LeYi Bio Secures Tens of Millions in RMB in Series Angel+ Funding to Advance Breath-Based Molecular Diagnostics

VCBeat learned at the earliest opportunity that in August 2023,Hangzhou Leyi Biotechnology Co., Ltd. (hereinafter referred to as "Leyi Biotech")Completed Angel+ round of financing. From 2022 to 2023, Leyi Biotech has completed three rounds of financing: Seed, Angel, and Angel+, with a total amount raised reaching tens of millions of RMB. Investors include Thunderstorm VC, Hangzhou Yuhang Venture Capital Co., Ltd., and others. The funds from this round will be used to continuously strengthen independent innovation and R&D efforts, advance clinical studies of core products, and comprehensively enhance market competitiveness and brand influence.

Leyi Biotech, a national high-tech enterprise integrating R&D, production, marketing, and services, wholly owns three subsidiaries: Leya Biotech, Lewei Health, and Kunyi Medical. The company is headquartered in Hangzhou Future Sci-Tech City, one of the four national future sci-tech cities designated by the Organization Department of the CPC Central Committee and the State-owned Assets Supervision and Administration Commission (SASAC). It operates one R&D center, one data center, and two production bases across China, with a total production area of 3,700 square meters.

The company’s founding team hails from prestigious Chinese universities and has been deeply engaged in the field of gut microbiota for over a decade. It focuses on research and innovation in cutting-edge biotechnologies for breath-based molecular diagnostics, committed to rapid diagnosis and early screening of digestive and other multi-system diseases.

As a “new target” for the prevention and treatment of functional gastrointestinal disorders and multisystem diseases, the gut microbiota has become a research hotspot in recent years. In 2021, “Research and Translation of Human Microbiome Microecology” was included as a key direction for technological innovation in the National Clinical Specialty Capacity Building Plan during the 14th Five-Year Plan period. In 2022, the 14th Five-Year Development Plan of the National Natural Science Foundation of China explicitly identified the gut microbiota and microecology as part of its disciplinary development strategy and priority areas for development.

Functional gastrointestinal disorders account for approximately 50%–70% of outpatient visits in gastroenterology departments in China. However, diagnosis and treatment still rely heavily on physicians’ clinical experience, lacking effective diagnostic tools. Through continuous R&D accumulation and technological innovation, Bioleya, an independently developed product under Leyi Biotech,^®(Leya) The methane and hydrogen breath test device, launched in 2021, has obtained the National Medical Device Registration Certificate. It is China’s first methane and hydrogen breath test device adopting “fixed-unit + gas chromatography” technology, complying with both the international “gold standard” and Chinese national standards.

Bioleya^®(Leya) The methane and hydrogen breath testing device is based on gas analysis technology derived from microbiota metabolomics. By isolating and measuring the concentrations of methane and hydrogen in human exhaled breath, it enables non-invasive, convenient, and precise diagnosis of various digestive system disorders, including dysbiosis, lactose intolerance, gastrointestinal motility issues, and pancreatic dysfunction. It serves to guide clinical efficacy assessment, differential diagnosis, and prognosis monitoring, thereby filling the “physiological blind spots” and “technological gaps” in the diagnosis of functional gastrointestinal disorders in China. The project has received unanimous recognition from professional organizations such as the Ministry of Science and Technology of the State Council and the China Association for Science and Technology for its innovation, clinical value, and social impact, and was awarded the First Prize in the “5th (2022) China Medical Device Innovation and Entrepreneurship Competition.”

In recent years, breath molecular diagnostics has emerged as one of the fastest-growing segments within the global in vitro diagnostics (IVD) industry. According to forecasts by authoritative third-party institutions, the global market for clinical-grade breath analyzers detecting gases such as methane and hydrogen is projected to grow at a compound annual growth rate (CAGR) of 3.7%, increasing from USD 32.5401 billion in 2022 to USD 40.4426 billion in 2028. At the onset of the pandemic, Cedars-Sinai Medical Center in Los Angeles—ranked as the second-best hospital in the United States and the top hospital in California—authorized a third-party company to offer at-home self-testing kits for methane and hydrogen breath analysis. Samples collected by patients were sent to CLIA-certified laboratories for testing, with an average cost per test reaching USD 319. This initiative pioneered a new “consumer healthcare” model in breath molecular diagnostics, enabling the authorized company to secure USD 19 million in Series A financing.

In the early stages of the breath molecular diagnostics market, the domestic market was essentially monopolized by imported brands. With the successive introduction of national policies such as the “14th Five-Year Plan for the Development of the Medical Equipment Industry” and the “Action Plan for High-Quality Development of the Medical Equipment Industry (2023–2025),” which encourage the procurement of domestically produced medical equipment and accelerate the substitution of imported medical devices, Bioleya®, as a leading enterprise in China’s breath molecular diagnostics sector, has achieved a breakthrough in import-related technical barriers after years of technological R&D, clinical application, and sample analysis. The Bioleya® methane and hydrogen breath testing device has realized an upgrade and iteration comparable to imported quality in terms of intelligence, accuracy, and stability, thereby providing a reliable basis for clinical diagnosis.

Since 2022, Leyi Biotech has garnered recognition from over a hundred leading clinical experts across China—including those at the Chinese PLA General Hospital, Peking Union Medical College Hospital, Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine, Zhongshan Hospital affiliated with Fudan University, the First Affiliated Hospital of Sun Yat-sen University, and West China Hospital of Sichuan University—by virtue of its robust R&D capabilities, innovative strength, and the significant clinical value of its products. The company has also conducted technical training and facilitated clinical applications in major hospitals nationwide.

Since the development of the 2009 Rome Consensus, methane and hydrogen breath testing has been extensively implemented across Asia, North America, Europe, and the Asia-Pacific region. The standard gastroenterological diagnostic protocol at NYU Langone Health includes endoscopy, colonoscopy, and hydrogen breath testing. This trend indicates that methane and hydrogen breath testing will be increasingly adopted by clinical centers for routine examinations and early disease screening.

Led by the Chinese Medical Association and the Institute of Digestive Diseases, with co-organization by Leyi Biology, China has launched the first expert consensus in this field along with a nationwide multicenter study. This initiative will fully integrate clinical experience with methane and hydrogen breath testing in China to establish high-quality diagnostic and therapeutic pathways and application standards tailored to the characteristics of the Chinese population, thereby providing valuable evidence-based medical data to empower primary care diagnosis, treatment, and health management.

Ms. Lu Kailun, Founder and Chairman of Leyi Bio“The company stated: ‘We extend our sincere gratitude to Thunderstorm VC and Hangzhou Yuhang Venture Capital Co., Ltd. for their recognition and support! Amidst the robust growth of exhaled breath molecular diagnostics, we will continue to uphold our mission and philosophy of “Empowering Physicians, Serving the Public.” Driven by frontier exploration and grounded in clinical needs, we are committed to advancing the large-scale clinical application of methane and hydrogen breath tests through continuous R&D and iterative innovation, thereby effectively addressing the diagnostic and therapeutic challenges of functional gastrointestinal disorders in patients.’”

Mr. Cai Wei, Chairman of Thunderstorm VCThunderstorm VC stated: “As a venture capital firm focused on early-stage healthcare investments, Thunderstorm VC is dedicated to identifying innovative medical enterprises with platform potential. We have witnessed Leyi Biology’s significant breakthroughs and rapid progress in technology R&D and clinical applications, which have established its core competitive advantages in this niche sector. Moving forward, we will continue to collaborate closely with Leyi Biology to comprehensively support the development of the breath-based molecular diagnostics industry and contribute to the innovation of domestically produced medical devices.”

For this round of financing,Yuhang Financial Holdingsstated that biomedicine has always been one of the company’s key investment areas. Breath-based molecular diagnostics, an emerging and non-invasive segment of the in vitro diagnostics industry, is currently in a “new blue ocean” phase characterized by market cultivation and expansion. This financing round marks another significant strategic move for the company within the broader health industry.

Thunderstorm VC is an angel investment firm dedicated to helping scientists launch startups, with a focus on the life sciences sector. Deeply rooted in the healthcare industry, the company leverages its professional expertise, extensive resources, networks, and channels to provide portfolio companies with specialized support in subsequent financing rounds, strategic planning, partnership development, resource matchmaking, recruitment of high-level talent, establishment of advanced corporate governance systems, and mergers and acquisitions.

Yuhang Financial Holdings is the first quasi-financial platform in Yuhang District to complete mixed-ownership reform. Leveraging its state-owned background, the company centers on equity investment, while synergistically developing debt investment and financial services. This three-pronged strategy has established a specialized, comprehensive service system characterized by no geographic restrictions on business development, no cyclical limitations on investment stages, and no industry or sector constraints on client coverage.