By Fineline Cube 
China-based pharmaceutical firm RemeGen (HKG: 9995) announced the third indication approval from the National Medical Products Administration (NMPA) for its telitacicept. The drug is now approved for the treatment of adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG) in combination with conventional therapies. This follows previous approvals for systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) in China.
Telitacicept Mechanism
Telitacicept is a novel recombinant fusion protein targeting both B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). It has received Breakthrough Therapy Designation and priority review status in China, as well as Orphan Drug Designation and fast-track designation in the US for the treatment of MG.
Clinical Trial Results
Data from a Phase III study demonstrated that after 24 weeks of treatment, 98.1% of patients in the telitacicept group achieved a ≥ 3-point improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score, compared to 12.0% in the placebo group. The drug also showed a good safety profile. RemeGen is currently advancing a global multi-center Phase III study for telitacicept in MG.-Fineline Info & Tech