Shionogi & Co., Ltd. and subsidiary Torii Pharmaceutical Co., Ltd. announced the submission of a manufacturing and marketing approval application in Japan for CORECTIM (delgocitinib) 0.5% lotion, a non‑steroidal topical JAK inhibitor for atopic dermatitis (AD). The new lotion formulation complements the already approved ointment, which is indicated for adults, children, and infants in Japan.
Manufacturing and marketing approval application (Japan)
Indication
Atopic dermatitis (AD)
Formulation Status
Lotion (new); Ointment (approved)
Ointment Approval
Adults, children, and infants (Japan)
CORECTIM Franchise in Japan
Aspect
Detail
First Approval
January 2020 – world’s first non‑steroidal topical JAK inhibitor
Current Indications (Ointment)
Atopic dermatitis in adults, children, and infants
Manufacturing/Distribution
Shionogi
Distribution/Promotion
Torii Pharmaceutical (co‑promotion with Shionogi)
Global Licensing – LEO Pharma Partnership
Parameter
Detail
Licensee
LEO Pharma (exclusive worldwide license, ex‑Japan)
Licensed Rights
Development and commercialization of topical skin preparations
Agreement Date
2014
Approved Indication (EU/US)
Chronic hand eczema
Brand Name (EU/US)
Anzupgo Cream
Strategic Implications
Formulation Expansion: The lotion formulation addresses patient preference and application flexibility—lotions offer easier spreadability for large surface areas vs. ointments, potentially improving adherence in widespread AD patients.
Pediatric Market Leadership: With infant approval for the ointment and anticipated lotion approval, Shionogi/Torii strengthen Japan’s AD treatment paradigm across all age groups, capitalizing on steroid‑sparing demand from parents and physicians.
JAK Inhibitor Differentiation: As the world’s first topical JAK inhibitor, delgocitinib has first‑mover experience; the lotion extension maintains competitive edge vs. emerging topical JAKs (ruxolitinib cream, Opzelura) and emerging topical biologics.
Global Value Realization: The LEO Pharma partnership monetizes ex‑Japan rights while Shionogi retains domestic franchise control—Anzupgo’s EU/US chronic hand eczema approval validates global commercial potential beyond AD.
Market Context
Factor
Impact
Japan AD Market
~ 500,000+ patients; high steroid‑sparing demand; JAK inhibitors gaining preference over calcineurin inhibitors
Topical JAK Competition
Incyte’s Opzelura (ruxolitinib) approved in US; delgocitinib maintains Japan market leadership through formulation breadth
Formulation Strategy
Ointment (barrier repair) + Lotion (ease of use) = comprehensive topical portfolio addressing diverse patient needs
LEO Pharma Synergies
Anzupgo expansion to AD in EU/US possible; chronic hand eczema approval establishes regulatory pathway
Forward‑Looking Statements This brief contains forward‑looking statements regarding Japan approval timelines, lotion launch expectations, and formulation market share. Actual results may differ due to risks including regulatory review outcomes, competitive topical JAK launches, and pricing pressure in Japan’s reimbursement system.-Fineline Info & Tech
By Fineline Cube 