LEO Pharma announces NMPA-approval of Anzupgo® (delgocitinib) cream for patients with moderate to severe chronic hand eczema (CHE) in China

• Anzupgo^® (delgocitinib) cream has been approved by China’s National Medical Products Administration (NMPA) for adult patients with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.
• The approval is supported by positive results from the DELTA China phase 3 trial, together with the broader delgocitinib clinical program, including DELTA 1, DELTA 2, DELTA 3 and DELTA Force.^1-7
• The approval reflects LEO Pharma’s commitment to improving care for adults living with moderate to severe chronic hand eczema in China, an exciting and important market for the company.

BALLERUP, Denmark--(BUSINESS WIRE)--NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

LEO Pharma A/S, a global leader in medical dermatology, today announced that China’s National Medical Products Administration (NMPA) has approved Anzupgo^® (delgocitinib) cream for the treatment of adult patients with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.

The approval represents a significant step in expanding access to Anzupgo for patients in China and provides a new treatment option for adult patients living with moderate to severe CHE.

“The approval of Anzupgo in China is an important milestone for LEO Pharma and for patients living with moderate to severe chronic hand eczema,” said Frederik Kier, Executive Vice President, International Operations, LEO Pharma. “China is an important market for LEO Pharma, and this approval reflects our continued commitment to supporting skin health in China and bringing innovative treatment options to those who need them most.”

With the approval of Anzupgo in China, LEO Pharma strengthens its presence in a large, important and evolving healthcare market in terms of patient numbers, underlining the scale of patient need and providing a strong foundation for making this treatment option available to adults with moderate to severe disease.

Chronic hand eczema is a fluctuating disease characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema and fissures on the hands and wrists.⁸

CHE can place a substantial psychological and functional burden on patients, affecting quality of life and daily functioning, with approximately 70% of individuals living with severe CHE reporting problems performing everyday activities and disruption in daily life due to the disease.^9-11

“People living with chronic hand eczema can experience a significant burden in their daily lives, Currently, there are no treatments specifically indicated for chronic hand eczema in China, creating a clear need for new treatment options in China,” said Byron Yin, General Manager, LEO Pharma China. “The approval of Anzupgo is an important step forward for patients and healthcare professionals, and we are proud to bring this innovation to China as part of our ongoing commitment to improving care for people living with skin diseases.”

The approval is supported by DELTA China, a phase 3 trial evaluating the efficacy, safety and pharmacokinetics of twice-daily applications of Anzupgo in Chinese patients with moderate to severe CHE.^1,2 In the double-blind treatment period of DELTA China, Anzupgo met the primary endpoint, showing a statistically significant improvement in CHE severity after 16 weeks of treatment compared with cream vehicle.^1,2 The approval is also supported by the broader delgocitinib clinical program, including DELTA 1, DELTA 2, DELTA 3, DELTA Force.^3-7

“The impact of chronic hand eczema goes beyond the skin. It can affect patients’ daily lives, careers and psychological well-being, yet these effects are often overlooked. Many patients face the burden of the disease on their own and continue searching for solutions as the disease flares repeatedly, said Professor Zhang Jianzhong of Peking University People’s Hospital, lead investigator of the DELTA China trial. “We hope to raise awareness of the challenges patients face and promote a better understanding of chronic hand eczema and its appropriate management. We are pleased that delgocitinib cream has now been approved, offering a new treatment option and additional possibilities for improving patients’ lives.”

About Chronic Hand Eczema
Chronic hand eczema (CHE) is defined as hand eczema that lasts for more than three months or relapses twice or more within a year.^12,13 CHE is one of the most common skin diseases of the hands with a global prevalence rate of approximately 4.7%.^14,15 In a substantial number of patients, hand eczema can develop into a chronic disease.¹⁴ CHE is a fluctuating disease characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema and fissures on hands and wrists.⁸
CHE has been shown to cause psychological and functional burdens that impact patient quality of life.^9,10 Approximately 70% of adults who live with severe CHE have reported problems in performing everyday activities and disruption in their daily life due to the condition.¹¹ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.¹⁶

About Anzupgo^® (delgocitinib) Cream
Anzupgo^® cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE in adults and adolescents. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.¹⁷
Anzupgo^® is approved in several markets, including the European Union, United Kingdom, Switzerland, Canada, Australia, South Korea and the United Arab Emirates for the treatment of moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or inappropriate. In the European Union and the United Arab Emirates, Anzupgo^® is furthermore approved for the treatment of moderate to severe chronic hand eczema in adolescents aged 12-17 for whom topical corticosteroids are inadequate or inappropriate. Anzupgo^® cream is also being rolled out in other markets.
Anzupgo^® (delgocitinib) cream is FDA approved in the U.S. for moderate to severe chronic hand eczema in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable.¹⁸
In 2014, LEO Pharma obtained the exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where Shionogi & Co., Ltd. owns the rights.

About the DELTA China trial
DELTA China is a phase 3 trial to evaluate efficacy, safety and pharmacokinetics of twice-daily applications of Anzupgo in Chinese patients with moderate to severe CHE.²
The primary endpoint of the DELTA China trial was the Investigator’s Global Assessment for CHE treatment success (IGA-CHE TS) at Week 16.²
Treatment success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline.²

About LEO Pharma
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 4,300 people worldwide. Together, we reach far beyond the skin.

For more information, visit www.leo-pharma.com.

References

1. LEO Pharma Press Release. LEO Pharma Meets Primary Endpoint in Phase 3 DELTA China Trial with Anzupgo^® (delgocitinib) Cream in Chinese Patients with Moderate to Severe Chronic Hand Eczema (CHE). Published: February 25, 2025. Last accessed: October, 2025. Available at: https://www.biospace.com/press-releases/leo-pharma-meets-primary-endpoint-in-phase-3-delta-china-trial-with-anzupgo-delgocitinib-cream-in-chinese-patients-with-moderate-to-severe-chronic-hand-eczema-che
2. ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy, Safety, and Pharmacokinetics of Delgocitinib Cream in Chinese Adults and Adolescents With Moderate to Severe Chronic Hand Eczema. Identifier: NCT06004050. https://clinicaltrials.gov/study/NCT06004050.
3. ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 1). Identifier: NCT04871711. https://clinicaltrials.gov/study/NCT04871711.
4. ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2). Identifier: NCT04872101. https://clinicaltrials.gov/ct2/show/NCT04872101.
5. Bissonnette R, Warren RB, Pinter A, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024;404(10451):461-473.
6. ClinicalTrials.gov. National Library of Medicine (U.S.). Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials (DELTA3). Identifier: NCT04949841. https://clinicaltrials.gov/ct2/show/NCT04949841.
7. ClinicalTrials.gov. National Library of Medicine (U.S.). A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema. Iden-tifier: NCT05259722. https://clinicaltrials.gov/study/NCT05259722.
8. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
9. Grant L, Seiding Larsen L, Burrows K, et al. Development of a Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative Interviews with Patients and Expert Dermatologists. Adv Ther. 2020;37(2):692-706.
10. Dalgard FJ, Gieler U, Tomas-Aragones L, et al. The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European countries. J Invest Dermatol. 2015;135(4):984-991.
11. Cortesi PA, Scalone L, Belisari A, et al. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014;70(3):158-168.
12. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011 Nov-Dec;15(6):360.
13. Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1-22.
14. Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). JEADV. 2010;24:1-20.
15. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of chronic hand eczema in adults: a cross-sectional survey of over 60 000 respondents from the general population of Canada, France, Germany, Italy, Spain and the UK. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3.
16. Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity of Hand Eczema in the Dutch General Population: A Cross-sectional, Questionnaire Study within the Lifelines Cohort Study. Acta Derm Venereol. 2022;102:adv00626.
17. Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag. 2021 Mar 18;17:233.
18. ANZUPGO^® (delgocitinib) cream. Prescribing Information. FDA. July 2025.