Unknown Closes Nearly $100 Million in Series B Funding, Launches 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. The company says this is one of the largest funding rounds in China's microbiome industry in recent memory. Gaorong Ventures led Unknown's Series A round in 2018 and has continued to invest in subsequent rounds.

The funds will be used to advance clinical trials, file Investigational New Drug (IND) applications in both the US and China, and develop candidate drug pipelines. The company also plans to actively pursue licensing deals and partnerships with major pharmaceutical firms, accelerate its international expansion, build out a US innovation center, and upgrade its technology platform to unlock the full potential of its "independent R&D + platform enablement" drug development system.

Leading Pipeline Progress in Asia, Covering All Major Drug Modalities

Founded in 2017, Unknown is currently one of China's leading AI pharmaceutical companies focused on gut microbiome therapeutics. The company aims to use microbial technology and bioinformatics, leveraging live biotherapeutic products and microbial small-molecule modulators, to alleviate or treat diseases. During its Series B fundraising period, in June 2021, one of Unknown's fecal microbiota transplantation (FMT) drugs received an IND clearance from the US FDA, officially entering clinical trials. According to publicly available FDA data, this was the first FMT drug approved in Asia. The project has also made significant progress domestically, with a Pre-IND application recently submitted to China's Center for Drug Evaluation (CDE).

Unknown currently 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. Multiple clinical-stage drugs have demonstrated significant efficacy. The company has also actively expanded its pipeline through licensing and co-development partnerships. In May 2021, Unknown signed an agreement with 3SBio to co-develop a full-bacteria capsule therapy for kidney disease. Just four years after its founding, Unknown's pipeline has achieved comprehensive coverage of all major microbiome therapeutic modalities, reflecting the company's ability to efficiently translate microbiome drug research into commercial reality.

Continuous Platform Upgrades, Building Out International Multi-Center Capabilities

This rapid translation capability stems from Unknown's substantial investment in its drug development platform and its strong emphasis on scientific research. The company has built advanced bioinformatics analysis and translational manufacturing platforms, creating a complete closed loop from "data to drug" for microbiome drug development.

On the bioinformatics front, over the past year, Unknown's multi-omics computing platform has expanded its processing capacity, its clinical analytics platform has tripled its analytical capabilities, and a new drug discovery platform has been assembled. AI algorithms have iterated rapidly, with important advances in data processing, computing power, analytics, and drug mechanism discovery — enabling data-driven pathological mining and the construction of genome-metabolic function-strain mapping relationships.

In drug R&D, Unknown has recently completed the construction of multiple live biotherapeutic product platforms, established a series of in vitro functional screening platforms and animal disease models, and advanced multiple LBP candidates into preclinical development. The company has independently developed core technologies for live biotherapeutic fermentation and formulation, and built a CMC system that has reached consensus with the US FDA.

Additionally, Unknown has been building out an innovation research center focused in Boston, with its US team expanding rapidly to cover bioinformatics, clinical operations, manufacturing, and business development in the near term. This will enable full participation in the entire international industry chain, including scientific research, industry partnerships, investment incubation, and licensing. The team is also actively expanding international collaborations in Boston, New York, Philadelphia, and Silicon Valley to source innovative projects and build future technology reserves.

"AI × BT" New Strategy: Independent R&D and External Enablement in Parallel

In recent years, public understanding of gut microbiota has deepened considerably. On the research front, multiple studies have been published in top-tier journals, bringing the field to center stage in academia. Researchers have discovered that microorganisms have comprehensive, extensive interaction mechanisms with their hosts that are intimately tied to health. Microbiome-derived therapeutics offer numerous advantages: abundant sources, high safety profiles, shorter R&D cycles, high production yields, significant combined effects, and broad applicability. The addressable market for microbiome drugs is estimated to reach hundreds of billions of dollars.

In China, the microbiome industry is a strategic priority at the national level. As a representative domestic microbiome pharmaceutical company, Unknown's technology is on par with world-leading standards, with rapidly advancing pipelines. Leveraging advantages in clinical resources, regulatory frameworks, and talent depth, the company is well-positioned to help Chinese innovative drugs achieve global breakthroughs.

Tan Yan, co-founder and CEO of Unknown, said: "We are grateful to our investors for their recognition and support of both the industry and Unknown. Over the past year, our self-developed drugs have entered registrational clinical trials, and our platform and technology have evolved rapidly. The global microbiome pharmaceutical industry is evolving by the day, and we hope to seize this opportunity to grow quickly while enabling the advancement of the entire industry with Unknown's technological achievements."

Regarding Unknown's next-phase development strategy, Tan Yan explained that the recent emergence of star companies and drugs in the global microbiome pharmaceutical industry signals that microbiome therapeutics have entered a mature translation phase. Unknown will seize this opportunity to launch its "AI × BT" strategy — continuously optimizing its business architecture, achieving deeper integration of AI and biotechnology (BT) capabilities and talent, and advancing in parallel on both independent drug development and external platform enablement. This will further improve microbiome drug translation efficiency and build a technology platform with core competitive advantages; expand multiple self-developed and licensed-in drug asset pipelines; and establish an industry-leading microbiome drug asset incubation platform.

A Gaorong Ventures representative commented: "As the 'second genome,' the human microbiome is critical to maintaining health and controlling disease onset and progression. Research in this field is flourishing globally, and the microbiome pharmaceutical industry has entered the translation and commercialization phase. As China's first AI-based microbiome pharmaceutical company, Unknown has been a true pioneer. Since our early investment, we have continuously witnessed the team build a complete closed loop for drug development, driven by three engines: leading AI+BT technology, rich clinical resources, and high-density talent — with hard power already demonstrated through significant efficacy in clinical trials. We believe Unknown will secure a significant position in the global microbiome pharmaceutical industry."

When Will We Achieve "Gene Sequencing Freedom"? | Gaorong "Future" Cornerstone Robotics, Innovative Surgical Robotics Leader, Completes 500 Million Yuan Series B Financing Mirxes Completes $87 Million Series C Financing, Developing Cancer Early Screening Products Based on Leading miRNA Technology