China-based RemeGen announced positive Phase III results for its BLyS/APRIL dual-target fusion protein telitacicept in primary Sjögren's syndrome (pSS), meeting primary endpoints in a randomised double-blind trial. The first-in-class biologic demonstrated sustained symptom improvement and favourable safety, prompting plans for a New Drug Application (NDA) submission to China's Centre for Drug Evaluation. Telitacicept simultaneously blocks B-cell activating factors BLyS and APRIL to modulate pathological immune responses underlying this autoimmune disorder affecting 0.3% to 0.7% of China's population.

The success follows RemeGen's USD 4.23 billion licensing deal with Vor Biopharma for ex-China rights to telitacicept, including USD 125 million upfront and warrants. The drug already holds approvals for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and myasthenia gravis in China. Detailed pSS trial data will be presented at upcoming international conferences, potentially establishing telitacicept as the first targeted therapy for this chronic inflammatory condition characterised by salivary gland dysfunction and multi-organ involvement.

PharmCube's NextBiopharm® database shows that fusion proteins are the third most common drug modality among currently active projects in Sjögren's syndrome. Click here to request a free trial for NextBiopharm®.