Humadx Completes Tens of Millions RMB Pre-A Financing to Accelerate Clinical Deployment of Fully Automated Multiplex Flow Fluorescence Platform

VCBeat has learned that Nanjing Chenguang Medical Technology Co., Ltd., the parent company of Beijing Human Intelligent Manufacturing Technology Co., Ltd. (hereinafter referred to as “Human Intelligent Manufacturing”), recently completedTens of millions of yuan in Pre-A round financing. This round of financing was exclusively invested by the Rui Youkang Fund under Nanjing Jiangbei Science and Technology Investment Fund, a subsidiary of ENNOVATION VENTURESS. The funds will be used forRegistration and filing of Humandi Intelligent Manufacturing’s fully automated multiplex flow fluorescence detection platform and supporting reagents, construction of a new production base, and expansion of the R&D team。

HUMAN Intelligent Manufacturing is a medical technology innovation company integrating R&D, production, and sales. Leveraging years of accumulated expertise in materials science, in vitro diagnostics (IVD) technology, and marketing, and built upon its core multi-flow fluorescence technology, the company is committed to providing clinical customers with fully automated, high-throughput, and highly competitive multi-flow fluorescence detection platforms and supporting reagents, focusing onDiagnosis of Major Immune Diseases, Complex Conditions, and Rare Diseases, while actively expanding into the emerging blue-ocean markets in the in vitro diagnostics sector.

Mr. Li Dongqi, Founder of HUMAN Intelligent Manufacturingstated that Human Intelligent Manufacturing focuses on the research, development, and production of fully automated multiplex flow fluorescence instruments and supporting reagents, while also possessing a relatively complete capability portfolio. Over the past five years, the core team hasFirst, a breakthrough was achieved in the field of materials science, masteringThe Core Technology of Multiplexed Encoded Magnetic Microspheres；Second is the capability to develop and integrate fully automated systems, including multi-parameter flow fluorescence detection modules; third is the continuous R&D of reagent pipelines and the ability to develop new biomarkers with significant clinical value; and finally, marketing and academic promotion capabilities.An IVD company with future competitiveness should possess foundational scientific capabilities, mid-tier R&D and manufacturing capabilities for reagents and instruments, as well as top-tier marketing and academic promotion capabilities. Therefore, the team boasts outstanding comprehensive capabilities, and the company’s short-term goal is to take the lead in the field of multiplex flow fluorescence.

In 1998, after graduating, Li Dongqi joined the drug regulatory system, where he was primarily engaged in establishing quality standards for pharmaceuticals and biological products. Following a period of work within the public sector, he left the drug regulatory system to embark on his first entrepreneurial venture. Together with colleagues and friends, he founded MedOnline, pioneering a profitable business model for professional medical media. This model attracted the attention of a Hong Kong-listed company, which subsequently acquired MedOnline at a premium. In 2003, Li Dongqi entered the in vitro diagnostics (IVD) sector, marking the beginning of his 20-year career in this field.

From regional distributor to head of HUMAN’s Asia-Pacific and China operations, and then to national general distributor—building momentum for entrepreneurship—Li Dongqi, a serial entrepreneur, has accumulated over 20 years of experience in the IVD industry. He possesses strong marketing capabilities and a keen drive to master core technologies. Meanwhile, he offers unique insights into the robust growth of China’s IVD market over the past two decades and its future trajectory.

While waiting to meet with hospital clients, Li Dongqi encountered a patient who had just been diagnosed with systemic lupus erythematosus (SLE). The patient’s despairing expression left a deep impression. SLE is a typical systemic autoimmune disease that was nearly untreatable at the time, resulting in poor survival rates and quality of life for patients. Later, an expert informed him that many such refractory diseases were prevalent in China, and the imported diagnostic kits used for disease diagnosis were prohibitively expensive.

This experience left a deep impression on Li Dongqi, planting the seed for his later entry into the IVD industry, where he focused on breakthroughs in core multiplex flow fluorescence technology and dedicated himself to reducing testing costs.

“We aim to provide medical laboratories with solutions that are fast, effective, high-quality, and cost-efficient—technologically advanced yet simple enough for anyone to operate. In selecting our R&D pipeline, we focus on major immune disorders, complex and refractory diseases, and rare diseases,” said Li Dongqi.

About a decade ago, Li Dongqi first encountered an autoantibody detection product based on multiplex flow fluorescence technology at a leading laboratory abroad. At that time, this technology was not uncommon overseas. German scientists explained to him that this method was particularly well-suited for projects requiring simultaneous multi-analyte testing, with results significantly superior to the then-mainstream ELISA technique and performance comparable to chemiluminescence immunoassay.

Upon returning to China, Li Dongqi began exploring application scenarios and commercial opportunities for multiplex flow fluorescence technology. In 2015, he founded Eurasia Pioneer, which served as the general distributor for European and American in vitro diagnostic (IVD) products in China. In 2017, Eurasia Pioneer initiated the research and development of multiplex flow fluorescence technology using its own funds. In 2021, Human Intelligent Manufacturing was established to accelerate the market launch and commercial promotion of multiplex flow fluorescence products.

HuMan Intelligent Manufacturing'sThe core team consists of veterans in the IVD industry, with an average of over 10 years of professional experience. Its members hail from leading domestic enterprises in the fields of in vitro diagnostics and life sciences, including CapitalBio, Autobio, Leadman, BioSays, and Si Zhengbai.Since 2017, these core team members have joined the company successively, continuously strengthening the company’s capability portfolio.

After five years of accumulation, under the leadership of the Chief Materials Scientist, the company has mastered the core technology of multi-magnetic encoded microspheres in the upstream sector. Under the leadership of the heads of the reagent and hardware platforms, it has completed the layout of three technology platforms based on a pyramid structure in the midstream sector.With the fully automated multiplex flow fluorescence detection platform and its supporting reagents as the apex of the pyramid, the fully automated chemiluminescence detection platform and its supporting reagents as the middle section, and the fully automated immunoblotting detection platform and its supporting reagents as the base.

Multiplex flow fluorescence, as the flagship product, is dedicated to increasing testing throughput and reducing costs in laboratories of tertiary hospitals. Chemiluminescence, serving as a complementary mid-tier offering to multiplex flow fluorescence, provides specialized single-analyte tests with significant clinical value. Immunoblotting, as the foundational entry-level product, primarily serves primary healthcare institutions to enhance their diagnostic capabilities.

As of now, Human Intelligent Manufacturing’s team has grown to over 30 members, with more than 90% engaged in R&D and over 25% holding master’s or doctoral degrees. Following a series of financing rounds that have bolstered its capabilities, the company expects to expand its workforce to more than 100 employees by year-end.

Against the backdrop of China’s rapid economic development, rising household disposable income, and increasing urbanization and aging rates, the HuMan Intelligent Manufacturing team predicts that the volume of specimens awaiting testing in Chinese medical laboratories will continue to grow significantly over the next decade.

In addition to the vast market potential, against the backdrop of deepening healthcare reforms in China and mounting financial pressure on the national medical insurance system, testing costs are expected to maintain a long-term downward trend. Fee schedules for in vitro diagnostic (IVD) reagents will continue to be adjusted downward, ultimately squeezing out profits from intermediary links and directly passing the pressure of price reductions onto manufacturers. “In other words, IVD manufacturers are currently still enjoying a period of favorable conditions; once this window closes, those with the capability to sustainably reduce costs are more likely to emerge as leaders,” said Li Dongqi.

According to Li Dongqi, Human Intelligent Manufacturing has completed the layout of three technology platforms based on a pyramid structure: at the apex, the fully automated multiplex flow fluorescence detection platform and supporting reagents; in the middle tier, the fully automated chemiluminescence detection platform and supporting reagents; and at the base, the fully automated immunoblotting detection platform and supporting reagents. Among these, the fully automated multiplex flow fluorescence detection platform and its supporting reagents, positioned at the apex, represent the company’s flagship project.

Multiplex flow fluorescence technology uses multiplex-encoded microspheres as a solid-phase carrier, on which proteins or nucleic acids are conjugated. These conjugated microspheres then react with the analytes of interest. Subsequently, based on the principle of hydrodynamic focusing, the microspheres pass through the detector one by one for quantitative analysis of the target analytes. As early as 2005, this technology was awarded the “2005 International Clinical Diagnostic Technology Innovation Award” by Frost & Sullivan, a globally authoritative organization in the technology industry. Although this technology has shone brightly in the field of scientific research, its clinical application and adoption have fallen short of initial expectations due to the lack of automated detection platforms.

After five years of dedicated development, HuMan Intelligent Manufacturing has not only achieved a breakthrough in the core technology of multiplex-encoded microspheres but also completed the development of a fully automated multiplex flow cytometry fluorescence detection platform, thereby resolving the major bottleneck hindering the widespread application of this technology in the IVD field.

In the IVD sector, it is not only essential to have an advantageous technology platform, but also crucial to make strategic choices in product pipeline development. The product pipeline should not only leverage the strengths of the technology platform but also address many current pain points in clinical diagnosis and treatment. Based on deep industry expertise, Huaman Intelligent Manufacturing has made distinctive choices in its product pipeline, currently focusing primarily on four major areas: autoimmune diseases, allergic disorders, cytokines, and thrombosis and hemostasis.

The market size for autoimmune and allergic diseases is approximately RMB 2.5 billion, with over 80% of the market dominated by traditional immunoblotting products.

Immunoblotting is a conventional multiplex detection technique. Its disadvantages include the ability to provide only qualitative results, requiring manual operation and visual interpretation by the operator. This technology has been applied in China for over 15 years. With the continuous iteration of diagnostic and therapeutic technologies, medical laboratories are increasingly interested in fully automated, quantitative, and rapid-result testing methods. However, due to cost and throughput constraints, chemiluminescence technology cannot upgrade or replace immunoblotting.

Multiplex flow cytometric fluorescence technology offers an ideal solution to this technological upgrade. According to data from the College of American Pathologists (CAP), nearly 60% of laboratories in the United States have adopted this multiplex flow cytometric fluorescence platform for autoantibody detection, aligning with international development trends.

Furthermore, Human Intelligent Manufacturing possesses robust marketing capabilities, along with specialized expertise and academic promotion strengths in the IVD subsectors. Its marketing network covers the entire country, and it maintains strong collaborative relationships with nearly 100 distributors, ensuring rapid sales rollout upon product launch.

“There are many companies focusing on multiplex detection technologies. I believe that beyond the technology itself, our greatest advantages lie in our sales execution capabilities and our understanding of the market,” said Li Dongqi.

Unlike companies founded by scientists,HUMAN Intelligent Manufacturing started out in IVD trading, which keeps it closer to the market and enables a stronger perception of customer needs.Beyond the technology itself, a strong application scenario is also crucial. On this basis, in addition to requiring its R&D staff to ensure high product quality, Human Intelligent Manufacturing also pays close attention toIdentify one or more suitable niche segments for the technology.

In addition to autoantibodies and allergens, Humandata continues to explore more emerging blue-ocean sectors. “For instance, assays for cytokines, thrombosis and hemostasis, neurological disorders, and reproductive diseases all address unmet clinical needs; however, the current market lacks high-quality products, making these niche areas well-suited for leveraging multiplex flow fluorescence technology platforms,” said Li Dongqi.

It is understood that the cytokine market is a rapidly emerging sector, with an average annual growth rate exceeding 50%. In the post-pandemic era, there is growing recognition of the significance of cytokines, and the field currently lacks dominant market leaders. Notably, Humab Biologics’ cytokine products have already obtained regulatory approval.

Thrombosis and hemostasis have also emerged as a new field in recent years, with detection methods shifting from traditional functional assays to immunological assays. Due to the extreme complexity of the underlying pathways, combined multi-parameter testing is required for accurate diagnosis.

Discussing future plans, Li Dongqi stated, “We have always held ourselves to a single principle: ‘Plan for five years, look ahead three years, and execute solidly for the current year.’ Therefore, we will concentrate our efforts on achieving this year’s objectives, namely securing regulatory approvals for all key projects on schedule. In the long term, we aim to complete another round of financing this year to strengthen our team, support a broader R&D pipeline, and continue refining our products.”

“For IVD companies, products are the top priority; only high-quality products can pave the way for a promising future,” concluded Li Dongqi.

For this round of financing,Dr. Kai Kai Shi, Partner at ENNOVATION VENTURESSstated: “ENNOVATION VENTURESS has been dedicated to venture capital investment in the biopharmaceutical and healthcare sectors, strategically investing in revolutionary new technologies, products, and business models across the global industrial chain of biopharmaceuticals and healthcare.”Since 2019, ENNOVATION VENTURES has closely monitored the multiplex flow fluorescence sector, striving to identify companies with a comprehensive capability portfolio in this field. The founding team of Human Intelligent Manufacturing has deep expertise in the IVD industry. Adhering to the value proposition of integrating clinical needs with technological innovation, they have proactively positioned themselves in the multiplex testing domain and possess complete R&D and production teams for microspheres, reagents, and instruments. Currently, their fully automated multiplex flow fluorescence detection platform and associated assay kits are in the registration application stage. We highly recognize the company’s mature and efficient R&D, production, and management teams, as well as its autonomous and controllable innovation across the industrial and supply chains. More importantly, the core team at Human Intelligent Manufacturing exhibits self-driven personalities and strong intrinsic motivation, which gives us great confidence in the company’s future development trajectory and market prospects.”

ENNOVATION VENTURES was established in 2015. It strategically invests in revolutionary new technologies and products across the global biopharmaceutical and healthcare industry chains, striving to become a specialized investment institution in the fields of biopharma and healthcare. The company’s management team and investors possess extensive investment experience and deep industry resources in the biopharmaceutical and healthcare sectors, while focusing on the commercial value generated by the integration of “life,” “health,” and “innovation.” ENNOVATION VENTURES specializes in life sciences, healthcare, and innovation, and is committed to serving as an investor, partner, and co-founder to enterprises.