YANTAI, China, July 25, 2022 /PRNewswire/ -- The 24th of July marks International Self Care Day, highlighting self-care as an essential component of wellness. On this special day, RemeGen Co., Ltd. (9995.HK, SHA: 688331), a commercial-stage biotechnology company, advocates an active and healthy lifestyle as a means of maintaining a high quality of life.
RemeGen actively develops new drugs along multiple pipelines and has made tremendous progress in its treatment of systemic lupus erythematosus (SLE) and Sjögren's Syndrome (SS). Additionally, the company has also helped many families in China to reduce financial stress and achieve a better quality of life with the official inclusion of telitacicept in the 2021 National Medical Insurance Drug Reimbursement Catalogue.
The global phase III clinical trial for the SLE treatment telitacicept has just completed enrollment for its first patient. The study is a multicenter, randomized, double-blind, placebo-controlled, two-phase trial evaluating the efficacy and safety of telitacicept in patients with moderately to severely active SLE. More than 100 research centers in South America, Europe, Asia, and other parts of the world will participate in this study. This marks telitacicept's progress internationally as it enters a stage of rapid advancement.
Additionally, a major clinical study on telitacicept's safety and efficacy as a treatment for refractory childhood-onset SLE (cSLE) has been published in Lupus, the only international journal devoted exclusively to lupus and related diseases.
CSLE is a systemic autoimmune disease characterized by multiple organ damage and the presence of a large number of autoantibodies in the body. Highly heterogeneous cSLE has a more acute onset, higher incidence of organ damage (especially kidney), a more protracted disease course, and relatively poor prognosis. Among them, fatal lupus nephritis (LN) is also a common clinical manifestation of SLE. The study is a before-and-after controlled trial of telitacicept aiming to accumulate experience for future multi-center clinical studies of cSLE and/or children's LN.
Telitacicept in combination with standard therapy significantly improves SRI-4 response rates in pediatric SLE patients, reduces glucocorticoid doses in refractory cSLE, and shows efficacy in LN. No obvious adverse events occurred during the study period and the related drug adverse events were controllable. This study suggests that the efficacy of telitacicept on children with SLE and LN is worthy of further study.
Likewise, RemeGen's domestic phase II clinical study for the treatment of primary Sjögren's syndrome has achieved positive results. 42 patients were randomly assigned into the 240mg or 160mg treatment groups or the placebo group. The results of the full analysis set and per protocol set showed that the changes in ESSDAI scores of patients in the two telitacicept treatment groups from baseline were significantly different from those in the placebo group. The ESSDAI score is currently the gold standard for measuring Sjögren's syndrome disease activity.
Presently, Sjögren's syndrome lacks a satisfactory treatment and evidence-based effective drugs for dryness, fatigue, pain, or internal organ damage. According to a Frost & Sullivan report, drugs that can relieve symptoms include cholinergic agonists, corticosteroids, and immunosuppressants. Corticosteroids and immunosuppressants can cause extensive non-selective immunosuppression, usually involving severe adverse effects, illustrating a huge unmet need for the treatment of Sjögren's syndrome. Targeted adoption of new biologics based on their pathogenesis such as telitacicept will bring hope for their treatment.
"After decades of research and development, we have brought new treatments to patients with autoimmune diseases that we are proud of," said Dr. Jianmin Fang, CEO and Chief Scientific Officer of RemeGen. "In December 2021, telitacicept was officially included in the 2021 National Medical Insurance Drug Reimbursement Catalogue, giving us more confidence to increase R&D investment, promote clinical trials for more indications, and strive to bring new drugs and treatment opportunities to more autoimmune disease patients."
About RemeGen Co. Ltd.
Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a commercial-stage biotechnology 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.cn
About Telitacicept (RC18)
Telitacicept is a proprietary novel fusion protein for the treatment of autoimmune diseases formulated using 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-cell 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. RemeGen is currently conducting several Phase II and III clinical studies for Telitacicept to treat other autoimmune diseases including SLE, rheumatoid arthritis, neuromyelitis optica spectrum disorder, IgA nephropathy, myasthenia gravis, Sjögren's syndrome and multiple sclerosis to address significant unmet medical needs in this therapeutic area.
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