LEO Pharma continues global rollout of Anzupgo® (delgocitinib) cream with submission of New Drug Application in China

BALLERUP, Denmark, October 16, 2025 -- LEO Pharma A/S, a global leader in medical dermatology, has today announced submission of the New Drug Application (NDA) to the National Medical Products Administration (NMPA) in China for Anzupgo® (delgocitinib) cream to treat adult Chinese patients living with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. The NDA has been accepted for review by NMPA.

“With this submission of our NDA for Anzupgo, LEO Pharma is demonstrating our position as a global leader in medical dermatology. This submission underscores Anzupgo’s position as a truly global brand, and we are now taking the next step in hopefully bringing this to Chinese patients” said Frederik Kier, Executive Vice President, International Operations. “China is a vital market for LEO Pharma, and we are proud to continuously invest in supporting skin health in Mainland China. Backed by our global expertise and commitment to innovation, we are excited to drive forward new innovative potential treatment options to provide support to those in China that need it most.”

The submission of this application marks an important milestone in potentially expanding treatment options for adult patients living with CHE in China. If approved, Anzupgo will aim to address a significant unmet medical need among adult patients with CHE, a disease that can have a considerable impact on both quality of life and everyday functioning.^8,9,10 There are currently no approved treatment options specifically indicated for moderate to severe CHE in China.

“LEO Pharma strives to enhance patient care and elevate quality of life for those living with complex skin diseases like chronic hand eczema,” said Byron Yin, General Manager for LEO Pharma, China. “Today’s submission is a crucial step towards offering a much-needed new treatment option in our region, in addition to the existing portfolio offering from LEO Pharma China.”

The NDA submission is supported by results from DELTA China, a phase 3 trial with Anzupgo^® (delgocitinib) 20mg/g cream, a topical pan-Janus kinase (JAK) inhibitor, for the potential treatment of Chinese adult patients with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.¹ 

Upon completion of the double-blind treatment period, the trial met its primary endpoint with a statistically significant improvement in CHE severity after 16 weeks of treatment with Anzupgo compared to cream vehicle.^1,11

The phase 3 trial consists of a 16-week randomized, double-blind, vehicle-controlled treatment period, followed by an open-label treatment period of 36 weeks.¹ A total of 362 subjects were recruited and randomized in a 2:1 ratio to receive either Anzupgo or cream vehicle.¹ The open-label treatment period of the DELTA China trial running from Week 16 to Week 52 and is still ongoing.¹ The results from this stage of the trial will be released at a later date.

Furthermore, the submission is also backed by the full clinical program of delgocitinib, which includes data from DELTA 1,2 and 3, DELTA Force and DELTA Teen. ^2-7

Following the Anzupgo filing acceptance by the Centre for Drug Evaluation (CDE), the full evaluation of the NDA has started. The regulatory review process is expected to conclude in 2027.

*ENDS*

About Chronic Hand Eczema

Chronic Hand Eczema (CHE) is defined as hand eczema (HE) 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, HE 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.¹⁶

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,^8,9 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition.¹⁰ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.¹⁷

About Anzupgo^® (delgocitinib) Cream

Anzupgo cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE in adults. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.¹⁸

Anzupgo is approved in 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 (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. Anzupgo cream is also under investigation in other markets.

Anzupgo^® (delgocitinib) cream is also FDA approved in the U.S. for moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Use of Anzupgo in combination with other JAK inhibitors or potent immunosuppressants is not recommended.¹⁹

In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.

About the DELTA China Trial

DELTA China is a phase 3 trial to evaluate efficacy, safety, and pharmacokinetics (PK) (only adults) of

twice-daily applications of Anzupgo in Chinese adults and adolescents (aged 12 and above) with moderate to severe CHE.¹

The primary endpoint of the DELTA China trial was the Investigator’s Global Assessment for CHE treatment success (IGA-CHE TS) at Week 16. 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.¹

 References

1. 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.  
2. 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.
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 2). Identifier: NCT04872101. https://clinicaltrials.gov/ct2/show/NCT04872101.
4. 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.
5. 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.
6. 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. Identifier: NCT05259722. https://clinicaltrials.gov/study/NCT05259722.
7. ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN). Identifier: NCT05355818. https://clinicaltrials.gov/study/NCT05355818.
8. 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.
9. 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.
10. 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.
11. 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
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. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
17. 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.
18. 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.
19. ANZUPGO^® (delgocitinib) cream. Prescribing Information. FDA. July 2025.

MAT-86206 October 2025