Immunoglobulin G1, anti-(human interleukin 36 receptor) (humanized monoclonal BI 655130 gamma1-chain), disulfide with humanized monoclonal BI 655130 kappa-chain, dimer、Spesolimab (genetical recombination) (JAN)、Spesolimab (INN)

+ [9]

靶点

IL-36R

作用方式

抑制剂

作用机制

IL-36R抑制剂(白细胞介素-36受体蛋白抑制剂)

治疗领域

免疫系统疾病皮肤和肌肉骨骼疾病其他疾病+ [1]

在研适应症

脓疱型银屑病泛发性脓疱型银屑病坏疽性脓皮病+ [1]

非在研适应症

溃疡性结肠炎克罗恩病肠梗阻+ [5]

原研机构

Boehringer Ingelheim International GmbH

在研机构

Boehringer Ingelheim GmbH

Leo Pharma, Inc.Boehringer Ingelheim International GmbH

+ [8]

非在研机构-

权益机构

Boehringer Ingelheim GmbH

LEO Pharma A/S

最高研发阶段批准上市

首次获批日期

美国 (2022-09-01),

泛发性脓疱型银屑病

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、孤儿药 (韩国)、孤儿药 (澳大利亚)、突破性疗法 (中国台湾)、突破性疗法 (中国)、优先审评 (美国)、优先审评 (中国)、孤儿药 (瑞士)、突破性疗法 (美国)

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结构/序列

Sequence Code 176702L

来源: *****

Sequence Code 9071670H

来源: *****

关联

项与佩索利单抗相关的临床试验

ChiCTR2600121266

/ Not yet recruiting临床4期IIT

Observational study on the efficacy of stapokibart in adults with atopic dermatitis affecting special sites

开始日期2026-04-01

申办/合作机构-

NCT06886009

/ WithdrawnN/A

A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Spesolimab in Korean Patients With Flares With Generalized Pustular Psoriasis

The primary and secondary objectives are to respectively monitor the safety and effectiveness of Spesolimab IV in Korean patients with flares with generalized pustular psoriasis (GPP) in a routine medical practice.

开始日期2026-03-31

申办/合作机构

Boehringer Ingelheim GmbH

NCT06624670

/ Recruiting临床3期

A Multi-centre, Randomised, Placebo-controlled, Double-blind, Parallel-group Trial to Evaluate Safety and Efficacy of Spesolimab (BI 655130) in Adult Patients With Ulcerative Pyoderma Gangrenosum (PG) Who Require Systemic Therapy

The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm^2 to 80 cm^2 in size.
This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo infusions look like spesolimab infusions, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth.
In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab.
In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks.
Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.

开始日期2025-02-05

申办/合作机构

Leo Pharma, Inc.

[+1]

100 项与佩索利单抗相关的临床结果

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100 项与佩索利单抗相关的转化医学

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100 项与佩索利单抗相关的专利（医药）

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193

项与佩索利单抗相关的文献（医药）

2026-10-01·INTERNATIONAL JOURNAL OF DERMATOLOGY

Subcutaneous Spesolimab for Amicrobial Pustulosis of the Folds

Letter

作者: Boggio, Francesca Laura ; Maronese, Carlo Alberto ; Bettolini, Luca ; Derlino, Federica ; Pilliu, Annapaola ; Sarno, Luisa ; Brevi, Marco ; Moltrasio, Chiara ; Marzano, Angelo Valerio ; Buffon, Stefano ; Genovese, Giovanni

2026-09-20·CHINESE MEDICAL JOURNAL

Spesolimab for patients with generalized pustular psoriasis flares: Real-world experience in China

Article

作者: Xu, Yuexiao ; Shi, Yuling ; Liu, Xiaoming ; Zhang, Furen ; Xu, Ai’e ; Lu, Qianjin ; Gao, Xinghua ; Tao, Juan ; Zhou, Yijun ; Pillai, Nichiren ; Chen, Fan ; Yang, Bin ; Jiang, Xian ; Li, Linfeng ; Zheng, Min

To the Editor: Generalized pustular psoriasis (GPP) is a chronic, systemic, neutrophilic inflammatory disease that is distinct from plaque psoriasis.[1] Flares are a hallmark of GPP and although the severity, frequency, and length of flares varies widely between patients, significant flares are often accompanied by systemic symptoms. Life-threatening complications of GPP include sepsis and renal, hepatic, respiratory, and heart failure. Reported GPP mortality rates range from 2% to 16%.[1] Spesolimab, a selective humanized monoclonal antibody targeting the interleukin-36 (IL-36) receptor, is approved in around 40 countries including China, the United States, European Union, and Japan for the treatment of GPP flares in adults.[2] We report safety and efficacy data for spesolimab from an expanded access program (EAP) that was conducted in Chinese patients with GPP who could not participate in clinical trials and to provide real-world evidence of spesolimab treatment. This was a multicenter, single-arm, open-label EAP of intravenous spesolimab 900 mg in patients with GPP presenting with a flare. The EAP was conducted at 12 sites in China from May 23, 2022, to July 17, 2023 (Trial registration: ClinicalTrials.gov, No. NCT05239039). The EAP was conducted and reported in accordance with the Declaration of Helsinki, guidelines for good clinical practice, and local regulations. All local ethics committees were informed and approved the study. All patients provided written informed consent. A schematic of the study design is shown in Supplementary Figure 1, https://links.lww.com/CM9/C578. After screening and enrolment, eligible patients received a single dose of spesolimab. If deemed necessary by the treating physician and if the flare symptoms persisted, patients could receive a second dose of spesolimab 1 week after the first dose. Each patient's study participation ended after conclusion of the 16-week follow-up period following the last administration of spesolimab. Patient enrolment in the EAP stopped when spesolimab became commercially available in China (May 2023). Inclusion and exclusion criteria are documented in Supplementary Materials and Methods, https://links.lww.com/CM9/C578. The primary endpoint was the occurrence of any treatment-emergent adverse events (TEAEs). Secondary endpoints were the occurrence of treatment-emergent serious adverse events (SAEs) and treatment-emergent adverse events of special interest (AESIs). Efficacy endpoints were Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) total scores at week 1 after the administration of spesolimab. The GPPGA total score assesses the average severity of pustulation, erythema, and scaling, with scores ranging from 0 (clear) to 4 (severe). Forty-four patients were screened; 39 entered the EAP and received spesolimab. All patients completed the trial, except for 1 patient (premature discontinuation from the trial by his/her own decision). Baseline demographic and characteristics of patients are summarized in Supplementary Table 1, https://links.lww.com/CM9/C578. All patients were Chinese with a mean (standard deviation [SD]) age of 39.3 (14.6) years and more were female than male (23 [59.0%] vs. 16 [41.0%]). Thirteen (33.3%) patients were diagnosed with GPP >10 years ago; 28 (71.8%) reported using at least one previous medication to treat GPP. Evaluation of common pathogenic mutations in GPP was conducted in 7 (17.9%) patients; no mutations in IL36RN, CARD14, and AP1S3 genes were detected. All patients presented with one GPP flare and none were treated with spesolimab for a recurrent flare after administration in the EAP. Of patients in the treated analysis set, 24 received one dose of spesolimab 900 mg and 15 received the second dose of spesolimab 900 mg 1 week apart. A summary of TEAEs reported during the flare treatment period, and their corresponding incidence rates (rate/100 patient-years), is presented in Table 1. Table 1 - Overall summary of the safety of spesolimab and treatment-emergent AEs during the GPP flare treatment period. Items Values Rate/100 pt-yrs Number of patients 39 Time at risk (pt-yrs) 12.2 Patients with any AE 30 (76.9) 629.0 Patients with severe AEs (RCTC Grade 3 or 4) 4 (10.3) 35.9 Patients with investigator-defined drug-related AEs 14 (35.9) 175.1 Patients with AEs leading to discontinuation of trial drug 0 0 Patients with investigator-defined AESIs 2 (5.1) 17.0 Patients with SAEs* 3 (7.7) 26.2 Resulting in death 0 0 Patients with other significant AEs† (according to project definition) 0 0 Values were shown as n or n (%). *Pneumonia and respiratory failure (1 patient), COVID-19 and pneumonia (1 patient), pustular psoriasis (1 patient); all SAEs recovered. †Significant AEs are those non-serious AEs which were reported with "action taken = drug withdrawn" or "action taken = dose reduced." AE: Adverse event; AESI: Adverse event of special interest; pt-yrs: Patient-years; GPP: Generalized pustular psoriasis; RCTC: Rheumatology Common Toxicity Criteria; SAE: Serious adverse event. Thirty patients (76.9%) experienced one or more TEAEs during the EAP (primary endpoint). The majority of TEAEs were of mild or moderate intensity. The frequency and incidence rate (per 100 patient-years) of adverse events (AEs) by system organ class (SOC) and preferred term (PT) during the GPP flare treatment period are shown in Supplementary Table 2, https://links.lww.com/CM9/C578. At the SOC level, the most frequently reported AEs were infections and infestations (19 patients, 48.7%). At the PT level, the most frequently reported AEs were coronavirus disease 2019 (COVID-19) (10 patients, 25.6%) and pyrexia (6 patients, 15.4%). Investigator-defined drug-related AEs were reported in 14 patients (35.9%). By SOC, the most frequently reported drug-related AEs were infections and infestations, investigations, and general disorders and administration site conditions (each 5 patients). Coding by PT, the most frequently reported drug-related AE was pyrexia (5 patients, 12.8%). In 4 out of 5 patients who experienced drug-related pyrexia, the event occurred in a timeframe close to the GPP flare; in the other patient, pyrexia was reported to be temporally close to a pneumonia event. Severe AEs were experienced by four patients (10.3%): pneumonia (n = 2, 5.1%), COVID-19 (n = 1, 2.6%), pustular psoriasis (n = 1, 2.6%), pyrexia (n = 1, 2.6%), all Grade 3; and Grade 4 respiratory failure (n = 1, 2.6%). All severe AEs were resolved. No AEs resulted in premature discontinuation in this study. Three patients (7.7%) experienced SAEs (which were also classified as severe AEs), comprising pneumonia and respiratory failure (1 patient), COVID-19 and pneumonia (1 patient), and pustular psoriasis (1 patient) [Table 1]. Reported AESIs were severe infections, namely, pneumonia (2 patients) and COVID-19 (1 patient). No AEs resulted in death during the study. Drug-related SAEs were reported in 2 patients (5.1%). One patient experienced pneumonia and non-serious dyspnea 3 days after spesolimab administration. On day 7, respiratory failure was reported, which required respiratory support with oxygen (3–5 L/min). These events were reported as temporally close to the GPP flare. The second patient experienced pustular psoriasis. All events recovered. Pregnant women were not allowed in the EAP. However, one event of spesolimab exposure during pregnancy was reported during the study. A 27-year-old female reported the pregnancy after receiving one dose of spesolimab 900 mg, and a healthy female newborn was delivered successfully. A total of 12 patients had recorded GPPGA scores at baseline. At week 1 after spesolimab administration, 9/12 patients achieved a GPPGA pustulation subscore of 0 and 6/12 patients achieved a GPPGA total score of 0 or 1 [Supplementary Table 3, https://links.lww.com/CM9/C578]. In addition, a total of 6 patients (6/12) were followed up over 16 weeks, of which 5 had a GPPGA pustulation subscore of 0 at each visit after the administration of spesolimab on day 1 until the end of the study visit. The current EAP, conducted in China, allowed patients with GPP flares early access to spesolimab and provides supportive data for the safety profile and efficacy of spesolimab in Asian patients. TEAEs were reported in 30 patients (76.9%) receiving spesolimab. There were no deaths, other significant AEs, or AEs leading to premature discontinuation in this study. The majority of TEAEs were of mild or moderate intensity and in line with expectations from the Effisayil® 1 and 2 clinical trials of spesolimab in GPP.[3,4] The most commonly reported AE was COVID-19 (10 patients, 25.6%), consistent with the fact that this trial was conducted in the context of the COVID-19 pandemic. For the AEs of pyrexia, occurring in 6 patients (15.4%), the association with the GPP flare itself cannot be excluded based on the onset date of the event (mostly 1 or 2 days after the initiation of GPP flare treatment with spesolimab). The frequency of SAEs was generally low (3 patients, 7.7%). All reported SAEs were resolved, including pneumonia (5.1%), COVID-19 (2.6%), respiratory failure (2.6%), and pustular psoriasis (2.6%). Overall, the EAP showed that intravenous spesolimab was associated with improvement of skin manifestations at week 1 compared with baseline. These results are consistent with those reported in Effisayil® 1,[3] although it should be noted that one-third of patients in the EAP had a baseline GPPGA total score of 2 whereas all patients in Effisayil® 1 had a baseline GPPGA total score of 3 or 4 (indicating more severe GPP); similarly, 2 patients in the EAP had a baseline GPPGA pustulation subscore of 1 whereas all patients in Effisayil® 1 had a baseline GPPGA pustulation subscore >1. In summary, to the best of our knowledge, this EAP conducted in China represents the largest real-world study of spesolimab in patients with GPP presenting with a flare and provides important safety evidence regarding the use of spesolimab for future clinical practice. Overall, spesolimab was safe and well tolerated. The improvements from baseline in skin manifestations are consistent with those reported in Effisayil® 1. Conflicts of interest This study was supported by Boehringer Ingelheim. Nichiren Pillai, Fan Chen, Yijun Zhou, and Yuexiao Xu are employees of Boehringer Ingelheim. All other authors have nothing to disclose. Data availability statement Datasets generated during and/or analyzed during the current study are available upon request via the link https://trials.boehringer-ingelheim.com/. Acknowledgements The authors thank Nora Pöntynen for her contributions to study design and conception and program implementation. Medical writing support, under the guidance of the authors, was provided by David P. Figgitt and Robert A.

2026-09-01·AMERICAN JOURNAL OF THERAPEUTICS

Spesolimab in Pregnancy: A Breakthrough Treatment for Coexisting Generalized Pustular Psoriasis and Hallopeau Acrodermatitis Continua

Article

作者: Gong, Juan ; Deng, Ya ; Yan, Shi

402

项与佩索利单抗相关的新闻（医药）

2026-09-29

·BioSpace

LEO Pharma to Showcase Its Broadest Ever Scientific Program at EADV 2026

LEO Pharma will present 28 accepted abstracts at the 2026 European Academy of Dermatology and Venereology Congress, taking place from 30 September to 3 October in Vienna, Austria. The EADV 2026 program reflects the strength and breadth of LEO Pharma’s portfolio, showcasing what’s now and what’s next in medical dermatology with new evidence across nine disease areas, six routes of administration and nine modes of action; including biologic injectables, topical formulations, and covering data across established dermatology brands and new innovation. The program underscores LEO Pharma’s continued commitment to advancing medical dermatology through evidence that addresses both highly prevalent chronic skin diseases and complex or rare, hard-to-treat conditions with significant unmet needs. BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, will present a broad scientific program at the 35th European Academy of Dermatology and Venereology Congress, held from September 30 to October 3, 2026 in Vienna, Austria. “At EADV 2026, we are proud to share a strong body of scientific evidence that reflects the breadth of our portfolio and our ambition to keep advancing medical dermatology while showcasing what’s now and what’s next,” said Jacob Thyssen, Chief Scientific Officer, LEO Pharma. “This year’s program brings forward clinically relevant data across common chronic skin diseases, rare and hard-to-treat conditions, and early-stage innovation - all with a focus on evidence that can support healthcare professionals and make a meaningful difference for patients.” A key focus of the program is tralokinumab, with eight original abstracts accepted, including two oral presentations and six ePosters. New real-world TRACE data will highlight tralokinumab’s impact in patients with moderate-to-severe atopic dermatitis involving high-burden areas such as head & neck, hands, feet and genitals, alongside associated changes in quality of life. LEO Pharma will also present six delgocitinib abstracts, including one oral presentation and five ePosters, further expanding the evidence base in chronic hand eczema. The program includes real-world data from the German REACHED study and an oral presentation on health-related quality of life in adolescents treated with delgocitinib cream. “Across atopic dermatitis and chronic hand eczema, our EADV 2026 data underline the importance of evidence that goes beyond traditional clinical endpoints,” said Sophie Lamle, Chief Development Officer, LEO Pharma. “By generating real-world evidence, long-term data and patient-centered outcomes, we are working to better reflect clinical practice and the lived experience of people with skin disease.” Looking further ahead, LEO Pharma will present first-in-human Phase 1 data for LEO-158968, a novel anti-IL-1RAcP monoclonal antibody that demonstrated a clear PK/PD relationship and strong pharmacological activity. The program includes four spesolimab abstracts covering generalized pustular psoriasis and pyoderma gangrenosum, with data on long-term efficacy, flare management and unmet needs in diagnosis and treatment. LEO Pharma will also present new brodalumab data in plaque psoriasis, including comparative analyses in patients with overweight or obesity. The full roster of new and encore abstracts 1-28 at the 2026 EADV congress includes: Tralokinumab Full title Authors ID & Format Initiating biologics in atopic dermatitis: Global practices and recommendations from the AMAZE project April W. Armstrong, Andrew E. Pink, Joe Gorelick, Mariateresa Rossi, Magdalena Trzeciak, Mette Deleuran, Hyun Jung Kim, Saeko Nakajima, Vimal H. Prajapati AS-2446 Oral presentation Session FC01: 08:40–08:50, Thu 1 Oct 2026, Hall N Real-world use of tralokinumab in patients with atopic dermatitis involving high-burden areas: Effectiveness and impact on quality of life in the prospective, non-interventional 12-month TRACE study April W. Armstrong, Andrew E. Pink, Ahmed Ameen, Marni Wiseman, Adrian Rodriguez, Alessandra Narcisi, Audrey Nosbaum, Teodora Festini, Kavita Kapoor, Frank Vinther, Ida Vittrup, Diamant Thaci AS-1845 Oral presentation Session FC02: 10:15–10:25, Thu 1 Oct 2026, Hall N Real-world characterization of early and delayed responses to tralokinumab among patients with atopic dermatitis: Results from the prospective, international, non-interventional 12-month TRACE study April W. Armstrong, Jose Juan Pereyra Rodriguez, Ahmed Ameen, Elena Pezzolo, Teodora Festini, Frank Vinther, Ida Vittrup, Diamant Thaci AS-1852 ePoster P1604 Determination of a head and neck response criterion as an optimal treatment target for patients with atopic dermatitis with head and neck involvement Raj Chovatiya, Simone Ribero, Andrew Blauvelt, Diamant Thaçi, Andrew E. Pink, Chih-ho Hong, Sebastien Barbarot, Rie von Eyben, Peter van Iperen, John Stinson, Stephan Weidinger AS-1949 ePoster P1609 Tralokinumab monotherapy improves atopic dermatitis severity in patients with moderate-to-severe atopic hand eczema Benjamin Ehst, H. Chih-ho Hong, Leon Kircik, Francisco J. Navarro-Trivino, Marie Tauber, April W. Armstrong, Frida Emanuelsson, Anne Louise Svendsen, Ann-Marie Tindberg, Stephan Weidinger AS-429 ePoster P1575 Tralokinumab monotherapy rapidly improves sleep, daily functions, and health-related quality of life in patients with atopic dermatitis and moderate-to-severe hand involvement Sebastian Volc, Irina Turchin, Marie Tauber, Richard Woolf, Maria Czubek, Thomas Rustemeyer, Ann-Marie Tindberg, Sylwia Cholewinska, Frank Vinther, Benjamin Ehst AS-1844 ePoster P1595 Tralokinumab provides early and sustained improvements in head and neck atopic dermatitis among adolescents with moderate-to-severe disease Raj Chovatiya, Simone Ribero, Andrew Blauvelt, Amy S Paller, Chih-ho Hong, Anthony Bewley, Andrew E Pink, John Stinson, Rie von Eyben, Peter van Iperen, Andreas Wollenberg AS-1046 ePoster P1581 Long-term efficacy and safety of tralokinumab in adolescents aged 12–17 years with moderate-to-severe atopic dermatitis Amy S Paller, Carsten Flohr, Michael Cork, Anthony Bewley, Andrew Blauvelt, H. Chih-Ho Hong, Shinichi Imafuku, Marie-Louise A Schuttelaar, John Stinson, Peter van Iperen, Rie von Eyben, Andreas Wollenberg AS-212 ePoster P1513 Delgocitinib Full title Authors ID & Format Real-world effectiveness of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: interim analysis after 8 weeks of treatment in the German REACHED study Sonja Molin, Christian Apfelbacher, Laura Burgahn, James Greig, Rie von Eyben, Khusru Asadullah AS-2192 ePoster P1613 Delgocitinib cream provides rapid improvements in itch and pain symptoms in adolescents with moderate to severe chronic hand eczema: Results from DELTA TEEN Sonja Molin, Francisco J. Navarro-Triviño, Ziad Reguiai, F. Elcin Darendeli, Eydna Didriksen Apol, Line Conradsen Hiort, Henrik Thoning, Anthony Bewley, Amy Paller AS-1702 ePoster P2395 Treatment with delgocitinib cream improves health-related quality of life in adolescents with moderate to severe chronic hand eczema: Results from DELTA TEEN; a randomized, double-blind, vehicle-controlled phase 3 trial Sonja Molin, Diana Rubel, Francisco J. Navarro-Triviño, Ziad Reguiai, Sofie De Schepper, James Halpern, Danielle Marcoux, John Su, Paweł Brzewski, F. Elcin Darendeli, Eydna Didriksen Apol, Henrik Thoning, Jeff Yu, Lawrence F. Eichenfield AS-1174 Oral presentation Session FC02: Free Communication 2: Atopic dermatitis/Eczema, Thu 1 Oct, 11:25–11:35, Hall N Delgocitinib cream reduces patient-reported disease severity in adults with moderate to severe Chronic Hand Eczema: pooled analysis of the Phase 3 DELTA 1 and DELTA 2 trials Anthony Bewley, Linda Stein Gold, James Greig, Kira Hyldekaer Janstrup, Sven Malte John AS-1236 ePoster P1525 [ENCORE] HRQoL and Work Productivity Improvements with Topical Delgocitinib vs Oral Alitretinoin in Chronic Hand Eczema: Phase 3 DELTA FORCE Results Andrea Bauer, Timo Buhl, Richard Woolf, James Greig, Jenny M. Norlin, Henrik Thoning, Ana Maria Gimenez-Arnau AS-1951 ePoster P1608 [ENCORE] Sustained Health-Related Quality of Life improvements with Delgocitinib 20 mg/g Cream in Chronic Hand Eczema – Results from the Phase 3 Open-Label Extension DELTA 3 Trial April W. Armstrong, Linda Stein Gold, Andrea Bauer, James Greig, Jenny M. Norlin, Henrik Thoning, Tove Agner AS-595 ePoster P1576 Spesolimab Full title Authors ID & Format Healthcare professional (HCP) perception of pyoderma gangrenosum (PG): Real-world insights of unmet needs and treatment goals Alavi A, Dini V, Kirsner RS, Sequeira R, Ortega Loayza AG AS-534 ePoster P0894 [ENCORE] Long-term disease control with subcutaneous spesolimab in GPP patients with or without IL-36RN mutation. Results from the EFFISAYIL ON study Krueger JG, Lebwohl MG, Morita A, Burden AD, Anadkat AJ, Reardon J, Tang M, Thoma C, Gudjonsson JE AS-525 ePoster P0881 [ENCORE] Long-term (≥3 year) efficacy and safety of subcutaneous spesolimab for treatment of generalized pustular psoriasis: Results from the EFFISAYIL program Gudjonsson JE, Navarini AA, Langley RG, Krueger JG, Mostaghimi A, Burden AD, Tang M, Reardon J, Thoma C, Morita A AS-530 ePoster P0879 [ENCORE] Intravenous spesolimab for (re)treatment of generalized pustular psoriasis flares in patients receiving subcutaneous spesolimab: Results from the 5-year, open-label, EFFISAYIL ON extension study Gordon K, Navarini AA, Choon SE, Warren RB, Anadkat MJ, Tang M, Reardon J, Thoma C, Lebwohl MG AS-532 ePoster P0893 Early Portfolio Full title Authors ID & Format LEO 158968, a Novel Anti-IL-1RAcP Monoclonal Antibody, Demonstrates a Clear PK/PD Relationship and Strong Pharmacological Activity in Patients: Results from a Phase 1 Program Tristan Pascart, Anne-Marie Schmitt, Victor Laurent, Gauthier Marchasson, Dorothée Brzyski, Mie Larsen Broberg, Jens Strodl Andersen, Frank Vinther, Petra Arlert, Thomas Quémeneur, Takashi Satoh, Lars E. French AS-2307 ePoster P1750 Development and content validity testing of two new Patient Reported Outcome (PRO) instruments in Palmoplantar Pustulosis (PPP) Andrew E. Pink, Robert Bissonnette, Jason Hawkes, Joanna Narbutt, Rotraut Mößner, Petra Arlert, Dale Chandler, Laura Grant, Megan Mayhew, Henrik Meincke, Anne Marie Schmitt, Matthias Augustin AS-2215 ePoster P2316 Core Brands Full title Authors ID & Format Matching-Adjusted Indirect Comparison of the Efficacy and Safety of Brodalumab and Secukinumab in the treatment of Patients with Moderate-to-Severe Plaque Psoriasis Weighing 90 kg or More Matteo Megna, Veena Lim, Emily Foreman, Corinne Le Reun, Marie Jablonski Bernasconi, Sascha Gerdes AS-1924 e-Poster P2610 Real world response to Cal/BD aerosol foam long-term maintenance treatment in patients with plaque psoriasis: an observational, prospective study in Greek clinical setting (the STABILITY study) Efterpi Zafeiriou, Efstathios Rallis, Georgios Gaitanis, Efstathios Gourvelos, John Katsantoni, Alexandra Kourouklidou, Natalia Rompoti, Dimitrios Sgouros, Irene Stefanaki, Eleftheria Tampouratzi, Athanasios Chaniotis, George Pesiridis, Efthymios Stathatos, Alexander Stratigos AS-1025 ePoster P1199 Brodalumab demonstrates rapid effectiveness in patients with moderate-to-severe plaque psoriasis: short-term results from the Greek REALITY-1 non-interventional study Efterpi Zafeiriou, Aimilios Lallas, Despina Arnaoutoglou, Pantelis Aronis, Alexandros Drosos, Maria Pizimola, Nikolaos Rotsiamis, Irene Stefanaki, Athanasios Chaniotis, George Pesiridis, Efthymios Stathatos, Alexander Katoulis, Sophia Georgiou AS-1018 e-Poster P1198 [ENCORE] Topical Calcineurin Inhibitors and Malignancy Risk: A Critical Review Andreas Wollenberg, Alejandro Arana, Michael J. Cork, Mette Deleuran, Regina Fölster-Holst, H. Chih-ho Hong, Anita Remitz-Reitamo, Diamant Thaçi AS-2229 e-Poster P0912 Epithelial-Derived IL-17C and IL-17E as Psoriatic Inflammation Amplifiers and Targets Paulo Oldani, Aline M F Magalhaes, Ana Vargas, Lucas Giglio Colli, Guilherme Muzy AS-1138 e-Poster P1776 IL-6 and IL-8: Drivers of Chronic Local Inflammation in Adult Female Acne (AFA) and Specific Modulation by Topical Azelaic Acid 15% Gel Diogo Pazzini Bomfim, Aline M F Magalhaes, Cristiane Damas Gil, Marco Rocha, Ediléia Bagatin AS-1132 e-Poster P1427 Sixty Years of Topical Fusidic Acid: From Discovery to Modern Evidence-Based Dermatology Mayra Ianhez, Aline Magalhaes, Pedro Mendes-Bastos AS-1113 e-Poster P2243 Cost Effectiveness Analysis of Biological Drugs Targeting IL-17 Pathway in Plaque Psoriasis From the Perspective of the Brazilian Private Healthcare System Paulo Oldani, Aline M F Magalhaes, Giovana Gouveia, Lucas Giglio Colli, Guilherme Muzy AS-1136 e-Poster P0414 In addition to the abstracts and poster presentations, LEO Pharma will also present a symposium and two industry hubs at the EADV Congress: Title Timing Location Chronic Hand Eczema Satellite Symposium October 2, 13:00 – 14:00 SAT 2.06, Level 2, Hall B Going beyond ulcers: A deeper look at Pyoderma Gangrenosum October 1 15:15 – 16:00 Hub 2 GPP Industry Hub October 2, 14:15 – 15:00 Hub 2 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. 29,30 CHE is one of the most common skin diseases of the hands with a global prevalence rate of approximately 4.7%. 31,32 In a substantial number of patients, HE can develop into a chronic disease. 31 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. 33 CHE has been shown to cause psychological and functional burdens that impact patient quality of life, 34,35 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. 36 Furthermore, careers and learning potential have also been shown to be impacted by the burden of living with CHE. 37 About Atopic Dermatitis Atopic Dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions. 38 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation. 39 Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology. 38,39 Excessive IL-22 production is also known to contribute to the pathogenesis of AD. 40 About generalized pustular psoriasis (GPP) GPP is a chronic, heterogenous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. 41,42 GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment. 41,42 GPP can become life-threatening, with reported mortality rates ranging from 2% to 16%, due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems. 42–44 GPP symptoms appear unpredictable and present on a continuum, which greatly impacts a patient’s quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities, and finances. 44,45 About Anzupgo ® (delgocitinib) Cream Anzupgo® cream is a topical non-steroidal 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. 46 Anzupgo® is approved in the European Union, United Kingdom, Switzerland, Canada, Australia, South Korea, Saudi Arabia, Macau 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® (delgocitinib) cream is 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 An-zupgo® in combination with other JAK inhibitors or potent immunosuppressants is not recommended by the U.S. FDA. 47 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 Adtralza ® (tralokinumab) / Adbry ® (tralokinumab-ldrm) Adtralza® (tralokinumab), which is marketed under the tradename Adbry® in the U.S., is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms. 48-50 Adtralza® / Adbry® is approved for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy in the European Union, United States, Canada, the United Arab Emirates and South Korea. Adtralza® is approved for use in adults with moderate to severe atopic dermatitis in Switzerland, Saudi Arabia and Japan. Adtralza is also approved for adolescents in Saudi Arabia. About Spevigo® Spevigo® is a humanized, selective antibody that specifically blocks activation of the IL-36R, a signalling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. Spevigo® is approved for the treatment of generalized pustular psoriasis (GPP) and is the first targeted therapy for this condition. It and has been evaluated in the largest clinical program specifically for the treatment of patients with GPP. 51-55 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 4,400 people worldwide. Together, we reach far beyond the skin. For more information, visit . References Armstrong AW, et al. Initiating biologics in atopic dermatitis: Global practices and recommendations from the AMAZE project. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. Oral presentation. AS-2446. Armstrong AW, et al. Real-world use of tralokinumab in patients with atopic dermatitis involving high-burden areas: Effectiveness and impact on quality of life in the prospective, non-interventional 12-month TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. Oral presentation. AS-1845. Armstrong AW, et al. Real-world characterization of early and delayed responses to tralokinumab among patients with atopic dermatitis: Results from the prospective, international, non-interventional 12-month TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. ePoster Presentation. P1604. Chovatiya R, et al. Determination of a head and neck response criterion as an optimal treatment target for patients with atopic dermatitis with head and neck involvement. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. ePoster Presentation. P1609. Ehst B, et al. Tralokinumab monotherapy improves atopic dermatitis severity in patients with moderate-to-severe atopic hand eczema. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. ePoster Presentation. P1575. Volc S, et al. Tralokinumab monotherapy rapidly improves sleep, daily functions, and health-related quality of life in patients with atopic dermatitis and moderate-to-severe hand involvement. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. ePoster Presentation. P1595. Chovatiya R, et al. Tralokinumab provides early and sustained improvements in head and neck atopic dermatitis among adolescents with moderate-to-severe disease. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. ePoster Presentation. P1581. Paller AS, et al. Long-term efficacy and safety of tralokinumab in adolescents aged 12–17 years with moderate-to-severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. ePoster Presentation. P1513. Molin S, et al. Real-world effectiveness of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: interim analysis after 8 weeks of treatment in the German REACHED study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. ePoster Presentation. P1613. Molin S, et al. Delgocitinib cream provides rapid improvements in itch and pain symptoms in adolescents with moderate to severe chronic hand eczema: Results from DELTA TEEN. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. ePoster Presentation. P2395. Molin S, et al. Treatment with delgocitinib cream improves health-related quality of life in adolescents with moderate to severe chronic hand eczema: Results from DELTA TEEN; a randomized, double-blind, vehicle-controlled phase 3 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. Oral presentation. AS-1174. Bewley A, et al. Delgocitinib cream reduces patient-reported disease severity in adults with moderate to severe Chronic Hand Eczema: pooled analysis of the Phase 3 DELTA 1 and DELTA 2 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. ePoster Presentation. P1525. Bauer A, et al. HRQoL and Work Productivity Improvements with Topical Delgocitinib vs Oral Alitretinoin in Chronic Hand Eczema: Phase 3 DELTA FORCE Results. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. ePoster Presentation. P1608. Armstrong AW, et al. Sustained Health-Related Quality of Life improvements with Delgocitinib 20 mg/g Cream in Chronic Hand Eczema – Results from the Phase 3 Open-Label Extension DELTA 3 Trial. Contacts Christian Bundgaard Global Corporate Communication +45 53 74 88 49 chbun@leo-pharma.com Jes Broe Frederiksen Global Corporate Communication +45 53 60 59 48 jebfe@leo-pharma.com Read full story here

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2026-09-23

·BiG生物创新社

银屑病市场，正在孕育下一个“药王”

10月23-24日，上海张江，第12届BiG IMPACT年会再度启幕！华奥泰总经理朱向阳博士将于10月24日在大分子论坛发表题为《Development of Rocibakibart and beyond》的主题报告。年会详情及报名入口见文末。银屑病是一种需要长期治疗和疾病管理的慢性炎症性皮肤病，庞大的患者群体构成了稳定的治疗需求。全球约有1.25亿银屑病患者，中国患者规模由2017年的650万人增至2022年的670万人，预计2030年将达到680万人，其中约20%—30%为中重度患者。随着治疗需求不断释放，银屑病药物市场也在持续扩容。据Global Market Insight数据，2022年全球银屑病治疗市场规模为265亿美元，预计2032年将达到605亿美元，年复合增长率为8.6%；中国市场增长更为迅速，市场规模由2018年的6.04亿美元增至2022年的14.36亿美元，预计2030年将进一步达到99.44亿美元。图1. 2021年至2032年银屑病治疗市场规模市场扩容的背后，生物制剂是重要驱动力之一。随着对银屑病发病机制认识不断深入，治疗靶点从TNF-α逐步延伸至IL-23、IL-17等通路，生物制剂在中国银屑病药物市场中的占比预计将由2022年的43.4%提升至2030年的50.3%。而靶向治疗的不断迭代不仅改变了银屑病的治疗方式，也造就了一批商业上的超级大单品。 TNF-α时代，艾伯维的阿达木单抗（修美乐）年销售额一度突破200亿美元；随着专利到期和生物类似药冲击，其销售额逐步回落。与此同时，治疗靶点向IL-23、IL-17等通路迭代，新的重磅产品开始接棒，其中利生奇珠单抗（喜开悦）2025年销售额已达到175.62亿美元。如今，IL-36R又打开了泛发性脓疱型银屑病（GPP）这一新的治疗市场。银屑病市场的下一个“药王”已经在路上。 01 银屑病生物治疗的起点 TNF-α是银屑病炎症反应中的重要细胞因子，主要由树突状细胞、巨噬细胞和T细胞等产生，可参与炎症反应的发生与维持。基于TNF-α在银屑病发病机制中的重要作用，以其为靶点的TNF-α抑制剂成为较早应用于银屑病治疗的一类生物制剂，并推动银屑病治疗进入生物制剂时代。表1. 已上市银屑病TNF-α抑制剂数据来源：公开资料整理注：表中“/”表示该药物无相应FDA获批记录；获批时间主要为公开报道中对应适应症的获批口径。其中，率先将TNF-α商业价值推向高位的是英夫利西单抗。在生物类似药大规模进入市场之前，英夫利西单抗已经成长为接近百亿美元体量的超级重磅药物，并一度成为强生在自免领域收入最高的产品。2016年，英夫利西单抗销售额达到82.34亿美元的峰值。随着专利到期以及生物类似药陆续进入市场，其销售额自2017年起持续下滑，2024年已降至16.05亿美元。2025年，英夫利西单抗销售额短暂升至17.68亿美元，但2026年上半年再度同比下降17.6%至7.60亿美元。从接近百亿美元的大单品到在生物类似药竞争中逐步退潮，英夫利西单抗完整演绎了首代重磅生物药的生命周期。依那西普是安进和辉瑞共同开发的TNF-α抑制剂，其商业表现同样亮眼。2016年，安进披露的依那西普销售额达到59.65亿美元，同比增长11%；同期，辉瑞负责市场的销售额达到29.09亿美元，依那西普当年的全球商业规模由此接近89亿美元，距离百亿美元门槛仅一步之遥。更重要的是，依那西普并非短期爆发的“昙花一现”，而是在相当长时间内维持数十亿美元的销售规模，成为TNF-α赛道最具代表性的现金牛产品之一。不过随着市场竞争加剧，其销售额也逐渐走低。2025年，安进披露的依那西普销售额为22.26亿美元，同比下降33%，较2016年的高峰已经明显回落。真正将TNF-α抑制剂商业价值推向巅峰的是阿达木单抗。与英夫利西单抗和依那西普相比，阿达木单抗拥有更广泛的适应症布局和更长市场统治力，并最终成长为自免领域最具代表性的超级大单品之一。2022年，阿达木单抗全球销售额达到212.37亿美元，贡献了艾伯维当年超过三分之一的收入。不过，随着阿达木单抗专利到期，自2023年起其销售额迅速回落，到2025年已进一步降至45.40亿美元。从百亿美元级重磅产品到真正意义上的“药王”，阿达木单抗一度定义了全球自免市场的黄金时代（表1）。尽管TNF-α抑制剂开创了银屑病生物治疗时代，并造就了多款超级重磅产品，但该类药物治疗效果有限，且存在注射部位反应、感染和免疫原性等不良反应，部分患者还面临给药频率较高、长期治疗负担较重等问题。随着对银屑病发病机制认识的不断深入，疗效更强、靶向性更高的新一代生物制剂也开始加速登场。 02 经典靶点，成熟赛道随着对银屑病免疫机制认识的不断深入，治疗靶点也逐渐从TNF-α向更下游的炎症因子延伸。当机体受到创伤、感染或药物等因素刺激时，树突状细胞可释放IL-23、TNF-α和IL-12等促炎因子，促进Th17等免疫细胞的活化和扩增，进而产生IL-17等细胞因子作用于角质形成细胞，形成持续放大的炎症循环。因此，IL-23和IL-17也成为继TNF-α之后银屑病生物制剂研发的两大核心靶点。表2. 已上市银屑病IL-23和IL-17生物制剂数据来源：公开资料整理注：表中“/”表示该药物无相应FDA获批记录；获批时间主要为公开报道中对应适应症的获批口径。其中，IL-23抑制剂研发经历了从p40到p19亚基的迭代。较早上市的乌司奴单抗由强生原研，通过靶向IL-12和IL-23共有的p40亚基发挥作用，并被广泛用于多种免疫介导性炎症疾病。国内方面，康方生物依若奇单抗于2025年4月获批上市。随着乌司奴单抗核心专利到期，生物类似药也加速进入市场，荃信生物赛乐信于2024年11月在国内获批，百奥泰BAT2206则于2025年5月获得美国FDA批准。相比p40抑制剂，新一代IL-23抑制剂选择性靶向p19亚基，代表产品包括古塞奇尤单抗、替瑞奇珠单抗和利生奇珠单抗等，在提高靶点选择性的同时展现出较好的长期疗效。与IL-23相比，IL-17位于炎症通路更下游，直接作用于银屑病炎症反应的关键效应环节，因此部分IL-17抑制剂具有起效较快、皮损清除率较高的特点，并迅速成为银屑病生物治疗的重要力量。司库奇尤单抗是全球首批获批的IL-17A抑制剂，2019年在中国获批。目前，司库奇尤单抗、依奇珠单抗以及国内的赛立奇单抗、夫那奇珠单抗等均已进入市场。除直接靶向IL-17A外，IL-17受体也成为另一条研发路径。布罗利尤单抗通过靶向IL-17RA，可同时阻断包括IL-17A、IL-17C、IL-17E和IL-17F在内的多种IL-17家族成员介导的信号。在此基础上，IL-17领域的研发又进一步向双靶点延伸。优时比的比奇珠单抗可同时靶向IL-17A和IL-17F，更全面地抑制相关炎症信号，并在多项头对头研究中相较乌司奴单抗、司库奇尤单抗等展现出较高的皮损清除率。尽管其念珠菌感染风险受到关注，但其“双重阻断”机制也进一步提高了银屑病生物制剂的疗效竞争门槛。商业化方面，乌司奴单抗凭借先发优势长期占据重要地位，但随着专利到期及生物类似药进入，其2025年全球销售额已降至60.78亿美元，2026年上半年进一步降至13.96亿美元。与此同时，艾伯维的利生奇珠单抗快速放量，销售额由2024年的117.18亿美元增至2025年的175.62亿美元，2026年上半年已达到99.88亿美元，同比增长27.3%。随着产品不断迭代，银屑病生物制剂市场已形成IL-23和IL-17两条通路并行竞争的格局（表2）。 03 IL-36R蓝海赛道在IL-17、IL-23等靶点不断提高斑块型银屑病治疗水平的同时，IL-36通路则打开了先天免疫驱动的泛发性脓疱型银屑病（GPP）的治疗窗口。GPP是一种罕见但可能危及生命的系统性炎症性皮肤病，急性发作时可出现广泛红斑和无菌性脓疱，并伴随发热、白细胞升高等全身炎症表现，严重时可发生脓毒症及多器官功能衰竭。研究显示，中国GPP患病率约为每百万人14例，据此估算患者约2万人；2023年，GPP被正式纳入我国《第二批罕见病目录》。与斑块型银屑病不同，GPP具有更突出的先天免疫和中性粒细胞炎症特征，其中IL-36通路过度激活被认为是其重要发病机制。IL-36R抑制剂的出现使GPP首次拥有了针对核心致病通路的生物制剂。勃林格殷格翰的佩索利单抗是全球首个获批的IL-36R单抗，该药于2022年9月获FDA批准，同年12月在中国获批，用于治疗成人GPP发作，完成了IL-36R靶点从机制研究到临床验证的关键跨越。不过，IL-36R目前展现出的临床价值具有较强的疾病特异性。佩索利单抗在GPP中取得成功，但在掌跖脓疱病等适应症的Ⅱ期研究中未达到主要终点。因此，与IL-17、IL-23面向庞大的斑块型银屑病人群不同，IL-36R当前更像是一个围绕GPP高未满足需求建立起来的精准治疗赛道。表3. 已上市银屑病IL-36R生物制剂及重点在研管线数据来源：公开资料整理国内企业也开始进入这一市场。2026年7月29日，华海药业控股子公司华奥泰生物自主研发的瑞西奇拜单抗（HB0034，商品名：华亦净）在中国获批，用于治疗体重≥40kg的成人GPP发作，成为继佩索利单抗之后国内第二款获批的IL-36R单抗，也是首款国产自研IL-36R单抗，为国内GPP患者带来了新的治疗选择。据Insight数据库，全球范围内仅有6款IL-36R单抗进入临床研发。其中，AnaptysBio开发的IL-36R单抗Imsidolimab已经完成Ⅲ期研究，其GEMINI-1研究达到主要终点；2026年2月，FDA正式受理其GPP生物制品许可申请，PDUFA目标日期为2026年12月12日，已进入上市审批阶段。国内方面，正大天晴的同机制新药TQH2929于2026年3月启动Ⅱ期关键注册研究，计划入组36例GPP急性发作患者，主要终点为治疗第1周达到GPPGA脓疱亚项0分的患者比例（表3）。整体来看，IL-36R单抗仍是一个玩家较少的蓝海赛道，与IL-17、IL-23的大市场逻辑并不相同，其聚焦的是GPP这一高未满足需求的罕见病领域。随着Imsidolimab、TQH2929等后续产品推进，IL-36R赛道有望进入竞争加速期。一个值得认真听的产品故事文章写到这里，银屑病市场的靶点迭代逻辑已经比较清晰，但有一个问题还悬着：当L-17赛道已经聚集了进口产品、国产产品，双靶点产品的时候，一个后来者到底靠什么站住位置? 这个问题，华奥泰有自己的答案。华奥泰是华海药业旗下生物创新药平台，其自免管线在银屑病领域形成了从IL-36R到L-17A、再到双靶点的系统布局，瑞西奇拜单抗(HB0034,华亦净)已于2026年7月获NMPA批准上市，成为国内首款国产自研IL-36R单抗。用于成人GPP发作。但更值得关注的是另一个产品：Rocibakibart(HB0017)，华奥泰自主研发的抗IL-17A单抗。其关键III期临床数据显示：治疗12周，PASI75应答率达到95.7%，安慰剂组仅7.4%；PASI90应答率达到88.0%；sPGA0/1达到87.0%。在维持治疗阶段，给药间隔可延长至每8周一次，52周时每8周组PASI100维持率达到65.8%，每4周组达到79.1%，未发现新的安全性信号，对于需要长期管理的慢性银屑病患者来说，8周一次的维持给药方案，在便利性上是一个值得关注的差异化点。目前，HB0017的新药上市申请已于2026年6月获NMPA受理，适应症覆盖中重度斑块状银屑病和强直性脊柱炎。但华奥泰的布局不止于IL-17A单抗。其管线中还有一款全球首创的IL-17A/IL-36R双特异性抗体HB0043，同时靶向IL-17A和IL-36R，已获得中国IND批件，目前正在化脓性汗腺炎、中重度痤疮等适应症上推进临床探索。换句话说，当行业还在讨论“IL-17和IL-36R两条通路并行竞争”的时候，华奥泰已经在尝试把两条通路合到同一个分子里，这正是华奥泰总经理朱向阳博士要在BiG12周年年会上来讲的故事。报告题目：Development of Rocibakibart and beyond 主讲嘉宾：朱向阳博士，上海华奥泰生物药业股份有限公司总经理朱向阳博士是国家特聘专家，在单抗筛选与鉴定、双靶点抗体工程改造、细胞株建立及工艺开发领域有超过20年的经验，曾长期在勃林格殷格翰从事生物药研发工作加入华奥泰后，他领导团队完成了16个项目的中美临床申报，目前正在推进中有4个III期、7个II期和3个1期临床项目，同时布局了10多个早期研发项目，涵盖双功能抗体和ADC。在这场报告中，朱博士将围绕Rocibakibart的临床开发路径，系统讲述华奥泰在银屑病领域的管线逻辑：从IL-17A单抗的疗效数据与维持给药方案，到IL-36R单抗的差异化定位，再到IL-17A/IL-36R双抗的“beyond”探索。对于关注自免赛道竞争格局和产品差异化策略的同行来说，这是一次难得的、来自产业一线的复盘。写在最后银屑病生物制剂的演进是一场围绕疗效和未满足需求不断推进的靶点迭代。随着老一代产品进入专利悬崖、新一代生物制剂持续接棒，新的竞争周期已经开启。而在这个周期里，什么样的产品能成为下一个“药王”，什么样的策略能让后来者在拥挤的赛道中站住位置，这些问题，或许在朱向阳博士的报告里能找到一些参考答案。 BiG 12周年第12届 BiG IMPACT年会10月23-24日将在上海张江正式启幕，本次年会汇聚顶级产学研投力量，打造中国创新对话世界的稀缺跨境平台！时间及地点：10月23-24日（周五-周六）上海-张江希尔顿；年会亮点：国际化程度高：哈佛医学院 Greg Verdine 教授首次在中国公开亮相，RA Capital 创始人 Peter Kolchinsky 携核心团队参与，并带来“Science2Startup”中国产业界首秀。中国最具代表性的声音：王晓东院士、孙勇奎院士、鲁白院长、徐沪济教授同台分享中国在创新与临床转化方面权威的观点。议程结构完整：设会前闭门研讨会、主论坛和平行分论坛，覆盖临床开发、AI 新药、BD/NewCo、大分子、小分子、CNS、自免、政策资本与 MNC BD 等前沿议题。主线清晰：围绕“创新·转化·全球化·生态”，从科学创始人、国家创新布局、顶层设计到全球生态和中美合作展开。产业与资本结合紧密：既有青年 BiG 领袖峰会和 S2S 项目路演，也有投资热点、BD 交易趋势和 MNC 合作讨论。报名入口 ▼ 参会通道观众通道：免费；审核制（仅含10月23-24公开会议，不含午餐及晚宴）；限临床/院校科学家、Biotech/Pharma研发人员会员 / 特邀通道：免费；审核制（限 BiG 会员 / 特邀 / 往届 speaker），权益同VIP门票 VIP 门票：3000 元 / 人；含：全部论坛 + 闭门会 + 23 日晚宴 + 24 日午餐会议门票：1000元/人；含：10月23-24日公开会议；适用于CRO/CDMO/CRDMO等及其他服务类企业、BD人员参考资料 [1] https://www.gminsights.com/industry-analysis/psoriasis-treatment-market [2] https://db.dxy.cn/v5/home [3] 华鑫证券研报 [4] 各企业官网及公开资料等共建Biomedical创新生态圈！如何加入BiG会员？

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2026-09-22

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推荐 | 银屑病市场，正在孕育下一个“药王”

10月23-24日，上海张江，第12届BiG IMPACT年会再度启幕！华奥泰总经理朱向阳博士将于10月24日在大分子论坛发表题为《Development of Rocibakibart and beyond》的主题报告。年会详情及报名入口见文末。银屑病是一种需要长期治疗和疾病管理的慢性炎症性皮肤病，庞大的患者群体构成了稳定的治疗需求。全球约有1.25亿银屑病患者，中国患者规模由2017年的650万人增至2022年的670万人，预计2030年将达到680万人，其中约20%—30%为中重度患者。随着治疗需求不断释放，银屑病药物市场也在持续扩容。据Global Market Insight数据，2022年全球银屑病治疗市场规模为265亿美元，预计2032年将达到605亿美元，年复合增长率为8.6%；中国市场增长更为迅速，市场规模由2018年的6.04亿美元增至2022年的14.36亿美元，预计2030年将进一步达到99.44亿美元。图1. 2021年至2032年银屑病治疗市场规模市场扩容的背后，生物制剂是重要驱动力之一。随着对银屑病发病机制认识不断深入，治疗靶点从TNF-α逐步延伸至IL-23、IL-17等通路，生物制剂在中国银屑病药物市场中的占比预计将由2022年的43.4%提升至2030年的50.3%。而靶向治疗的不断迭代不仅改变了银屑病的治疗方式，也造就了一批商业上的超级大单品。TNF-α时代，艾伯维的阿达木单抗（修美乐）年销售额一度突破200亿美元；随着专利到期和生物类似药冲击，其销售额逐步回落。与此同时，治疗靶点向IL-23、IL-17等通路迭代，新的重磅产品开始接棒，其中利生奇珠单抗（喜开悦）2025年销售额已达到175.62亿美元。如今，IL-36R又打开了泛发性脓疱型银屑病（GPP）这一新的治疗市场。银屑病市场的下一个“药王”已经在路上。01 银屑病生物治疗的起点TNF-α是银屑病炎症反应中的重要细胞因子，主要由树突状细胞、巨噬细胞和T细胞等产生，可参与炎症反应的发生与维持。基于TNF-α在银屑病发病机制中的重要作用，以其为靶点的TNF-α抑制剂成为较早应用于银屑病治疗的一类生物制剂，并推动银屑病治疗进入生物制剂时代。表1. 已上市银屑病TNF-α抑制剂数据来源：公开资料整理注：表中“/”表示该药物无相应FDA获批记录；获批时间主要为公开报道中对应适应症的获批口径。其中，率先将TNF-α商业价值推向高位的是英夫利西单抗。在生物类似药大规模进入市场之前，英夫利西单抗已经成长为接近百亿美元体量的超级重磅药物，并一度成为强生在自免领域收入最高的产品。2016年，英夫利西单抗销售额达到82.34亿美元的峰值。随着专利到期以及生物类似药陆续进入市场，其销售额自2017年起持续下滑，2024年已降至16.05亿美元。2025年，英夫利西单抗销售额短暂升至17.68亿美元，但2026年上半年再度同比下降17.6%至7.60亿美元。从接近百亿美元的大单品到在生物类似药竞争中逐步退潮，英夫利西单抗完整演绎了首代重磅生物药的生命周期。依那西普是安进和辉瑞共同开发的TNF-α抑制剂，其商业表现同样亮眼。2016年，安进披露的依那西普销售额达到59.65亿美元，同比增长11%；同期，辉瑞负责市场的销售额达到29.09亿美元，依那西普当年的全球商业规模由此接近89亿美元，距离百亿美元门槛仅一步之遥。更重要的是，依那西普并非短期爆发的“昙花一现”，而是在相当长时间内维持数十亿美元的销售规模，成为TNF-α赛道最具代表性的现金牛产品之一。不过随着市场竞争加剧，其销售额也逐渐走低。2025年，安进披露的依那西普销售额为22.26亿美元，同比下降33%，较2016年的高峰已经明显回落。真正将TNF-α抑制剂商业价值推向巅峰的是阿达木单抗。与英夫利西单抗和依那西普相比，阿达木单抗拥有更广泛的适应症布局和更长市场统治力，并最终成长为自免领域最具代表性的超级大单品之一。2022年，阿达木单抗全球销售额达到212.37亿美元，贡献了艾伯维当年超过三分之一的收入。不过，随着阿达木单抗专利到期，自2023年起其销售额迅速回落，到2025年已进一步降至45.40亿美元。从百亿美元级重磅产品到真正意义上的“药王”，阿达木单抗一度定义了全球自免市场的黄金时代（表1）。尽管TNF-α抑制剂开创了银屑病生物治疗时代，并造就了多款超级重磅产品，但该类药物治疗效果有限，且存在注射部位反应、感染和免疫原性等不良反应，部分患者还面临给药频率较高、长期治疗负担较重等问题。随着对银屑病发病机制认识的不断深入，疗效更强、靶向性更高的新一代生物制剂也开始加速登场。02 经典靶点，成熟赛道随着对银屑病免疫机制认识的不断深入，治疗靶点也逐渐从TNF-α向更下游的炎症因子延伸。当机体受到创伤、感染或药物等因素刺激时，树突状细胞可释放IL-23、TNF-α和IL-12等促炎因子，促进Th17等免疫细胞的活化和扩增，进而产生IL-17等细胞因子作用于角质形成细胞，形成持续放大的炎症循环。因此，IL-23和IL-17也成为继TNF-α之后银屑病生物制剂研发的两大核心靶点。表2. 已上市银屑病IL-23和IL-17生物制剂数据来源：公开资料整理注：表中“/”表示该药物无相应FDA获批记录；获批时间主要为公开报道中对应适应症的获批口径。其中，IL-23抑制剂研发经历了从p40到p19亚基的迭代。较早上市的乌司奴单抗由强生原研，通过靶向IL-12和IL-23共有的p40亚基发挥作用，并被广泛用于多种免疫介导性炎症疾病。国内方面，康方生物依若奇单抗于2025年4月获批上市。随着乌司奴单抗核心专利到期，生物类似药也加速进入市场，荃信生物赛乐信于2024年11月在国内获批，百奥泰BAT2206则于2025年5月获得美国FDA批准。相比p40抑制剂，新一代IL-23抑制剂选择性靶向p19亚基，代表产品包括古塞奇尤单抗、替瑞奇珠单抗和利生奇珠单抗等，在提高靶点选择性的同时展现出较好的长期疗效。与IL-23相比，IL-17位于炎症通路更下游，直接作用于银屑病炎症反应的关键效应环节，因此部分IL-17抑制剂具有起效较快、皮损清除率较高的特点，并迅速成为银屑病生物治疗的重要力量。司库奇尤单抗是全球首批获批的IL-17A抑制剂，2019年在中国获批。目前，司库奇尤单抗、依奇珠单抗以及国内的赛立奇单抗、夫那奇珠单抗等均已进入市场。除直接靶向IL-17A外，IL-17受体也成为另一条研发路径。布罗利尤单抗通过靶向IL-17RA，可同时阻断包括IL-17A、IL-17C、IL-17E和IL-17F在内的多种IL-17家族成员介导的信号。在此基础上，IL-17领域的研发又进一步向双靶点延伸。优时比的比奇珠单抗可同时靶向IL-17A和IL-17F，更全面地抑制相关炎症信号，并在多项头对头研究中相较乌司奴单抗、司库奇尤单抗等展现出较高的皮损清除率。尽管其念珠菌感染风险受到关注，但其“双重阻断”机制也进一步提高了银屑病生物制剂的疗效竞争门槛。商业化方面，乌司奴单抗凭借先发优势长期占据重要地位，但随着专利到期及生物类似药进入，其2025年全球销售额已降至60.78亿美元，2026年上半年进一步降至13.96亿美元。与此同时，艾伯维的利生奇珠单抗快速放量，销售额由2024年的117.18亿美元增至2025年的175.62亿美元，2026年上半年已达到99.88亿美元，同比增长27.3%。随着产品不断迭代，银屑病生物制剂市场已形成IL-23和IL-17两条通路并行竞争的格局（表2）。03 IL-36R蓝海赛道在IL-17、IL-23等靶点不断提高斑块型银屑病治疗水平的同时，IL-36通路则打开了先天免疫驱动的泛发性脓疱型银屑病（GPP）的治疗窗口。GPP是一种罕见但可能危及生命的系统性炎症性皮肤病，急性发作时可出现广泛红斑和无菌性脓疱，并伴随发热、白细胞升高等全身炎症表现，严重时可发生脓毒症及多器官功能衰竭。研究显示，中国GPP患病率约为每百万人14例，据此估算患者约2万人；2023年，GPP被正式纳入我国《第二批罕见病目录》。与斑块型银屑病不同，GPP具有更突出的先天免疫和中性粒细胞炎症特征，其中IL-36通路过度激活被认为是其重要发病机制。IL-36R抑制剂的出现使GPP首次拥有了针对核心致病通路的生物制剂。勃林格殷格翰的佩索利单抗是全球首个获批的IL-36R单抗，该药于2022年9月获FDA批准，同年12月在中国获批，用于治疗成人GPP发作，完成了IL-36R靶点从机制研究到临床验证的关键跨越。不过，IL-36R目前展现出的临床价值具有较强的疾病特异性。佩索利单抗在GPP中取得成功，但在掌跖脓疱病等适应症的Ⅱ期研究中未达到主要终点。因此，与IL-17、IL-23面向庞大的斑块型银屑病人群不同，IL-36R当前更像是一个围绕GPP高未满足需求建立起来的精准治疗赛道。表3. 已上市银屑病IL-36R生物制剂及重点在研管线数据来源：公开资料整理国内企业也开始进入这一市场。2026年7月29日，华海药业控股子公司华奥泰生物自主研发的瑞西奇拜单抗（HB0034，商品名：华亦净）在中国获批，用于治疗体重≥40kg的成人GPP发作，成为继佩索利单抗之后国内第二款获批的IL-36R单抗，也是首款国产自研IL-36R单抗，为国内GPP患者带来了新的治疗选择。据Insight数据库，全球范围内仅有6款IL-36R单抗进入临床研发。其中，AnaptysBio开发的IL-36R单抗Imsidolimab已经完成Ⅲ期研究，其GEMINI-1研究达到主要终点；2026年2月，FDA正式受理其GPP生物制品许可申请，PDUFA目标日期为2026年12月12日，已进入上市审批阶段。国内方面，正大天晴的同机制新药TQH2929于2026年3月启动Ⅱ期关键注册研究，计划入组36例GPP急性发作患者，主要终点为治疗第1周达到GPPGA脓疱亚项0分的患者比例（表3）。整体来看，IL-36R单抗仍是一个玩家较少的蓝海赛道，与IL-17、IL-23的大市场逻辑并不相同，其聚焦的是GPP这一高未满足需求的罕见病领域。随着Imsidolimab、TQH2929等后续产品推进，IL-36R赛道有望进入竞争加速期。一个值得认真听的产品故事文章写到这里，银屑病市场的靶点迭代逻辑已经比较清晰，但有一个问题还悬着：当L-17赛道已经聚集了进口产品、国产产品，双靶点产品的时候，一个后来者到底靠什么站住位置?这个问题，华奥泰有自己的答案。华奥泰是华海药业旗下生物创新药平台，其自免管线在银屑病领域形成了从IL-36R到L-17A、再到双靶点的系统布局，瑞西奇拜单抗(HB0034,华亦净)已于2026年7月获NMPA批准上市，成为国内首款国产自研IL-36R单抗。用于成人GPP发作。但更值得关注的是另一个产品：Rocibakibart(HB0017)，华奥泰自主研发的抗IL-17A单抗。其关键III期临床数据显示：治疗12周，PASI75应答率达到95.7%，安慰剂组仅7.4%；PASI90应答率达到88.0%；sPGA0/1达到87.0%。在维持治疗阶段，给药间隔可延长至每8周一次，52周时每8周组PASI100维持率达到65.8%，每4周组达到79.1%，未发现新的安全性信号，对于需要长期管理的慢性银屑病患者来说，8周一次的维持给药方案，在便利性上是一个值得关注的差异化点。目前，HB0017的新药上市申请已于2026年6月获NMPA受理，适应症覆盖中重度斑块状银屑病和强直性脊柱炎。但华奥泰的布局不止于IL-17A单抗。其管线中还有一款全球首创的IL-17A/IL-36R双特异性抗体HB0043，同时靶向IL-17A和IL-36R，已获得中国IND批件，目前正在化脓性汗腺炎、中重度痤疮等适应症上推进临床探索。换句话说，当行业还在讨论“IL-17和IL-36R两条通路并行竞争”的时候，华奥泰已经在尝试把两条通路合到同一个分子里，这正是华奥泰总经理朱向阳博士要在BiG12周年年会上来讲的故事。报告题目：Development of Rocibakibart and beyond主讲嘉宾：朱向阳博士，上海华奥泰生物药业股份有限公司总经理朱向阳博士是国家特聘专家，在单抗筛选与鉴定、双靶点抗体工程改造、细胞株建立及工艺开发领域有超过20年的经验，曾长期在勃林格殷格翰从事生物药研发工作加入华奥泰后，他领导团队完成了16个项目的中美临床申报，目前正在推进中有4个III期、7个II期和3个1期临床项目，同时布局了10多个早期研发项目，涵盖双功能抗体和ADC。在这场报告中，朱博士将围绕Rocibakibart的临床开发路径，系统讲述华奥泰在银屑病领域的管线逻辑：从IL-17A单抗的疗效数据与维持给药方案，到IL-36R单抗的差异化定位，再到IL-17A/IL-36R双抗的“beyond”探索。对于关注自免赛道竞争格局和产品差异化策略的同行来说，这是一次难得的、来自产业一线的复盘。写在最后银屑病生物制剂的演进是一场围绕疗效和未满足需求不断推进的靶点迭代。随着老一代产品进入专利悬崖、新一代生物制剂持续接棒，新的竞争周期已经开启。而在这个周期里，什么样的产品能成为下一个“药王”，什么样的策略能让后来者在拥挤的赛道中站住位置，这些问题，或许在朱向阳博士的报告里能找到一些参考答案。BiG 12周年第12届 BiG IMPACT年会10月23-24日将在上海张江正式启幕，本次年会汇聚顶级产学研投力量，打造中国创新对话世界的稀缺跨境平台！时间及地点：10月23-24日（周五-周六）上海-张江希尔顿；年会亮点：国际化程度高：哈佛医学院 Greg Verdine 教授首次在中国公开亮相，RA Capital 创始人 Peter Kolchinsky 携核心团队参与，并带来“Science2Startup”中国产业界首秀。中国最具代表性的声音：王晓东院士、孙勇奎院士、鲁白院长、徐沪济教授同台分享中国在创新与临床转化方面权威的观点。议程结构完整：设会前闭门研讨会、主论坛和平行分论坛，覆盖临床开发、AI 新药、BD/NewCo、大分子、小分子、CNS、自免、政策资本与 MNC BD 等前沿议题。主线清晰：围绕“创新·转化·全球化·生态”，从科学创始人、国家创新布局、顶层设计到全球生态和中美合作展开。产业与资本结合紧密：既有青年 BiG 领袖峰会和 S2S 项目路演，也有投资热点、BD 交易趋势和 MNC 合作讨论。参考资料[1] https://www.gminsights.com/industry-analysis/psoriasis-treatment-market[2] https://db.dxy.cn/v5/home[3] 华鑫证券研报[4] 各企业官网及公开资料等本文内容来源：BiG生物创新社注：版权归原作者所有，供读者学习、研究或者欣赏，不得用于商业用途如有问题与建议，不吝交流与提出，love&peace

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外链

KEGG	Wiki	ATC	Drug Bank
D12066	-	-	DB15626

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
脓疱型银屑病	日本	Nippon Boehringer Ingelheim Co., Ltd.	2022-09-26
泛发性脓疱型银屑病	美国	LEO Pharma A/S	2022-09-01
泛发性脓疱型银屑病	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2022-09-01

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
坏疽性脓皮病	临床3期	美国	Boehringer Ingelheim International GmbH	2025-02-04
坏疽性脓皮病	临床3期	日本	Boehringer Ingelheim International GmbH	2025-02-04
坏疽性脓皮病	临床3期	阿根廷	Boehringer Ingelheim International GmbH	2025-02-04
坏疽性脓皮病	临床3期	澳大利亚	Boehringer Ingelheim International GmbH	2025-02-04
坏疽性脓皮病	临床3期	奥地利	Boehringer Ingelheim International GmbH	2025-02-04
坏疽性脓皮病	临床3期	比利时	Boehringer Ingelheim International GmbH	2025-02-04
坏疽性脓皮病	临床3期	巴西	Boehringer Ingelheim International GmbH	2025-02-04
坏疽性脓皮病	临床3期	加拿大	Boehringer Ingelheim International GmbH	2025-02-04
坏疽性脓皮病	临床3期	芬兰	Boehringer Ingelheim International GmbH	2025-02-04
坏疽性脓皮病	临床3期	法国	Boehringer Ingelheim International GmbH	2025-02-04

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06241573 (CTgov)	临床2/3期	化脓性汗腺炎	39	Placebo+Spesolimab (Spesolimab Low Dose)	廠鑰選築淵廠積齋廠夢 = 鹽築憲壓網醖鬱蓋衊憲糧廠簾鑰餘艱壓衊襯鏇 (艱選憲衊鏇獵顧選願鬱, 鑰淵簾顧衊衊範遞壓淵 ~ 築淵餘糧鹹衊夢積夢鏇) 更多	-	2026-06-17
				Spesolimab (Spesolimab High Dose)	廠鑰選築淵廠積齋廠夢 = 築鏇鑰遞築鏇積範鹹鏇糧廠簾鑰餘艱壓衊襯鏇 (艱選憲衊鏇獵顧選願鬱, 繭積艱衊艱淵獵衊淵窪 ~ 艱醖鏇廠簾夢構構顧憲) 更多
NCT06092216 (CTgov)	临床2期	坏疽性脓皮病	5	Spesolimab	憲網遞醖蓋獵構淵鑰繭(願淵遞齋窪構糧襯積夢) = 襯夢衊齋鏇築餘鑰顧構廠遞壓鏇鏇窪遞襯鹹憲 (糧餘衊鹽夢顧製築構齋, 2) 更多	-	2026-03-31
NCT03886246 (EFFISAYIL ON, AAD2026)	临床2期	泛发性脓疱型银屑病	131	Intravenous spesolimab	鏇夢鏇窪衊壓簾衊艱艱(鹽築壓鹽鑰鏇膚獵淵襯) = 廠廠願鹹齋範夢積製積憲觸淵構簾齋鏇鹹簾選 (廠齋衊鏇蓋鹹窪製膚襯 ) 更多	积极	2026-03-27
AAD2026	N/A	泛发性脓疱型银屑病 IL36RN mutations	233	Imsidolimab	鹹簾獵憲範蓋構築獵觸(艱選淵選積壓衊廠艱淵) = 顧獵鹽壓艱餘襯蓋繭齋餘積觸廠鹹鑰廠衊餘簾 (構願鬱餘憲鏇網築廠餘 ) 更多	积极	2026-03-27
				Recibokibart	壓憲繭鏇衊顧獵範齋積(願窪糧繭窪鹽鏇鬱鹽艱) = 鑰築衊鹹選蓋窪淵鬱壓構鹽襯築簾製艱襯醖製 (憲範選窪窪鹽衊構鹹顧 ) 更多
NCT05856526 (CTgov)	临床2/3期	Netherton综合征	43	Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection (Placebo)	鑰鏇觸遞網膚夢鑰鑰製 = 選願鹹壓艱鹽廠衊積構範網廠願範網淵齋構鹽 (鑰鑰壓網鹹襯蓋製膚夢, 壓憲糧淵繭簾壓醖觸窪 ~ 繭範製製窪構窪膚淵鏇) 更多	-	2026-03-12
				Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection (Spesolimab)	鑰鏇觸遞網膚夢鑰鑰製 = 餘襯膚窪襯築壓構衊鬱範網廠願範網淵齋構鹽 (鑰鑰壓網鹹襯蓋製膚夢, 選鏇淵觸觸網鏇夢顧艱 ~ 選餘膚製窪鏇願願選繭) 更多
NCT05819398 (CTgov)	临床2/3期	化脓性汗腺炎	209	Placebo matching Spesolimab i.v.+Spesolimab s.c. (Placebo)	窪製鏇襯築淵網鬱夢繭(構艱醖餘鹹構醖鑰襯簾) = 觸積構鬱鏇鬱鹽鹽膚艱膚顧醖獵窪製齋願齋範 (網鬱顧憲衊餘鏇遞窪廠, 7.7) 更多	-	2025-11-05
				Spesolimab i.v. (Spesolimab low dose group)	窪製鏇襯築淵網鬱夢繭(構艱醖餘鹹構醖鑰襯簾) = 繭鬱製鑰窪襯顧鑰衊餘膚顧醖獵窪製齋願齋範 (網鬱顧憲衊餘鏇遞窪廠, 7.8) 更多
NCT04876391 (CTgov)	临床2期	化脓性汗腺炎	45	Placebo matching 600 mg Spesolimab+Spesolimab 1200 mg (Prior Placebo (PP))	獵積遞鏇鑰範醖廠衊網 = 鑰鏇鑰淵鹽構蓋餘觸願網糧夢窪餘鏇網齋選淵 (選築夢築範艱遞齋壓淵, 築鹽壓蓋築選積顧窪淵 ~ 選繭齋網獵鹽網艱範築) 更多	-	2025-06-08
				Placebo matching 1200 mg Spesolimab+Spesolimab 600 mg (Prior Spesolimab (PS))	獵積遞鏇鑰範醖廠衊網 = 襯顧網衊觸憲膚顧齋淵網糧夢窪餘鏇網齋選淵 (選築夢築範艱遞齋壓淵, 餘齋餘醖糧膚鹽繭衊獵 ~ 構蓋蓋窪鑰遞繭艱膚積) 更多
NCT04399837 (EFFISAYIL 2, Pubmed \| J Am Acad Dermatol)	临床2期	泛发性脓疱型银屑病	150	Spesolimab 600 mg SC LD followed by 300 mg SC q4w	積網醖襯壓鏇構鏇鏇齋(獵鬱艱獵壓鹹觸窪艱鬱) = 遞製艱鑰鑰醖艱鑰衊醖醖夢窪窪鏇蓋繭繭選廠 (壓憲憲醖選鹽艱選襯構 ) 更多	积极	2025-06-01
				Placebo	積網醖襯壓鏇構鏇鏇齋(獵鬱艱獵壓鹹觸窪艱鬱) = 鏇顧鏇艱齋艱壓蓋構網醖夢窪窪鏇蓋繭繭選廠 (壓憲憲醖選鹽艱選襯構 ) 更多
AAD2025	临床3期	坏疽性脓皮病	90	spesolimab + low-dose oral corticosteroid (ulcerative pyoderma gangrenosum)	蓋積糧鹽憲蓋築鏇觸鏇(製夢廠蓋壓遞壓蓋襯繭) = 願齋膚蓋觸餘鑰顧網糧廠廠膚衊衊壓鏇襯鏇選 (鹽壓鑰簾憲鬱網鏇壓鏇 ) 更多	积极	2025-03-07
				placebo + low-dose oral corticosteroid (ulcerative pyoderma gangrenosum)	鹽鏇窪構顧蓋窪觸窪製(顧遞構夢選鬱鏇積選糧) = 憲製蓋構夢蓋壓網構淵觸網膚壓網構鏇齋製願 (襯願鬱築鏇餘範築鑰繭 ) 更多
NCT05819398 (AAD2025)	临床2/3期	化脓性汗腺炎	209	Spesolimab low-dose	築蓋觸淵夢膚範顧淵網(構鑰蓋觸壓構憲壓構壓) = 糧繭鏇艱築襯繭觸壓窪獵鑰鏇願衊範鑰糧淵願 (網鏇艱網鏇膚製鏇蓋簾 )	积极	2025-03-07
				Placebo	憲鹽繭選艱製構鹹壓鹽(糧範觸選構夢鏇簾觸鹹) = 壓觸網製窪鬱鹽範艱餘襯齋鹽簾構醖積鏇觸願 (鑰製積鬱構獵憲壓淵衊 ) 更多