By Fineline Cube 
China-based pharmaceutical firm RemeGen (HKG: 9995) announced that the China National Intellectual Property Administration has approved a 1,827 – day patent term extension (PTE) for the core patent of telitacicept (“Optimized TACI – Fc Fusion Protein”, Patent No. ZL200710111162.2). The patent expiry date has been extended from June 15, 2027 to June 15, 2032.
Telitacicept’s Mechanism and Approval
Telitacicept is a novel recombinant fusion protein targeting both B lymphocyte stimulator (BLyS) and a proliferation – inducing ligand (APRIL). By simultaneously inhibiting these two key cytokines, it prevents abnormal B – cell differentiation and maturation, making it effective for treating autoimmune diseases. The drug was conditionally approved in China for systemic lupus erythematosus (SLE) in March 2021, with this status converted to full approval in November 2023.
Patent Extension Process
The drug underwent two PTE application attempts. The first filing was made in June 2021 but was rejected due to the conditional approval status. It was resubmitted early last year and approved following full SLE approval. With this extension, telitacicept will enjoy approximately 11 years and 3 months of patent protection for the SLE indication from its initial approval date.-Fineline Info & Tech