RemeGen's Telitacicept (RC18) Granted Fast Track Designation by United States FDA for Treatment of Primary Sjögren's Syndrome

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RemeGen Co. receives Fast Track Designation from the FDA for its innovative drug Telitacicept to treat primary Sjögren's syndrome. Telitacicept is a dual-target fusion protein drug that inhibits B-cell overexpression, addressing autoimmune diseases. Phase III clinical trials are ongoing in China.

YANTAI, China, April 2, 2024 /PRNewswire/ -- RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, obtained Fast Track Designation (FTD) by the United States Food and Drug Administration (FDA) recently for its innovative BLyS/APRIL dual-target fusion protein drug, Telitacicept (RC18), independently developed by RemeGen for the treatment of patients with primary Sjögren's syndrome (pSS). The FDA grants FTD to accelerate the development and review of new drugs that have the potential to treat life-threatening conditions and address unmet medical needs.

Primary Sjögren's syndrome (pSS) is a common rheumatic disease characterized by autoimmune exocrinopathy that clinically manifests as dry eyes and mouth caused by glandular dysfunction as a result of autoimmune damage with multiple organ systems also at risk of being affected. Studies have shown that B-cells are key immune cells involved in the pathogenesis of pSS, and excessive activation of B-cells is a pathogenic indicator of pSS that has long been regarded as a key target for intervention.

Independently developed by RemeGen, Telitacicept is an innovative BLyS/APRIL dual-target fusion protein drug that simultaneously inhibits the overexpression of two cytokines, B-cell lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). Telitacicept prevents abnormal differentiation and maturation of B-cells through a two-pronged approach, thereby treating various autoimmune diseases mediated by B-cells. In December 2023, Telitacicept was granted Investigational New Drug (IND) by the FDA for the treatment of active pSS in adults. A phase III clinical trial for this indication is currently underway in China.

Dr. Jianmin Fang, CEO of RemeGen, commented, "As the first fusion protein drug of its kind independently developed by RemeGen, we are delighted the FDA has recognized Telitacicept for fast track designation. It has performed well in clinical studies for multiple indications that have been marketed in China, including primary Sjögren's syndrome (pSS) and systemic lupus erythematosus (SLE) with rheumatoid arthritis, igA nephritis, and myasthenia gravis (MG) in the pipeline. Multiple Phase III clinical trials are progressing smoothly both domestically and abroad and we are accelerating global development of multiple indications of Telitacicept, and we are confident of cementing a leadership position in B-cell-mediated autoimmunity drugs."

About Telitacicept (RC18) 

Telitacicept (RC18) is RemeGen's proprietary novel fusion protein for the treatment of autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G(IgG). Telitacicept targets two cell-signaling molecules critical for B-lymphocyte development: B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases. It was granted completed marketing approval by China's National Medical Products Administration (NMPA) to treat systemic lupus erythematosus (SLE) in November 2023.

About RemeGen Co. Ltd.

Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices throughout China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases.

For more details, please visit: www.remegen.com

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SOURCE RemeGen Co., Ltd

FAQ

What is the Fast Track Designation received by RemeGen Co. for its drug Telitacicept?

RemeGen Co. obtained Fast Track Designation (FTD) from the FDA for its innovative BLyS/APRIL dual-target fusion protein drug, Telitacicept, to treat patients with primary Sjögren's syndrome (pSS).

What is the purpose of Fast Track Designation by the FDA?

The FDA grants Fast Track Designation to accelerate the development and review of new drugs that have the potential to treat life-threatening conditions and address unmet medical needs.

What is primary Sjögren's syndrome (pSS)?

Primary Sjögren's syndrome (pSS) is a common rheumatic disease characterized by autoimmune exocrinopathy that clinically manifests as dry eyes and mouth due to glandular dysfunction.

What is Telitacicept and how does it work?

Telitacicept is an innovative BLyS/APRIL dual-target fusion protein drug developed by RemeGen that inhibits the overexpression of B-cell lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL) to prevent abnormal differentiation and maturation of B-cells.

What clinical trial status does Telitacicept have?

In December 2023, Telitacicept was granted Investigational New Drug (IND) by the FDA for the treatment of active pSS in adults. A phase III clinical trial for this indication is currently underway in China.

Who is the CEO of RemeGen Co. and what did he comment on the FDA's Fast Track Designation?

Dr. Jianmin Fang, CEO of RemeGen, expressed delight in the FDA recognizing Telitacicept for fast track designation, highlighting its performance in clinical studies for multiple indications and the ongoing Phase III trials domestically and abroad.