Novartis AG Sponsored ADR (NVS.US) declared that the BTK inhibitor "Rimbrutinib" has been filed for first listing in China.

On February 27th, the official website of CDE showed that Novartis AG Sponsored ADR (NVS.US) BTK inhibitor remibrutinib has been applied for approval in China. Based on the progress of clinical trials and financial information, it is speculated that the indication for this application is chronic spontaneous urticaria. Chronic spontaneous urticaria (CSU) is an unpredictable systemic skin disease characterized by spontaneous and recurrent hives or angioedema on the skin, accompanied by itching and/or pain, lasting for at least 6 weeks. This condition affects approximately 40 million people worldwide, most commonly in the 20-40 age group, with females being affected twice as often as males. Treatment options for CSU are limited, with about 60% of patients unable to fully control the condition after first-line treatment with antihistamines. Remibrutinib is a novel, oral, covalent irreversible BTK inhibitor with very high selectivity. It can rapidly bind to inactive BTK conformations, thus preventing histamine release that causes itching, hives/rashes, and swelling. Unbound drug is cleared from the body, reducing systemic exposure and decreasing toxic side effects. Updated long-term data in 2024 showed that compared to placebo, the significant symptom improvement demonstrated by remibrutinib at week 12 continued until week 24. According to the evaluation at week 52, nearly half of the patients had no itching and urticaria symptoms at all.