Hisun Pharmaceutical Initiates Phase III Clinical Trial of Anti-IL-6R Monoclonal Antibody HS628 for Moderate to Severe Rheumatoid Arthritis

On July 10, the Insight database showed that HISUN’s “Recombinant Humanized Monoclonal Antibody Injection against Interleukin-6 Receptor” (code name HS628) initiated Phase III clinical trials, with the indication being moderate to severe rheumatoid arthritis.

HS628 shares the same mechanism of action as Roche’s Actemra® (tocilizumab injection) and is indicated for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Actemra® was launched in the United States in 2010 and in China in 2013, with global sales exceeding CHF 2.311 billion in 2019, representing a year-on-year increase of 7%.

Image source: Insight Database

Currently, Actemra® has been approved in China as a Class B drug under the National Reimbursement Drug List, with the latest winning bid price at RMB 830 per vial.

In addition to HISUN, tocilizumab biosimilars from three other companies—Bio-Thera, Jinyu Bio-technology, and Livzon Mabpharm—are currently in Phase III clinical trials.

Currently, HISUN is aggressively expanding its presence in the biologics sector. In addition to its approved adalimumab biosimilar and the antibody fusion protein Anbainuo, ten monoclonal antibody drugs are currently in clinical trials. The bevacizumab biosimilar and infliximab biosimilar, which are among the most advanced in development, have already submitted marketing applications.