Betamethasone Dipropionate/Calcipotriene

NMPA approval of Enstilar® in China marks a significant milestone for LEO Pharma, expanding access to a new treatment option for the estimated 6.5 million adults living with plaque psoriasis in the world’s largest market measured by patient numbers.1 China represents a strategically important pillar in LEO Pharma’s long-term growth, and the approval strengthens the company’s position in medical dermatology by expanding its psoriasis portfolio in an exciting market for innovative treatments. Enstilar builds on LEO Pharma’s established leadership in topical psoriasis treatments, offering a clinically proven, foam-based formulation that has been widely adopted in more than 50 markets worldwide and is supported by robust phase 3 clinical data.2,3 LEO Pharma A/S, , a global leader in medical dermatology, today announced that China's National Medical Products Administration (NMPA) has approved Enstilar® (calcipotriene/betamethasone dipropionate) to treat adult patients in China living with plaque psoriasis. The approval means that the estimated 6.5 million people in China suffering from the disease will soon have access to a new treatment option.1 Enstilar is a foam formulation, which allows the medication to be applied in an aerated form that spreads easily over the skin, including hair-bearing areas, and can facilitate even distribution of the active ingredients with a rapid relief achieved in clinical studies.4 “China is the largest market in terms of patient numbers and represents an important pillar in LEO Pharma’s long-term growth strategy,” said Frederik Kier, EVP, International Operations, LEO Pharma. “The Chinese market is characterized by a growing focus on innovative dermatology treatments. With the introduction of Enstilar, we are proud to broaden our portfolio and offer millions of patients a new treatment option while continuing to invest in innovation and strengthening our commercial presence in one of the world’s most significant dermatology markets.” LEO Pharma is a global market leader in topical treatments for psoriasis, with close to three million patients worldwide using its products within this disease.5 With the approval of Enstilar in China, the company strengthens its position in the largest single market measured by patient numbers. China joins more than 50 other markets where Enstilar is approved, and the country’s large patient population, evolving healthcare landscape and increasing access to innovative treatments provide a strong foundation for the introduction of both established and future dermatology therapies. “The NMPA approval represents an important milestone for LEO Pharma in China,” said Byron Yin, General Manager, LEO Pharma China. “For patients living with plaque psoriasis, it means access to a treatment that has been widely adopted in other markets and has become an important part of clinical practice. This approval not only expands treatment options for patients in China, but also marks a key step in building the foundation for the broader portfolio of dermatology treatments we plan to bring to the Chinese market in the near future.” The NMPA-approval is supported by results from a phase 3 trial comparing the efficacy and safety of a once daily application with Enstilar foam and Daivobet® (calcipotriene/betamethasone) ointment after 4 weeks of treatment in adult Chinese subjects with stable plaque psoriasis (N=604).2,3 The trial achieved its primary and secondary endpoints, with Enstilar demonstrating superiority to Daivobet ointment. 2,3 Enstilar® is an aerosol spray foam containing calcipotriol monohydrate 50 mcg/g and betamethasone dipropionate 0.5 mg/g. In the EU, it is indicated for the treatment of psoriasis vulgaris in adults for up to 4 weeks. Patients who have responded at 4 weeks’ treatment using Enstilar once daily are suitable for long-term maintenance treatment. 4,6,7,8 Psoriasis is a chronic, systemic inflammatory disease that primarily affects the skin in 125 million people worldwide.9,10 Psoriasis is the result of skin barrier cell proliferation and the activation of cytokines (a family of proteins involved in immune responses) that cause inflammation.11 About 80% to 90% of patients are affected by plaque psoriasis, the most common clinical form of psoriasis.12 LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. Together, we reach far beyond the skin. References 1.Ding X, Wang T, Shen Y, et al. Prevalence of psoriasis in China: a population-based study in six cities. Eur J Dermatol. 2012;22(5):663-667. 2.ClinicalTrials.gov. National Library of Medicine (U.S.). A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis. Identifier: NCT05919082. 3.LEO Pharma Press Release. LEO Pharma Announces Topline Results of Phase 3 Trial in China for Enstilar® Demonstrating Superiority in Adult Chinese Subjects With Stable Plaque Psoriasis. Published: May 04, 2024. Last accessed: Feb, 2026. Available at: 4.Leonardi C, et al. Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris—a Randomized Phase III Study (PSO-FAST). J Drugs Dermatol. 2015;14(12):1468-1477. 5.LEO Pharma. Patient numbers by brand. Data on file. 2025 6.Zhang, XJ et al., Chin J Dermatol, July 2023, Vol. 56, No. 7, Guideline for the diagnosis and treatment of psoriasis in China (2023 edition). 7.Enstilar® EU Summary of Product Characteristics July 2022. 8.Koo J, Tyring S, Werschler WP, et al. Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris--A randomized phase II study. J Dermatolog Treat. 2016;27(2):120-127. 9.Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol 2009; 60: 643-659. 10.National Psoriasis Foundation. Psoriasis Statistics. Last updated: Dec 21, 2022. Last accessed: Feb, 2026. Available at: 11.Hawkes JE, Chan TC, Krueger JG. Psoriasis pathogenesis and the development of novel targeted immune therapies. J Allergy Clin Immunol. 2017;140(3):645-653. 12.National Psoriasis Foundation. Plaque Psoriasis. Last updated: Mar 26, 2025. Last accessed: Feb, 2026. Available at: https://www.psoriasis.org/plaque/ . The content above comes from the network. if any infringement, please contact us to modify.