Sanofi (SNY.US) BTK inhibitor approved for market launch in China.

On September 3, the official website of the National Medical Products Administration (NMPA) announced the approval of Sanofi's (SNY.US) BTK inhibitor Rilzabrutinib tablets for marketing. This medication is indicated for adult patients with persistent or chronic primary immune thrombocytopenia (ITP) who have previously had an inadequate response or intolerance to treatments such as glucocorticoids and immunoglobulin. Rilzabrutinib is an oral, reversible, covalent BTK inhibitor. In September 2020, Sanofi acquired Principia Biopharma for $3.68 billion, gaining access to the latter's two BTK inhibitors, Rilzabrutinib and Tolebrutinib. In August 2025, Rilzabrutinib received FDA approval, becoming the first BTK inhibitor approved for ITP. The FDA's approval was based on positive results from the pivotal Phase III clinical trial LUNA 3. This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study aimed at assessing the efficacy and safety of Rilzabrutinib compared to placebo in treating adult and adolescent patients with persistent or chronic ITP who had previously been treated. In addition to its ITP indication, Sanofi is also exploring the therapeutic potential of Rilzabrutinib in other autoimmune diseases, including chronic spontaneous urticaria, IgG4-related disease, and atopic dermatitis. According to the Insight database, the world's first BTK inhibitor, Ibrutinib, was approved in November 2013. Over the past decade since its approval, nine additional BTK inhibitors have been approved, mainly focused on oncology indications. With the approval of Sanofi's Rilzabrutinib and Novartis AG Sponsored ADR's Remibrutinib for autoimmune indications in 2025, the commercial ceiling for BTK inhibitors will be further expanded.