Core Viewpoint - Junshi Biosciences (01877) has received acceptance for its new drug application for the injection of Rocabotilumab, a recombinant humanized anti-IL-17A monoclonal antibody, aimed at treating moderate to severe plaque psoriasis in adult patients suitable for systemic therapy or phototherapy [1] Group 1 - The National Medical Products Administration has issued an acceptance notice for the new drug application of Rocabotilumab [1] - Rocabotilumab is a specific anti-IL-17A monoclonal antibody developed by the company [1] - IL-17A is a multifunctional cytokine closely related to the development of autoimmune diseases such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis [1] Group 2 - Rocabotilumab works by binding with high affinity to IL-17A and selectively blocking its interaction with receptors IL-17RA/IL-17RC, thereby inhibiting the activation of downstream signaling pathways and the release of inflammatory factors [1] - As of the date of the announcement, all participants in the Phase II clinical study of Rocabotilumab for the treatment of active ankylosing spondylitis have completed treatment and entered the safety follow-up period [1]
君实生物(01877):偌考奇拜单抗注射液新药上市申请获得受理