March 3, 2025

KYORIN Pharmaceutical Co., Ltd. announced today that it entered into a global license agreement with Novartis Pharma AG (Basel, Switzerland, “Novartis”) on March 3, 2025, for KRP-M223 and its back-up compounds discovered by KYORIN.

Under this agreement, KYORIN grants Novartis an exclusive worldwide license to develop, manufacture, and commercialize KRP-M223. KYORIN retains an option to commercialize in Japan and manufacture the product for the Japan market with Novartis retaining an option to co-promote with KYORIN in Japan. KYORIN will receive an upfront payment of USD 55 million and is eligible to receive milestone payments of up to USD 777.5 million tied to the progress of development, approval, and commercialization of KRPM223 as well as tiered royalties on net sales.

KRP-M223 is an MRGPRX2 antagonist for allergic and inflammatory diseases involving mast cells, such as chronic spontaneous urticaria. KYORIN has developed KRP-M223 which now is in the pre-clinical stage and Novartis will be responsible for global development.

KYORIN aims to create high-value new drugs that meet medical needs under its long-term vision “Vision 110”. KYORIN aims to contribute to better health through the global development of its products.

The impact of this transaction on consolidated financial forecast for the fiscal year ending March 2025 is currently under review. We will promptly announce any developments that require disclosure.

About MRGPRX2 antagonist

MRGPRX2 (Mas-related G protein-coupled receptor member X2) is G protein-coupled receptor mainly expressed on mast cells. MRGPRX2 induces mast cell activation via various ligands such as substance P released from sensory nerves, leading to the release of mediators such as histamine and tryptase, which causes urticaria with angioedema and intense itching. The involvement of MRGPRX2 mediated mast cell activation has been reported in various diseases such as chronic spontaneous urticaria.

About Chronic Spontaneous Urticaria (CSU)

CSU is characterized by the sudden appearance of itchy wheals (hives) or swelling of deep tissue (angioedema occurring in the face, throat, hands, or feet), or both, lasting for more than six weeks1. Approximately 40 million people worldwide suffer from CSU2,3. CSU causes significant psychological distress; the majority of patients suffer from sleep deprivation, have a high incidence of psychiatric disorders such as anxiety and depression, and experience an impact on work productivity2.

1. Zuberbie T, et al. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022; 77:734-766

2. Maurer M, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy. 2011; 66:317–330.

3. The World Bank. Population, total. Available from: https://data.worldbank.org/indicator/SP.POP.TOTL.