RemeGen Marks World Lupus Day 2024 by Enhancing Lupus Awareness through Key Information Sharing

The biotechnology company RemeGen Co. Ltd. continues to offer hope to systemic lupus erythematosus (SLE) patients around the world through its latest advancements in the proprietary novel fusion protein drug, Telitacicept. On May 10, 2024, coinciding with World Lupus Day, RemeGen shared significant updates on Telitacicept (RC18), the world’s first approved dual-target fusion protein drug for SLE, highlighting its ongoing efforts to raise awareness about lupus and its impact on millions worldwide.

Dr. Jianmin Fang, CEO of RemeGen, emphasized the importance of advocating for improved treatment options for lupus on this day. He highlighted that World Lupus Day is an opportunity to bring attention to the severity of the disease and to demonstrate how technological advancements and global solidarity can aid in combating it. He noted that their development of Telitacicept represents a beacon of hope for millions suffering from lupus, transforming their lives through this medical breakthrough.

Lupus is a chronic autoimmune disease characterized by long-term damage to various organs. Often referred to as an "incurable cancer," its symptoms range from widespread rashes and prolonged fevers to severe pain and damage to the kidneys, respiratory, and nervous systems. Although the prognosis for SLE is generally poor, advancements in treatment have improved the 10-year survival rate of SLE patients from under 50% to between 60% and 70%, helping transition the disease from being highly fatal to more manageable and chronic.

RemeGen faced substantial challenges in developing new SLE treatments, with a dedicated research period spanning from 2008 to 2021. In March 2021, Telitacicept was approved in China, setting a milestone as the first dual-target biological drug for SLE. The drug uniquely inhibits two cytokines, a B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), showcasing innovative targets and mechanisms that position it as a potential best-in-class treatment.

Traditionally, most lupus patients have relied on steroids for treatment despite their adverse side effects, such as obesity, hirsutism, hypertension, hypokalemia, and gastric ulcers. These side effects are particularly impactful for the primary demographic affected by SLE, young women aged 18-45. The approval of Telitacicept as the first dual-target biological drug represents a significant breakthrough, offering a more effective treatment with fewer negative consequences.

Phase III clinical studies of Telitacicept demonstrated its efficacy, with the 160mg dose group achieving a significantly higher SLE responder index (SRI) compared to the placebo group (82.6% vs 38.1%). This data underscores its effectiveness as a treatment option for SLE.

Telitacicept was included in China’s National Medical Insurance Drug List in January 2022 and successfully renewed in late 2023. Additionally, key findings from a Phase Ib clinical study were published in the Annals of The Rheumatic Diseases, the leading rheumatology journal. In the United States, the FDA has designated Telitacicept for fast track review, and a global multi-center Phase III clinical study has been approved by the European Union and China's CDE, marking rapid progress in its global clinical development.

As part of the World Lupus Day 2024 celebration, RemeGen encourages sharing on social media to raise awareness about lupus and Telitacicept, aiming to make lupus more visible globally in 2024 and beyond.

Founded in 2008, RemeGen is a prominent Chinese biopharmaceutical company dedicated to addressing unmet clinical needs in life-threatening illnesses. With research facilities and offices across China and the United States, RemeGen focuses on developing and commercializing innovative biological drugs for autoimmune, oncology, and ophthalmic diseases. Telitacicept, their proprietary fusion protein, targets critical cell-signaling molecules involved in B-lymphocyte development, effectively reducing autoimmune responses linked to multiple autoimmune diseases.