China-based pharma firm RemeGen (HKG: 9995) has announced the conclusion of a Phase III confirmatory study for its fusion protein drug telitacicept in systemic lupus erythematosus (SLE) in China, releasing preliminary data. The study enrolled 335 patients, randomized to receive telitacicept (160mg) or placebo via subcutaneous injection once per week for 52 weeks.
Study Results and Significance
Preliminary results showed that patients treated with telitacicept produced a higher SLE disease activity index-4 (SRI-4) results at week 52 than placebo (82.6% vs 38.1%, P < 0.001). All sensitivity analysis results indicated that telitacicept produced a significantly higher SRI-4 than placebo (P < 0.001), confirming that the primary endpoint was reached. These results were consistent with earlier studies in China.
Drug Overview and Market Access
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 to treat SLE in March 2021, marking the first domestic SLE drug in the country. RemeGen set a standard retail price of RMB 2,586 ($395) per shot on March 31, the day it was officially launched into the market. The drug was included in the National Reimbursement Drug List (NRDL) at the end of 2021.
Future Outlook
The positive Phase III results for telitacicept underscore RemeGen’s commitment to advancing innovative treatments for SLE. With its conditional approval and inclusion in the NRDL, telitacicept is well-positioned to address significant unmet needs in the treatment of systemic lupus erythematosus.-Fineline Info & Tech
