Rongchang Bio applies for market launch of new drug for Sjögren's Syndrome

Recently,Rongchang Bio (688331.SH/09995.HK) announced: The marketing application for its globally pioneering BLyS/APRIL dual-target fusion protein innovative drug, Telitacicept, used to treat Sjögren's syndrome, has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).The first biologic drug in the world to apply for marketing in the field of Sjögren's syndrome.

Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocytic infiltration and exocrine gland damage. In addition to persistent dry mouth and dry eyes caused by salivary and lacrimal gland dysfunction, it can also affect multiple systemic organs.

Existing studies show that the prevalence of Sjögren's syndrome in China is less than 1%, with some research suggesting a range of 0.29% to 0.77%. The prevalence among the elderly is 3% to 4%, but the condition can occur at any age.Sjögren's syndrome occurs more frequently in women, with approximately 90% of patients being female. Some scholars speculate that it is related to estrogen.

Studies show that the overactivation of autoreactive B cells is an important pathological basis for the development of Sjögren's syndrome. Telitacicept, a novel dual-target fusion protein independently developed by the company, can simultaneously target and inhibit the overexpression of B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), effectively preventing the abnormal differentiation and maturation of B cells. It has demonstrated good efficacy and safety in both clinical trials and real-world studies.