Ustar Biotechnologies Secures Over RMB 300 Million Series E+ Financing Led by CPE GenCap to Advance Molecular POCT Capabilities

Recently,USTAR Officially Announces Completion of Over RMB 300 Million in Series E+ Financing, Led by CPE Yuanfeng and Participated by Existing Shareholder Oriental Fortune CapitalBairong Capital served as the exclusive financial advisor for this round of financing. This is an additional round of funding for USTAR, following its approximately RMB 200 million Series E financing led by Oriental Fortune Capital six months ago. The proceeds from this round will continue to be used to increase production capacity and expand the test menu for the core product, EasyNat high-throughput nucleic acid amplification platform, as well as to support mass production of the nucleic acid-based home self-testing platform and development of the next-generation testing platform.

Since its establishment, USTAR has adhered to the mission of “Molecular Diagnostics, Anywhere, Anytime” and has been dedicated to the research and development of innovative molecular POCT products, making itThe First Molecular POCT Company in China with Dual Approval for Reagents and Instruments. USTAR's integrated solution for nucleic acid extraction, amplification, and detection has been approvedNMPA, CE, ANVISA, TGA, and HSAcertified by authoritative institutions, and its independently developed nucleic acid amplification testing analyzer has also obtainedU.S. FDACertification. Currently, USTAR's molecular POCT productsCovering more than 2,000 institutions in Chinamedical and health institutions, and sold toSixty Countries. In addition, the company has also developedSelf-Driven Microfluidic Home Self-TestingProduct, alsoChina's First Nucleic AcidHome self-testing products, thereby making USTAR one of the few companies globally to coverNucleic Acid Testing for Dual Scenarios: Medical Endpoints and Home Self-TestingOne of the testing companies.

In early 2020, Dr. You Zhimin, Chief Scientist at USTAR, led his team in developing a reliable and effective POCT nucleic acid test kit for COVID-19 using proprietary technology. The kit was included in the National Ministry of Science and Technology’s Major Special Project on Emergency Rapid Nucleic Acid Testing, filling a gap in China’s COVID-19 POCT nucleic acid testing sector. USTAR integrated the classic magnetic bead method to extract nucleicAcid extraction and nucleic acid amplification are integrated into a single, independent, sealed detection tube., in combination with USTAR’s instruments, provides an integrated “sample-in, result-out” solution for rapid nucleic acid testing, making significant contributions to epidemic prevention and control;

To date, the instrument platform has completedMultiple Product Iterations, including2-channel, 4-channel, 8-channel, and 16-channel modelsIt can cover a variety of rapid testing scenarios, ranging from primary healthcare institutions to fever clinics and clinical laboratories in hospitals of all tiers.

USTAR Nucleic Acid Amplification Detection and Analysis System (High-Throughput) Image Source: USTAR

Complemented by a comprehensive reagent menu, USTAR will provide clinical solutions for pathogen detection across multiple application scenarios, including respiratory tract infections, reproductive health, and hospital-acquired infections., providing physicians across multiple clinical departments with rapid, accurate, and convenient nucleic acid testing to improve the efficiency of disease diagnosis and treatment.

Performance Metrics Comparable to International Standards: In the detection of Mycobacterium tuberculosis, the thick cell wall of the bacterium makes nucleic acid extraction challenging, while its high infectivity demands exceptionally stringent containment during instrument-based testing. These issues have long posed significant hurdles in the development of molecular point-of-care testing (POCT). Currently, USTAR products, manufactured in China, have been evaluated by Chinese clinical researchers.Testing accuracy has reached international standards.。

Rooted in China, with a Global Vision: USTAR continues to refine its intelligent manufacturing technologies in China, aiming to provide global healthcare institutions with more convenient, efficient, and cost-effective solutions. In 2021, USTAR’s products garnered significant attention at the MEDICA trade fair in Düsseldorf, Germany. Currently, USTAR’s integrated nucleic acid testing solutions have been deployed in approximately 60 countries worldwide.

USTAR Attends MEDICA in Düsseldorf, Germany | Image Source: USTAR

Home self-testing represents another vast blue-ocean market in the future of in vitro diagnostics. Overseas shortages of at-home COVID-19 testing products have highlighted their consumer-goods attributes, including mass-market appeal, strong channel accessibility, high public willingness to purchase, and frequent demand.

USTAR"Self-Driven Microfluidic Nucleic Acid Self-Testing Platform": A Domestic First and Globally Leading Proprietary Development, enabling standardized sampling and automated result interpretation, allowing users to obtain accurate test results without professional training. This product is highly suitable for self-testing by the general public at home. Based on this platform, USTAR is poised to develop a variety of nucleic acid testing products, such as assays capable of detecting and differentiating among four pathogens: influenza A, influenza B, SARS-CoV-2, and SARS-CoV-2 variants.

USTAR Home Nucleic Acid Self-Testing Platform Image Source: USTAR

Regarding the success of this financing round, Lin Yizhi, Chairman of USTAR, stated, USTAR's goal is toTechnologyDriving the development of the global molecular POCT industry, we leverage technological innovation to popularize testing scenarios and reduce costs, fulfilling our mission of “Molecular Diagnostics, Accessible Everywhere.” Through 16 years of independent iterative innovation, USTAR has achieved significant breakthroughs in its product and reagent menu, equipment throughput, and application scenarios ranging from home use to clinical settings. We are delighted to observe that over the past two years, USTAR’s products have not only substantially improved the efficiency of clinical healthcare professionals in top-tier Grade A tertiary hospitals, but also enabled more primary healthcare institutions to gradually build nucleic acid testing capabilities. This progress better aligns with national policies on joint prevention and control as well as tiered diagnosis and treatment. Our greater aspiration is to leverage Chinese technological innovation to expand the application of global molecular POCT across various scenarios, including pathogen diagnosis and tumor companion diagnostics, while continuously addressing the unequal distribution of global health resources to make molecular POCT products affordable for people in more countries. We extend our sincere gratitude to CPE Yuanfeng and all existing shareholders of USTAR for their recognition and support! We will continue to deepen our R&D efforts and contribute superior solutions to the molecular diagnostics industry through unwavering dedication.

CPE Source Peak Investment Team statedMolecular diagnostic technologies offer higher sensitivity and stronger specificity, enabling faster and more timely detection of pathogen infections through direct nucleic acid testing. Therefore, molecular diagnostics represent a significant iteration over traditional testing methods in terms of timeliness and precision. The integration of molecular diagnostics with Point-of-Care Testing (POCT) has greatly reduced dependence on laboratory environments, facilitating the widespread adoption of molecular diagnostics across hospitals of all tiers in China. This development holds substantial significance for primary healthcare infrastructure both nationally and globally. CPE Yuanfeng has consistently focused on new breakthroughs in medical technology and on outstanding enterprises that drive progress within China’s healthcare industry. We are highly optimistic about USTAR’s continuous improvement of its technological layout in diagnostic equipment and reagents. We look forward to the company launching more products and solutions with clinical value in the future, thereby contributing to the advancement of the healthcare industry.

Wang Peijun, Partner at Oriental Fortune Capital, stated thatFuhai Medical has been deeply engaged in the field of in vitro diagnostics (IVD) for many years, covering the entire industry chain from innovative R&D teams to end-users such as medical laboratories. We have had the privilege of supporting USTAR through multiple rounds of financing. As a leading domestic molecular POCT company, USTAR’s team not only possesses unique insights into technological direction, product strategy, and channel strategy, but also demonstrates strong execution capabilities. Based on a profound understanding of clinical needs, the company has built several unique technology platforms and rapidly developed a diverse portfolio of products. We believe that Chinese molecular diagnostics companies will inevitably establish their own brands in the international market, and USTAR is poised to become such a leader.

CPE Yuanfeng is an asset management firm with a global perspective and extensive experience in China. It aims to leverage a long-term vision and value investment strategies to provide innovative investment solutions for leading enterprises in five key sectors: healthcare and wellness, consumer and internet, technology and industry, software and enterprise services, and real estate. Currently, CPE Yuanfeng’s funds under management have earned the trust and support of over 200 institutional investors both domestically and internationally, with cumulative assets under management exceeding RMB 100 billion. Over the past decade, the company’s core team has invested in more than 200 companies, accumulating profound industry insights and an extensive resource network. Through a robust investment research framework and professional post-investment management capabilities, CPE Yuanfeng is committed to building long-term partnerships with its portfolio companies. It strives to support their sustainable development, deliver substantial returns to investors, drive overall industry progress, and create positive social impact.

Shenzhen Oriental Fortune Capital Investment Management 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 experience, proven track records, outstanding investment performance, and significant influence in China’s venture capital sector. Since its establishment, the company has managed funds totaling nearly RMB 25 billion, with 45 funds currently under management. It has invested in over 450 projects to date, among which 114 have achieved exit through initial public offerings (IPOs), mergers and acquisitions (M&A), and other means.