PR98492

SUZHOU,China, Oct. 27, 2022 /PRNewswire=KYODO JBN/

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