Shanghai, China, March, 31, 2020 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Company has recently entered into an exclusive license agreement with Mabxience Research, S.L. (“Mabxience”), a global biotechnology company, to develop and commercialise HLX02 (trastuzumab for injection) in Argentina, Uruguay and Paraguay.
HLX02 is a biosimilar developed and manufactured by Henlius in accordance with international standards. It was evaluated in a multi-centre (Mainland China, Ukraine, Poland and the Philippines) Phase 3 clinical study aiming for head-to-head comparison between HLX02 and the originator. It has been accepted for review by the National Medical Products Administration (NMPA) and European Medicines Agency (EMA), marking a key milestone of the company’s globalisation strategy. Its New Drug Application (NDA) was accepted for review by the NMPA in April 2019 and was subsequently assigned to priority review list, potentially for the treatment of HER2-positive early-stage breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer, also making it the first China-manufactured trastuzumab accepted for NDA review by the NMPA. Its Marketing Authorisation Application (MAA) was accepted for review by EMA in June 2019, making it the first China-manufactured biosimilar accepted for MAA review by EMA. At present, it has passed the EMA “good clinical practice”(“GCP”) inspection, and the “good manufacturing practice”(“GMP”) on-site inspection has been completed and moved forward according to the plan.
The cooperation with Mabxience not only further recognizes Henlius’ high-quality and independently-developed biologic medicines in a global setting, but also takes Henlius another step closer to the globalisation. Prior to this, Henlius has proactively expanded global presence for HLX02 through continuous strategic collaboration with global leading pharmaceutical companies including Accord Healthcare, a generic pharmaceutical company from UK with 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; Cipla, a top international pharmaceutical company with exclusive development and commercial rights of HLX02 in emerging markets in Asia Pacific and Latin America; and Jacobson Medical, a top pharmaceutical company based in Hong Kong, China with exclusive commercial rights of HLX02 in Hong Kong and Macau, China. Henlius will expeditiously capture local market share through the established capabilities and resources of Mabxience, thus further accelerating the globalisation of HLX02 and benefit more patients to fulfil the huge unmet needs of high-quality and affordable biologic medicines in the emerging markets.
With this cooperation, Henlius has reached strategic cooperation agreements with many global leading pharmaceutical companies for the 3 core products including rituximab HLX01, trastuzumab HLX02 and novel anti-PD-1 mAb HLX10, to access nearly 100 countries and regions in Europe, Latin America, Southeast Asia, the Middle East and North Africa etc. Henlius will not only expand its footprint in the mature markets in Europe and America, but also strength the presence in emerging markets as its strategy focus. Looking forward, with the long-term commitment to “affordable innovation”, Henlius will partner with more international leading companies and organisations to deliver more effective products to patients worldwide.
About Mabxience
Mabxience, part of Insud Pharma, is a global biotechnology company with ten years’ experience in the research, development, manufacturing and marketing of biosimilar monoclonal antibodies. Mabxience strives to provide quality treatments to more patients that require high-cost medications, contributing to the sustainability of healthcare systems. Mabxience has three facilities for development and production, one in Spain and two in Argentina. In December 2014, Mabxience launched its first biosimilar, rituximab, which is now approved and distributed in various markets globally. Its second product, bevacizumab, was launched in its first market in November 2016.