RemeGen Co., Ltd. (RemeGen, 9995.HK) announces that telitacicept (RC18, Brand Name: 泰爱®), the dual targeted TACI-Fc fusion protein independently developed in-house by the Company, has been granted conditional marketing approval by the National Medical Products Administration of China (NMPA) for the treatment of patients with Systemic Lupus Erythematosus (SLE).
SLE has one of the highest mortality and disability rates among autoimmune rheumatic diseases. According to Frost & Sullivan, the global SLE prevalence was approximately 7.7 million in 2019, estimated to reach 8.6 million by 2030. In China, there were approximately 1.0 million SLE patients in 2019, and the prevalence is estimated to grow to approximately 1.1 million by 2030. According to Frost & Sullivan, the market size of global SLE biological therapeutics is estimated to grow at a CAGR of 26.8% from US$0.8 billion in 2019 to US$10.8 billion by 2030.
Telitacicept is the second innovative biologics drug approved to treat SLE in China over the past 60 years. 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-cell 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. RemeGen is currently conducting a number of phase II or III clinical studies for telitacicept to treat other indications within the autoimmune disease area, in an attempt to address the significant unmet or underserved medical needs in this therapeutic area.