ZhiYi Bio Completes RMB 110 Million Series B Financing to Accelerate Clinical Development and Pipeline Expansion of Live Biotherapeutic Products

VCBeat (WeChat ID: vcbeat) has learned that Guangzhou Zhiyi Biological Technology Co., Ltd. (hereinafter referred to as “ZYBio”) announced the completion of its RMB 110 million Series B financing round,Jointly invested by SDIC Venture Capital, Puhua Guoxin, KIP Capital, and Zhuhai Lehong, with existing shareholder Yichangda continuing to participate in the investment.. The funds raised in this round will be primarily used for the clinical development of the company's innovative drugs and the expansion of its new pipeline.

Previously, the company completed its RMB 50 million Series A financing in August 2018, with investments from Shenzhen Capital Group, Tsinghua Holdings Jinxin, and Shangdong Meiyu Investment.

Founded in 2013, ZYBio is a leading enterprise in China in the fields of live biotherapeutics (LBPs) and next-generation probiotics. The company possesses internationally competitive platforms for researching the relationship between human pathogenic commensal bacteria spectra and diseases, screening new functional strains and identifying targets, and developing live bacterial drugs. It has established a complete industrialization system, with business operations covering live bacterial drugs, conventional foods, and health supplements.

In November 2019, ZYBio's SK08 live bacterial powder (Bacteroides fragilis) was approved for clinical trials, markingChina's First LBP to Enter Clinical Trials, featuring novel bacterial strains and original innovation, with significant industry impact. The company has established a comprehensive technical system in microbial and pathogenic spectra, isolation of new functional strains and target identification, development of new live biotherapeutic products, and active ingredient-based drugs, while also possessing a complete industrialization platform spanning from preclinical stages to New Drug Application (NDA).

Since completing its Series A financing in 2018, ZYBio has achieved rapid development and actively advanced SK08 through Phase I clinical trials.Phase II clinical trials are currently being initiated.。Dr. Wang Ye, CEO of ZYBiotold VCBeat: “ZYBio has multiple new drug candidates in its pipeline advancing rapidly, with the second candidate expected to achieve Investigational New Drug (IND) approval next year; this is an innovative drug urgently needed for clinical use.”

Significant international progress in LBPs and live biotherapeutic drugs this year has validated the company’s accurate strategic positioning within this sector. Against the backdrop of imminent breakthroughs in microbiomics and LBPs, ZYBio remains committed to addressing genuine unmet clinical needs by focusing on highly accessible indications and pharmaceutical formulations, thereby providing new therapeutic options to benefit patients.

Regarding securing this round of financing,Dr. Wang Ye, CEO of ZYBiostated, “We are committed to fostering deeper collaboration with the scientific research and industrial sectors to further accelerate the clinical translation of LBPs. This financing round has garnered significant industry attention, with our Series B investors comprising central state-owned enterprise investment platforms, industrial capital, and overseas investment institutions. We extend our gratitude to our investors for their strong endorsement.”

Regarding the investment in ZYBio,SDIC Venture CapitalIn this regard, it is acknowledged that the human microbiome serves as the body’s “second genome,” containing critical genetic information. It encompasses up to 10 million encoded genes, a number that can reach 150 times that of the human genome itself. The microbiome is closely linked to human health; in particular, the gut microbiota plays a vital role in maintaining human development and health, directly or indirectly regulating the functions of multiple physiological systems. Currently, the global market for gut microbiota-related therapeutics is substantial.

Building on SK08, ZYBio has established and streamlined a development pathway for live biotherapeutic products (LBPs) that meets current national review and approval standards, with a focus on the druggability of single-strain candidates. This pathway is critical to the successful development of microbial therapeutics. SK08 is the only gut microbiota-based drug project supported by the National High-Tech Research and Development Program (863 Program), and has also received support from the Guangdong Province Major Scientific and Technological Achievement Transformation Special Project and the Guangzhou Innovation Leading Team Project. This investment will accelerate the clinical development of the flagship product SK08 and enhance the capability to develop subsequent platform products, further raising technical barriers, addressing unmet clinical needs, and expediting the clinical and market translation of scientific and technological achievements.

InvestorsPu'en Guoxin's New General Manager, Zhao Fengyi“Live biotherapeutic products have emerged as a research hotspot in recent years and represent a strategic focus for major pharmaceutical companies both in China and abroad. As a leading domestic R&D enterprise specializing in second-generation probiotics and live bacterial therapeutics, ZYBio boasts profound technical expertise and a robust pipeline. The company has established a first-class, end-to-end industrialization platform in China, covering strain screening, functional evaluation, and drug development. Puen Guoxin holds strong confidence in ZYBio’s growth trajectory, believing that under the leadership of its professional R&D team, the company is poised to become an internationally leading enterprise in live biotherapeutic products.”

InvestorsHu Jingzhi, Partner at KIP Capital ManagementHe stated, “ZYBio’s ongoing research into novel live biotherapeutic products (LBPs) represents a highly prominent area of focus within the global biotechnology sector, and KIP places significant emphasis on advancements in such innovative technologies. We value ZYBio’s position as the only company in China to have advanced an LBP candidate into Phase I clinical trials, its team of leading domestic experts in this field, and its robust product pipeline with substantial market potential. We look forward to ZYBio developing additional pipelines and emerging as a leader in the broader LBP market, thereby addressing the needs of more patients.”

Dr. Kim Ji-soo, Investment Director at KIPIt also acknowledged: “The microbiome has a profound and extensive impact on human health and disease pathogenesis. The development of microecological drugs holds significant potential, currently standing at the early stage of translation from scientific research to industrial application. As an internationally recognized next-generation direction with substantial clinical value, it presents a prime opportunity for strategic investment. There are relatively few enterprises in China engaged in this field, giving ZYBio a first-mover advantage. Furthermore, ZYBio’s founding team possesses extensive experience in clinical practice, gut microecology, and new drug development, having successfully developed multiple innovative therapies. We anticipate that ZYBio will achieve even greater breakthroughs.”

InvestorChen Wei, General Manager of Xinwan Investment“He stated, ‘Live biotherapeutic products hold vast promise, with the domestic market still in its nascent stage. ZYBio’s SK08 is the first live biotherapeutic product in China to be developed as an LBP and approved for clinical trials, representing a breakthrough achievement. The founding team possesses industry-leading R&D capabilities, a robust pipeline, and the ability to simultaneously translate both pharmaceuticals and derivative products into commercial applications, ensuring sustainable growth. We remain firmly optimistic about the prospects of this field and ZYBio’s development potential.’”

SDIC Innovation was established in 2016 as a private equity fund management company specially set up by China State Development & Investment Corporation (SDIC) in accordance with market-oriented principles. It was founded to implement the national innovation-driven development strategy, deepen comprehensive strategic cooperation with the Ministry of Science and Technology, and accelerate the transfer and commercialization of national scientific and technological achievements. Through platforms such as the National Science and Technology Major Project Achievement Transformation Fund, the SDIC Beijing-Tianjin-Hebei Scientific and Technological Achievement Transformation Fund, the SDIC High-Tech (Shenzhen) Venture Capital Fund, and the SDIC (Ningbo) Scientific and Technological Achievement Transformation Fund, SDIC Innovation has consistently focused on investment goals centered on the commercialization of scientific and technological achievements. It targets key sectors including advanced manufacturing, electronic information, biomedicine, and materials and energy, while aligning with national regional development strategies in the Beijing-Tianjin-Hebei region, the Yangtze River Delta, and the Guangdong-Hong Kong-Macao Greater Bay Area. The firm is committed to continuously driving breakthroughs in independent innovation of core key technologies and building a robust investment ecosystem for the transformation of scientific and technological achievements.

Puen Guoxin was jointly established by Guoxin Sichuang Investment Fund Management (Beijing) Co., Ltd. and CSPC Pharmaceutical Group (01093.HK), a leading domestic pharmaceutical company. Focused on investing in the innovative biopharmaceutical sector, it aims to synergistically empower portfolio companies and enhance their value by combining industrial capital with socialized capital, thereby generating returns for investors and achieving multi-party win-win outcomes.

KIP Capital is a leading venture capital firm in Asia. Since its establishment in Seoul, South Korea, in 1986, it has maintained a steady investment pace and gradually grown into a VC firm headquartered in Asia with investment reach extending to multiple regions worldwide. KIP Capital established its China headquarters in Shanghai in 2008, focusing on the development of various emerging sectors, particularly biopharmaceuticals/big health, consumer/financial technology, and advanced technology/intelligent manufacturing. Its portfolio companies are distributed globally, backed by extensive investment experience and market-validated performance.

Zhuhai Lehong, established in 2016 as a subsidiary of Xinwan Group, maintains a strategic partnership with Fangyuan Group, a top-100 real estate developer. Deeply rooted in the Guangdong-Hong Kong-Macao Greater Bay Area, the company specializes in investment management, asset management, and equity investment. Its portfolio spans multiple sectors, including fintech, biopharmaceuticals, high-end manufacturing, and industrial internet. Since its inception, several of its invested companies have successfully listed on the STAR Market, the SME Board, and NASDAQ.