Sanofi Accelerates China Expansion as Novel Anti-CD40L Monoclonal Antibody Frexalimab Receives Dual Clinical Trial Approvals

　　【Pharmaceutical Network Industry Dynamics】Sanofi, a multinational pharmaceutical company, has always placed great importance on deeply cultivating the Chinese market. In recent years, with China accelerating drug approval reviews, it has also been quicker to bring innovative drugs and indications to Chinese patients.
 

The website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration recently announced that frexalimab injection, a Class 1 new drug from Sanofi, has received two implied clinical trial permits. These are intended for the development of treatments for adult relapsing multiple sclerosis (RMS) and adult non-relapsing secondary progressive multiple sclerosis (nrSPMS), respectively.
 

Public information shows that frexalimab is a monoclonal antibody targeting CD40L. The product has already reached the primary endpoint in a Phase 2 clinical trial for the treatment of multiple sclerosis, and the study results have been published in The New England Journal of Medicine.
 

Multiple Sclerosis (MS) is a rare disease in China. It is a chronic inflammatory demyelinating disease that affects the central nervous system, with "relapses and progression" corresponding to "inflammation and degeneration," which are intertwined throughout the course of the disease. This condition is more likely to occur in young women aged 20-40, and currently, there are over 30,000 patients with multiple sclerosis in China.
 

Experts in the field point out that one of the goals of managing RMS is to preserve neurological function and slow the progression of disability. Although there are currently some disease-modifying therapies (DMTs) available on the market for the treatment of RMS, most RMS patients still experience disease activity. Evidence suggests that initiating highly effective treatment early can improve the long-term prognosis for RMS patients.
 

Frexalimab (SAR441344) is a novel monoclonal antibody under research by Sanofi. The product is believed to block the co-stimulatory CD40/CD40L pathway, which is essential for the activation and function of both adaptive (T and B cells) and innate (macrophages and dendritic cells) immune cells, without causing lymphocyte depletion.
 

The product was approved by the U.S. FDA in August 2020 as a subcutaneous injection for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. In March 2021, Kesimpta received approval from the European Union for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features.
 

As a new generation of B-cell depleting agent, it has the advantages of faster B-cell depletion while preserving immune function, along with the convenience of once-monthly subcutaneous self-administration, which is expected to benefit patients.
 

According to information on the ClinicalTrials website, Sanofi has initiated two Phase 3 clinical trials of frexalimab for the treatment of adult non-relapsing secondary progressive multiple sclerosis (nrSPMS) and relapsing multiple sclerosis (RMS), respectively. In addition to multiple sclerosis, Sanofi is currently evaluating the potential of frexalimab in treating other autoimmune diseases in Phase 2 clinical trials, including Sjögren's syndrome, systemic lupus erythematosus, type 1 diabetes, and more.
 

It is reported that in the 42 years since entering China, Sanofi has introduced more than 60 innovative drugs and vaccines for Chinese patients. In 2023 alone, Sanofi received approval for 12 innovative products and indications in the Chinese market, covering areas such as oncology, rare diseases, immunology, and neurology. At the same time, the company continues to increase its local investment, relying on its global strategy to create a "China solution," accelerating the delivery of more innovative solutions to Chinese patients.
 

By intensifying its layout in the Chinese market, Sanofi has also reaped substantial "rewards." Sanofi's 2023 financial report shows that the total annual revenue reached 43.07 billion euros, a year-on-year increase of 5.3%. Revenue from the Chinese market amounted to 2.91 billion euros, with a year-on-year growth of 19.2% in the fourth quarter to 640 million euros.
 

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