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Henlius Adalimumab Received Acceptance of New Drug Application


  Henlius has recently received a New Drug Application (NDA) acceptance from the National Medical Products Administration (NMPA) for its adalimumab HLX03, a recombinant anti-TNF-α human monoclonal antibody injection.

 HLX03 is a biosimilar of Humira developed by Henlius with complete intellectual property rights for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PS) and ankylosing spondylitis (AS). In December 2015 and April 2017, HLX03 was approved by the China Food and Drug Administration (CFDA, now NMPA) to initiate clinical trial for treating RA and PS successively. The phase 1 clinical trial study preliminary demonstrated similarity in pharmacokinetic, safety and immunogenicity profiles between HLX03 and Humira.

      Humira is the first approved fully human anti-TNF (tumor necrosis factor) monoclonal antibody and also the best-selling drug accumulating total sales of more than USD 100 billion in the world. Since it launched in China in 2010, Humira was approved to treat RA, PS and AS successively. As of today, none of the biosimilars of Humira has been approved in China. It’s difficult to access for most patients family according to the high costs of Humira. In the future, the approvals of more biosimilars will ease the financial burden of domestic patients, and provide more therapeutic options for them.

      HLX03 is Henlius’ second product receiving acceptance of the New Drug Application. In October 2017, Henlius has submitted its first NDA of its rituximab HLX01 (MabThera®/Rituxan® biosimilar, the first product developed by Henlius) to NMPA, which soon assigned HLX01 into its priority evaluation list in early 2018. More and more products in the pipeline of Henlius are entering the late stage of clinical development and New Drug Application, indicating that the research and development footprint of Henlius will embrace the fruitful outcomes after many years.

About Henlius

Shanghai Henlius Biotech, Inc., a joint venture company co-founded by Fosun Pharma and a team of overseas scientists in December 2009, with its R&D footprint in Shanghai, Taipei and California, USA, specializes in the discovery, development, manufacturing and commercialization of high-quality biologics including biosimilar, bio-better and novel monoclonal antibody, to treat tumor and auto-immune disease.

      Until now, Henlius has completed IND/CTA filings of 13 products and 1 combination therapy with 22 indications and obtained 28 successful IND/CTA approvals (18 approvals from China; 3 from the United States; 3 from Taiwan; each 1 from the European Union, Ukraine, Philippines and Australia).Two products of Henlius have their New Drug Application under review and one of them, HLX01, is potentially the first biosimilar approved in China.