Telitacicept

The biotech company continues to offer hope to systemic lupus erythematosus (SLE) patients globally by sharing the latest developments of its proprietary novel fusion protein drug Telitacicept YANTAI, China, May 10, 2024 /PRNewswire/ -- RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a commercial-stage biotechnology company, is celebrating World Lupus Day 2024, which falls on May 10, by sharing the latest developments of the world's first approved dual-target new fusion protein drug Telitacicept (RC18). RemeGen continues to raise global awareness of lupus, highlighting its impact on millions of people living with the disease around the world. Dr. Jianmin Fang, CEO of RemeGen, commented, "On World Lupus Day, it is vital that we continue to advocate for improved safe and effective treatments for lupus. On this day every year, RemeGen not only underscores the seriousness of this disease, but also demonstrates how we can fight it together through global solidarity and technological advancement. Our mission is to change the lives of people living with lupus, and our development of Telitacicept is more than just a medical breakthrough, it brings hope to millions of people around the world." Lupus, an autoimmune disease that cannot be completely cured, often causes long-term damage to organs. Referred to as "incurable cancer," lupus's clinical manifestations vary, including large areas of rash, extended days of fever, pain, kidney damage, respiratory and nervous system involvement, among others. SLE can be life-threatening and has a poor prognosis but with the gradual improvement of treatment technology, the 10-year survival rate of SLE patients has gradually increased from less than 50% to between 60% and 70%, marking the transformation of SLE from an acute and highly fatal disease to a chronic and controllable disease. RemeGen's Telitacicept is at the forefront of SLE treatment globally Research and development of new drugs for the treatment of SLE has proven to be extremely challenging but RemeGen persevered for over thirteen years for that from 2008 to 2021. In March 2021, Telitacicept was approved in China, becoming the world's first dual-target biological new drug approved for the treatment of SLE. The drug can simultaneously inhibit two cytokines in the human body, a B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), and is characterized by new targets, structures, and mechanisms, and has shown huge best-in-class potential. For most lupus patients, steroids are still the go-to treatment, but these drugs often cause adverse side effects such as obesity, hirsutism, hypertension, hypokalemia, and gastric ulcers, among others. SLE mostly occurs in young women aged 18-45 and long-term use of steroids can have significant negative impacts on patients. As the world's first dual-target biological new drug approved for the treatment of SLE, the approval of Telitacicept marks a significant breakthrough in the global treatment of the disease. Data from the Phase III confirmatory clinical study of Telitacicept in the treatment of SLE showed that the SLE responder index (SRI) of the 160mg dose group was significantly higher than that of the placebo control group (82.6% vs 38.1%) making it the most efficient treatment for the disease. Telitacicept was included in the National Medical Insurance Drug List in China in January 2022 and was successfully renewed at the end of 2023. In December 2023, key Phase lb clinical study results for this indication were published in the Annals of The Rheumatic Diseases (ARD), the journal with the highest impact factor in rheumatology. In the United States, the indication of Telitacicept for the treatment of systemic lupus erythematosus has been approved by the FDA for fast track designation and a global multi-center Phase III clinical study has been approved by the European Union and CDE, respectively, and is advancing rapidly. Join RemeGen this #WorldLupusDay by sharing on social media to #MakeLupusVisible in 2024 and beyond. 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: About Telitacicept (RC18) Telitacicept (RC18) is RemeGen's proprietary novel fusion protein for the treatments 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. SOURCE RemeGen Co., Ltd

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: SOURCE RemeGen Co., Ltd