Novartis' key new drug Remibrutinib wins approval in China

On November 25, Novartis announced that Remibrutinib tablets have been approved in China for the treatment of adult patients with chronic spontaneous urticaria (CSU) whose symptoms persist despite H1-antihistamine therapy.

Remibrutinib is a Bruton's tyrosine kinase inhibitor (BTKi) developed by Novartis. It works by targeting and blocking the BTK signaling pathway, thereby inhibiting the release of histamine and other pro-inflammatory mediators from mast cells. The drug had previously received U.S. FDA approval on September 30, 2025, making it the first BTK inhibitor approved by the FDA for CSU.

Notably, the marketing application for Remibrutinib was submitted in China one month earlier than in the U.S. It was accepted on February 27, 2025, designated for priority review, and granted formal approval within just nine months.

The approval was based on two pivotal Phase III clinical trials: the REMIX-1 study (NCT05030311) and REMIX-2 study (NCT05032157). Clinical data released by Novartis in May 2024 showed that in patients with ongoing symptoms despite second-generation H1-antihistamine treatment, Remibrutinib demonstrated rapid and sustained symptom improvement, which was maintained through week 52.

Key Clinical Outcomes

BTK inhibitors have achieved remarkable success in lymphoma. In 2024 alone, just three of them—Ibrutinib (Johnson & Johnson/AbbVie), Acalabrutinib (AstraZeneca), and Zanubrutinib (BeOne Medicines)—generated global sales exceeding USD 12 billion.

Given this potential, which rivals that of oncology, the autoimmune field has undoubtedly become a major new development focus for pharmaceutical companies.

Although BTK inhibitors previously faced setbacks in autoimmunity due to toxicity and efficacy concerns, 2025 has unequivocally emerged as their breakthrough year. Sanofi's Rilzabrutinib led the way with its U.S. approval for immune thrombocytopenia (ITP), followed closely by Novartis's Remibrutinib for CSU. Meanwhile, Roche's Fenebrutinib appears poised for success, with two pivotal Phase III trials in multiple sclerosis having been announced.

It is worth noting that, according to the Insight database, Novartis has laid extensive and thorough groundwork for Remibrutinib across multiple indications, signaling a promising outlook:

For its lead indication, CSU, beyond securing approval in China and the U.S. and submitting applications in Europe and Japan, Novartis has also initiated a head-to-head Phase III trial (RECLAIM study) against the blockbuster drug Dupilumab.

In other disease areas, despite a setback in Sjögren's syndrome, development programs for multiple sclerosis, hidradenitis suppurativa, and myasthenia gravis have all advanced to Phase III.

Remibrutinib's Key Indication Development Progress

Chronic urticaria is characterized by the daily or intermittent occurrence of wheals, pruritus, or angioedema (or a combination of these symptoms) persisting for more than six weeks. Chronic spontaneous urticaria (CSU) represents the most prevalent form of chronic urticaria, affecting over 10 million patients in China with particularly high incidence among young women aged 20-40.

While antihistamines remain the first-line treatment, more than half of patients demonstrate inadequate response to antihistamine therapy. Among these refractory cases, fewer than 20% of eligible patients receive injectable treatments. This substantial treatment gap highlights the significant unmet need in this disease area. As a twice-daily oral tablet, Remibrutinib offers substantially greater convenience compared to injectable alternatives.

The recent approval of Remibrutinib in China will provide chronic urticaria patients with a more competitive therapeutic option.