FDA Grants Fast Track Designation to RemeGen’s Telitacicept as a Treatment for Systemic Lupus Erythematosus
Fast Track designation facilitates development of new therapies that treat serious conditions and fulfill unmet needs for patients
YANTAI, China, (April 15, 2020) – RemeGen today announced that the US Food and Drug Administration (FDA) granted Fast Track designation for RC18, a novel recombinant TACI-Fc (transmembrane activator and calcium modulator and cyclophilin ligand interactor) fusion protein, for the treatment of systemic lupus erythematosus (SLE). With its novel dual-target mechanism, RC18 shows statistically significant improvement for patients at multiple doses.
A drug development program with Fast Track designation is eligible for greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
“SLE is a chronic autoimmune disease which attacks healthy tissue,” said Jianmin Fang, Ph.D., founder and CEO of RemeGen. “With no cure, SLE is estimated to affect between 322,000 and 1.5 million people in the US.i With limited treatment options available for patients, the Fast Track designation gives RemeGen the opportunity to help those impacted by offering a therapy with first-in-class and best-in-class potential.”
The Fast Track designation for RC18 arrives on the heels of RemeGen’s recently completed $100 million plus financing, led by Lilly Asia Ventures and Lake Bleu Capital.
About RC18 (telitacicept)
RC18 is a novel recombinant TACI-Fc (transmembrane activator and calcium modulator and cyclophilin ligand interactor) fusion protein that was developed to treat autoimmune diseases. RC18 has a dual-targeting mechanism that inhibits the development and survival of plasma cells and mature B cells, which are implicated in several autoimmune diseases. RC18 works by binding to two cell-signaling molecules, B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). By only affecting mature B cells, RC18 has minimal impact on early and memory B cells, which are important for normal body immune function. RC18 is currently being studied in several late-stage clinical trials across autoimmune diseases, including systemic lupus erythematosus, rheumatoid arthritis and NMOSD.
RemeGen, Ltd. (“RemeGen”) is a leading biopharmaceutical company in China dedicated to fulfilling unmet medical needs for patients with life-threatening conditions. RemeGen's main focus is research and development, manufacturing and commercialization of novel biologics, most notably monoclonal antibodies (mAb) and antibody-drug conjugates (ADCs). Headquartered in Yantai, Shandong Province, China, RemeGen has labs/offices in Beijing and California. Since its inception in 2008, RemeGen has created more than 10 novel drug molecules that are in various stages of clinical development. Currently, there are two products in late stage clinical development to treat autoimmune and oncology indications.
For more information about RemeGen, please visit: www.remegen.com
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i U.S. National Library of Medicine. Genetics Home Reference. Systemic Lupus Erythematosus. 2020. Available at https://ghr.nlm.nih.gov/condition/systemic-lupus-erythematosus#