SUCCESSFUL PASSING OF EU QP AUDIT ON TOT BIOPHARM’S COMMERCIAL PRODUCTION BASE FOR MONOCLONAL ANTIBODY DRUG SUBSTANCES AND ANTIBODY DRUG CONJUGATES

TOT BIOPHARM International Company Limited (TOT BIOPHARM, Stock code: 1875.HK) has recently received a GMP compliance inspection report approved by a Qualified Person (“QP”) in the European Union (“EU”) in respect of the manufacturing facilities and associated quality systems of the Group’s commercial production base for its self-developed HER2-targeted antibody drug conjugate (“ADC”) candidate, TAA013.

Pursuant to EudraLex Volume 4 regulations (EU Good Manufacturing Practice, “EU GMP”) and the guiding principles of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), this EU QP audit involved a comprehensive and in-depth audit mainly focused on the production quality of monoclonal antibody (“mAb”) drug substances, ADC drug substances and ADC drug products of TAA013. The audit covered manufacturing management system, quality management system, plant facilities and equipment management system, validation and computerized system, data integrity verification and management, material management system, product testing and release management and other aspects, thereby further affirming that the Group’s commercial production base possesses EU GMP-compliant quality systems and production capacity. This indicates that the Group’s commercial production and quality management systems for mAb drug substances and ADC drugs have been recognized by an international professional institution, laying a solid foundation for the high-quality commercialization of TAA013 and the Group’s international development.

ABOUT TOT BIOPHARM’S ADC ONE-STOP INDUSTRIALIZATION PLATFORM

Located at the Group’s headquarters in Suzhou Industrial Park, TOT BIOPHARM’s ADC one-stop industrialization platform possesses core research and development technology advantages. It is equipped with a full range of capabilities from drug development to commercial production, which can realize the one-stop commercial production of antibodies and ADC drug substances and drug products, as well as flexible and diverse production capacity to meet the needs of different production scales for small trials, pilot tests and commercialization.

SOURCE: TOT Biopharm Company Limited