Xuniverse Biotech and Qihui Bio Announce Strategic Collaboration to Advance Standardization and Innovation in Gut Microbiome Therapeutics

Recently, Xbiome Co. Ltd. ("Xbiome") and Qihui Biotech (Yangzhou) Co. Ltd. ("Qihui Biotech") jointly announced a strategic partnership. Both parties will integrate their respective technical and platform advantages to carry out in-depth cooperation in the fields of gut microbiota extraction, purification, clinical application, and AI drug development. They will also work hard to promote the standardization of quality control and regulatory compliance of gut microbiota extraction technology and micro-ecological clinical preparation technology in China, facilitating the orderly, healthy, and positive development of the gut microbiome industry.

The micro-ecosystem constituted by the human symbiotic microbiota is a symbiotic functional organ that co-evolves with the host genome. It is one of the material bases for maintaining physiological homeostasis and determining disease heterogeneity. "Microbiome Medicine," which targets the regulation of micro-ecosystem functions, is currently at a critical period before industrialization explodes.

Due to the inherent differences in the composition of micro-ecosystems among individuals, traditional pharmaceutical quality control and regulatory methods struggle to implement effective quality control and regulation for differentiated preparations like "intestinal microbiota." This is a key issue that must be addressed to safely, effectively, and compliantly carry out clinical micro-ecological treatments, and also a significant challenge faced during the industrialization of related technologies; from another perspective, it represents a tremendous opportunity for innovation in the micro-ecological preparation industry.

Research on the intestinal microbiome is currently receiving significant global attention, with rapid advancements in studies exploring the relationship between gut microbiota and human immune, metabolic, and nervous systems. Xbiome and Qihui Biotech are both technology-driven innovators in the field, possessing substantial research reserves and outputs in gut microbiota isolation and microbiome-based product development. Both parties agree that a clear and rigorous quality control and standardization process is essential for the healthy and sustainable growth of the intestinal microbiome industry.

In this collaboration, Xbiome and Qihui Biotech will leverage their respective strengths in the field of gut microbiota to carry out strategic cooperation in the following key areas. First, the two parties will collaborate in areas such as microbiota sample testing, flora extraction, formulation technology, product preparation, and functional validation, utilizing their technological and platform advantages to drive innovation in microbiota product processes. Second, based on their business cooperation, the two parties will jointly promote the establishment of quality control and standardization processes for gut microbiota. Third, they will engage in research and development cooperation on breakthrough technologies in the field of gut microbiota products.

Xbiome Co. Ltd. Co-founder and CEO, Yan TanSaid: "We are very pleased to cooperate with Qihui Biotech. In recent years, the relationship between gut microbiota and human health and disease has sparked extensive research and discussion in academia. As one of the frontier fields, the industrialization process of gut microbiota is also gradually accelerating. Xbiome, as an AI pharmaceutical company specializing in microbiome drug development, has rich experience in drug R&D and clinical transformation and is at the leading level in the industry in terms of drug preparation technology. Qihui Biotech is committed to developing intestinal flora extraction technology and enhancing the standardization quality control and regulatory compliance of microbiome clinical preparations. Through this cooperation, we hope to integrate the technical advantages of both parties, improve the efficiency and quality of innovative live bacterial drug development, jointly explore technological innovations in microbiome products, and promote the healthy development of the industry."

Gou Zhenhui, Founder and CEO of Qihui BiotechExpressed: "I am very much looking forward to the cooperation with Xbiome. Qihui Biotech is a professional team specializing in intestinal microecology extraction technology and preparation technology, with its core intestinal microbiota extraction technology being world-leading. Xbiome is one of the top microbial AI pharmaceutical companies in China, possessing an outstanding talent pool and remarkable achievements in the correlation between gut microbiota and clinical applications. Qihui and Xbiome share a common vision, and our expertise complements each other. We hope that our collaboration will lead to breakthroughs and significant advancements in the clinical field of intestinal microecology."

Xbiome is a leading AI pharmaceutical company in China that focuses on gut microbiome therapeutics, possessing an advanced and comprehensive microbial drug research and development platform. The company aims to alleviate or treat diseases by utilizing live biotherapeutics and microbial small molecule modulators through microbiological technology and bioinformatics. Xbiome has established a world-leading bioinformatics analysis platform and a translation and production platform, bridging the entire chain of transformation from "data" to "drug," achieving a complete closed loop in microbiome drug development.

In June 2021, the U.S. FDA officially approved Xbiome's Investigational New Drug (IND) application for its fecal microbiota transplantation (FMT) drug. According to publicly disclosed official data from the U.S. FDA, this is the first FMT live biotherapeutic product in China and even Asia to receive U.S. clinical trial authorization. In the field of AI-driven microbiome drug development, Xbiome has continued to attract significant attention from the capital market, with cumulative financing reaching hundreds of millions of yuan, placing it at a leading level in China’s microbiome pharmaceuticals industry.

Qihui Biotech (Yangzhou) Co., Ltd., established in 2019, is a rapidly developing high-tech enterprise. Qihui Biotech focuses on precision extraction technology for intestinal microbiota and has independently developed the world's first fully automated and standardized intestinal microbiota extraction device, which uses ultra-micro layer flow separation technology to achieve standardized extraction of full microbiota separation and enrichment from feces, along with a real-time monitoring distributed AI system, possessing complete independent intellectual property rights. Qihui’s intestinal microbiota extraction technology is the only one capable of achieving qualitative and quantitative quality control for full microbiota extraction. The company also has a self-developed remote interactive backend and quality management system.

Qihui Biotech has an experienced and highly creative R&D innovation team. In 2019, it received a 25 million yuan high-tech industry support fund from the Jiangdu District of Yangzhou City, as well as recognition from Jiangsu Province's "Double Innovation Talent Plan" and the Yangzhou "Green Willow Golden Phoenix Entrepreneurial Talent Award." The company has currently partnered with several leading hospitals to jointly establish a quality control center for personalized intestinal microbiome preparations. Qihui focuses on independent innovation and is committed to building an integrated industrial platform for intestinal microbiome using world-leading technology.