Zhiyi Biotechnology is at the forefront of developing live biotherapeutic products (LBPs), focusing on innovative treatments for gastrointestinal conditions. Their lead candidate, SK10, is a heat-killed formulation of Bacteroides fragilis designed to address chemotherapy-induced diarrhea (CID). The Phase I clinical trial for SK10 demonstrated promising safety and tolerability, with all treatment-emergent adverse events being mild. This product is notable for being the first Bacteroides fragilis-based LBP to receive FDA IND approval, marking a significant milestone in the development of next-generation probiotics. The mechanism of action for SK10 involves ameliorating chemotherapy-induced intestinal damage through pathways that reduce inflammation and enhance mucosal barrier function.

In addition to SK10, Zhiyi is advancing SK08, which is currently undergoing Phase III clinical trials for the treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D). The company has established a comprehensive technical and industrial platform that encompasses the entire process from strain discovery to product development. This positions Zhiyi as a leader in the LBP sector in China, with a commitment to addressing urgent medical needs in gastrointestinal health. The recent funding of nearly CNY 100 million will further accelerate the clinical development of their drug pipeline, underscoring the company's dedication to innovation in biopharmaceuticals.

China

Zhiyi is a leading company in live biotherapeutics (LBPs) and next-generation probiotics in China. The company’s SK08（Bacteroides fragilis） was approved for clinical trials in November 2019.It is the first LBP in China with immense influence. Zhiyi has established a complete technical system for the spectra of microorganisms and pathogenic bacteria, the isolation and target identification of new functional strains as well as the development of new live biotherapeutics and active ingredients. Zhiyi also has a complete industrialization platform from preclinical to NDA.

Zhiyi Biotechnology

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