Remegen (688331.SH/09995.HK), a China-based pharmaceutical company, announced on Wednesday that its global first-in-class BLyS (BAFF)/APRIL dual-target fusion protein drug, Telitacicept, met the primary endpoint in its Phase III clinical trial for the treatment of primary Sjogren's syndrome (pSS) in China, as per the pre-specified study protocol.

The company says that it intends to promptly submit a Biologics License Application (BLA) to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) and plans to present the detailed data at major international academic conferences in due course.

According to Remegen, Telitacicept is the world's first BLyS/APRIL dual-target fusion protein drug to complete a Phase III study in the Sjogren's syndrome treatment field.

This multicentre, randomised, double-blind, placebo-controlled Phase III clinical study aimed to evaluate the efficacy and safety of Telitacicept in patients with primary Sjogren's syndrome. The primary endpoint was the change from baseline in the ESSDAI score (the gold standard for measuring Sjogren's syndrome disease activity) at Week 24. The company says that clinical results demonstrated that Telitacicept sustainably and effectively improved the clinical symptoms of Sjogren's syndrome patients, while showing favourable safety profile.

Sjogren's syndrome is a chronic inflammatory autoimmune disease characterised primarily by lymphocyte infiltration and damage to exocrine glands.

In China, Telitacicept has been recommended by multiple authoritative guidelines, including the Chinese Clinical Practice Guideline for Off-Label Use of Drugs in Sjogren's Syndrome, the Chinese Expert Consensus on B-Cell Targeted Therapy for Rheumatic Immune Diseases, and the Multidisciplinary Expert Consensus on the Diagnosis and Treatment of Primary Sjogren's Syndrome. Internationally, Telitacicept's Sjogren's syndrome indication has been granted Fast Track designation by the US FDA and the approval to initiate a global multicenter Phase III clinical trial.