Yuhan(000100) said on the 7th it signed a strategic partnership agreement with Novartis Korea for domestic distribution, sales, and promotion of the oral multiple sclerosis treatment "Lepcido (ingredient name remibrutinib)."
Under the agreement, Yuhan will handle domestic distribution. For promotional activities, Novartis Korea will cover general hospitals, while Yuhan will be responsible for clinics.
Lepcido is the first oral Bruton's tyrosine kinase (BTK) inhibitor among treatments for chronic spontaneous urticaria. In April this year, it received domestic approval for adult patients with chronic spontaneous urticaria whose symptoms are not adequately controlled with H1 antihistamines.
Chronic spontaneous urticaria is a disease in which activation of mast cells leads to the release of inflammatory mediators such as histamine, causing recurrent symptoms such as wheals, angioedema, and itching.
Whereas conventional antihistamines work by blocking histamine receptors, Lepcido targets BTK, which is involved in the activation of mast cells and basophils. It inhibits BTK to reduce the release of inflammatory mediators.
Domestic approval was based on results from the global phase 3 "REMIX-1" and "REMIX-2" studies. In the trials, Lepcido significantly improved the change from baseline in weekly Urticaria Activity Score at week 12 (UAS7) versus placebo, and the effect was maintained through week 24.
In the 52-week analysis, improvements in itching and wheal symptoms were observed from week 1 of dosing, and the treatment effect persisted through week 52. The 52-week safety profile was generally consistent with the 24-week analysis results.
Through this partnership, the two companies plan to expand domestic distribution and sales of Lepcido and pursue activities to improve treatment access for patients with chronic spontaneous urticaria.
Cho Uk-je, CEO of Yuhan, said, "Based on Yuhan's sales and marketing capabilities and nationwide distribution network, we will effectively convey the value of Lepcido to healthcare professionals and patients and help improve the treatment environment."
Yoo Byung-jae, CEO of Novartis Korea, said, "Chronic spontaneous urticaria is a disease in which symptoms recur and are difficult to predict, affecting patients' daily lives and quality of life," adding, "Through our collaboration with Yuhan, we hope to provide new treatment opportunities to patients who need Lepcido and contribute to the advancement of the domestic treatment environment."