Recently, Shanghai Henlius Biotech, Inc. (“Henlius”) and Accord Healthcare Ltd. (“Accord”) have formally signed a License Agreement for HLX02 - a Recombinant Humanized Anti-HER2 Monoclonal Antibody for Injection developed by Henlius. Under this agreement, Accord is exclusively authorized to commercialize HLX02 in the territory covering 53 countries including UK and France in Geographical Europe, 17 countries including Saudi Arabia and the United Arab Emirates in Middle East-North Africa (“MENA”) and some Commonwealth of Independent States (“CIS”).
The successful cooperation with Accord is an important movement for Henlius to implement its international strategy. In order to achieve “Affordable Innovation”, Henlius strives to fulfill the unmet needs of patients with high quality and affordable protein therapeutics. With the global footprint of Accord and its strong developing, manufacturing and marketing capability, Henlius is looking forward to launching HLX02 in more markets around the world to benefit more patients.
HLX02, a Recombinant Humanized Anti-HER2 Monoclonal Antibody for Injection, is the second monoclonal antibody developed by Henlius, indicated for the patients with breast cancer and gastric cancer.
At the end of 2012, Henlius submitted the investigational new drug (IND) of HLX02 to the China Food and Drug Administration (CFDA) to treat breast cancer, and obtained the approval in 2015. Until now, Henlius has completed its phase I clinical trial and conducted a global multi-center phase III clinical trial in China, Ukraine, Poland and Philippines. HLX02 is also the first Chinese biosimilar product that gets study approvals outside China. Moreover, Henlius also filed IND for gastric cancer and received the CFDA approval of clinical trial in early 2016.
With an extensive presence in North America, Europe, South America, Australia, New Zealand and South Africa and more recently in the MENA and ASEAN regions, Accord Healthcare has very rapidly become one of the fastest growing generic pharmaceutical companies. With a robust product portfolio in growth segments, such as Oncology, Cardiology, Neurology, Nephrology, Urology, Psychiatry, Diabetology, Pain management and Gastroenterology, Accord’s marketing and distribution network now reaches over 70 countries.
Accord is committed to uncompromised quality for its products and services across the globe. Its products are manufactured under the highest international standards and our manufacturing plants are approved by major global regulatory agencies including the USFDA, MHRA, EMA, TGA, MCC, ANVISA. Increasingly Accord is investing in higher barrier to entry developments such as Biosimilar and New Chemical Entities and is set to evolve into a leading global healthcare provider.
Shanghai Henlius Biotech, Inc., a joint venture company founded by Fosun Pharma and a team of overseas scientists in December 2009, specializes in the discovery, development, manufacturing and commercialization of high-quality biological therapeutics to treat a range of chronic and often life-threatening diseases.
As of now, Henlius has completed IND filings of 11 products with 16 indications, and 4 biosimilar mAbs of these are in late-stage development currently. Apart from biosimilars, Henlius has been devoting continuous efforts in developing novel monoclonal antibodies in a timely fashion. Phase I clinical trials of the first 4 novel products were conducted successfully.
In October 2017, Henlius submitted its first New Drug Application (NDA) of HLX01 (Rituximab Injection) to CFDA, which soon assigned HLX01 into its priority evaluation list in early 2018, making HLX01 potentially the first approved biosimilar in China. Recently, Henlius has completed its first Phase III study of HLX01 for the treatment of NHL and initated Phase I study for the treatment of RA.