RemeGen (HKG: 9995), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has granted full approval for its drug telitacicept, which is used in combination with methotrexate for the treatment of moderate to severe rheumatoid arthritis (RA) patients who have not responded well to methotrexate alone. Additionally, the NMPA has approved the fusion protein drug for clinical studies in primary membranous nephropathy (PMN).
The transition from conditional to full approval was supported by the positive outcomes of a Phase III study, which was a randomized, double-blinded, placebo-controlled, multi-center trial involving 479 RA patients. The study evaluated the efficacy and safety of telitacicept in combination with methotrexate. The results indicated that telitacicept significantly improved the ACR20 response rate, with 67.4% of patients responding at 24 weeks and 72.2% at 48 weeks. It also delayed joint structural damage, with 92.8% of patients showing no imaging progression at 24 weeks and 89.9% at 48 weeks. Furthermore, telitacicept improved inflammation levels and physical function, providing pain relief and showing a consistent safety profile.
In the case of PMN, previous case reports have demonstrated the successful use of telitacicept in treating patients with membranous nephropathy, including those with concurrent HIV infection or those who have failed multiple treatments. The drug has shown the potential for complete remission of urinary protein in such cases.
Telitacicept, a novel recombinant fusion protein that targets both B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL), was conditionally approved in China for the treatment of systemic lupus erythematosus (SLE) in March 2021, with full approval granted in November 2023. The drug is included in the National Reimbursement Drug List (NRDL) and has ongoing clinical studies for primary Sjogren’s syndrome, myasthenia gravis, and other indications.- Flcube.com
