LEO Pharma strengthens psoriasis portfolio in China with NMPA approval of Enstilar®

LEO Pharma has announced that China’s National Medical Products Administration (NMPA) has approved Enstilar® (calcipotriene/betamethasone dipropionate) for the treatment of adult patients with plaque psoriasis, marking a significant expansion of the company’s dermatology portfolio in its most populous patient market.

The approval provides a new treatment option for an estimated 6.5 million adults living with plaque psoriasis in China, where demand for innovative dermatology therapies continues to grow alongside increasing awareness and diagnosis of chronic skin conditions.

Enstilar is a foam-based topical formulation designed to improve ease of application across affected areas, including hair-bearing regions, while enabling more uniform distribution of active ingredients. In clinical studies, the treatment has demonstrated rapid symptom relief and established efficacy in plaque psoriasis management.

The approval is supported by results from a Phase 3 clinical trial conducted in 604 adult Chinese patients with stable plaque psoriasis. The study compared once-daily Enstilar foam with Daivobet® ointment over a four-week treatment period and met both its primary and secondary endpoints, demonstrating superior efficacy for Enstilar.

China represents a strategically important growth market for LEO Pharma, which is seeking to expand its presence in medical dermatology across high-burden disease areas. The company already serves close to three million patients globally with its psoriasis treatments and markets Enstilar in more than 50 countries worldwide.

“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 at LEO Pharma.

“With the introduction of Enstilar, we are broadening our portfolio and offering patients a new treatment option while strengthening our commercial presence in one of the world’s most significant dermatology markets.”

The company highlighted that China’s evolving healthcare landscape and growing focus on innovative dermatology treatments provide a strong foundation for the continued introduction of its psoriasis portfolio.

Byron Yin, General Manager of LEO Pharma China, said the approval represents a key milestone in expanding patient access to established therapies already widely used in other global markets.

“For patients living with plaque psoriasis, this means access to a treatment that has been widely adopted internationally and integrated into clinical practice,” Yin said. “This approval also lays an important foundation for future dermatology innovations we plan to bring to China.”

Following NMPA approval, LEO Pharma plans to launch Enstilar in China later this year.

Psoriasis affects an estimated 125 million people worldwide and is a chronic inflammatory condition driven by immune system dysregulation, leading to red, scaly, and often painful skin lesions. Plaque psoriasis accounts for approximately 80–90% of cases globally and commonly affects areas such as the scalp, elbows, knees, and torso.

With this approval, LEO Pharma further consolidates its position in the global topical psoriasis market while advancing its strategy to expand access to dermatology treatments in high-need regions such as China.