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UCB announces approval of Cimzia in China

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• After receiving priority review in 2018, CIMZIA® (certolizumab pegol) is now approved in China for the treatment of Moderate-to-Severe Rheumatoid Arthritis • CIMZIA approval in China reinforces UCB’s ongoing commitment to supporting patient value across China and to offering Chinese patients innovative medicines to help manage their disease

Brussels (Belgium), July 22, 2019 – 07:00 (CET): Belgium-based global bio-pharmaceutical company UCB today announced it has received an Import Drug License (IDL) from the National Medical Product Administration (NMPA), enabling people living with moderate-to-severe rheumatoid arthritis to access CIMZIA® (certolizumab pegol) in China. This approval provides the first biologic therapy in UCB’s portfolio in China, allowing the company to transition its agile biopharmaceutical model into this important patient population.

The NMPA granted priority review for the approval of CIMZIA to treat moderate-to-severe RA in 2018, based on the therapeutic advantage seen with the therapy. The submission was based on Phase 3 clinical trial results, RAPID-C and RAPID-C open-label extension (OLE), which demonstrated efficacy and safety for the approved indication in China. In the 24-week RAPID C study, Cimzia in combination with methotrexate showed a rapid onset of response, sustained effects in reducing the signs and symptoms of rheumatoid arthritis and improving physical function compared with methotrexate alone with an acceptable safety profile in Chinese patients with rheumatoid arthritis and an inadequate response to methotrexate. UCB also included in the submission specific pregnancy and lactation information, based on findings from two first-of-their-kind studies in women of childbearing age, CRIB and CRADLE, together with pregnancy outcomes data.

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 evidence from clinical studies from conception to late pregnancy and lactation.

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