China Regulators Approve First Biosimilar HXL01 from Henlius

Mar 1, 2019 | Biosimilars, Cancer, China Drug Development, Non-Hodgkin Lymphoma, Oncology

As reported by the Center for Biosimilars, regulators in China have approved the country’s first biosimilar—a rituximab product referencing Rituxan. Known as HLX01, the product was developed by Henlius and will be used primarily for treatment of non-Hodgkin lymphoma Rituximab was developed by researcher Nabil Hanna and coworkers at IDEC Pharmaceuticals. A U.S. patent was issued in 1998 and expired in 2015. It was approved in 1997 to treat B-cell non-Hodgkin lymphomas resistant to other chemotherapy regimens.  

Rituximab, in combination with CHOP chemotherapy, is superior to CHOP alone in the treatment of diffuse large B-cell lymphoma. In 2010, it was approved the European Commission for maintenance treatment post initial treatment for follicular lymphoma. Rituximab is currently co-marketed by Biogen and Genentech (Roche) in the United States, by Roche in Canada and the EU, Chugai Pharmaceuticals in Japan and AryoGen in Iran. It is reported to be in the World Health Organization’s List of Essential Medicines. In 2014, Genentech reclassified Rituxan as a specialty drug making it only available through specialty distributors in the United States. As wholesalers’ discounts and rebates were no longer were relevant, hospitals would pay more. Patents expired in Europe in 2013 and in the U.S. toward end of 2016. Several biosimilars are approved in India, the EU, Switzerland, Japan and Australia—now China.

Henlius Background

Henlius is a Shanghai, China joint venture company formed by Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and Henlius Biopharmaceuticals Co., Ltd. in February 2010. The company focuses on the development, production and commercialization of mAb biosimilar drugs, bio-betters and novel mAbs using cutting-edge technology. Registered in Shanghai Zhangjiang, they have so far invested over 400 million RMB in the early development of monoclonal antibody drugs.


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