Haimiao Bio Announces IPO Filing: Pioneering Global Expansion in Infectious Disease and Cancer Diagnostics with FDA-Recommended COVID-19 Test
“No matter how glamorous it may be abroad, it still belongs to others. We need to build our own ‘garden,’ so I decided to return to China to start a business.”
Tan Miao, Founder of HymonBioDuring his doctoral studies at the Chinese Academy of Sciences, he conducted academic exchanges at the Max Planck Institute in Germany.For over a decade, Tan Miao has been engaged in research on gene expression regulation and the pathogenesis of cancer, as well as in the development of diagnostic reagents for emerging and re-emerging infectious diseases.At the conclusion of her visiting scholar exchange, clinical molecular technology in China was still in its nascent stages. Consequently, she decided to return home as soon as possible to introduce foreign technologies, leverage her expertise, and build from the ground up to advance clinical diagnostic techniques in China.In August 2015, HymonBio was born.
Currently,HymonBio has completed the layout of multiple specialized pipelines in the fields of oncology and infectious diseases., with comprehensive capabilities in R&D, production, and marketing. To date,Filed 26 patent applications, obtained 6 granted patents, and secured nearly 20 product certifications from the U.S. FDA, China’s medical device regulatory authorities, and the EU CE marking., its independently developed “One-Step SARS-CoV-2 Nucleic Acid Detection Kit” is the only SARS-CoV-2 testing product in China officially recommended by the U.S. FDA.
Most medical decisions are based on diagnoses, and in vitro diagnostics (IVD) constitute a critical component of disease prevention and treatment. The proportion of IVD in overall healthcare expenditure continues to rise, with the market size experiencing steady growth. Although China’s IVD industry started relatively late, market demand has continued to grow, driven by factors such as rising national income levels, the advancement of the tiered diagnosis and treatment system, population aging, and national policy preferences for domestically produced brands. China now boasts strong enthusiasm and a favorable environment for entrepreneurship in this sector.
HymonBio’s R&D team possesses extensive experience and patented technologies in nucleic acid sample processing, extraction, and PCR detection. Since cancer screening and infectious disease testing, both of which are primarily based on molecular diagnostics, rely on these technologies,Cancer and Infectious Diseases Become HymonBio’s Key Strategic Focus Areas。
HymonBio's Product Portfolio (Image source: HymonBio)
Although many IVD companies have successively launched their own diagnostic products, there is still considerable room for improvement in the workflow from sample nucleic acid extraction to molecular detection. Current limitations include prolonged nucleic acid extraction and processing times, low extraction efficiency, and extended testing turnaround times.
HymonBio has developed a “one-step” SARS-CoV-2 nucleic acid detection kit based on its OT buffer system technology, achieving the world’s fastest high-throughput laboratory testing with a turnaround time of only 30 minutes and a detection sensitivity of 200 copies/mL. It is the only domestic COVID-19 testing product officially recommended by the U.S. FDA, enabling early screening and differentiation of complex multi-locus genetic markers, such as those associated with co-infections in COVID-19.In addition, the combined test kits for influenza A virus, influenza B virus, and SARS-CoV-2 all have a detection time of within 30 minutes. They are currently undergoing FDA registration review and are expected to be launched on the market soon.
Introduction to HymonBio's Infectious Disease Testing Products
The core technology in the field of early cancer screening involves detecting shed cancer cell components and pathogens from blood samples, utilizing extraction and amplification techniques to enhance detection efficiency. The innovative one-step technique (simultaneous extraction and methylation analysis) developed through this research is applicable to colorectal cancer, lung cancer, and pan-cancer screening. It offers advantages such as being non-invasive, rapid, low-cost, and highly scalable for broad cancer coverage.
Currently, the extraction efficiency of cell-free nucleic acids remains a technical challenge, with the industry’s overall extraction efficiency standing at only around 30%. By leveraging its proprietary trace cell-free nucleic acid extraction technology, HymonBio Co., Ltd. has increased extraction efficiency to 90%. Furthermore, by applying nanobody molecular lock amplification technology, the company addresses interference from wild-type genes during mutant gene amplification. This technique “locks” wild-type genes through antibody binding to prevent their amplification, achieving a 90% removal efficiency for wild-type genes and 100% specific recognition in the amplification of effective mutant genes. The colorectal cancer early screening genetic testing kit has already obtained CE certification and is being exported to overseas markets.
From the perspective of clinical needs and patient acceptance, the convenience of sampling and testing, as well as the turnaround time for results, directly influence end-user acceptance.HymonBio’s products feature simple sample extraction, short processing times, and rapid detection, while significantly enhancing detection sensitivity and specificity and reducing sample volume requirements.For example, colorectal cancer can be detected using just 5 mL of peripheral blood.Significantly improved patient compliance.
From basic research to industrial applications, HymonBio has always adhered to technological innovation. With technology as the foundation for corporate development, a belief in science, and an unrelenting spirit of inquiry, only through dedicated passion can fruitful results be achieved.
Led by Tan Miao, the 12-member R&D team, guided by eight PhDs, has achieved numerous zero-to-one breakthroughs at HymonBio over the past seven years. Comprising professionals from industry, academia, and healthcare institutions, the team consists of multidisciplinary experts with extensive experience covering the entire lifecycle of in vitro diagnostic (IVD) reagents, including development, clinical trials, and commercial-scale manufacturing.
Through the joint efforts of its R&D team, HymonBio has obtained domestic drug regulatory approvals for a cumulative total of 11 products, CE certification from the European Union for 7 products, and FDA approval from the United States for 1 product.
In China, HymonBio andInstitute of Interdisciplinary Studies in Biology and Chemistry, Chinese Academy of Sciences、Laboratory of Genetic Engineering, Sun Yat-sen University、Centre for Laboratory Sciences of the Department of Health, The Hong Kong Polytechnic Universityestablish technical collaborations with research institutions. With a global outlook, the company hasU.S. FDA Division of Microbiology and Medical Devices、Royal University General Hospital NHS Foundation Trust、Philippine National Reference Laboratory、Kenya National Reference LaboratoryQuality evaluation of collaborative COVID-19 test kits and detection of mutant strains, its productsApproved for clinical use and market authorization in over 10 countries, including the United States, Europe, and Southeast Asia.。
In 2021, HymonBio Co., Ltd. signed an equity investment agreement with PerkinElmer, a leading U.S. company in the IVD industry, injecting strong momentum into HymonBio’s rapid development and market expansion.
Driven by the outbreak of the COVID-19 pandemic, testing demand has experienced explosive growth. The market for PCR-based cancer companion diagnostics has also seen significant acceleration. With the number of new cancer cases increasing year by year, market demand is steadily rising for both companion diagnostics for oncology drugs and early cancer screening. Molecular diagnostics is the fastest-growing segment within the in vitro diagnostics (IVD) industry. Fueled by the advancement of clinical precision medicine, molecular diagnostics is expected to maintain its rapid growth trajectory.
Currently,HymonBio has its headquarters located on the Bund in Shanghai and has established an industrial base in Suzhou.. The facility covers an area of over 2,000 square meters and comprises a sub-R&D center and a production center. Among these, 800 square meters are dedicated to GMP-compliant production areas (including one Class 10,000 cleanroom, one Class 100,000 cleanroom, and a process water production system), with a daily production capacity of over 400,000 COVID-19 nucleic acid testing kits and over 300,000 colorectal cancer early screening kits.
In the future, HymonBio will leverage the advantages of its proprietary technologies to strive for a larger market share.
For the Domestic Market, the oncology product portfolio will be expanded to include single-analyte kits and multi-cancer combined panels for early screening and companion diagnostics across various cancer types, such as gastric cancer, lung cancer, bladder cancer, and urothelial carcinoma. The infectious disease series will primarily focus on developing single-analyte kits for high-volume market segments, including hepatitis B, hepatitis C, and tuberculosis (TB). Meanwhile, kit development will be aligned with the project needs of third-party clinical laboratories, covering areas such as oncology companion diagnostics and prognostic assessment, cardiovascular diseases, and pharmacogenomics.
For the overseas marketHymonBio will focus on rapid and multiplex diagnostic products for infectious diseases. Its colorectal cancer early screening test has obtained CE certification, and the company will proceed with commercial deployment in European, Asian, and Middle Eastern markets. Meanwhile, supporting instruments, animal reagents, and rapid test strip reagents will be promptly adapted and customized to meet market demands.
With the unveiling and inauguration of its new office building and R&D center, HymonBio has embarked on a new journey. The next five years will be a critical period for expanding its strategic footprint and accelerating commercialization. We look forward to HymonBio successfully achieving its IPO goals!