RemeGen Completes Patient Enrollment in Two Phase III Clinical Trials Using Telitacicept for Treatment of IgA Nephropathy and Primary Sjögren’s Syndrome

YANTAI, China, May 21, 2024 /PRNewswire/ — RemeGen Co. Ltd. (“RemeGen” or “the Company”) (9995.HK, 688331.SH), a commercial-stage biotechnology company, recently announced significant progress of Telitacicept (RC18), that two Phase III clinical trials in China for the treatment of IgA nephropathy and primary Sjögren’s syndrome (pSS) have completed patient enrollments.

Dr. Jianmin Fang, CEO of RemeGen, commented, “This marks further continued progress in RemeGen’s research achievements for the treatment of these two diseases and we remain steadfastly committed to providing patients with more efficient and convenient treatment options. The smooth progress of these two clinical trials is an important milestone on the road to achieving this goal.”

IgA nephropathy is a kidney disease, for which there is currently no cure, caused by the build-up of a germ-fighting protein called immunoglobulin A (IgA) in the kidneys, causing inflammation that can make it harder for the kidneys to filter waste from the blood. A total of 318 patients were enrolled between June 2023 and May 2024 in the clinical study led by Professor Zhang Hong from Peking University First Hospital. It has been designed to evaluate the efficacy and safety of RemeGen’s telitacicept in the treatment of patients with primary IgA nephropathy who are at risk of progression to end-stage kidney disease (ESKD). The study uses pre-filled injections which can provide patients with a more convenient administration method and simplified medication use compared with the approved lyophilized powder injection form of telitacicept for the treatment of systemic lupus erythematosus (SLE).

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. A total of 381 patients were enrolled between the end of 2022 and May 2024 in the clinical study led by Professor Zeng Xiaofeng from Peking Union Medical College Hospital. This study aims to evaluate the efficacy and safety of telitacicept in the treatment of patients with primary Sjögren’s syndrome (pSS) with a primary endpoint of a change in the EULAR Sjögren’s syndrome (SS) disease activity index (ESSDAI) score from baseline at week 24 of treatment. Telitacicept has previously displayed a significant clinical benefit in a randomized, double-blind, placebo-controlled Phase II clinical trial in the treatment of adult patients with pSS that can significantly improve ESSDAI scores and Multidimensional Fatigue Inventory (MFI-20), thereby reducing immunoglobulin levels in patients.

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.

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