Sanofi's Class 1 New Drug Amlitelimab Granted Clinical Approval in China for Severe Alopecia Areata

Intelligent Finance APP learned on July 29 that the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that the clinical trial application for Amlitelimab Injection, a Class 1 new drug developed by Sanofi (SNY.US), was approved for the treatment of severe alopecia areata. Amlitelimab is a potential "first-in-class" OX40 signaling pathway blocker with the potential to treat a range of immune-mediated and inflammatory diseases. Sanofi considers it to have blockbuster drug potential. The approval for clinical trials in severe alopecia areata indicates that Sanofi is about to conduct clinical research targeting patients with alopecia areata in China.

According to the Chinese Clinical Trial Registry and Information Disclosure Platform, amlitelimab is undergoing several clinical studies in China for the treatment of atopic dermatitis, as well as a clinical trial for the treatment of systemic sclerosis-associated interstitial lung disease.

It is reported that alopecia areata is a common inflammatory non-scarring hair loss condition, ranking as the second most prevalent hair loss condition globally. According to the ClinicalTrials website, a Phase 3 clinical trial of amlitelimab for the treatment of atopic dermatitis is currently underway. It is also being tested in clinical trials for the treatment of other inflammatory diseases such as asthma, multiple sclerosis, and hidradenitis suppurativa.