Telitacicept Meets Primary Endpoint in Phase III Trial for Primary Sjögren's Syndrome in China

Rhea-AI Summary

RemeGen (REGMY) announced that its novel drug Telitacicept successfully met the primary endpoint in its Phase III clinical trial for primary Sjögren's syndrome (pSS) treatment in China. The drug, a first-in-class BLyS/APRIL dual-target fusion protein, demonstrated sustainable efficacy in improving clinical symptoms while maintaining a favorable safety profile.

The multicenter, randomized, double-blind, placebo-controlled study measured changes in ESSDAI scores at Week 24. Telitacicept targets a significant market, with 4-10 million potential patients in China alone, where the prevalence rate is 0.3% to 0.7%. The company plans to submit a Biologics License Application to China's NMPA and has already received Fast Track designation from the US FDA for global trials.

Positive

• Successfully met primary endpoint in Phase III trial for Sjögren's syndrome
• First BLyS/APRIL dual-target fusion protein to complete Phase III study in this field
• Addresses large market potential of 4-10 million patients in China
• Received FDA Fast Track designation for global development
• Already recommended in multiple Chinese clinical practice guidelines

Negative

• Will require additional global trials for markets outside China
• Faces complex regulatory pathway with multiple jurisdictions

YANTAI, China, Aug. 13, 2025 /PRNewswire/ -- On August 13th, Remegen (688331.SH/09995.HK) announced 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 Sjögren's syndrome (pSS) in China, as per the pre-specified study protocol. The company will promptly submit a Biologics License Application (BLA) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and plans to present the detailed data at major international academic conferences in due course. Telitacicept is the world's first BLyS/APRIL dual-target fusion protein drug to complete a Phase III study in the Sjögren's syndrome treatment field.

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

Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized primarily by lymphocyte infiltration and damage to exocrine glands. Beyond persistent dry mouth and dry eyes caused by salivary and lacrimal gland dysfunction, it can also affect multiple organ systems. The prevalence rate of Sjögren's syndrome in China is 0.3% to 0.7%, or 4-10 million potential patient pool. The clinical manifestations of this disease are complex, and for a long time, there has been a lack of effective treatment methods rigorously validated by evidence-based medicine.

Research indicates that the overactivation of autoreactive B cells is a crucial pathological basis for Sjögren's syndrome. Telitacicept, a novel dual-target fusion protein independently developed by Remegen, simultaneously inhibits the overexpression of B Lymphocyte Stimulator (BLyS) and A Proliferation-Inducing Ligand (APRIL). It effectively blocks the abnormal differentiation and maturation of B cells and has demonstrated favorable efficacy and safety in both clinical and real-world studies.

In China, Telitacicept has been recommended by multiple authoritative guidelines, including the Chinese Clinical Practice Guideline for Off-Label Use of Drugs in Sjögren'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 Sjögren's Syndrome. Internationally, Telitacicept's Sjögren'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.

 

FAQ

What were the results of RemeGen's Telitacicept Phase III trial for Sjögren's syndrome?

Telitacicept met its primary endpoint in the Phase III trial, showing sustainable improvement in clinical symptoms with a favorable safety profile, measured by ESSDAI score changes at Week 24.

How many potential patients could benefit from RemeGen's Telitacicept in China?

Based on the 0.3% to 0.7% prevalence rate in China, approximately 4-10 million patients could potentially benefit from Telitacicept treatment.

What makes RemeGen's Telitacicept unique in treating Sjögren's syndrome?

Telitacicept is the world's first BLyS/APRIL dual-target fusion protein to complete a Phase III study for Sjögren's syndrome, targeting both B Lymphocyte Stimulator and A Proliferation-Inducing Ligand.

What regulatory approvals has RemeGen's Telitacicept received?

Telitacicept has received Fast Track designation from the US FDA and is preparing for BLA submission to China's NMPA following successful Phase III results.

How does RemeGen's Telitacicept work in treating Sjögren's syndrome?

Telitacicept works by simultaneously inhibiting BLyS and APRIL overexpression, effectively blocking abnormal B cell differentiation and maturation, which is crucial in Sjögren's syndrome pathology.