Molecular POCT Platform Company Ustar Biotechnologies Completes Hundreds of Millions RMB in New Financing Round

VCBeat (WeChat ID: vcbeat) has learned that USTAR Biotechnologies (Hangzhou) Co., Ltd. (“USTAR”), a leading enterprise in the molecular POCT industry, recently announced the completion of a new round of financing amounting to hundreds of millions of yuan. The round was led by Shenzhen Oriental Fortune Capital Co., Ltd., with participation from Chende Capital, Jiangu Capital, and Juxie Capital. The proceeds will be primarily used for the R&D and registration of new products, as well as the expansion of existing production lines. Bairong Capital served as the exclusive financial advisor for this round of financing.

USTAR Headquarters

USTAR, founded in 2005, specializes in the field of molecular POCT diagnostics. Leveraging its proprietary Cross-Priming Amplification (CPA) isothermal amplification technology and reagent vitrification technology, USTAR has developed fully automated integrated systems for nucleic acid extraction and amplification, along with a comprehensive range of配套 reagents. This technology platform represents one of the few domestic solutions that truly achieve a “sample-in, result-out” workflow, offering an integrated, closed, and fully automated process from extraction to amplification. The system is user-friendly, contamination-free, and delivers detection sensitivity at the highest level in China. Furthermore, the products can be stored and transported at ambient temperature, significantly reducing logistics costs and making them particularly well-suited to the practical needs of developing countries in regions such as Africa and South America.

In 2020, the world faced challenges from the COVID-19 pandemic. In response, USTAR acted swiftly and proactively, obtaining China’s first registration certificate for molecular point-of-care testing (POCT) for COVID-19 in March 2020. The company subsequently secured overseas registrations and rapidly ramped up production. Its products underwent rigorous testing and extensive application both domestically and internationally, earning consistent acclaim. Throughout 2020, USTAR shipped over 2,000 instruments, covering more than two-thirds of China’s Top 100 hospitals and exporting to over 40 countries worldwide. Meanwhile, the company achieved comprehensive coverage across various application scenarios, including customs, inspection and quarantine, and public security and prison systems.

USTAR is widely used around the world

Lin Yizhi, Chairman and CEO of USTAR, stated that the company aims to become a global leader in the molecular POCT industry. Through 16 years of independent iterative innovation, USTAR will launch products in 2021 across areas such as reagents, equipment throughput, and multiplex single-tube testing. Committed to meeting clinical needs for greater accuracy, simplicity, speed, and safety, USTAR is developing high-quality, cost-effective molecular POCT products, truly making “molecular diagnostics accessible everywhere.”

Facing market competition in the post-pandemic era, USTAR has established a clear strategic roadmap. In terms of its assay menu, USTAR is strategically focusing on three key areas: respiratory diseases, reproductive health, and hospital-acquired infections, providing molecular POCT platform solutions. Currently, its multiplex testing products for disease and drug resistance have been finalized, with four assay projects undergoing clinical evaluation. It is expected that four to five products will obtain Class III medical device registration certificates within the year. In January 2021, USTAR officially launched a higher-throughput all-in-one molecular POCT system. Departments can choose from 4-, 8-, or 16-channel configurations based on their needs. The total reaction time has been reduced to under 50 minutes, with a limit of detection (LOD) reaching 200 copies, delivering accuracy comparable to standard PCR.

USTAR Molecular POCT All-in-One System

Essential Tools for Molecular Testing at the Primary Care Level: Molecular diagnosis refers to the analysis of gene structure and function at the DNA or RNA level using molecular biology methods to diagnose diseases, serving as the gold standard for detecting various viruses, including SARS-CoV-2. The National Center for Clinical Laboratories (NCCL) under the National Health Commission defines molecular point-of-care testing (POCT) as follows: “Nucleic acid extraction and amplification detection are both completed on the same closed, portable instrument; no manual operations are required from sample loading to result reporting, and the entire process takes no longer than 90 minutes.” Compared with traditional standard PCR, molecular POCT offers advantages such as simple operation, lower requirements for testing environments and personnel, and lower per-test costs. It is particularly suitable as the primary platform for rapid diagnosis in outpatient departments and emergency surgeries, as well as for nucleic acid testing in hospitals below the tertiary level. In February 2021, the National Health Commission proposed the policy of “sample collection at township level and testing at county level,” requiring township health centers to provide testing services. Meanwhile, it encouraged qualified primary healthcare institutions to establish nucleic acid testing laboratories or equip mobile nucleic acid testing vehicles to conduct巡回 testing in rural areas, providing convenient services for residents returning to their hometowns. Molecular POCT solutions, represented by USTAR, have become essential testing tools at the primary care level.

The potential annual market for instruments reaches tens of billions of RMB, while the reagent market exceeds 10 billion RMB: In the winter of 2020, the resurgence of the COVID-19 pandemic highlighted transmission at the grassroots level. The State Council, the National Health Commission, and provincial epidemic prevention task forces issued multiple regulations mandating that grassroots medical institutions must possess nucleic acid testing capabilities. Based on this, it is estimated that medical institutions at all levels across China should be equipped with at least 300,000 molecular POCT devices. With current market penetration below 2%, the potential market size could reach tens of billions of RMB annually. From the perspective of the reagent market, the number of patients visiting fever clinics and reproductive health clinics each exceeds 100 million per year. There is an urgent demand for rapid nucleic acid testing among these populations, making the potential reagent market size for just these two departments exceed 10 billion RMB annually.

Companies with extensive product portfolios will hold a competitive advantage: The COVID-19 pandemic has effectively educated the entire population on molecular diagnostics. In the post-pandemic era, while nucleic acid testing for SARS-CoV-2 remains standard in fever clinics, the penetration of molecular diagnostics for other common respiratory diseases—such as influenza A and B, Mycoplasma pneumoniae, and respiratory syncytial virus (RSV)—will increase significantly. Consequently, molecular point-of-care testing (POCT) instruments will evolve from “dedicated single-use devices” to “multi-functional platforms.” Companies that secure early adoption in leading hospitals and offer comprehensive test menus will gain the upper hand in future competition.

Wang Peijun, Partner at Oriental Fortune CapitalFuhai Medical has been deeply engaged in the field of in vitro diagnostics for many years, covering the entire industry chain from innovative R&D teams to end-users such as medical laboratories. We are honored to serve as the lead investor in this funding round. USTAR is a leading domestic enterprise in molecular point-of-care testing (POCT). The team not only possesses unique insights into technical direction, product strategy, and channel strategy but also demonstrates strong execution capabilities. Based on a profound understanding of clinical needs, USTAR has built multiple unique technology platforms and rapidly developed a diverse portfolio of products. We believe that Chinese molecular diagnostics companies will certainly establish their own brands in the international market in the future, and USTAR is poised to become such a pioneer.

Wu Zhiguang, Managing Director of Chende CapitalStatement: We are delighted to have the opportunity to participate in USTAR’s investment. Molecular point-of-care testing (POCT) liberates molecular diagnostics from the constraints of PCR laboratory environments and the need for specialized personnel, significantly expanding the application scope of molecular diagnostics and representing a key future direction for the field. We hold strong confidence in USTAR Biotechnology’s technology platform and the innovative, enterprising spirit of its team. We believe USTAR will make the vision of “Molecular Diagnostics, Accessible Everywhere” a reality!

Gui Zhaoyu, Founding Partner of Jiangu CapitalUSTAR’s product design philosophy best aligns with the core demands of molecular POCT, namely fully automated, rapid testing outside of laboratory settings—a capability that has gained widespread recognition from many leading Tier-3 Grade-A hospitals. As the penetration rate of molecular diagnostics in clinical testing rises rapidly, USTAR is poised for broader market prospects in primary healthcare. The company boasts a top-tier R&D, regulatory affairs, and management team, along with a rich and well-positioned product pipeline. We look forward to continuing our support for USTAR as it strives to become a leading enterprise in the molecular POCT field.

Shenzhen Oriental Fortune Capital Co., Ltd. (hereinafter referred to as “OFC” or “Oriental Fortune Capital”) is a professional venture capital management firm founded by several industry experts with extensive tenure in China’s venture capital sector, rich practical experience, outstanding investment performance, and significant influence within the industry. Since its establishment, the company has managed a cumulative fund size of nearly RMB 25 billion, with 45 funds currently under management. To date, it has invested in over 450 projects, with 114 projects successfully exited through initial public offerings, mergers and acquisitions, and other means.

The SME Development Fund (Shenzhen Nanshan Limited Partnership) was established in 2016 as a national-level fund directly capitalized by the National SME Development Fund Co., Ltd. With a fund size of RMB 4.5 billion, it is managed by Shenzhen Fuhai SME Development Fund Equity Investment Management Co., Ltd., which is controlled and operated by Oriental Fortune Capital. The fund primarily invests in high-growth strategic emerging industries encouraged by the state, including semiconductors, artificial intelligence, biopharmaceuticals, information security, and enterprise services.

Oriental Fortune Capital’s Medical Fund II focuses on investing in companies in the healthcare sector that possess innovative products, advanced processes, forward-looking technologies, and distinctive business models. It has established a professional post-investment service system tailored to projects at the early incubation stage, the accelerated growth stage, and the standardized maturity stage.

Chende Capital is an investment firm specializing in the life sciences and medical technology sectors, managing multiple USD and RMB funds with a total asset under management exceeding RMB 5 billion. The firm is managed and operated by a professional team with extensive experience in the healthcare industry. To date, Chende Capital has completed investments in nearly 60 projects and achieved successful exits from multiple portfolios.

Jiangu Capital, established in 2017, is a leading private equity investment firm in China, with its inaugural RMB fund totaling RMB 3 billion. Founded by Mr. Gui Zhaoyu, former Managing Director at The Carlyle Group, Jiangu Capital’s team primarily comprises professionals from top-tier domestic and international private equity firms and investment banks. The firm focuses on sectors such as intelligent technology, healthcare, and innovative consumption. Adhering to the “Investment + Management” business model, Jiangu Capital specializes in investing during companies’ high-growth phases and pre-IPO stages, deeply uncovering enterprise value and continuously empowering business development.

Bairong Capital is a research-driven financial advisory firm focused on the healthcare sector. It aims to facilitate the rapid growth of healthcare enterprises through its extensive transaction experience and to provide investment institutions with insights into valuable investment opportunities through rigorous, in-depth research. Bairong Capital’s areas of focus cover multiple healthcare sub-sectors, including healthcare services, medical devices and consumables, IVD and precision medicine, biopharmaceuticals, and healthcare informatics. The core team of Bairong Capital consists of professionals from top-tier consulting firms and renowned investment banks.