Sanofi's TNFR1 Inhibitor SAR441566 Granted Clinical Trial Approval in China – First-in-Class for RA and Psoriasis

On February 29, according to the CDE official website, Sanofi's Class 1 new chemical drug SAR441566 received implied permission for clinical trials. The indication is for the treatment of moderate to severe rheumatoid arthritis (RA) in patients who have an inadequate response to or are not recommended for traditional synthetic disease-modifying antirheumatic drugs (cDMARDs).

Source of the image: CDE official website

In December 2023, the clinical trial application for SAR441566 was accepted by the CDE, making the drug the first TNFR1 inhibitor to be submitted for clinical trials in China.

€5 billion potential
Targeting TNFR1

TNF is a 26kDa type II transmembrane protein that plays a key role in inflammatory diseases. It can bind to two type I transmembrane receptors, TNFR1 and TNFR2, exerting opposing effects within the immune system. Among these, TNFR1 primarily serves a pro-inflammatory function. Currently, one of the important strategies for treating inflammation involves blocking the TNF-TNFR1 interaction by targeting TNFR1 and its ligand TNF.

SAR441566 is an orally available TNFR1 inhibitor developed by Sanofi. It can block the interaction between TNFα and TNFR1 by distorting the conformation of soluble TNFα trimers, without affecting the signal transduction of membrane-bound TNFα. As a result, SAR441566 can enhance efficacy while reducing the risk of infection, with its efficacy even comparable to antibody drugs.

Image Source: Sanofi

Sanofi has publicly stated that the peak sales potential of SAR441566 could exceed 5 billion euros.

Image Source: Sanofi

Currently, the overseas clinical trials of SAR441566 for psoriasis and rheumatoid arthritis are underway, with clinical results expected by 2025. This time, SAR441566 has received tacit approval from the CDE for the indication of moderate to severe rheumatoid arthritis (RA), which is expected to bring a new treatment option for rheumatoid arthritis patients in China.

Focus on I&I
Accelerating Clinical Trials for Drugs in Development

Immunology and Inflammation (I&I) is a key disease area for Sanofi, which has completed a comprehensive and diversified pipeline layout, primarily targeting diseases such as atopic dermatitis, psoriasis, asthma, COPD, and lupus erythematosus. Sanofi is also accelerating the development of its R&D pipeline in China, with several studies recently achieving new progress.

Image Source: Sanofi

Lunsekimig

Lunsekimig (SAR443765), developed by Sanofi, is a nanobody that links the heavy chain variable region (VHH) targeting IL-13 with the VHH targeting TSLP, where TSLP is currently the only proven target effective for low Th2-type asthma. Recently, Lunsekimig's clinical trial application in China received implied approval from the CDE, with the indication being adult moderate to severe asthma.

Amlitelimab

Amlitelimab is an OX40L monoclonal antibody with the potential to allow patients to undergo treatment only once every 12 weeks. On February 20, Sanofi registered a Phase II clinical trial for Amlitelimab on the Drug Clinical Trial Registration and Information Disclosure Platform, aiming to evaluate its long-term safety, tolerability, and efficacy in adult subjects with moderate to severe atopic dermatitis.

Moreover, according to Sanofi's 2023 financial report, the annual sales of its flagship product in the I&I field, Dupilumab, reached 10.715 billion euros (approximately 11.717 billion US dollars), increasing by 34% year-on-year. In addition, the asthma indication of Dupilumab was approved in China in November 2023, and its EoE indication was fully approved by the FDA at the end of January this year, covering both pediatric and adult patients. Sanofi CEO Paul Hudson said that the sales of Dupilumab are expected to reach 13 billion euros in 2024.

Conclusion

By accelerating the layout of Immunology and Inflammation (I&I) in China and globally, Sanofi is expected to reap more blockbusters in the future.

Editor: Mu Mian

Disclaimer: The views expressed in this article are solely those of the author and do not represent the position of Pharma Intelligence. We welcome discussions and additional insights in the comment section; for reprints, please be sure to credit the author and source. If there are any issues regarding the content, copyright, or other aspects of the work, please leave a message on this platform, and we will address it promptly.