5Y News | AI Microbiome Drug Developer "Unknown" Closes Nearly $100 Million Series B Financing
Launching a new AI×BT strategy.
Unknown, a Shenzhen-based biotech company focused on AI-driven gut microbiome drug development, recently announced the completion of a new funding round, bringing its total Series B financing to nearly $100 million. This is understood to be one of the largest funding rounds in China's microbiome industry in recent times. The company attracted additional investment from prominent domestic and international investors including Legend Capital, Gaorong Capital, Sky9 Capital, 5Y Capital, Primavera Venture Partners, and HIKE Capital, reflecting investor confidence in Unknown's position in the microbiome therapeutics space. The proceeds are expected to fund clinical trials, IND applications in both the US and China, and pipeline R&D; they will also support active business development through licensing deals and big pharma partnerships, accelerate international expansion, establish a US innovation center, and advance platform upgrades to unlock the potential of its "independent R&D + platform enablement" drug development system.
5Y Capital's Managing Director Xu Tian Jing stated: "Microbiome therapeutics is a new treatment modality we are very optimistic about. As a leading company in this field, Unknown is at the forefront globally in terms of technology and product innovation. The fact that its product obtained FDA clinical clearance as a novel drug modality represents a significant milestone. We believe that as algorithms and data play an increasingly important role in drug discovery, China's advantages in clinical resources and data algorithm capabilities will inevitably give rise to a new generation of biotech companies capable of consistently producing products with high clinical value."
Unknown co-founder and CEO Yan Tan said, "We are grateful for our investors' recognition and support for both the industry and Unknown. Over the past year, our independently developed drugs have entered registrational clinical trials, and our platform and technology have evolved rapidly. The global microbiome therapeutics industry is advancing by the day, and we hope to seize this opportunity for rapid growth while working to empower the entire industry's development with Unknown's technological achievements."
Founded in 2017, Unknown is currently a leading AI-driven pharmaceutical company in China focused on gut microbiome therapeutics. The company aims to achieve disease remission or treatment through microbiome technology and bioinformatics, utilizing live biotherapeutic products and microbial small-molecule modulators.
During its Series B funding period, in June 2021, Unknown received FDA Investigational New Drug (IND) clearance for a fecal microbiota transplantation (FMT) drug, officially entering clinical trials. According to publicly available FDA data, this was the first FMT drug approved in Asia. The company has also made important progress in domestic regulatory filings, having recently submitted a Pre-IND application to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration.
Unknown's fecal microbiota transplantation (FMT) drug received FDA IND clearance, officially entering clinical trials
Currently, Unknown has five self-developed First-in-class microbiome drug pipelines and has established clinical collaborations with numerous prestigious Chinese hospitals including Peking University Cancer Hospital, Peking Union Medical College Hospital, and Nanfang Hospital of Southern Medical University, with multiple clinical drugs demonstrating significant efficacy.
Meanwhile, Unknown has actively expanded its pipeline through licensing deals and co-development partnerships. In May 2021, the company entered into a co-development agreement with 3SBio for full-spectrum capsule therapy in nephrology. In just four years since its founding, Unknown's pipeline has achieved comprehensive coverage of the major drug modalities in microbiome therapeutics, demonstrating the company's efficient translation capability in advancing microbiome pharmaceuticals from research to industry.
This rapid translation capability stems from Unknown's substantial investment in its drug development platform and its emphasis on scientific research. Unknown has built advanced bioinformatics analysis and translational manufacturing platforms, creating a complete closed-loop for microbiome drug development that connects the full chain from "data" to "drug."
On the bioinformatics front, over the past year, Unknown's multi-omics computing platform has expanded its computational capacity, with clinical analysis capabilities increasing by 300% year-over-year. A new drug discovery platform has been assembled, with rapid iteration of AI algorithms. The company has made important progress across data, computing power, analytics, and drug mechanism discovery, achieving data-driven pathological mining and constructing genomic-metabolic function-strain mapping relationships for microbial communities.
On the drug R&D front, Unknown has recently completed construction of multiple live biotherapeutic product development platforms, establishing a series of in vitro functional screening platforms and animal disease models, with multiple LBP candidate drugs entering preclinical development. The company has independently developed core technologies for live biotherapeutic fermentation and formulation, and established a CMC system aligned with FDA standards.
Additionally, Unknown has in recent years been building an innovation research center centered on Boston, with its US-based team expanding rapidly to cover bioinformatics, clinical development, manufacturing, and industry operations in the near term, fully engaging in the complete international industry chain including research, industry partnerships, investment incubation, and licensing. The team is also actively expanding international collaborations in Boston, New York, Philadelphia, and Silicon Valley, positioning innovative projects and future technology reserves.
In recent years, public understanding of gut microbiota has deepened considerably. On the research front, numerous studies have been published in top-tier journals, bringing the field to center stage in academia. Researchers have discovered comprehensive and extensive interaction mechanisms between microorganisms and their hosts, with profound implications for health. Microbiome-derived therapeutics offer advantages including abundant sourcing, high safety profiles, shorter development timelines, high production yields, significant comprehensive effects, and broad indications. The addressable market for microbiome drugs is estimated to reach hundreds of billions of dollars.
Over the past year, the global microbiome therapeutics industry has seen a string of positive developments, with an oral drug reaching its primary endpoint in Phase 3 trials. Capital markets have also shown tremendous enthusiasm for microbiome companies—French biotech MaaT Pharma's recent IPO in Paris stands as one of the year's landmark industry events.
In China, the microbiome industry is a strategically important direction receiving high-level national attention. As a representative domestic microbiome pharmaceutical company, Unknown's technological capabilities are on par with world-leading levels, with rapid pipeline progress. Leveraging advantages in clinical resources, regulatory frameworks, and talent pool depth, the company is well-positioned to help Chinese innovative drugs achieve leapfrog development on the global stage.
Regarding Unknown's next-phase development strategy, Yan Tan explained that the recent emergence of star companies and drugs in the global microbiome therapeutics industry demonstrates that microbiome drugs have entered a mature translation stage. Unknown will seize this development opportunity to launch its "AI × BT" strategy—continuously optimizing its business architecture, achieving deeper integration of AI and biotechnology (BT) capabilities and talent, advancing in parallel on both proprietary drug development and external enablement, further improving microbiome drug translation efficiency, and building a technology platform with core competitive advantages; while laying out multiple proprietary and licensed-in drug asset pipelines to create an industry-leading microbiome drug asset incubation platform.
5Y Capital (formerly Morningside Venture Capital) currently manages approximately RMB 32 billion in dual-currency USD and RMB funds. 5Y Capital seeks out, supports, and inspires founders who are alone in their vision, providing support from the spiritual to all operational aspects. We believe that if the "crazy" you in others' eyes begins to be believed in, the world will become a different place.
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