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Henlius Receives EU GMP Certificate for HLX02 (Trastuzumab for Injection)


Shanghai, China, April 23, 2020 – 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 Union (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 regarded as a “passport” for drugs to be launched in international market and has significant global impact.

With the EU GMP Certificates, 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 that has passed the EU GMP inspection. This means that the company has already built a commercial-scale manufacturing facility and a quality management system that are in line with the EU standards. This also means that China-developed antibody drug is breaking the GMP barriers to be launched on international market, laying a solid foundation for the company to further expand its global footprints.      
Dr. Scott Liu, co-founder and CEO of Henlius, said, "We are very 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.

Complying with the Highest Quality Standards, Building the World-class Platform

The EU has pioneered in the establishment of the regulations of biosimilar medicines in the world. In 2004, the European Medicines Agency (EMA) issued the draft biosimilar guidelines, opening up a new era for global biosimilars. Since the first biosimilar was approved in 2006, the EU has become the world's most mature market for biosimilars. The Xuhui Facility is located in Caohejing High-tech Park, Xuhui District, Shanghai, designed and built in accordance with the standards of the EU, China and the United States. Ever since its foundation, Henlius has adhered to the highest quality standards in the world and all R&D and production activities are carried out in line with EU quality standards. Head-to-head comparisons have been conducted between biosimilars and originators in the pre-clinical and clinical stages, which has laid the foundation for the company’s globalisation strategy. The Xuhui Facility and its supporting quality management system have passed a number of on-site inspections or audits by the NMPA, EU qualified person and international business partners, and have obtained a GMP certificate from the NMPA.

China-developed Trastuzumab to Benefit Global Patients

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, which is a key milestone of the company’s globalisation strategy. 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.  
To fulfil the huge unmet needs of high-quality and affordable biologic medicines worldwide, Henlius has proactively expanded its global presence through continuous strategic collaboration with global leading pharmaceutical companies and 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. With an extensive presence in North America, Europe, Australia, South Africa etc., Accord has become one of the fastest growing generic pharmaceutical companies focused on developing, manufacturing and distributing generics and biosimilars. Henlius has granted Accord 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.
Looking forward, while keeping with the core values of “Affordable Innovation · Reliable Quality”, Henlius will continue its dedication in the field of oncology and deliver more innovative biologic medicines to provide affordable and effective treatment options for patients worldwide, highlighting the company’s vision of becoming the most trusted and admired biotech company in the world.