BALLERUP, Denmark, April 17, 2026

LEO Pharma A/S has secured a major regulatory milestone with the approval of Enstilar® (calcipotriene/betamethasone dipropionate) by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with plaque psoriasis. This approval significantly expands access to an innovative topical therapy for an estimated 6.5 million patients in China, marking a critical step in strengthening LEO Pharma’s presence in one of the largest dermatology markets globally.

Regulatory Approval Expands Access in High-Burden Market

The NMPA approval of Enstilar® represents a strategic advancement in addressing the growing burden of psoriasis in China, where increasing awareness and demand for innovative dermatology treatments are shaping the healthcare landscape. As the largest market globally by patient population, China plays a central role in LEO Pharma’s long-term growth strategy.

With this approval, millions of patients will gain access to a clinically validated, foam-based treatment that has already been adopted in more than 50 markets worldwide. The launch, planned later in 2026, is expected to further strengthen LEO Pharma’s leadership in topical psoriasis therapies, reinforcing its commitment to expanding treatment options for chronic skin conditions.

The approval also reflects increasing regulatory support for advanced dermatology solutions in China, where healthcare systems are evolving to integrate more effective and patient-friendly therapies into routine clinical practice.

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Phase 3 Data Demonstrate Superior Clinical Efficacy

The regulatory decision is supported by robust Phase 3 clinical trial data involving 604 adult patients with stable plaque psoriasis, comparing Enstilar® foam with Daivobet® ointment. The study successfully met both primary and secondary endpoints, with Enstilar demonstrating superior efficacy and safety outcomes after four weeks of once-daily treatment.

The foam-based formulation allows for enhanced skin penetration and even distribution, particularly in hair-bearing areas, providing rapid symptom relief and improved patient adherence. This delivery method represents a significant improvement over traditional ointment-based therapies, offering greater convenience and clinical effectiveness.

Psoriasis, affecting approximately 125 million people worldwide, is a chronic inflammatory disease characterized by itchy, painful, and scaly skin lesions, with plaque psoriasis accounting for 80–90% of cases. The availability of more effective treatments such as Enstilar is critical in improving quality of life and long-term disease management.

Strengthening Dermatology Leadership and Market Expansion

LEO Pharma’s approval in China reinforces its position as a global leader in medical dermatology, with its products currently serving millions of patients worldwide. The introduction of Enstilar into the Chinese market represents a key step in expanding the company’s dermatology portfolio and commercial footprint, while supporting future pipeline developments.

The company continues to invest in innovation, research, and global expansion, focusing on delivering targeted therapies for chronic skin diseases. China’s evolving healthcare environment, combined with its large patient population, offers significant opportunities for introducing both established treatments and next-generation dermatology solutions.

By aligning regulatory success with market expansion, LEO Pharma is positioning itself to play a pivotal role in advancing dermatology care and patient access to innovative therapies across Asia and beyond.

The approval of Enstilar® in China marks a major milestone for LEO Pharma, expanding access to a clinically proven, innovative psoriasis treatment in one of the world’s most important healthcare markets. Supported by strong Phase 3 data and global adoption, this development highlights the growing importance of advanced topical therapies in managing chronic skin diseases, reinforcing LEO Pharma’s leadership in dermatology innovation and global healthcare impact.

Source: LEO Pharma press release