On November 11, 2024, Shanghai Taichu Biotechnology Co., Ltd. (hereinafter referred to as "Taichu Bio") received the updated "Drug GLP Certification Certificate" issued by the NMPA. This certification adds three new accredited items to the company's existing qualifications, including single and repeated dose toxicity studies in monkeys.
Taichu Bio first obtained the "Drug GLP Certification" issued by the NMPA in January 2024 and successfully passed the NMPA's GLP certification extension inspection this September. This extension significantly expands the scope and capabilities of Taichu Bio in undertaking preclinical toxicology studies.
Since commencing operations in early 2023, Taichu Biol has rapidly established a comprehensive preclinical drugability assessment platform in a relatively short timeframe. The platform covers efficacy, pharmacokinetics, toxicology, and early-stage drug screening services, while continuously improving its quality management system to provide high-quality drug R&D services for clients. Prior to this, in late October, Taichu Bio received full AAALAC accreditation, signifying its preclinical evaluation platform and quality system are rapidly advancing towards international standards and gaining increasing client recognition. To date, Taichu Bio has served over 100 domestic and international clients, involving more than 20 different types of drugs, and completed hundreds of non-clinical evaluation studies for new drugs across stages including preclinical candidate (PCC), Investigational New Drug (IND), and New Drug Application (NDA). Taichu Bio has successfully assisted multiple domestic client projects in obtaining clinical trial approvals.
Currently, the companies within the Taichu Group have completed the strategic layout for group-wide development. The Group's business encompasses various sectors includingPre-Clinical Research,Antibody Discovery and Design,Biologics Development and Manufacturing,Nucleic Acid Drug Process Development and GMP Manufacturing.. The Group provides clients with reliable and rapid pre-clinical research services to advance new drug development.
Adhering to the philosophy of "Advocate of Ethics and Integrity, Quest for Verity" ,the Taichu Group is committed to providing superior technology and service solutions to global clients, striving to make greater contributions to the advancement and application of biotechnology.