A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis

Phase 3 study to evaluate the efficacy and safety of subcutaneous tildrakizumab in subjects with moderate to severe genital psoriasis.

开始日期2025-03-21

申办/合作机构

Sun Pharmaceutical Industries Ltd.

ChiCTR2400092920

/ Not yet recruiting临床4期IIT

A multicenter, prospective, observational real-world study evaluating the efficacy and safety of switching biological treatments in patients with moderate to severe plaque psoriasis.

开始日期2024-10-11

申办/合作机构

南京医科大学附属苏州医院

[+1]

NCT06488170

/ Active, not recruitingN/A

Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting - Light Version

The main purpose of this study to investigate the relationship between clinical symptoms and quality of life (QoL) in participants who receive Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the summary of product characteristics (SmPC).

开始日期2024-04-04

申办/合作机构

Almirall SA

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100 项与替瑞奇珠单抗相关的专利（医药）

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342

项与替瑞奇珠单抗相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Tildrakizumab 200 mg: a step forward in psoriasis treatment with added metabolic benefits

Article

作者: Rivieccio, Antonia ; Campione, Elena ; Bianchi, Luca ; Artosi, Fabio ; Lanna, Caterina ; Cattani, Chiara

BACKGROUND:

Psoriasis is frequently associated with metabolic syndrome and an increased cardiovascular risk. Tildrakizumab, an IL-23 inhibitor, may affect metabolic parameters in addition to improving skin severity.

AIM OF THE STUDY:

To evaluate the impact of increasing tildrakizumab dosage on lipid and glucose levels in psoriasis patients with metabolic syndrome who showed a partial response to the standard 100 mg dose.

MATERIALS AND METHODS:

Twenty-five patients with psoriasis and metabolic syndrome were enrolled in a 52-week prospective study. After 16 weeks of treatment with 100 mg tildrakizumab, patients with an absolute PASI >2 were switched to 200 mg. Total cholesterol, LDL, and glucose were measured at baseline, week 16, week 40, alongside PASI and DLQI.

RESULTS:

At baseline, mean total cholesterol, LDL, and glucose were 190.7, 120.1, and 99.4 mg/dL, respectively. The 100 mg dose did not result in significant metabolic changes at week 16. However, switching to 200 mg tildrakizumab led to significant reductions at week 40 in total cholesterol (178.3 mg/dL), LDL (110.1 mg/dL), and glucose (87.2 mg/dL) (all p < 0.05). Significant improvements in PASI (1.2) and DLQI (0.2) were also observed (p < 0.05).

CONCLUSIONS:

Increasing the tildrakizumab dose to 200 mg in partial responders with metabolic syndrome significantly improved both skin severity and metabolic profiles, lowering cholesterol, LDL, and glucose. These findings suggest a possible dose-dependent effect of tildrakizumab on metabolic parameters through enhanced IL-23 inhibition.

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Interleukin-23p19 inhibitors for the treatment of moderate-to-severe psoriasis: an expert opinion of real-world evidence studies in Europe

Review

作者: Thaçi, D. ; Ständer, S.

Background: Psoriasis is a chronic inflammatory disease affecting about 2% of the global population, with moderate-to-severe forms requiring systemic treatment for successful disease management. By targeting the interleukin (IL)-23p19 subunit of IL-23, the master cytokine of psoriasis pathogenesis, guselkumab, tildrakizumab, and risankizumab offer improved risk-benefit profiles.Objective: While randomized clinical trials (RCTs) provide controlled data, real-world evidence (RWE) offers insights into the performance of these therapies in diverse patient populations, including those with comorbidities or difficult-to-treat areas affected. With RWE on these inhibitors constantly emerging, a comprehensive overview and expert interpretation are essential for providing key insights into psoriasis management in clinical practice.Methods: This review, therefore, examined RWE on the effectiveness and safety of IL-23p19 inhibitors compared to their pivotal RCTs.Results: Despite some gaps between RCT and RWE outcomes, particularly in underrepresented subpopulations, IL-23p19 inhibitors show strong effectiveness and favorable safety across both settings in the short- and especially in the long term, accompanied by an improvement in health-related quality of life and reduction of the main symptoms.Conclusion: Altogether, these factors make these medicines ideal treatment options. Future research should focus on improving patient-reported outcomes, specifically addressing psychological and quality-of-life aspects, to further optimize psoriasis management.

2025-09-01·Dermatology and Therapy

Time to Onset of Action for Biologics and Targeted Treatments in Psoriasis: Systematic Targeted Literature Review and Network Meta-Analysis

Article

作者: Yang, Ya-Wen ; Grewal, Parbeer ; Purdy, Kerri ; Oroz, Irina ; Langley, Richard G ; Vender, Ron ; Abbarin, Nastaran ; Papp, Kim A ; Vigelis, Sandra ; Lansang, Perla ; Park-Wyllie, Laura ; Lovegrove, Fiona ; Disher, Tim ; Hooper, Becky

INTRODUCTION:

For some patients with plaque psoriasis (PsO), a rapid response (i.e. short interval to time to onset of action [TOA]) is desired. The primary objective was to determine average time to achieve a Psoriasis Area and Severity Index (PASI) 90 response (50% of patients) for individual biologics or targeted therapies. Secondary outcomes included the average time to achieve a PASI 75 response (50% of patients), as well as PASI 90 and PASI 75 responses over the first 16 weeks of therapy.

METHODS:

A systematic targeted literature review was conducted to identify phase III and IV randomised, double-blinded trials according to pre-specified eligibility criteria that investigated interleukin (IL)-12/23 inhibitors, IL-17 inhibitors, IL-23 inhibitors, Janus kinase (JAK) inhibitors, and phosphodiesterase (PDE) inhibitors. Using proportions of patients achieving PASI 90 or 75 responses over 16 weeks, network meta-analyses were conducted to estimate response over time. This was presented as curves, and TOA was summarized as median time to reach the 50th percentile.

RESULTS:

Forty-five trials were included in the main analyses. The IL-17 inhibitors bimekizumab, ixekizumab, brodalumab, and secukinumab 300 mg were estimated to provide the earliest onset of PASI 90 response at approximately 6 to 8 weeks. This was followed by the IL-23 inhibitors risankizumab and guselkumab at approximately 9-10 weeks, and the IL-12/23 inhibitor at 11-12 weeks. Although wide and overlapping credible intervals and similar point estimates were observed, these results suggest onset of action does not vary greatly across biologics in these classes. Onset of PASI 90 response could not be estimated by the model for tildrakizumab, and JAK and PDE4 inhibitors. Onset of PASI 75 response showed similar trends to PASI 90 response.

CONCLUSIONS:

IL-17 inhibitors, followed by IL-23 inhibitors, have the most rapid TOA among PsO biologics evaluated; any differences in onset of action between specific agents within the same drug class are not statistically or clinically significant. These analyses will allow clinicians to make more informed treatment decisions for their patients.

117

项与替瑞奇珠单抗相关的新闻（医药）

2025-09-18

·ETPharma

Focusing on specific needs key differentiator for Sun Pharma: Dilip Shanghvi

New Delhi: For India’s largest drug maker Sun Pharma , focusing on specific needs unaddressed by existing therapies stands as a differentiator, said Dilip Shanghvi , its Executive Chairman at an event on quality management that had representations from across industries. Sun Pharma has distinguished itself by sharply focusing on specific areas in contrast to companies that constantly chase newer segments and products. Speaking at the Indian Foundation for Quality Management (IFQM) Symposium over a virtual call, Shanghvi noted when Sun Pharma started operations in India, the market was dominated by large international companies but because of its small size, an agile workforce and by connecting with the customers, the company could identify areas that did not fill the requirement of patients. “We focus on developing drugs which can avoid some of the side effects of the existing products with a better delivery system and fulfill the needs of patients more effectively” he added. “Currently our R&D spend is around $450 million (annually) which is increasing year-on-year and the idea is to develop products that address the unmet challenges patients face with currently available therapies and this helps to differentiate us in the market” Shanghvi said at a panel discussion. Sun Pharma commands a portfolio of therapies that is engineered to target therapeutic domains overlooked by existing treatments and unlocks niche markets that, though modest in scale but have limited competition. Sun Pharma’s innovative drugs portfolio spans dermatology, anti-cancer and ophthalmology drugs. One of the successful products in the company’s specialty business is Ilumya (tildrakizumab-asmn), an interleukin-23 (IL-23) inhibitor which competes against giants such as Johnson and Johnson ’s Stelara (Ustekinumab) which targets two cytokines— IL-12 and IL-23— and both approved for plaque psoriasis by the US FDA . Launched in FY2019, Ilumya recorded net sales of (FY25) $681 million dollar (around ₹5,750 crore). Notably, similar projections have been made for its recently launched Leqselvi , a JAK 1/2 inhibitor indicated for the treatment of severe alopecia areata (a condition that leads to severe hair loss). According to industry experts Leqselvi has a higher dose of 8mg twice daily schedule, which places it in a dominant position against its rival Olumiant of Eli Lilly which is a 2mg and 4mg once-daily pill. During the discussion the industry veteran who founded Sun Pharma in 1983 also noted that, “India accounts for a large patient base, it represents about 2 percent of the global pharmaceutical market so for us as a company to grow it was important to go outside India while we focus on India.” “Today, two-thirds of our total revenue comes from international markets. While it took longer than expected for our US business to generate cash flows, with our continued investments in products tailored for the US market, has delivered very positive results over the years,” he added. Commenting on acquisitions and their integration Shanghvi said, “ Historically we have acquired business which are not very different, and our largest acquisition of Ranbaxy took us very long time but I am quite happy with the change it has brought ” “We recognise that even if, as a company, we haven’t succeeded in some cases that doesn’t mean the strategy is wrong. One simply has to find a better way to execute it,” he stressed. The Indian drugmaker had onboarded Ranbaxy in 2014 from Japanese giant Daiichi Sankyo for a total consideration of around $4billion— $3.2 billion for the acquisition and around $800 million for debt. Before its takeover by Sun Pharma, Ranbaxy was embroiled in charges of fraud and fabrication of data to gain product approvals in the US. It later pleaded guilty of distributing adulterated drugs in the US and was charged a $500 million fine by the US government. By Abhijeet Singh ,

并购上市批准生物类似药

2025-09-17

·Business Wire

EADV 2025: Almirall Advances Skin Science and Leads Innovation for Holistic Patient Care in Medical Dermatology

PARIS--(BUSINESS WIRE)--Almirall, S.A. (ALM) a global biopharmaceutical company dedicated to medical dermatology, is a major contributor to the 2025 European Academy of Dermatology and Venereology Congress (EADV) presenting new data across its broad portfolio of dermatological treatments including new real-world data of lebrikizumab on atopic dermatitis, new clinical data of tildrakizumab on psoriasis and tirbanibulin on actinic keratosis. The 34th EADV congress will take place from September 17 to 20 in Paris, France. At the congress, Almirall contributes a total of 44 scientific abstracts focused on advancing patient care across the company’s broad portfolio of dermatological treatments including atopic dermatitis, psoriasis, actinic keratosis, and hidradenitis suppurativa. With a strong emphasis on real-world evidence, patient-reported outcomes, and well-being, Almirall’s scientific programme includes multiple presentations, two expert-led symposia on psoriasis and atopic dermatitis, and an interactive exhibition booth supporting dermatologists in their daily practice and effective treatment choices for their patients. “The EADV congress is one of the most important platforms for exchange and learning about scientific and clinical advances in Dermatology. The Almirall team is excited to engage in conversations with leading experts and researchers to advance skin science and to develop meaningful solutions for patients. We are looking forward to discussing our new real-world evidence and clinical data for treatments across our broad portfolio to improve health outcomes for patients and support dermatologists in everyday practice,” said Dr. Volker Koscielny, Almirall’s Chief Medical Officer. Atopic Dermatitis: first real-world evidence study and new data on long-term efficacy and well-being of lebrikizumab Almirall presents interim results from the ADlife study, offering – for the first time - real-world evidence on the treatment of atopic dermatitis with lebrikizumab, featuring 100 patients treated for 16 weeks. The ADlife study demonstrates lebrikizumab is highly effective in treating moderate to severe atopic dermatitis with clinically relevant improvements in AD symptoms, already after 4 weeks of treatment, and a consistent safety profile. This data suggests that efficacy seen in randomized clinical trials translates well into the real-world setting - even in a more complex patient population. New data from the long-term extension ADjoin study shows that out of the patients showing significant improvement of their AD symptoms at week 16, those responses remained sustained after two-years of continuous treatment with lebrikizumab, as measured by absolute scores which are considered clinically relevant as they show response regardless of baseline severity. Further supporting its long-term efficacy, improvements in patient reported outcomes, such as itch and sleep (measured by POEM) were also observed up to 3 years of treatment with lebrikizumab. The ADvantage study – the first trial to utilize the WHO-5 Well-being Index in the assessment of an atopic dermatitis treatment – demonstrates the positive impact of lebrikizumab on holistic care for patients with moderate-to-severe atopic dermatitis who often show a significant impairment of their psychological well-being. Treatment with lebrikizumab was associated with improved psychological well-being in adult and adolescent patients to levels similar to a healthy population – already after 16 weeks - and were maintained for up to 52 weeks of treatment. Results from the ADvocate 1 and 2 studies reinforce lebrikizumab’s ability to deliver high rates of both skin clearance and itch relief after 16 weeks of treatment. First results were observed as early as week 4 compared to placebo and were maintained through to 52 weeks after treatment was initiated. Improvements in both the severity of the skin condition and itch translate into meaningful improvements in patient‑reported outcomes in atopic dermatitis1. Almirall’s symposium on atopic dermatitis, “Long-term control in Atopic Dermatitis: Elevating Therapeutic Goals” will be chaired by Prof. Sébastien Barbarot (France), and feature Prof. Tilo Biedermann (Germany), Prof. Richard Warren (UK), and Dr. Alessandra Narcisi (Italy). It will showcase new evidence on the role of IL-13 in AD pathogenesis, supporting the real-world evidence and the long-term efficacy of lebrikizumab delivering meaningful health benefits for patients. “Our symposium will highlight the unmet needs in atopic dermatitis and the pivotal role of IL-13 in disease pathophysiology. Through long-term data from clinical trials, real-world evidence and clinical cases, we’ll discuss how systemic biologic therapies like lebrikizumab are transforming care for patients and healthcare professionals”, commented Prof. Sébastien Barbarot. Psoriasis: advancing disease management and patient outcomes Almirall will present new effectiveness data on tildrakizumab for the treatment of moderate-to-severe plaque psoriasis from the real world ZODIPSO and CzATCH studies. These studies demonstrate high effectiveness of the treatment in high impact areas including nails, scalp, and the genital area. The TIL-SENIOR study explores the needs of elderly patients and how treatment with biologics like tildrakizumab can address these and offer a meaningful therapeutic option, while the TIL-TWO study shows how patients with elevated body weight or high-burden of disease can benefit from treatment with tildrakizumab 200 mg. The PROCARE-t study demonstrates high patient satisfaction with the psoriasis care provided by both hospital pharmacists and dermatologists during the treatment with tildrakizumab. Healthcare Professionals (HPCs) also expressed high satisfaction with the treatment showing the importance of multidisciplinary care in dermatology involving dermatologists and pharmacists. New data from the PRO-SCALP study show that CAL/BPD PAD(TM) cream delivers significant symptom relief of mild-to-moderate psoriasis of the scalp – which is particularly challenging to treat. It also demonstrated the treatment achieving enhanced emotional well-being, and overall improvements in daily life for patients. Almirall will also host a focused symposium on remaining unmet needs in psoriasis, “Psoriasis: Is there anything left to solve?”, Chaired by Prof. Jo Lambert (Belgium), with Dr. Andreas Pinter (Germany) and Dr. Pedro Mendes Bastos (Portugal). R&D pipeline: new insights on the treatment of large areas affected by Actinic Keratosis (AK), and phase I data on novel treatment for Hidradenitis Suppurativa (HS) Almirall will share new data from the TirbAKare study demonstrating tirbanibulin’s suitability for treating large skin areas of up to 100 cm2 affected by actinic keratosis. The results show that tirbanibulin provides statistically significant and clinically meaningful reduction in AK lesion count compared to vehicle at day 57 while offering a favorable safety profile. These results confirm tirbanibulin’s efficacy and tolerability, consistent with previous findings in controlled trials and real-world evidence when treating larger AK areas. Late-breaker: Phase I data on LAD191, a monoclonal antibody targeting the Interleukin-1 Receptor Accessory Protein (IL-1RAP), in patients affected by Hidradenitis Suppurativa suggest a favorable safety and tolerability profile, along with early signs of clinical improvement supporting the continued development of this asset. Advancing skin science at EADV 2025 Almirall’s booth at EADV (Pavilion 7.2, Booth D06) will offer visitors the opportunity to explore the latest innovations in dermatology and insights into patient needs through interactive educational content and global disease awareness initiatives. Highlights include: the global campaign, “Sanctuary Salon”, which educates about the impact of skin conditions on daily life and self-care, especially in the scalp area, a spotlight on the emotional burden experienced by AD patients, and the possibility for visitors contribute to a psoriasis patient association. About Almirall Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients´ needs. Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2024: €990 MM, over 2000 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries. For more information, please visit https://www.almirall.com/ Legal notice: This document includes only summary information and is not intended to be exhaustive. The facts, figures, and opinions contained in this document, in addition to the historical ones, are "forward-looking statements." These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals, or estimates contained in this document to reflect any changes in the assumptions, events, or circumstances on which such forward-looking statements are based, unless required by the applicable law. ANNEX: 34th EADV Congress presentations and poster details Satellite Symposium on psoriasis: Psoriasis: is there anything left to solve? Chair: Prof. Jo Lambert, Belgium Speakers: Dr. Andreas Pinter, Germany; Dr. Pedro Mendes Bastos, Portugal Thursday 18th September at 17:45 (CEST) / Room S06. Pavilion 7.3. Satellite Symposium on atopic dermatitis: Long-term control in Atopic Dermatitis: Elevating Therapeutic Goals. Chair: Prof. Sébastien Barbarot, France Speakers: Prof. Tilo Biedermann, Germany; Prof. Richard Warren, United Kingdom; Dr. Alessandra Narcisi, Italy. Friday, 19th September at 13:00 (CEST)/ Room S05, Pavilion 7.3. Full abstracts will be available on the EADV 2025 Congress platform from 07:00 CEST on 17 September 2025 – see full list of accepted abstracts below: Ebglyss® (lebrikizumab) Ilumetri® (tildrakizumab) Wynzora® (CAL/BDP) PAD™ Cream Klisyri® (tirbanibulin) and actinic keratosis LAD191 and Hidradenitis Suppurativa 1 Silverberg et al. J Dermatolog Treat 2024; 35(1):2428729.

临床结果临床1期

2025-08-28

·康哲药业

康哲药业：创新药口服JAK1抑制剂Povorcitinib获白癜风、化脓性汗腺炎适应症IND批件

Povorcitinib是一种选择性口服小分子JAK1抑制剂，有望为相关自身免疫性和炎症性皮肤病患者带来新的治疗选择德镁医药于28日收到非节段型白癜风和中重度化脓性汗腺炎的中国IND批件，并积极准备开展相关临床试验工作 Povorcitinib将与德镁医药在售创新药益路取、独家药喜辽妥、以及在研创新药磷酸芦可替尼乳膏等协同增效康哲药业控股有限公司（“康哲药业”或“本集团”）欣然宣布，旗下德镁医药有限公司（“德镁医药”，专业聚焦皮肤健康的创新型医药企业，正申请于香港联合交易所有限公司主板独立上市，详见本公司日期为2025年4月22日发布的公告）连同其附属公司于2025年8月27日获中国国家药品监督管理局（NMPA）签发的药物临床试验批准通知书，于8月28日收到药物临床试验批准通知书。NMPA同意开展povorcitinib（拟定中文通用名：磷酸泊沃昔替尼片）（“povorcitinib”或“产品”）用于非节段型白癜风和中重度化脓性汗腺炎（HS）的临床试验。 Povorcitinib是一种选择性口服小分子JAK1抑制剂，在区域内特定国家/地区拥有物质和用途专利。Povorcitinib目前正在海外若干国家进行非节段型白癜风、HS和结节性痒疹的3期临床试验，另外，治疗哮喘和慢性自发性荨麻疹的2期临床试验也在进行中。 2023年3月，Incyte公布povorcitinib达到了非节段型白癜风的全球多中心2b期临床研究的主要终点。结果显示：治疗24周，与安慰剂相比，接受每日一次povorcitinib治疗的患者的全身皮损显著复色。随后该2b期试验的开放标签延长期结果表明，长期使用povorcitinib可进一步改善全身和面部色素沉着且耐受性良好[1]。 2025年3月，Incyte公布povorcitinib治疗HS患者的两项3期临床试验均达到主要终点：治疗12周后，与安慰剂相比，接受每日一次povorcitinib治疗的患者，获得化脓性汗腺炎临床反应的比例明显更高，即脓肿和炎性结节总数较基线减少≥50%，且脓肿或引流隧瘘的数量较基线并未增加。Povorcitinib的总体耐受性良好，并未出现新的安全性信号[2]。 JAK信号通路的过度活跃被认为会驱动炎症，从而参与白癜风、HS的发病机制和进展。白癜风是一种慢性自身免疫性疾病，其特征是皮肤色素脱失，其发病原因为产生色素的细胞即黑素细胞的缺失。据估算，中国白癜风患者约1030万，其中820万人患有非节段型白癜风[3]。目前白癜风疗法选择有限且难以治疗，特别是对于累及面积大的白癜风患者。若于中国获批，有望为非节段型白癜风患者提供差异化的治疗选择，包括口服JAK1抑制剂povorcitinib和外用制剂芦可替尼乳膏。 HS是一种慢性复发性炎症性皮肤病，其特征是会出现疼痛性炎性结节、脓肿、破溃以及窦道和瘢痕形成。据估算，中国HS患者约47万，其中，中重度患者约占75%[4]。HS在中国被纳入第二批罕见病目录。HS病情的性质使人衰弱，它可能对患者的生活品质产生深远的负面影响，但目前在中国，NMPA批准上市用于治疗中重度HS的药物有限，povorcitinib为HS提供了潜在新的口服治疗选择。待povorcitinib于中国获批上市后，将在专家网络与市场资源等方面补充德镁医药产品组合，包括在售创新药益路取（替瑞奇珠单抗注射液）、在售独家药喜辽妥（多磺酸粘多糖乳膏）、以及在研创新药磷酸芦可替尼乳膏，助力产品快速实现临床和商业价值，惠及更多皮肤疾病患者。本集团于2024年3月31日，通过德镁医药的附属公司与Incyte就povorcitinib订立合作和许可协议（“许可协议”），获得在中国大陆、香港特别行政区、澳门特别行政区、台湾地区及东南亚十一国（“区域”）研究、开发、注册及商业化产品的独家许可权利，以及在区域内生产产品的非独家许可权利。德镁医药的附属公司已将povorcitinib除中国大陆外的其他区域的相关权利再许可予本集团（不包括德镁医药及其附属公司）。本集团正积极准备开展相关临床试验工作，力争该产品尽快上市。关于康哲药业康哲药业是一家链接医药创新与商业化，把控产品全生命周期管理的开放式平台型企业，致力于提供有竞争力的产品和服务，满足尚未满足的医疗需求。康哲药业专注于全球首创（FIC）及同类最优（BIC）的创新产品，并高效推进创新产品临床研究开发和商业化进程，赋能科研成果向诊疗实践的持续转化，造福患者。康哲药业聚焦专科领域，拥有被验证的商业化能力，广泛的渠道覆盖和多疾病领域专家资源，核心在售产品已获领先的学术与市场地位。康哲药业围绕优势专科领域不断纵深发展，以巩固心脑血管/消化/眼科/皮肤健康业务竞争力，其中皮肤健康业务已成为该细分领域的龙头企业，带来专科规模效率。同时，康哲药业持续深化东南亚及中东区域业务发展，助力高质量持续健康发展。参考文献/资料 1. 产品非节段型白癜风适应症的全球多中心2b期临床结果可在Incyte官网查询：https://investor.incyte.com/news-releases/news-release-details/incyte-announces-data-phase-2b-study-evaluating-povorcitinib 2. 产品HS适应症的两项3期临床结果可在Incyte官网查询：https://investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-topline-results-two-phase-3-clinical 3. 数据来自灼识咨询报告 4. Wang et al., Prevalence of Acne Inversa (Hidradenitis Suppurativa) in China: A Nationwide Cross-Sectional Epidemiological Study. International Journal of Dermatology and Venereology (2022) 5:1. doi: 10.1097/JD9.0000000000000204 康哲药业免责与前瞻性声明本新闻无意向您做任何产品的推广，非广告用途。本新闻不对任何药品和医疗器械和/或适应症作推荐。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。医疗卫生专业人士作出的任何与治疗有关的决定应根据患者的具体情况并遵照药品说明书。由康哲药业编制的此新闻不构成购买或认购任何证券的任何要约或邀请，不形成任何合约或任何其他约束性承诺的依据或加以依赖。本新闻由康哲药业根据其认为可靠之资料及数据编制，但康哲药业并无进行任何说明或保证、明述或暗示，或其他表述，对本新闻内容的真实性、准确性、完整性、公平性及合理性不应加以依赖。本新闻中讨论的若干事宜可能包含涉及本集团的市场机会及业务前景的陈述，该等陈述分别或统称为前瞻性声明。该等前瞻性声明并非对未来表现的保证，存在已知及未知的风险、不明朗性及难以预知的假设。本集团并不采纳本新闻包含的第三方所做的任何前瞻性声明及预测，本集团对该等第三方声明及预测不承担责任。关注我们了解更多

临床3期临床2期临床申请临床成功

100 项与替瑞奇珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	替瑞奇珠单抗	L04AC	DB14004

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
斑块状银屑病	美国	Sun Pharmaceutical Industries Ltd.	2018-03-20

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
银屑病	临床3期	美国	Sun Pharmaceutical Industries Ltd.	2025-03-21
银屑病	临床3期	保加利亚	Sun Pharmaceutical Industries Ltd.	2025-03-21
银屑病	临床3期	匈牙利	Sun Pharmaceutical Industries Ltd.	2025-03-21
银屑病	临床3期	波兰	Sun Pharmaceutical Industries Ltd.	2025-03-21
甲银屑病	临床3期	美国	Sun Pharmaceutical Industries Ltd.	2021-05-13
甲银屑病	临床3期	澳大利亚	Sun Pharmaceutical Industries Ltd.	2021-05-13
头皮银屑病	临床3期	美国	Sun Pharmaceutical Industries Ltd.	2019-03-29
头皮银屑病	临床3期	澳大利亚	Sun Pharmaceutical Industries Ltd.	2019-03-29
银屑病关节炎	临床3期	阿根廷	Sun Pharmaceutical Industries Ltd.	2018-08-29
银屑病关节炎	临床3期	匈牙利	Sun Pharmaceutical Industries Ltd.	2018-08-29

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临床结果

适应症

分期

评价

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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


reSURFACE 1 and reSURFACE 2 (Pubmed \| Br J Dermatol)	临床3期	银屑病	-	Tildrakizumab	製襯壓獵膚繭鬱衊艱築(鑰鑰醖糧齋選糧獵糧衊) = 積觸齋糧壓選繭願製網憲觸壓繭鑰網鑰淵廠蓋 (積憲淵醖蓋醖夢鹹簾繭 ) 更多	积极	2025-08-18
				Placebo	製襯壓獵膚繭鬱衊艱築(鑰鑰醖糧齋選糧獵糧衊) = 膚顧積廠夢糧艱鏇遞淵憲觸壓繭鑰網鑰淵廠蓋 (積憲淵醖蓋醖夢鹹簾繭 ) 更多
NCT04314544 (INSPIRE 1, NEWS) 人工标引	临床3期	银屑病关节炎	385	Ilumya	鬱窪鏇廠鑰夢獵簾齋積(襯窪蓋積簾鹽膚艱醖遞) = achieved the primary endpoint 簾憲壓繭艱窪顧觸鏇憲 (鹹醖繭醖構製鏇範遞遞 ) 达到	积极	2025-07-23
				Placebo
NCT04314531 (INSPIRE-2, NEWS) 人工标引	临床3期	银屑病关节炎	385	Ilumya	膚齋製網衊餘襯顧簾觸(選艱鏇衊簾壓廠遞齋艱) = achieved the primary endpoint. 蓋鬱夢網糧選簾鑰餘網 (築窪夢觸鏇範鬱淵選遞 ) 达到	积极	2025-07-23
				Placebo
NCT04112810 (CTgov)	临床2期	急性髓性白血病 \| 急性移植物抗宿主病 \| 急性淋巴细胞白血病 ... 更多	51	Tildrakizumab	觸齋構鹽選顧網網膚築 = 鏇範蓋構醖鏇餘範窪選衊壓積鹽繭衊齋襯鑰遞 (構糧衊鏇鹹顧選窪遞衊, 餘製選衊窪窪獵網獵膚 ~ 積網鬱醖積網獵壓鏇製) 更多	-	2025-07-04
NCT03897075 (CTgov)	临床3期	甲银屑病 \| 斑块状银屑病	99	placebo (Placebo)	艱醖憲鏇餘淵糧膚簾艱 = 衊顧艱夢鏇獵遞膚鏇糧遞艱鏇膚廠淵夢淵鹽膚 (鏇膚製網鑰壓網鏇窪繭, 窪艱鹹淵鹹艱蓋淵範醖 ~ 積觸餘廠膚鹹蓋鬱範願) 更多	-	2025-06-06
				Tildrakizumab (Tildrakizumab 100 mg)	艱醖憲鏇餘淵糧膚簾艱 = 鏇鑰窪鑰範顧糧築壓醖遞艱鏇膚廠淵夢淵鹽膚 (鏇膚製網鑰壓網鏇窪繭, 網餘醖積鏇壓憲網廠選 ~ 夢壓鹹願餘鏇襯鬱齋簾) 更多
PRNewswire 人工标引	临床3期	斑块状银屑病	99	ILUMYA	積鹽膚顧艱窪壓築餘鑰(簾範窪夢廠鹹廠製築鹹) = 網鏇鹽壓廠網獵顧構築膚餘築遞襯積鹹壓願鹹 (蓋鬱鑰膚襯積顧齋觸鬱 ) 更多	积极	2025-03-07
				Placebo	積鹽膚顧艱窪壓築餘鑰(簾範窪夢廠鹹廠製築鹹) = 襯網鬱窪繭獵繭簾觸築膚餘築遞襯積鹹壓願鹹 (蓋鬱鑰膚襯積顧齋觸鬱 ) 更多
NCT03552276 (CTgov)	临床2/3期	银屑病关节炎	281	Tildrakizumab (Tildrakizumab 200 mg q4 Weeks)	積窪窪壓觸鹹觸膚網襯 = 壓壓繭壓鹽膚繭鑰遞淵膚顧簾淵醖憲膚淵壓積 (築鏇積構積蓋蓋糧願築, 艱襯鏇遞淵築鏇鏇窪願 ~ 遞壓鬱顧製鹹窪淵鬱壓)	-	2024-11-21
				Tildrakizumab (Tildrakizumab 200 mg q12 Weeks)	積窪窪壓觸鹹觸膚網襯 = 鏇齋範壓簾壓淵繭窪廠膚顧簾淵醖憲膚淵壓積 (築鏇積構積蓋蓋糧願築, 獵製遞衊積壓齋範餘簾 ~ 壓製製齋簾鬱齋鑰鑰獵)
Pubmed 人工标引	N/A	银屑病	-	Tildrakizumab 200 mg	範築觸鏇蓋衊憲醖選淵(襯憲鏇遞餘鹽鏇壓齋齋) = 鏇鬱蓋鬱鑰餘襯糧憲製鏇網艱鹹鬱齋鹹餘鑰製 (淵繭鹹觸壓構顧淵遞壓 ) 更多	积极	2024-10-27
NCT04541329 (CTgov)	临床4期	炎症性皮肤病 \| 寻常性银屑病	7	Tildrakizumab	積築餘糧壓廠觸繭鏇醖(壓網鬱艱壓鏇築餘範築) = 廠鏇窪觸願鏇獵衊積襯鹹夢簾網窪糧願壓鏇繭 (簾遞築壓蓋淵夢膚淵夢, 4.1) 更多	-	2024-04-30
NCT05108766 (Pubmed) 人工标引	临床3期	斑块状银屑病	220	Tildrakizumab 100 mg	顧醖齋網積顧淵廠鹽鬱(選鹹顧壓鬱製鑰範築蓋) = 蓋鹹醖膚願構簾齋遞製窪窪窪糧鹽窪齋糧鹽簾 (鹽製簾膚範鑰鏇蓋簾鏇 ) 更多	积极	2024-01-09