First Microbiome Therapy Approved: Rebyota's FDA Milestone Ignites the Microbial Therapeutics Sector
Microecological pharmaceuticals are medicinal preparations made from normal microorganisms or substances that regulate the normal growth of microorganisms, including microecological modulators and microecological drugs.
Last Friday (November 30), the FDA approved Rebiotix’s fecal microbiota therapy, Rebyota (RBX2660), for marketing. This marks the first fecal microbiota therapy approved by the FDA and represents a significant milestone in the field of microbiome drug development.
- Why is the approval of this drug considered a milestone in the microbiome therapeutics sector? How should one understand and define the scope and subfields of this sector?
- What key signals does FDA approval provide? What are the similarities and differences in regulatory logic between China and other countries? Is regulation based on medical technology or pharmaceuticals?
-What are the barriers to the technological translation of FMT (Fecal Microbiota Transplantation)? What strategic layouts are required to achieve success?
- Which segments of the industry can ramp up activities after this milestone? Where will the next milestone be?
December 6 (this Tuesday) 20:00-21:30,VCBeat New Medicine and XBiome jointly hosted an online panel, inviting Professor Chen Ye, Vice President of Shenzhen Hospital of Southern Medical University; Dr. Le Beilin, Executive Director at Gaorong Capital; and Mr. Hao Yi, Co-founder and COO of XBiome. Using the first FDA-approved microbiome therapy as a starting point, they discussed the aforementioned issues.
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Guest Introduction
Chen Ye
Vice President, Shenzhen Hospital of Southern Medical University
- Professor at Southern Medical University, Chief Physician, Doctoral Supervisor, and Distinguished Professor under the “Pearl River Scholar” Program
- Vice President of Shenzhen Hospital, Southern Medical University; Academic Leader in Gastroenterology; Director of the Center for Integrated Microecological Diagnosis and Treatment
- Member of the Chinese Society of Gastroenterology, Vice Leader of the Helicobacter pylori Study Group, and Vice Leader of the Gastrointestinal Microecology Study Group
- Member of the Gastroenterology Branch of the Chinese Medical Doctor Association
- Vice Chair of the Female Gastroenterologists Committee, Chinese Women Physicians Association
- Standing Committee Member, Microecology Branch, Chinese Preventive Medicine Association
- Chairman, Branch of Gastroenterologists, Guangdong Medical Doctor Association
- Member of the Clinical Research Committee of the World Gastroenterology Organisation (WGO)
- Primary Research Focus: Clinical and Translational Studies on Diseases Associated with Helicobacter pylori Infection and Gastrointestinal Microecological Imbalance
Lebeilin
Gaorong Capital Executive Director
B.S. in Biology from Fudan University; Ph.D. from the Yong Loo Lin School of Medicine, National University of Singapore. Currently serves as an Executive Director at Gaorong Capital, overseeing investments in healthcare and biotechnology companies including Qitan Technology, Conatus, ProfoundBio, Bio-Thera Solutions, ZhiXiang Biopharmaceuticals, MiRXES, Beikang Maternal & Infant Care, Huashi Pharmaceutical, UnknownBiome, Westlake Omics, Xiruan Technology, and Yinjia Biology.
Hao Yi
Co-founder & COO of Xbiome, Head of Microecological Medical Division
With 15 years of cross-sector experience spanning finance and industry, deep expertise in the microecology sector, and extensive experience in industrialization, has established a collaborative framework for clinical research and translational applications with dozens of Grade A tertiary hospitals, pioneering an industrialization model that empowers the broader health sector through AI-driven microecological technologies.
Organizer Introduction
Shenzhen X-Biotics Co., Ltd., established in 2017, is an industry-leading AI-driven microbiome research and industrialization platform. By independently developing core algorithms and building its proprietary platform, X-Biotics aims to alleviate or treat diseases through live biotherapeutic products (LBPs) and microbiome-derived molecular modulators, leveraging microbiome technology and artificial intelligence. The company is committed to advancing microbial pharmaceuticals from scientific exploration to commercial implementation.
Currently, Xbiome has over 10 drug pipelines, with four having entered clinical stages. In 2021, its fecal microbiota transplantation (FMT) drug developed by Xbiome received approval for clinical trials from the U.S. FDA. According to publicly disclosed information, this is the first FMT drug in Asia to obtain clinical trial approval from the U.S. FDA.
X-Bio’s core team comprises scientists from prestigious universities and research institutions, including Harvard University and the Massachusetts Institute of Technology (MIT). The drug development team brings R&D experience from internationally renowned pharmaceutical companies; the clinical team possesses extensive expertise in clinical trials, regulatory submissions, and drug review processes; and the Scientific Advisory Board consists of academicians from China and the United States, former FDA drug review experts, and industry specialists.
Since its inception, Xbiome has been named one of the “50 Smartest Companies” by MIT Technology Review, selected as one of the “Top 50 Most Innovative Companies in China” by Fast Company, and recognized as one of the Top 20 Leading Biotechnology Enterprises in Shenzhen and one of the Top 50 Innovative Biotechnology Enterprises in the Greater Bay Area. In 2020, Xbiome was certified as a “National High-Tech Enterprise”; in 2021, it was recognized as a “Specialized, Refined, Differential, and Innovative” (SRDI) SME in Shenzhen.
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