Jiayujian (infliximab biosimilar) / Walvax - LARVOL DELTA

Genor Biopharma announces China NMPA approval for GB242, infliximab (GenorBio Press Release) - "Genor Biopharma...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."

Non-US regulatory • Crohn's disease • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis • Ulcerative Colitis

Fine Comparison of the Efficacy and Safety Between GB242 and Infliximab in Patients with Rheumatoid Arthritis: A Phase III Study. (PubMed, Rheumatol Ther) - P3 | "GB242 demonstrated equivalent efficacy to INF at week 30. Moreover, GB242 was well tolerated, with a similar immunogenicity and safety profile comparable to INF."

Clinical • Journal • P3 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology