Yuanjing Tech Files IPO Prospectus: Pioneering Microfluidic Electrochemical Technology for Cost-Effective Diagnostics in Primary Care

“To this day, I believe it should not be a stage for purely showcasing technology. Only by selecting the appropriate pathway and developing products with higher cost-effectiveness can their significant value be realized within China’s current medical insurance system.”Beijing OriginGene-tech Biotechnology Co., Ltd.(hereinafter referred to as: OriginGene-tech) founder Zhu Kun mentioned in an interview with VCBeat.

OriginGene-techIt represents the culmination of Zhu Kun’s 20 years of expertise in the fields of genetic engineering pharmaceuticals and in vitro diagnostics.How to Carve Out a Unique Path Among Molecular Diagnostics and Domestic Substitution Companies? Zhu Kun’s Latest ChoiceStarting from the R&D of Core Components for Molecular Diagnostics, in the form of building blocksDevelopment of a Product Series, thereby establishing a robust pipeline portfolio to meet customers’ multi-tiered needs in the field of molecular diagnostics.

In the field of molecular POCT, years of development—particularly driven by the demands of COVID-19 testing—have spurred the continuous emergence of new companies and products both in China and abroad. For the current domestic market, “innovation” and “cost-effectiveness” are both indispensable for successful commercialization, and they also contribute significantly to the development of the national healthcare security system.

OriginGene-tech'sMicrofluidic PCR Strip Platform, was developed in response to this need. It creatively combines classic PCR technology with traditional colloidal gold detection, whileAchieved Dual Cost Reductions in Both Equipment and Consumables。

In terms of equipment, OriginGene-tech has eliminated the reliance on relatively expensive optical components that are heavily dependent on imports by integrating a visual interpretation platform, while all other components have been independently developed.Equipment Costs Significantly Reduced. Meanwhile, by integrating its proprietary second-generation dual-temperature zone technology, the classic PCR amplification time for 40 cycles is reduced to approximately 20 minutes.Results Available Immediately。

Secondly, OriginGene-tech also changed the format of consumables, replacing traditional PCR tube-based consumables withPlate-based Consumables Equipped with Microfluidic Amplification Chips, multi-target detection is achieved through a multi-channel design. The plate-based consumables have a relatively increased specific surface area, which enhances heat transfer efficiency and thereby shortens the PCR amplification time. Furthermore, after lyophilization, the plate-based consumablesEasier to store at room temperature for extended periods, thereby improving the foundational conditions for adaptation to primary healthcare settings.

Meanwhile, Beijing OriginGene-tech Biotechnology Co., Ltd. also designed aDisposable Sealed Adhesive Strip Cartridge, enabling highly accurate PCR testing to be completed in just 30–45 minutes. The closed-cartridge design prevents aerosol contamination, allowing testing to be performed without the need for a professional laboratory, thereby overcoming the technical challenges associated with the seamless integration of microfluidic chips and cartridges.Sample In, Result Out, achieving "foolproof" operation for nucleic acid testing, while the planar design also reduces consumable costs.

Currently, Beijing OriginGene-tech Biotechnology Co., Ltd. has developed nine product pipelines across three major categories—respiratory pathogens, diarrheal pathogens, and large economic animals—on its microfluidic PCR strip platform. With some of its equipment and reagent products already having obtained CE and FDA certifications, the company is poised to secure numerous domestic regulatory approvals in China starting from 2023.

What better demonstrates the technological innovation of Beijing OriginGene-tech Biotechnology Co., Ltd. than its microfluidic PCR strip platform is its developedChina's First Microfluidic Electrochemical Nucleic Acid Detection Platform。

Electrochemical technology has been developed in the IVD field for many years, with its earliest application being blood glucose testing; however, this represents only a relatively basic application of electrochemistry.To enable applications in nucleic acid and immunoassay testing, it is necessary to develop an electrochemical signal acquisition board with a sensitivity of at least the nanoampere (nA) level., and it can no longer rely solely on the potentiostat’s acquisition mode; instead, it must support multiple electrochemical acquisition methods, including SWV and DPV. Currently, Beijing OriginGene-tech Biotechnology Co., Ltd.’s electrochemical signal acquisition board has alreadyUpdated to the Fourth Generation——10nA-level microcurrent acquisition.

By integrating this microfluidic electrochemical technology platform and focusing on nucleic acid detection, Beijing OriginGene-tech Biotechnology Co., Ltd. completed the development of its first-generation research instrument in June 2021, with expectations toComplete the integrated development of commercial units by December this year.. Next, OriginGene-tech will alsoPerformance, Throughput, and Integrated TestingUpgrades in Three Areas.

In terms of performance, the electrochemical signal acquisition board will continue to be upgraded to achieve picoampere (pA) sensitivity, while electrode labeling amplification technology will be progressively enhanced to the microampere (μA) level, enabling amplification-free nucleic acid detection. Furthermore, throughput will be significantly increased; the current 4-channel detection system will be scaled up to 8, 16, and ultimately as many as 512 channels with random-access capability, thereby achieving truly compact, high-throughput testing. Ultimately, Beijing OriginGene-tech Biotechnology Co., Ltd. expects to complete, by the end of 2023, the integration of simultaneousIntegrated Biochemical, Immunological, and Nucleic Acid Testing, to create aMiniaturized Laboratory。

In terms of products, OriginGene-techIn the three testing fields of biochemistry, immunology, and nucleic acids, focusing respectively on chronic disease management, cytokine detection, and the development of products related to pathogenic microorganisms, while supporting open collaboration for the microfluidic electrochemical technology platform.

Over the years, the company has also developed disposable electrodes using various manufacturing processes, including carbon-silver electrodes, gold-film electrodes, electroless gold-plated electrodes, and low-temperature gold-printed electrodes, offering a cost-effective solution for in vitro diagnostics.For Zhu Kun, the search for novel electrochemical markers is more of a personal passion.He has set his sights on developing China’s key strategic resource—rare earth elements. As a member of the Xiamen Institute of Rare Earth Materials, Chinese Academy of Sciences, Zhu Kun aims to investigate the electrochemical properties of rare earth complexes.Establish China’s Own Electrochemical Detection Platform!

Most existing molecular POCT products adopt the fluorescent PCR technical route, which entails relatively high overall costs. Furthermore, industry awareness remains limited at this stage, and the curve interpretation method is not readily accepted by individuals without laboratory experience. Consequently, current molecular POCT testing has primarily targeted scenarios with high willingness to pay as a breakthrough point, such as hospital emergency departments, intensive care units (ICUs), specialized outpatient clinics, and disaster medical rescue sites.However, it is difficult to implement in general primary care hospitals.。

For the specific scenario of primary healthcare, there is a greater need for products that are low-cost, easy to operate, and yield easily interpretable results. The aforementioned two products from Beijing OriginGene-tech Biotechnology Co., Ltd. are designed to address this pain point.Taking into account the competitive landscape, OriginGene-tech has implemented commercial deployment for overseas markets and grassroots community levels.

Molecular diagnostics are currently widely applied in secondary and tertiary hospitals as well as third-party testing centers in China. Driven by the COVID-19 pandemic, the market has become highly competitive and intensely saturated, whileCompetition is relatively limited in grassroots subdistrict markets and overseas markets., targeting markets where competitors are relatively weak is an inevitable choice. Yuanjing Taike’s current strategic layout involves co-building laboratories in county-level and township areas as well as in developing countries, while focusing on individual clinics and family physician services in developed countries.

Secondly,All early-stage products developed by OriginGene-tech are designed with primary care attributes.From the two major technology platforms of microfluidic PCR strips and microfluidic electrochemistry, to diagnostic products for the initial diagnosis of common infectious diseases and chronic disease management, all are targeted at specific market demands and will inevitably extend to more services in the post-pandemic era.

OriginGene-tech, as a provider of comprehensive solutions for molecular diagnostics,FutureIn addition to continuing to deepen its presence in overseas markets and the primary healthcare sector, it will also expand into non-clinical markets, including disease control, customs, animal testing, and public spaces, as well as address the specific application needs of large and medium-sized hospitals for faster testing speeds and more flexible throughput.Consumer-facing (C-end) applications targeting the general public will constitute a longer-term target market.。

“Based on their product attributes and characteristics, molecular POCT will expand into at least three major application directions in the future, gradually forming a landscape of vigorous competition among numerous players.”Zhu KunMentioned in the interview,For Critically Ill Patients in Large and Medium-Sized HospitalsImplementation of more than 10 multi-target precision diagnostics,For Outpatient and Emergency Care and Primary HealthcareInitial diagnosis using 3–5 targets,For the Home Use Marketsingle-use initial screening will be the three major development directions for future molecular POCT products.

Beijing OriginGene-tech Biotechnology Co., Ltd. Chooses to Target the Second Application Direction and Cultivate It Deeply, already last yearCompleted Pre-A Round Financing, preparations for the Series A financing round are also underway. Having completed the development and refinement of core components, Beijing OriginGene-tech Biotechnology Co., Ltd. has entered the stage of serialized product development and established a commercialization strategy tailored to specific application scenarios based on its product pipeline architecture.

First, enter the domestic grassroots market, overseas markets, and the domestic non-clinical market with cost-effective microfluidic PCR strip products; then gradually replace them with more cost-effective electrochemical nucleic acid detection products, while expanding into biochemical and immunological product lines, ultimately achieving integrated biochemical, immunological, and nucleic acid testing on a single platform.Beijing OriginGene-tech Biotechnology Co., Ltd. aims to become a full-scenario diagnostic service provider.。

China’s tiered diagnosis and treatment system is gradually entering a “deep-water zone,” and, in alignment with the overall layout of the “Rural Revitalization” strategy, state investment in primary healthcare has been increasing year by year.Beijing OriginGene-tech Biotechnology Co., Ltd. is determined to seize the opportunity and carve out its own path in business model innovation, leveraging the unique characteristics of its products!