RemeGen's Telitacicept Achieves Success in Phase III Trial for Sjögren's Syndrome
On August 13, 2025, RemeGen Co., Ltd. announced a significant milestone in the treatment of primary Sjögren's syndrome with the successful results of its Phase III clinical trial for the novel drug Telitacicept. This drug, recognized as a groundbreaking therapeutic option, is a dual-target fusion protein that specifically aims to inhibit both B Lymphocyte Stimulator (BLyS) and A Proliferation-Inducing Ligand (APRIL). The trial results confirm that Telitacicept met its primary endpoint, demonstrating efficacy and safety in patients suffering from primary Sjögren's syndrome.
The Phase III study was meticulously designed as a multicenter, randomized, double-blind, placebo-controlled trial, aiming to assess the potential of Telitacicept in alleviating the symptoms of Sjögren's syndrome. The primary endpoint was based on the change from baseline in the ESSDAI (EULAR Sjögren’s Syndrome Disease Activity Index) score at Week 24. The results of this pivotal trial indicated that Telitacicept significantly improved clinical symptoms while maintaining a positive safety profile for patients.
Primary Sjögren's syndrome is a chronic autoimmune condition characterized by the immune system attacking its glands, particularly the salivary and lacrimal glands, leading to persistent dry mouth and dry eyes. In some cases, this condition can also have systemic implications, affecting various organ systems. In China, the prevalence of this syndrome ranges between 0.3% and 0.7%, translating into a potential patient pool of approximately 4 to 10 million individuals. Historically, the management of this condition has been challenging, with few effective treatments validated through rigorous evidence-based medical research.
The underlying pathology of primary Sjögren's syndrome frequently involves the overactivation of autoreactive B cells. Telitacicept's innovative approach seeks to address this pathology by simultaneously targeting and inhibiting the actions of both BLyS and APRIL, key players in B-cell proliferation and survival. By doing so, the drug effectively stops the abnormal differentiation and maturation of these cells, showcasing promising results in both clinical settings and real-world studies.
In China, Telitacicept has garnered authoritative endorsements, being featured in various clinical practice guidelines such as those from the Chinese Expert Consensus on B-Cell Targeted Therapy for Rheumatic Immune Diseases. Additionally, this drug's indication has received recognition internationally, including Fast Track designation by the U.S. FDA, supporting its global significance in the treatment of Sjögren's syndrome.
As RemeGen prepares to submit a Biologics License Application (BLA) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), the company also plans to present detailed findings from its trials at major international academic conferences. These steps mark important advancements in the quest for effective treatments for Sjögren's syndrome, paving the way for better patient outcomes and enhanced quality of life for those affected by this challenging condition.
The Phase III study was meticulously designed as a multicenter, randomized, double-blind, placebo-controlled trial, aiming to assess the potential of Telitacicept in alleviating the symptoms of Sjögren's syndrome. The primary endpoint was based on the change from baseline in the ESSDAI (EULAR Sjögren’s Syndrome Disease Activity Index) score at Week 24. The results of this pivotal trial indicated that Telitacicept significantly improved clinical symptoms while maintaining a positive safety profile for patients.
Primary Sjögren's syndrome is a chronic autoimmune condition characterized by the immune system attacking its glands, particularly the salivary and lacrimal glands, leading to persistent dry mouth and dry eyes. In some cases, this condition can also have systemic implications, affecting various organ systems. In China, the prevalence of this syndrome ranges between 0.3% and 0.7%, translating into a potential patient pool of approximately 4 to 10 million individuals. Historically, the management of this condition has been challenging, with few effective treatments validated through rigorous evidence-based medical research.
The underlying pathology of primary Sjögren's syndrome frequently involves the overactivation of autoreactive B cells. Telitacicept's innovative approach seeks to address this pathology by simultaneously targeting and inhibiting the actions of both BLyS and APRIL, key players in B-cell proliferation and survival. By doing so, the drug effectively stops the abnormal differentiation and maturation of these cells, showcasing promising results in both clinical settings and real-world studies.
In China, Telitacicept has garnered authoritative endorsements, being featured in various clinical practice guidelines such as those from the Chinese Expert Consensus on B-Cell Targeted Therapy for Rheumatic Immune Diseases. Additionally, this drug's indication has received recognition internationally, including Fast Track designation by the U.S. FDA, supporting its global significance in the treatment of Sjögren's syndrome.
As RemeGen prepares to submit a Biologics License Application (BLA) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), the company also plans to present detailed findings from its trials at major international academic conferences. These steps mark important advancements in the quest for effective treatments for Sjögren's syndrome, paving the way for better patient outcomes and enhanced quality of life for those affected by this challenging condition.
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