RemeGen’s Telitacicept Receives NMPA Approval for Clinical Trial in IgG4 Related Diseases

RemeGen (HKG: 9995), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate telitacicept in IgG4 related diseases (IgG4 RD), which are at risk of recurrence.

Telitacicept is a novel recombinant fusion protein that targets both the B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). It can inhibit the maturation and differentiation of B cells, reduce the secretion of autoantibodies, and better control the activity of diseases such as pSS. The drug was conditionally approved in China for the treatment of systemic lupus erythematosus (SLE) in March 2021 and received full approval in November 2023. IgG4 related disease (IgG4-RD) is an immune-mediated chronic inflammatory condition with fibrosis that can affect multiple parts of the body, including the pancreas, bile ducts, and salivary glands. The disease typically progresses gradually in most patients, potentially leading to irreversible organ damage.- Flcube.com

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