BRIEF—UCB's bid to market Cimzia in China makes progress

Belgium’s largest drugmaker UCB says that the submission of an application for an Import Drug License to the Chinese Food and Drug Administration (CFDA) for the approval of Cimzia (certolizumab pegol) to treat moderate-to-severe rheumatoid arthritis (RA).

Cimzia, which generated full-year 2017 sales of 1.42 billion euros ($1.75 billion) for UCB, up 9% on 2016, is not currently marketed in China.

The submission is based on results from two Phase III clinical trials, RAPID-C and RAPID-C open-label extension (OLE), which evaluated the efficacy and safety of Cimzia plus methotrexate (MTX) in Chinese adults with moderate-to-severe active rheumatoid arthritis who had previously experienced inadequate response to MTX.

Results concluded that patients experienced greater improvement in relief of the signs and symptoms of RA when CIMZIA was used in combination with MTX, compared with MTX alone.1

While rheumatic diseases are typically less common in Asia than in other parts of the world, RA has a prevalence of 0.41% in China (0.69% in women and 0.11% in men), indicating a need for effective treatment options.

The results of the RAPID-C and RAPID-C OLE trials demonstrate the potential value of Cimzia for Chinese patients.

In addition, due to its unique Fc-free molecular structure, Cimzia is the only anti-TNF that has robust evidence from conception to late pregnancy and lactation.