Recently, Shanghai Henlius Biotech, Inc. has completed data analysis of the Phase 1 study for its HLX03 (Recombinant Anti-TNFα Human Monoclonal Antibody Injection, a proposed adalimumab biosimilar).
In December 2015 and April 2017, HLX03 was accepted by the China Food and Drug Administration (CFDA), receiving clinical trial approvals for treating rheumatoid arthritis (RA) and plaque psoriasis (PS) successively. In December 2016, Henlius initiated a phase 1 clinical trial comparing pharmacokinetics, safety, tolerability and immunogenicity between HLX03 and Humira® (the originator marketed in China). In October 2017, Henlius initiated a phase 3 study of HLX03 for treatment of plaque psoriasis in China based on the results of phase 1 clinical trial.
Recently, this randomized, double-blind, active-control phase 1 clinical trial was completed in 213 healthy males to receive a single subcutaneous injection of HLX03 or Humira. The study demonstrated similarity in pharmacokinetic, safety and immunogenicity profiles between HLX03 and Humira (the clinical data are sourced from our final CSR).
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 27 successful IND/CTA approvals (17 approvals from China; 3 from the United States; 3 from Taiwan; each 1 from the European Union, Ukraine, Philippines and Australia).
Henlius has submitted its first New Drug Application (NDA) of its rituximab HLX01 (MabThera®/Rituxan® biosimilar), the first product developed by Henlius) to National Medical Products Administration (formerly CFDA), which soon assigned HLX01 into its priority evaluation list in early 2018, making HLX01 potentially the first approved biosimilar in China.