SHANGHAI, April 23, 2020 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that 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.
Dr. Scott Liu, co-founder and CEO of Henlius, said, "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."
Mr. Zhang Wenjie, President of Henlius, said, "In February 2019, the company's first product, HLX01 (rituximab injection), was officially approved by China National Medical Products Administration (NMPA), becoming the first biosimilar launched in China. Following the successful launch of HLX01, the NDA of HLX02 has been assigned to the priority review list by NMPA and HLX02 is expected to be launched this year. The EU GMP Certificates are another recognition of the company's high-quality and independently-developed products by the world's authoritative drug regulatory agencies."
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 (MAA) 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.