Recently, Henlius completed a Phase 1/2 study of HLX01 (Rituximab Injection, a recombinant human/murine chimeric anti-CD20 monoclonal antibody injection) in rheumatoid arthritis (RA).
Henlius initiated a phase 1/2 clinical trial comparing pharmacokinetics, pharmacodynamics, safety, tolerability and immunogenicity of HLX01 and the reference rituximab in mainland China in January 2016. The study is a randomized, double-blind, parallel-controlled, double-arm phase 1/2 clinical trial that enrolled 196 patients with severe and mild active RA. Results of the study met defined primary and secondary endpoints, demonstrating equivalence of pharmacokinetic, safety and immunogenicity profiles between HLX01 and reference rituximab. (the results source from the final CSR of HLX01-RA01)
In October 2017, Henlius submitted New Drug Application (NDA) to CFDA for HLX01 Non-Hodgkins lymphoma (NHL) indication. HLX01 was then assigned to priority evaluation list in early 2018, making HLX01 potentially the first approved biosimilar in China. Henlius completed phase 3 study of HLX01 in NHL patients. The results met its primary and secondary endpoints demonstrating the equivalence of clinical efficacy and safety of HLX01 and reference rituximab in treating NHL.
Except China, the reference rituximab was approved for treating RA in both the European Union and the United States. By implementing a differentiation strategy for HLX01 to develop both RA and NHL indications, Henlius is the first domestic company in China that initiated the phase 3 clinical study of rituximab in RA. Succeeding with the clinical trial progress in RA, HLX01 will benefit more patients who are not affordable to reference rituximab in China.
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.