君实生物偌考奇拜单抗注射液新药上市申请获得受理

Core Viewpoint - Junshi Biosciences has received the acceptance notice from the National Medical Products Administration for its new drug application of Rocabotamab injection, aimed at treating moderate to severe plaque psoriasis in adult patients suitable for systemic therapy or phototherapy [1] Group 1 - The product Rocabotamab is a recombinant humanized anti-IL-17A monoclonal antibody injection [1] - The acceptance of the new drug application marks a significant step for Junshi Biosciences in expanding its product portfolio in the dermatology sector [1] - As of the announcement date, all participants in the Phase II clinical study of Rocabotamab for treating active ankylosing spondylitis have completed treatment and entered the safety follow-up period [1]