Shanghai Henlius Biotech announced the company's drug substance (DS) line and drug product (DP) line for HLX02 trastuzumab biosimilar have successfully passed the European United (EU) Good Manufacturing Practice (GMP) on-site inspection and the company has received two EU GMP Certificates (Certificate of GMP Compliance of a Manufacturer) from Poland's Chief Pharmaceutical Inspector. As one of the most authoritative and rigorous inspections globally, EU GMP inspection is recognized by nearly 30 EU Member States, and the inspection results may also be shared with other countries that have signed Mutual Recognition Agreements (MRAs) with the EU, including the United States, Canada etc. Therefore, EU GMP Certificate is considered a "passport" for drugs to be launched in international markets and has significant global impact.
Henlius' Xuhui Facility has become China's first EU certified GMP site to manufacture a self-developed antibody drug and HLX02 trastuzumab biosimilar is the first China-developed biosimilar to pass the EU GMP inspection. This means the company has already built a commercial-scale manufacturing facility and a quality management system in line with EU standards. This also means a China-developed antibody drug is breaking the GMP barriers to be launched internationally, laying a foundation for the company to expand its global footprints.
"We are pleased with the successful pass of the EU GMP inspection. This could never be achieved without the team's 10-year hard work, dedication and Henlius' pursuit of high quality. We will make every effort to accelerate the global commercialisation progress of HLX02, hoping to benefit more patients and to represent China in the 'World Cup' to compete with the world's top bio-pharmaceutical companies from Europe, the United States, South Korea, etc," Dr. Scott Liu, co-founder and CEO of Henlius, said.
HLX02 is a biosimilar developed and manufactured by Henlius in accordance with international standards, potentially for the treatment of HER2-positive early-stage breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer. It was evaluated in an international multi-centre (Mainland China, Ukraine, Poland and the Philippines) Phase 3 clinical study aiming for head-to-head comparison between HLX02 and the originator.