J&J's Tremfya Wins NMPA Approval for Crohn's Disease Treatment

J&J’s Tremfya Wins NMPA Approval for Crohn’s Disease Treatment

Johnson & Johnson (J&J, NYSE: JNJ) announced that its Tremfya (guselkumab) has received marketing approval from China’s National Medical Products Administration (NMPA) for treating moderate to severe active Crohn’s disease (CD) in adults who have not responded adequately to traditional therapies or biologics.

Drug Profile
Tremfya, an interleukin-23 monoclonal antibody, was previously approved in China for moderate to severe plaque psoriasis. The new approval is supported by data from two Phase III trials in the GALAXI program, which showed Tremfya outperformed placebo and Stelara (ustekinumab) in improving endoscopic outcomes for CD patients.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry