Novartis' (NVS.US) BTK inhibitor "Ruxolitinib" was the first to submit an application for market approval in China, marking a significant milestone in the company's efforts to bring innovative treatments to patients in the country.

On February 27, the CDE's website indicated that Novartis (NVS.US) BTK inhibitor remibrutinib tablets were the first to apply for market approval in China. According to the progress of clinical trials and financial information, it is speculated that the indication for this application is chronic spontaneous urticaria. Remibrutinib is a new, oral, covalent, irreversible BTK inhibitor with high selectivity, which can quickly bind to the inactive conformation of BTK to prevent the release of histamine that causes itching, urticaria/eczema, and swelling, and the drug that does not bind will be eliminated from the body to reduce systemic exposure and reduce side effects. The updated long-term data in 2024 showed that the significant symptom improvement shown at week 12 of remibrutinib compared to placebo persisted to week 24. According to the assessment at week 52, nearly half of the patients had no symptoms of itching and urticaria.