LEO Pharma Secures NMPA Approval for Enstilar Foam in China – First and Only Calcipotriol/Betamethasone Foam Formulation for Plaque Psoriasis Demonstrates Superior Efficacy vs. Ointment
LEO Pharma A/S has received marketing approval from China’s National Medical Products Administration (NMPA) for Enstilar (calcipotriol 50 mcg/g, betamethasone dipropionate 0.5 mg/g), a foam formulation for the treatment of plaque psoriasis in adult patients. The approval establishes Enstilar as the first and only foam-based therapy for this indication in China, backed by Phase III data demonstrating superior efficacy compared to the established Daivobet ointment, with enhanced patient convenience through a patented foam applicator designed for even application on hair-bearing skin areas.
First and only foam formulation approved in China for plaque psoriasis
Dosage
Once daily application
Key Differentiator
Patented foam applicator for hair-bearing areas
Clinical Evidence – Phase III Superiority Trial
Trial Parameter
Detail
Study Design
Phase III randomized, controlled trial
Patient Population
604 adult patients with stable plaque psoriasis
Comparator
Daivobet (calcipotriol/betamethasone ointment)
Treatment Duration
Four weeks, once daily
Primary Endpoint
Met with statistical significance
Secondary Endpoints
All met with Enstilar demonstrating superior efficacy
Key Finding
Enstilar more effective than Daivobet ointment
Technology & Formulation Innovation
Foam Delivery System: Patented applicator enables easy, even medication distribution across skin surfaces
Hair-Bearing Areas: Specifically designed for application to scalp and other hair-covered regions where traditional formulations struggle
Supersaturated Solution: Forms supersaturated solution on skin surface, accelerating active ingredient penetration
Rapid Symptom Relief: Enhanced bioavailability translates to faster onset of therapeutic effect
Patient Compliance: Improved ease of use expected to enhance treatment adherence compared to ointments
Market Opportunity & Competitive Landscape
Market Element
Impact
China Psoriasis Prevalence
Estimated 6-7 million plaque psoriasis patients, representing significant unmet need
Current Treatment Gap
Limited topical options optimized for scalp and difficult-to-treat areas
Formulation Advantage
Foam technology addresses key limitation of existing ointments and creams
Pricing Position
Premium pricing potential due to superior efficacy and convenience benefits
Competitive Differentiation
Only foam formulation creates unique market positioning vs. generic ointments
Commercial Strategy & Market Access
Launch Focus: Initial targeting of dermatology specialty centers and major hospitals in Tier 1 cities
Physician Education: Comprehensive training program on foam application advantages and clinical superiority data
Reimbursement Strategy: Pursuing inclusion in provincial reimbursement catalogs leveraging superior efficacy profile
Patient Support: Implementation of adherence programs and educational materials on proper foam application technique
Market Penetration: Leveraging LEO Pharma’s established dermatology presence in China for rapid commercial rollout
Strategic Implications for LEO Pharma
China Market Expansion strengthens LEO’s position in one of the world’s fastest-growing pharmaceutical markets
Innovation Leadership reinforces reputation for developing differentiated dermatological formulations
Portfolio Enhancement complements existing psoriasis portfolio with premium, patent-protected product
Global Harmonization aligns Chinese launch with international markets where Enstilar is already established
Industry Context & Regulatory Environment
Topical Psoriasis Market in China dominated by generic ointments with limited innovation
NMPA Priority Review reflects recognition of meaningful therapeutic advancement over existing options
Patient-Centric Innovation aligns with China’s healthcare reform emphasis on improving quality of life outcomes
Dermatology Focus benefits from increasing awareness and diagnosis rates of psoriasis in urban Chinese populations
Forward‑Looking Statements This brief contains forward-looking statements regarding commercial performance, market penetration, and competitive dynamics. Actual results may differ due to risks including reimbursement decisions, market adoption rates, competitive pressures, and regulatory developments.-Fineline Info & Tech
By Fineline Cube 