrun Biotech has also made in-depth investments in automation platforms, facilitating efficient, simple, and standardized clinical testing.

Currently, Guangzhou Kangrun Biotech has obtained registration certificates for multiple sex hormone testing and autoantibody testing products, established a sales network covering China, and secured benchmark hospital clients across the country. Recently, at an event hosted by Zhongchuang Industry Research Institute and KPMG China, and organized by Guangdong Medical Valley,At the “Greater Bay Area Biotech Innovation and Development Summit & 4th Selection of Top 50 Biotech Innovation Enterprises in the Guangdong-Hong Kong-Macao Greater Bay Area,” Guangzhou Kangrun Biotech was successfully selected.

With the declining birth rate, rising prevalence of infertility, and the trend toward later marriage and childbearing, national emphasis on assisted reproductive technology and gynecological endocrinology will continue to intensify, driving rapid expansion of the sex hormone testing market. Meanwhile, as the government has introduced multiple policies targeting autoimmune diseases, the autoantibody testing market is poised for rapid growth.

Furthermore, Fu Xiaoyang believes thatThe sex hormone testing segment is facing significant opportunities for domestic products to replace imports, while the autoantibody testing segment represents one of the few areas in China’s in vitro diagnostics (IVD) industry capable of leading global trends, with the potential to establish a landscape where Chinese manufacturers take the lead and international brands play catch-up.“Since its inception, Guangzhou Kangrun Biotech has benchmarked imported brands in project initiation, R&D, and production. Its product quality rivals that of imported brands, while offering significant cost advantages. Against the backdrop of import substitution, the company is poised to stand out.”

In this context, Guangzhou Kangrun Biotech, which specializes in both sex hormone testing and autoantibody testing, holds promising prospects for future development.

In the future, Guangzhou Kangrun Biotech will uphold its relentless pursuit of product quality excellence while driving technological innovation to address urgent clinical needs. By consistently delivering high-performance products and professional technical services, the company aims to establish itself as a leading brand in the two specialized sectors of sex hormone testing and autoantibody testing.

“Top 50 Biotech Innovation Enterprises in the Guangdong-Hong Kong-Macao Greater Bay Area” selection campaign is hosted by the Zhongchuang Industry Research Institute and organized by Guangdong Medical Valley. The selection aims to cultivate an integrated innovation ecosystem combining industry, academia, and research in the Greater Bay Area, promote the in-depth integration and development of biotechnology—a strategic emerging industry—across Guangdong, Hong Kong, and Macao, clearly document the developmental trajectory of biotech innovation in the region, and drive the growth of the local biotechnology sector.

This selection covers three sectors: medical devices, biopharmaceuticals and technology, and healthcare services. It will comprehensively evaluate participating companies’ technological innovation and future development prospects from three dimensions: innovative technology, market application, and capital. A panel of expert judges from government agencies, third-party research firms, professional investment firms, and medical institutions will compile an authoritative list of innovative enterprises after conducting in-depth on-site visits and due diligence. This initiative aims to identify future unicorns in the Greater Bay Area’s biotechnology sector and showcase the region’s urban cluster achievements in biotech industry development.

“Top 50 Biotech Innovation Enterprises in the Guangdong-Hong Kong-Macao Greater Bay Area” has garnered extensive attention and coverage from government agencies, scholars and experts, media outlets, and biotechnology companies since its inaugural edition in 2018.