28 April 2020 - - China-based Shanghai Henlius Biotech, Inc.'s (2696.HK) drug substance line and drug product line for HLX02 trastuzumab biosimilar have successfully passed the European United Good Manufacturing Practice 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, the company said.

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 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.

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.

The study results were presented in the 2019 ESMO Asia Congress held in Singapore, demonstrating that HLX02 has no clinically meaningful differences from the originator trastuzumab in terms of efficacy and safety in patients with recurrent or metastatic HER2+ breast cancer.

Henlius has reached strategic cooperation agreements with Accord, Cipla, Mabxience and Jacobson Medical for the commercialisation of HLX02 in over 80 countries and regions around the world.

Henlius has granted Accord, one of generic pharmaceutical companies, exclusive commercial rights of HLX02 in over 70 countries and regions in Europe, the Middle East and North Africa and the Commonwealth of Independent States.

In June 2019, Accord submitted a Marketing Authorization Application to the EMA on HLX02, making HLX02 the first China-developed trastuzumab biosimilar accepted by the EMA for MAA review, and therefore HLX02 has the potential to become the first China biosimilar approved in the EU.