Genor Biopharma announces China NMPA approval for GB242, infliximab
Shanghai, China, March 1, 2022 - Genor Biopharma (Stock code: 6998.HK) announced today that GB242 (infliximab) has received approval from China’s National Medical Products Administration (NMPA) for the treatment of Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriasis, Adult Ulcerative Colitis, Adult and Pediatric Crohn's Disease and Fistulising Crohn’s Disease.
The NDA approval of GB242 is based on a Phase 3 clinical trial in China to evaluate the safety and efficacy of GB242 compared to Remicade® in adult patients with Rheumatoid Arthritis.
“NMPA approval of GB242, the company’s first commercial drug, will bring more treatment options to Chinese patients,” said Dr. GUO Feng, Chairman of the Board and Chief Executive Officer, Genor Biopharma. “It is also an important milestone in Genor Biopharma's development and a successful example of the close cross-functional collaboration and excellent execution. I would like to thank all the patients and researchers who contributed to the successful clinical development of GB242, as well as the regulatory authorities for the thorough, professional and effective review to address the urgent and unmet medical needs of the vast number of Chinese patients.”
About GB242 (infliximab)
GB242 (infliximab) is biosimilar to Remicade (infliximab). Similar to Remicade, GB242 is able to bind to TNF-α at low doses and thus suppresses the body’s natural response to TNF-α and ameliorates inflammatory reaction and autoimmune disease. The Phase 3 trial enrolled 570 patients and the primary endpoint of the study was ACR20 at week 30. Based on the study results, GB242 showed equivalent efficacy compared with Remicade, and no significant difference of immunogenicity between GB242 and Remicade.