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

SHANGHAI, July 29, 2020 /PRNewswire/ -- The European Commission (EC) has approved Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord)'s Zercepac®, a biosimilar trastuzumab, for the treatment of certain patients with HER2-positive early breast cancer, HER2-positive metastatic breast cancer and previously untreated 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®, demonstrating comparable efficacy and safety to the reference product, Herceptin®.

The approval of this medicine developed and manufactured by Henlius, is a significant milestone for both companies. Zercepac® is the first monoclonal antibody (mAb), and third biosimilar, launched by Accord in Europe, and it is the first mAb developed by Henlius to be approved in the EU.

Dr Scott Liu, co-founder and CEO of Henlius, said, "Henlius' mission is to improve patients' lives by 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 "This product 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 complex medicines to market ? to ensure improved patient access, and to provide cost-effective alternatives to overstretched health systems."

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologics for patients worldwide with a focus on oncology and autoimmune diseases. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation throughout the whole product life cycle. It has three R&D facilities in Shanghai, Taipei and California and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice.

Henlius has built a product pipeline covering over 20 monoclonal antibodies (mAb) and has continued to explore immuno-oncology combination therapies with HLX10 (anti-PD-1 mAb) as backbone. In addition to HLX01 rituximab launched and two products (HLX02 trastuzumab and HLX03 adalimumab) under NDA review, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide. Products have been licensed out to nearly 100 countries and regions.

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 us 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.