Sanofi has secured Chinese approval for CD3 antibody teplizumab to delay progression from Stage 2 to Stage 3 type 1 diabetes (T1D) in adults and children aged 8 years and older. The Fc-modified antibody preserves pancreatic beta cells by modulating T-cell activity, demonstrating 48.4-month median time to diagnosis versus 24.4 months for placebo in Phase II trials. Sanofi acquired global rights through its USD 2.9 billion purchase of Provention Bio in 2023 after the drug's initial US market approval in 2022.

Teplizumab reduces annual diabetes diagnosis rates from 35.9% to 14.9% in high-risk individuals with multiple autoantibodies and dysglycaemia. As the first disease-modifying therapy for T1D prevention, it addresses critical unmet needs in autoimmune diabetes management. The approval expands Sanofi's immunology portfolio beyond traditional metabolic diseases, offering intervention before clinical symptom onset in this progressive autoimmune disorder.

PharmCube's NextBiopharm® database shows that teplizumab is under development in six other indications. Click here to request a free trial for NextBiopharm®.