▎WuXi AppTec Content Team Report

The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration recently announced,Sanofi (Sanofi)The Phase 1 new drug SAR442970 Injection, developed by Sanofi, has received implied permission for clinical trials and is intended for the treatment ofAdults and adolescents aged 16 years and above with primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD)。Public information shows that SAR442970 is aBispecific Nanobody (VHH) Targeting TNFα and OX40L, which is currently in Phase 2 clinical trials internationally.This is the first time that the product has been approved for an IND in China.

Screenshot source:CDE Official Website

SAR442970 Injection is a bispecific antibody developed based on Nanobody technology.Targeting TNFα and OX40L。The application potential of TNFα and OX40L in inflammation and autoimmune diseases has been clinically validated in a series of trials. Sanofi has previously developed assets targeting both pathways and has already advanced programs involving them.Monoclonal Antibody Targeting OX40LamlitelimabSanofi believes that the drug has the potential to become a blockbuster; as well as developed an oral TNFα inhibitor referred to as the "next-generation oral medication."SAR441566。

According toClinicalTrialsOfficial website, currently, Sanofi is conducting two Phase 2 clinical trials internationally for SAR442970 injection, one of which is to evaluate SAR442970 compared with placebo in the treatment ofAdult Suppurative HidradenitisEfficacy and safety. In this study,The patient will receive an injection of SAR442970 every two weeks (Q2W).. Another study will evaluate SAR442970 compared with two other positive control drugs in treating patients aged 16 to 75.Primary Focal Segmental Glomerulosclerosis (FSGS) or Primary Minimal Change Disease (MCD)The efficacy and safety of the patients, which is precisely the indication for which the product has been approved for clinical trials in China this time.

Focal Segmental Glomerulosclerosis (FSGS) is a type of APOL1-mediated chronic kidney disease. Hereditary gain-of-functionAPOL1Protein generated by gene mutations can lead to podocyte injury. This injury disrupts the normal filtration function of the kidneys, causing proteinuria and rapidly progressive kidney disease. Podocyte damage is closely associated with various glomerular diseases, including FSGS and minimal change disease (MCD).

The approval of SAR442970 injection for clinical use in China marks that the product is about to enter the clinical research stage in China.

According to the pipeline information on Sanofi's official website, the company has multiple nanobodies based on Nanobody technology under development. In addition to the recently approved SAR442970 injection for clinical trials, several other products have also made progress in China, including lunsekimig (targeting IL-13 and TSLP).Nanobody), SAR444200 (anti-GPC3/TCR nanobody), etc., have all entered the clinical research stage in China.

[1] Center for Drug Evaluation, National Medical Products Administration of ChinaWebsite. Retrieved Dec 31, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2] Sanofi Official Website. From https://www.sanofi.com/en/our-science/our-pipeline