SK08 first subject enrollment
SK10 US Phase I clinical completed. Nearly 100 million RMB raised in Series C1 funding.
About Us
Zhiyi Biotech, founded in 2013, is a leading clinical-stage company in live biotherapeutics (LBPs) and next-generation probiotics (NGPs) in China. It has established a platform for the relationship study between microbiome and diseases, the isolation and identification of new functional strains, as well as the development of new LBPs.
The company’s lead drug candidate SK08, was approved for clinical trial by NMPA in November 2019. Based on a unique bacterial strain Bacteroides fragilis, SK08 is the first oral LBP that entered clinical stage in China, with immense influence on the industry. Its Phase II clinical trial to treat IBS-D was completed in the end of 2022.Furthermore, the IND approval for another indication of SK08 combined with PD-1 inhibitor for advanced solid tumor was received in March 2022, which was the first IND approval of LBP in oncology by NMPA.
In October 2022, FDA has approved the Company’s IND application to develop SK10 (Inactivated Bacteroides fragilis) for the treatment of Chemotherapy-induced Diarrhea (CID) . It is the world's first IND application of LBPs with CID as an indication, while SK10 is the first Bacteroides fragilis-based LBP that obtained FDA IND approval. This achievement is an essential milestone for Zhiyi, signifying that Zhiyi has fully penetrated the technical and registration pathway of pre-clinical development of LBP to both FDA and NMPA.
Nowadays, nearly $15 million has been invested in Guangzhou Science City by Zhiyi to build up a modern and advanced R&D center and two GMP-like facilities.
Additionally, the company has successfully completed a total of $49 Million in A, B, B+ and B++ funding , with investors including Shenzhen Capital Group, Qingkong SinoKing Capital, SDIC Venture Capital, KIP ,Guangzhou Development District Industry Fund Investment Group etc.
It is worth mentioning that the research of Zhiyi has attracted the attention from the world, which has been reported in NATURE Microbiology and Frontiers Research Topics. We are glad that the company has been granted as Top 50 Guangzhou Innovative Biomedical Companies, 2021 Guangzhou Future Unicorn of Innovation Enterprise, 2022 Top100 Chinese Pharmaceutical Innovative Seed Enterprises etc.
Timeline
SK08 start Phase III Clinical Trials in China
SK10 first subject dosed in the America Phase I clinical Trial.
SK08 combined with PD-1inhibitors to treat cancer was approved for clinical trial
100 million RMB raised in Series B++ funding. SK10 recieved FDA IND approval.
SK08 enters Phase II clinical trials
SK10 IND acceptance. Series B+ funding . Inauguration of LBPs Engineering and Technology Research Center of Guangdong.
SK08 Phase 1 clinical trial success
110 million RMB raised in Series B funding.
SK08 clinical trial approval
SK08 approval by Guangdong Province Major Scientific and Technological Special Project for Significant New Drugs Development.
Series A funding is raised
Guangzhou Innovation Leading Team Project approved. Investigational New Drug Application (IND) of SK08.
Construction of R & D center and production site in Guangzhou Science City
Supported by Guangdong Provincial Major Scientific and Technological Achievement Transformation Special Project. Nature research journals introduce Zhiyi’s NGP development.
SK08 Chinese National Programs for High Technology Research and Development (863 Program) approval
Academy of Military Sciences completes SK08 strain safety evaluation, the first in China to be assessed.
Founding of Zhiyi
Preclinical study of SK08 begins.
Contact Us
Tel:
020-82258826
Email:
public@zypharm.com.cn
Tel:
020-82515346
Address:
3/F Building A, No.2 Ruitai Road, Huangpu District, Guangzhou
Region:
Guangdong, China