SOUTH SAN FRANCISCO, Calif., Nov. 3, 2022 /PRNewswire/ -- RemeGen Co., Ltd., a leading biopharmaceutical company with fully integrated capabilities in research and discovery, clinical development, manufacturing, and commercialization of biologic drugs, will join the event of American Society of Nephrology (ASN) Kidney Week 2022, hosted from November 3rd. to 6th. Related abstract from Telitacicept (RC18) presented in ASN 2021 and NMOSD abstract will be available from the booth.
About Telitacicept
Telitacicept is a novel fusion protein composed of a transmembrane activator and CAML interactor (TACI) and the Fc portion of IgG, which targets and neutralizes B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). BLyS (also known as B-cell activating factor, or BAFF) and APRIL are both involved in the development of B cells from pre-B lymphocytes to mature B cells, and ultimately to plasma cells, the professional cells producing antibodies, as well as in the co-stimulation of T-cell proliferation under certain conditions. Telitacicept blocks BLyS and APRIL from binding to BAFF-R, BCMA, and TACI receptors expressed on B-cell surface, suppressing the BLyS and APRIL signaling, and inhibiting the development and survival of mature B cells and plasma cells.
Systemic lupus erythematosus (SLE) is the principal indication of Telitacicept. Through priority review, Telitacicept was approved by China National Medical Products Administration (NMPA) and is included in the National Reimbursement Drug List (NRDL). Telitacicept also received FDA Fast Track Designation as a treatment for SLE with an ongoing global Phase III study.
In addition to SLE, the company is actively developing Telitacicept for six other B cell-mediated autoimmune diseases and refractory autoimmune disease with unmet clinical needs in China, including Neuromyelitis optica spectrum disease, rheumatoid arthritis, IgA nephropathy, primary Sjogren's syndrome, relapsing-remitting multiple sclerosis, and systemic myasthenia gravis.
Telitacicept Indicated for IgA Nephropathy
This is a Phase II, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of Telitacicept compared with placebo when added to standard therapy in high-risk for progression IgA nephropathy patients. Participants were centrally randomized 1:1:1 to subcutaneous Telitacicept 160mg, 240mg, and placebo group stratified by proteinuria (<3g/day or ≥3g/day).
The primary endpoint will evaluate the change of proteinuria at week 24. The secondary endpoints will assess the changes in estimated GFR from baseline over 24 weeks and levels of IgA from baseline at week 24. The incidence of adverse events will also be documented. In this trial, Telitacicept is expected to reduce proteinuria in patients with IgA nephropathy and reduce the risk of progression to end-stage renal disease.
About RemeGen
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
Investor Contact
Annaly Godwin
SOURCE RemeGen
Share this article