Sanofi's Diabetes Drug Raises Concerns, Type1 Diabetes Treatment May Be a Trap: Can It Really Delay Disease Onset by 3 Years?

On August 28, the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China announced on its official website that Sanofi's application for the marketing of Tilizumab injection has been officially accepted. Previously, on Aug. 20, the drug had been proposed for a priority review process aimed at slowing the progression from stage 2 to stage 3 in adults and children 8 years and older with type 1 diabetes. The drug was approved for marketing by the U.S. Food and Drug Administration (FDA) in November 2022.

Tilizumab (teplizumab), a monoclonal antibody drug targeting CD3, represents an innovative targeted therapy for delaying the progression of type 1 diabetes. Of particular note, the drug was also named one of the best inventions of 2023 by Time magazine.

As a "first-in-class" CD3-targeting monoclonal antibody, Tilizumab is able to fundamentally protect islet beta cells, delaying the onset of type 1 diabetes by nearly three years. The drug, which was approved in the United States in November 2022 under the brand name Tzield, is the first innovative targeted therapy approved by the FDA to delay the onset of type 1 diabetes.

Back in October 2007, Eli Lilly and MacroGenics entered into an agreement to acquire development and commercialization rights to tillizumab for a total price of $641 million. Three years later, however, Eli Lilly ended its relationship with MacroGenics. In May 2018, Provention Bio acquired all rights to tillizumab from MacroGenics and made it the company's core product, based on which Provention Bio successfully conducted a $56 million initial public offering (IPO). In October 2022, Sanofi entered into an agreement with Provention Bio to acquire rights to commercialize tillizumab in the United States. Following the successful FDA approval of tillizumab, Sanofi acquired Provention Bio for $2.9 billion, giving it full rights to the product.