Completed Series C3 Financing
Received the Acceptance Notice of the IND application from the NMPA for a Phase II clinical trial of SK10 in China regarding prevention and treatment of CID
About Us
Zhiyi Biotech, founded in 2013，We are a pioneer and leading enterprise in the field of second-generation LBP in China. By virtue of our core technological breakthroughs and rapid clinical advancement, we have positioned ourselves among the first tier of global LBP R&D. Our Core Product SK08 and key product SK10 have achieved multiple industry-defining milestones, establishing our first-mover and leadership advantages.
As a benchmark in China’s second-generation LBP field, SK08 has delivered multiple groundbreaking achievements. According to Frost & Sullivan, SK08 is the first LBP to obtain registrational clinical trial approvals from both the NMPA and the U.S. FDA. SK08 is currently in the Phase III clinical trial for IBS-D, making it the only late-stage clinical biological drug candidate in the global IBS-D field, as of the Latest Practicable Date.
SK08 has also received NMPA approval for the clinical trial targeting pediatric rotavirus diarrhea, representing a major breakthrough for LBP in pediatric medicine in China and further expanding the clinical application scope of LBP. As of the Latest Practicable Date, SK08 is the only clinical-stage LBP candidate targeting pediatric rotavirus diarrhea globally. Concurrently, SK08 was the first LBP in China approved to conduct registrational clinical trial in oncology patients. The strain safety evaluation study of SK08 was recognized as a classic research work in NGP on Frontiers, and SK08 was highlighted as a representative LBP candidate on Nature Microbiology, thereby fully validating our world-class R&D capabilities and Core Product competitiveness.
In addition, we were also the first company in China to advance an inactivated second-generation LBP into clinical development, and our key product SK10 has achieved multiple breakthroughs. It was the first LBP using Bacteroides fragilis to receive FDA clearance for clinical trials in the U.S., and also the world’s first FDA clearance for an LBP targeting CID. SK10 has successfully completed its Phase I clinical trial in the U.S., demonstrating our ability to conduct global R&D and navigate complex regulatory pathways.
Our Core R&D team has led and participated in six national and provincial major research projects, receiving broad recognition from the industry and authoritative institutions for our technological capabilities. Specifically, the SK08 project has been supported by key national and provincial research programs, including the National High-tech R&D Program of China, the National Natural Science Foundation of China, and the Guangdong Provincial Major Special Program for New Drug Innovation and Development . In addition, we have been honored with several prestigious awards, including the Guangdong Provincial “Specialized, Refined, Distinctive and Innovative Small and Medium-sized Enterprise” and the Guangzhou Innovation Leadership Team , fully demonstrating our outstanding technological innovation capabilities and industry influence.
Timeline
Received the approval for conducting a phase II clinical trial for SK08 from the FDA in the treatment of UC.
AKK AM06 has obtained FDA Self-GRAS certification
Commenced the Phase III clinical trial of SK08 .
Completed the phase I clinical trial for SK10 in the United States. Nearly 100 million RMB raised in Series C1-2 funding. We received the IND approval from the NMPA for a Phase II clinical trial of SK08 in the treatment of pediatric rotavirus diarrhea.
Received confirmation from the CED for SK08 Phase III (IBS-D )
SK10 first subject dosed in the America Phase I clinical Trial.
completed the Phase II clinical trial for SK08 in the treatment of IBS-D
100 million RMB raised in Series B++ funding. SK10 recieved FDA IND approval. Manufacturing platform successfully undergone compliance assessment for the production of the raw material AKK AM06™
Commenced the phase II clinical trial for SK08
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 was selected to take part in the Guangdong Provincial Major Special Program for New Drug Innovation and Development.
Series A funding is raised
Guangzhou Innovation Leading Team Project approved.
Construction of R & D center and production site in Guangzhou Science City
SK08 was highlighted as a representative global LBP candidate on Nature Microbiology. Completed Angel Financing.
We completed safety evaluation for SK08 in China.
Founding of Zhiyi
Preclinical study of SK08 begins.
Contact Us
Tel:
020-82258826
Email:
sales-akk@zypharm.com.cn
Tel:
020-82515346
Address:
3/F Building A, No.2 Ruitai Road, Huangpu District, Guangzhou
Region:
Guangdong, China