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Henlius and Accord Healthcare Receive EMA Approval for Zercepac®, trastuzumab biosimilar

Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord) jointly announced the European Commission (EC) has approved Zercepac® (HLX02), a trastuzumab biosimilar developed and manufactured by Henlius, for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer. The approval was based on a series of robust studies including comparative quality studies, preclinical and clinical studies. The results confirmed the biosimilarity of Zercepac®(HLX02), demonstrating comparable efficacy and safety to the reference product, Herceptin®.

Zercepac® (HLX02) is the first China-developed monoclonal antibody (mAb) biosimilar that has successfully entered the EU market. Under the leadership of Henlius’ co-founders Dr. Scott Liu and Dr. Weidong Jiang, the development and manufacturing process of Zercepac®(HLX02) is in line with international standard to ensure it meet the requirements to serve patients around the globe. During the development process of Zercepac® (HLX02), Henlius strictly followed the NMPA and EMA biosimilar guidelines and has taken multiple head-to-head comparisons between Zercepac®(HLX02) and the reference trastuzumab , including comparative quality studies, preclinical studies, a Phase 1 clinical study and a global multi-certre Phase 3 clinical study. Manufacturing site of Zercepac® and its quality management system have obtained EU GMP certificates. Henlius’ Xuhui Facility has become China's first EU certified GMP site to manufacture a self-developed antibody biosimilar. This also means that Henlius is breaking the GMP barriers for China-developed mAb biologics to be launched on international market, laying a solid foundation for the successful approval of Zercepac®(HLX02).

Professor Binghe Xu, principal investigator of the international multi-centre Phase 3 clinical study of Zercepac® (HLX02), said, "I’m very glad to see that an international drug regulatory authority has acknowledged the efficacy and safety of Henliu’s self-developed biosimilar, which also means our clinical trial is of international standard. I’m looking forward to seeing more HER2 positive breast cancer and gastric cancer patients benefiting from China-developed trastuzumab in more countries and regions.”

Dr. Scott Liu, co-founder and CEO of Henlius, said "Henlius' mission is to improve patients' lives by timely providing them with quality and affordable protein therapeutics through technical innovation and operational excellence. The approval of Zercepac® in the EU is a significant milestone of our global strategy. This achievement announces that our capability in the development and manufacturing of biologics has reached international standards. In the future, Henlius will provide more high quality biologics as new treatment options to benefit patients worldwide.” 

Paul Tredwell, Accord VP Speciality Brands, EMENA said,  “Zercepac® is an exciting new addition to our growing oncology portfolio which now provides access to over 30 high-quality, cost effective oncology treatments to patients across Europe. With Zercepac®, our first mAb, we firmly establish our expertise in bringing high quality complex medicines to market – to ensure improved patient access, and to provide cost effective alternatives to overstretched health systems.”  

Looking forward, Henlius will keep on with its core values of “Affordable Innovation · Reliable Quality” and continue its dedication in the field of oncology. Henlius will actively promote the discovery and development of novel biologics as well as process innovation to realize its vision of becoming the most trusted and admired biotech company in the world.

About Accord Healthcare

Headquartered in the United Kingdom, Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables Accord to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. The approach of Accord is agile and inventive, always seeking to improve products and patients' access to them. Accord are driven to think differently and deliver more for the benefit of patients worldwide.

Reference Note
[1] European Medicines Agency. Human medicine European public assessment report (Zercepac).