Yuhan, Novartis Korea launch co-promotion of oral hives drug Rapsido

Yuhan has teamed up with Novartis Korea to distribute and co-promote Rapsido (remibrutinib) — the first oral Bruton's tyrosine kinase (BTK) inhibitor approved for chronic spontaneous urticaria (CSU) — in South Korea.

Yuhan announced Monday that it had signed a strategic partnership agreement with Novartis Korea covering the domestic distribution, sales and promotion of Rapsido. The two companies held a formal signing ceremony Thursday.

Under the agreement, Yuhan will take sole responsibility for Rapsido's domestic distribution. Promotional activities will be divided by institution type: Novartis Korea will handle general and tertiary hospitals, while Yuhan will cover clinics and private practices, with the split designed to maximize synergies.

Rapsido is an oral drug that selectively inhibits BTK, a key enzyme involved in mast cell activation and inflammatory signaling, thereby reducing the release of histamine and other inflammatory mediators at the source. While existing treatments work by blocking histamine receptors, Rapsido employs a differentiated mechanism that intervenes at the mast cell and basophil activation stage. The Ministry of Food and Drug Safety approved it in April for adult CSU patients whose symptoms are not adequately controlled by H1 antihistamine therapy.

In the global Phase 3 trials that supported the approval — REMIX-1 and REMIX-2 — Rapsido significantly improved the weekly Urticaria Activity Score (UAS7) at week 12 compared with placebo, with consistent efficacy through week 24. A 52-week long-term analysis found that improvements in itch and wheal symptoms were observed as early as week one, and that both the therapeutic effect and the safety profile were maintained throughout the full 52-week treatment period.

The collaboration is expected to broaden treatment options for CSU patients who have not responded to first-line therapies by offering a convenient oral drug, while leveraging Yuhan's extensive clinic and hospital distribution network to accelerate the new drug's establishment in the domestic market.

"Rapsido is an innovative treatment that opens new therapeutic possibilities for patients with chronic spontaneous urticaria," Yuhan CEO Cho Wook-je said. "We will contribute to improving the treatment landscape by drawing on Yuhan's strong sales and marketing capabilities and its nationwide distribution network."

"Our partnership with Yuhan, which has a deep understanding of dermatology care at the clinic level, marks an important milestone in bringing Rapsido closer to patients," said Yu Byung-jae, CEO of Novartis Korea. "By combining the strengths of both companies, we will work to advance the treatment environment for chronic spontaneous urticaria in Korea."