FireGen Biomedicals Secures Tens of Millions in Series A+ Funding to Advance Nucleic Acid Rapid Diagnostic Kits and Devices into Regulatory Approval Pathway

VCBeat has learned that FanZhi Medicine completed its tens-of-millions-yuan A+ round of financing in January 2020, with participation from Jiangsu New Lingchuang Capital and Tianjin Science and Technology Innovation Capital."This round of financing will be used to further accelerate the registration process for the company's multiple rapid diagnostic test kits and devices."

FireGen Biomedicals is a globally operating biopharmaceutical company founded by a team of overseas-returnee scientists with 30 years of experience in the world’s leading pharmaceutical companies.Establish an advanced R&D platform for next-generation rapid nucleic acid diagnostic reagents and instruments targeting major diseases,Innovative development of gene sequencing kits, rapid gene analyzers, and detection chips,Accelerating the integration of rapid genetic diagnosis into primary healthcare systems,Build an internationally advanced brand for next-generation rapid nucleic acid testing equipment and reagents.

It is understood that FanZhi Medicine has established a large-scale R&D center and production base in Kunshan, China, and has set up branches or representative offices in the United States, Australia, Beijing, Tianjin, Nanjing, Suzhou, Wuhan, and other locations. In addition, the company has established close cooperative relationships with more than 30 overseas distributors.To date, the company has provided products and services to thousands of hospitals, pharmaceutical companies, research institutes, and genetic testing firms worldwide, establishing a strong brand advantage. Its notable clients include the Chinese Academy of Sciences, Peking Union Medical College Hospital, the PLA General Hospital, and Fosun Pharma.

Previously, Fanzhi Medicine had already received fromCCB Medical Growth Fund、Hairong Capital...and investments from professional medical funds. Song Keqing, Founder and Chairman of Fanzhi Medicine, stated, “The company currently holds over 100 authorized intellectual property rights. Its innovative technological capabilities have reached an internationally advanced level. It operates high-specification GMP-compliant manufacturing facilities that meet the regulatory, registration, and production system standards of China’s NMPA (formerly CFDA), the EU CE, and the US FDA. Furthermore, our products possess distinct technological advantages; while achieving domestic import substitution in China, they have also experienced rapid growth in overseas markets. These strengths have established Fanzhi Medicine as a precision medicine brand under close scrutiny by the government, investment institutions, and industry stakeholders.”

Heavy reliance on imports, cumbersome testing procedures, and high sequencing costs have become significant factors constraining the robust development of China’s genetic testing industry and its expansion to grassroots levels. To address the pain points in China’s genetic testing sector and enable advanced technologies to move out of laboratories and into primary healthcare systems, the team of overseas-returnee scientists at FanZhi Medicine has achieved major breakthroughs in three areas.

I. Achieve in-house R&D and manufacturing of test kits.For key processes such as sample collection, gene extraction, and library preparation—including large-sample cfDNA extraction kits, RNA extraction kits, and one-step library preparation kits used in liquid biopsy—Fanzhi Medicine has achieved independent research, development, and manufacturing. Its technological capabilities have reached an internationally advanced level, enabling the replacement of imported products.

II. Develop the integrated, fully enclosed FireChip detection chip to realize a "lab-on-a-chip."FireChip offers low cost and simple operation, requiring no specialized personnel. It accepts sample input volumes of up to 200 μL, utilizes pre-packaged reagents to prevent cross-contamination, and does not require cold-chain logistics, allowing for room-temperature transport and storage.

FireChip: Integrated Fully Enclosed Detection Chip

3. Launch of the integrated rapid testing instrument, FirePOC.This compact and user-friendly instrument significantly reduces amplification and detection time through innovative fully automated sample lysis, one-step nucleic acid extraction and purification, and fluidic moving-heating technologies, ensuring rapid, high-precision, and high-sensitivity amplification and detection following nucleic acid purification.

Integrated Rapid Testing Instrument FirePOC

By achieving in-house development and manufacturing of test kits, along with the independent R&D of FireChip and FirePOC, testing can be completed at primary healthcare institutions without the need to send samples to large laboratories. This significantly shortens the turnaround time for genetic testing, reduces costs, and benefits a vast number of underserved regions. Currently, FireChip and FirePOC are awaiting approval from the National Medical Products Administration (NMPA).

Recently, a sudden outbreak of the COVID-19 epidemic has swept across China. Due to relatively weak transportation, medical and health services, and other infrastructure in economically underdeveloped areas, epidemic prevention and control efforts are more arduous.

In response to this outbreak, FanZhi Medicine has successfully developed, leveraging its own precision medicine and antiviral-related nucleic acid R&D support platform,2019-nCoV Detection Lyophilized Powder Kit. This product is available in a lyophilized powder form, eliminating the need for cold-chain storage and transportation conditions.Assist relevant authorities in rapidly extending epidemic prevention and control measures to remote and impoverished areas, thereby providing enhanced support to economically underdeveloped regions severely affected by the outbreak., eliminating "blind spots" and "gaps" in epidemic prevention and control.

In the future, this kit will be further integrated with the FirePOC device to enable rapid point-of-care testing, providing swift and robust support for combating viral infections. Currently, the product is undergoing relevant regulatory registrations, including CE marking in the European Union.

In addition, Fan Zhi Medicine has also developedRapid Diagnostic Chip and POCT Device for Novel CoronavirusCompared with traditional laboratory-based RT-PCR methods, the rapid diagnostic chips and POCT devices developed by Fanzhi Medicine significantly reduce the requirements for laboratories and operators. They can be rapidly deployed to small and medium-sized cities to enable quick diagnosis of individuals suspected of having novel coronavirus infection, and even facilitate mass screening in severely affected areas, thereby reducing the backlog of suspected cases and effectively controlling the epidemic.

Hairong Capital is an equity investment management firm focused on the healthcare sector. Established in 2012 and headquartered in Beijing, it is a special member of the Securities Association of China. The firm’s founding partners graduated from prestigious institutions such as the Graduate School of the People’s Bank of China, Peking University, Renmin University of China, and Peking Union Medical College. They possess extensive experience in the investment industry, along with profound insights and keen acumen in the healthcare field.

Hairong Capital has cultivated deep expertise in the healthcare and medical sector, with its investment and cooperative projects encompassing well-known industry brands such as Yiming Pharmaceutical (002826.SZ), Yabao Pharmaceutical (600351.SH), Yuekang Pharmaceutical, Hezong Pharmaceutical, Weikang Bio, Kangbeide Pharmaceutical (837905.OC), and Danda Bio.This strategic investment in Fanzhi Medical represents a key strategic move in the POCT sector.

Jiangsu Xinlingchuang Capital is an investment platform for cutting-edge technology entrepreneurs in the fields of intelligent manufacturing, big health, and new energy across Jiangsu, Zhejiang, and Shanghai. It boasts abundant resources in government, capital, and markets within the Yangtze River Delta region.It can further support the growth and expansion of FanZhi Medicine’s R&D base in Kunshan.

Tianjin Sci-Tech Innovation Capital is an investment platform under the Tianjin Municipal Science and Technology Commission. Established in 2006, it is dedicated to investing in technological projects with significant technical strength and potential influence on emerging high-tech industries, providing enterprises with resources such as financing, government project support, and entrepreneurial mentorship.

The CCB Medical Growth Fund is a venture capital fund under CCB International, operating on a market-oriented basis and focusing on investments in growth-stage healthcare companies. The fund is led by CCB International and jointly established with high-quality institutions such as Kun Gaoxin Group.

Leveraging CCB International’s extensive project sourcing capabilities, synergies with investment banking services, and the expertise of its professional healthcare investment team, the Fund combines these strengths with high-quality healthcare industry resources from its investors to precisely select technology commercialization projects in the healthcare sector and accelerate the cultivation of innovative tech enterprises. Drawing on its rich investment and management experience as well as deep industry connections, the Fund provides comprehensive post-investment value-added services to its portfolio companies. The Fund is committed to growing together with both enterprises and investors.

CCB Medical Fund is a series of equity investment funds established by CCB International to lay out the medical and health industry in China. The funds under management include CCB Medical Fund Phase I, CCB Medical Growth Fund, and Jianxing Medical Fund.