China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for its novel fusion protein telitacicept in myasthenia gravis (MG). The FDA has also awarded telitacicept fast-track status, highlighting the potential significance of this therapy in addressing unmet medical needs.
Telitacicept: Mechanism and Development
Telitacicept is a novel recombinant fusion protein targeting both B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). The drug was conditionally approved in China in March 2021 for the treatment of systemic lupus erythematosus (SLE) and was included on the National Reimbursement Drug List (NRDL) at the end of 2021. Telitacicept is also undergoing clinical studies in multiple autoimmune diseases, positioning it as a potential treatment option for a range of conditions.
Regulatory Milestones and Future Outlook
In November 2022, China’s regulators awarded telitacicept breakthrough therapy designation (BTD) for the treatment of myasthenia gravis (MG). The FDA’s approval for a Phase III study and the fast-track designation underscore the drug’s potential to significantly improve outcomes for patients with MG. These milestones highlight RemeGen’s commitment to advancing innovative therapies in autoimmune diseases.-Fineline Info & Tech
