Sanofi's (SNY.US) nanobody-based biologics candidate has been approved for clinical trials in China.

The National Medical Products Administration's (NMPA) Center for Drug Evaluation and Research (CDE) recently announced that Sanofi's (SNY.US) SAR442970 injection, a Class 1 new drug, has been granted a clinical trial approval, which is intended for the treatment of adult and adolescent patients aged 16 and above with primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD). According to public information, SAR442970 is a dual-specificity nanobody (VHH) targeting TNFα and OX40L, which is currently in Phase 2 clinical trials worldwide. This is the first time the product has been approved for an IND in China. SAR442970 injection is a dual-specificity antibody developed based on Nanobody technology, targeting TNFα and OX40L. The potential of TNFα and OX40L in inflammation and autoimmune diseases has been validated by a series of clinical trials. FSGS is a type of chronic kidney disease mediated by APOL1. The protein produced by the gain-of-function mutation of the APOL1 gene causes podocyte damage. This damage disrupts the normal filtration function of the kidney, leading to proteinuria and rapid progression of kidney disease. Podocyte damage is closely related to a variety of glomerular diseases, including FSGS and MCD. The approval of SAR442970 injection for clinical trials in China means that the product is about to enter the clinical research stage in China.