The FDA sent a full response letter to Sanofi sutimlimab rejecting its listing application

Compiled on November 14, the FDA issued a full response letter regarding the application for permission for Sanofi supplement C1s inhibitor Sutimlimab biologics.
The reply was that the review body concerned had found certain deficiencies during a pre-licensing examination of the third-party manufacturer responsible for production, but did not mention clinical or safety deficiencies in the application in the reply.
A successful resolution of the review results is required from a third-party manufacturer prior to approving the biologics license application, Sanofi will maintain close contact with the FDA and third-party manufacturers in the future in order to reach a timely solution.
Sutimlimab is an anthogenic monoclonal antibody used to target serine protease C1s in C1 complex, C1 complex is the first step in activating the immune system's classic complement pathway, the potential application is to treat condensation syndrome (CAD), CAD is a rare, serious chronic autoimmune hemolytic disease, in which the immune system in the complement system will mistakenly attack the body's own healthy red blood cells.
Sutimlimab was acquired by Sanofi in 2018 when it bought Bioverativ for $11.6 billion, and before Bioverativ's acquisition, Bioverativ bought Suttimlimab from True North Therapeutics for $400 million in advance.
source: FDA issues Complete Response Letter for sutimlimab, an investigational treatment for hemolysis in adults with cold agglutinin disease