Biotech company RemeGen commemorates International Self-Care Day with health initiatives

YANTAI, China, July 24, 2022 /PRNewswire/ — July 24 marks International Self-Care Day, emphasizing that self-care is an essential component of well-being. On this special day, RemeGen Co., Ltd. (9995.HK, SHA: 688331), a commercial-stage biotechnology company, advocates an active and healthy lifestyle as a way to maintain a high quality of life.

RemeGen is actively developing new drugs along multiple pipelines and has made tremendous progress in its treatment of systemic lupus erythematosus (SLE) and Sjögren’s syndrome (SS). In addition, 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 Catalog.

The global Phase III clinical trial for telitacicept, a treatment for SLE, has just completed enrolling 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 phase of rapid advancement.

Additionally, a major clinical study on the safety and efficacy of telitacicept as a treatment for childhood refractory SLE (cSLE) has been published in Lupus, the only international journal devoted exclusively to lupus and related disorders.

CSLE is a systemic autoimmune disease characterized by multiple organ damage and the presence of large numbers of autoantibodies in the body. Highly heterogeneous cSLE has a more acute onset, a higher incidence of organ damage (particularly renal), a more prolonged disease course, and a relatively poor prognosis. Among them, fatal lupus nephritis (LN) is also a common clinical manifestation of SLE. The study is a controlled before-and-after trial of telitacicept aimed at accumulating experience for future multicenter clinical studies of cSLE and/or LN in children.

Telitacicept in combination with standard therapy significantly improves SRI-4 response rates in pediatric patients with SLE, reduces glucocorticoid doses in refractory cSLE, and shows efficacy in LN. No obvious adverse events occurred during the study period and drug-related adverse events were controllable. This study suggests that the efficacy of telitacicept in children with SLE and LN warrants further investigation.

Similarly, RemeGen’s national phase II clinical study for the treatment of primary Sjögren’s syndrome has achieved positive results. 42 patients were randomly assigned to the 240 mg or 160 mg treatment groups or the placebo group. Results from both the full analysis set and the protocol set showed that the changes in ESSDAI scores of patients in both 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 disease activity.

Currently, Sjögren’s syndrome lacks satisfactory treatment and evidence-based effective medications for dryness, fatigue, pain, or damage to internal organs. According to a Frost & Sullivan report, medications that can relieve symptoms include cholinergic agonists, corticosteroids, and immunosuppressants. Corticosteroids and immunosuppressants can cause extensive non-selective immunosuppression, usually involving serious 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 Scientific Director of RemeGen. “In December 2021telitacicept has been officially included in the 2021 National Medical Insurance Drug Reimbursement Catalog, 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 patients with autoimmune diseases.

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 diseases. 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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About telitacicept (RC18)

Telitacicept is a novel, patented fusion protein for the treatment of autoimmune diseases formulated using the extracellular domain of human transmembrane activator and modulator calcium receptor and cyclophilin ligand interactor (TACI) and fragment domain crystallizable (Fc) of human immunoglobulin G (IgG).

Telitacicept targets two cell signaling molecules essential for B-cell development: B-cell stimulator (BLyS) and proliferation-inducing ligand (APRIL), enabling it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases. diseases. RemeGen is currently conducting multiple Phase II and III clinical studies of 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. .

Forward-looking statements

This press release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend” and similar expressions, with respect to RemeGen, are intended to identify certain of these forward-looking statements. RemeGen does not intend to regularly update these forward-looking statements.

These forward-looking statements are based on RemeGen’s management’s existing beliefs, assumptions, expectations, estimates, projections and understandings regarding future events at the time such statements are made. These statements are not guarantees of future developments and are subject to risks, uncertainties and other factors, some of which are beyond RemeGen’s control and are difficult to predict. Accordingly, actual results may differ materially from the information contained in the forward-looking statements due to changes or future developments in our business, RemeGen’s competitive environment and political, economic, legal and social conditions.

RemeGen, the directors and employees of RemeGen assume (a) no obligation to correct or update any forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements do not materialize or prove to be incorrect.

SOURCE RemeGen Co.,Ltd

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