ILUMYA®（tildrakizumab-asmn）在美国获批用于治疗活动性银屑病关节炎成人患者-动脉网

ILUMYA® (tildrakizumab-asmn) approved in the U.S. for the Treatment of Adults with Active Psoriatic Arthritis

CISION 等信源发布 2026-10-30 19:02

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IL-23 inhibitor approved exclusively for healthcare provider-administered treatment

IL-23抑制剂获批仅用于由医疗保健提供者给药的治疗

Expands use of ILUMYA beyond moderate-to-severe plaque psoriasis strengthening Sun Pharma's portfolio in psoriatic disease

将ILUMYA的适应症从重度斑块状银屑病扩展至更广泛领域，从而加强Sun Pharma在银屑病疾病领域的产品组合

MUMBAI, India and PRINCETON, N.J.

印度孟买和新泽西州普林斯顿

，

Oct. 30, 2026

2026年10月30日

/PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, 'Sun Pharma' and includes its subsidiaries and/or associated companies) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for ILUMYA.

/PRNewswire/ -- 太阳制药工业有限公司（路透社代码：SUN.BO，彭博代码：SUNP IN，印度国家证券交易所代码：SUNPHARMA，孟买证券交易所代码：524715，简称“太阳制药”，包括其子公司和/或关联公司）今日宣布，美国食品药品监督管理局（FDA）已批准ILUMYA的补充生物制品许可申请（sBLA）。

(tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis (PsA).

（替达利珠单抗-asmn）用于治疗活动性银屑病关节炎（PsA）成人患者。

'FDA approval of ILUMYA for adults with active psoriatic arthritis represents another important innovative medicine milestone for Sun Pharma and builds on the established clinical experience of ILUMYA in plaque psoriasis,' said Rick Ascroft, North America CEO, Sun Pharma. 'As an IL-23 inhibitor administered exclusively by a healthcare provider, ILUMYA is now an option for adults with active psoriatic arthritis who are unable to self-administer treatment or who may benefit from regular in-office care.'.

Sun Pharma 北美首席执行官 Rick Ascroft 表示：“FDA 批准 ILUMYA 用于患有活动性银屑病关节炎的成人患者，标志着 Sun Pharma 在创新药物领域又迈出了重要一步，这也进一步巩固了 ILUMYA 在斑块状银屑病治疗中已确立的临床经验。作为一种仅由医疗保健专业人员给药的 IL-23 抑制剂，ILUMYA 现在为那些无法自行给药或可能从定期门诊护理中获益的活动性银屑病关节炎成年患者提供了一种新的治疗选择。”

Approximately 2.4 million Americans live with psoriatic arthritis, which can cause joint pain, swelling and stiffness that may lead to permanent joint damage. The approval expands the use of ILUMYA, an IL-23 inhibitor approved by the FDA in 2018 for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy..

约有240万美国人患有银屑病关节炎，该病可引起关节疼痛、肿胀和僵硬，可能导致永久性关节损伤。此次批准扩大了ILUMYA的适用范围；ILUMYA是一种IL-23抑制剂，于2018年获得美国食品药品监督管理局（FDA）批准，用于治疗适合接受系统治疗或光疗的中重度斑块状银屑病（PsO）成人患者。

'Psoriatic arthritis is a complex and chronic disease. As clinicians, we need a range of therapeutic options that allow us to individualize care based on each patient's symptoms and treatment goals. Adding an IL-23 inhibitor option that is administered by a healthcare provider gives us a new way to offer appropriate patients additional support and engagement with their healthcare team,' said Philip Mease, Director of Rheumatology Research at the Swedish Medical Center and Providence St Joseph Health and Clinical Professor at the University of Washington School of Medicine, Seattle, WA. .

“银屑病关节炎是一种复杂且慢性的疾病。作为临床医生，我们需要一系列治疗选择，以便根据每位患者的症状和治疗目标实现个体化护理。增加一种由医疗保健提供者给药的IL-23抑制剂选项，为我们提供了一种新的方式，为合适的患者提供额外的支持，并加强他们与医疗团队的互动，”华盛顿州西雅图华盛顿大学医学院临床教授、瑞典医疗中心和普罗维登斯圣约瑟夫健康机构风湿病学研究主任菲利普·米斯表示。

The approval is supported by Phase 3 INSPIRE-1 and INSPIRE-2 clinical studies, which evaluated the efficacy and safety of ILUMYA after only two doses at 24 weeks in adult patients with active psoriatic arthritis.

该批准得到了III期INSPIRE-1和INSPIRE-2临床研究的支持，这两项研究评估了ILUMYA在活动性银屑病关节炎成年患者中仅接受两次给药后、于第24周时的疗效和安全性。

Safety data in the studies was consistent with the well-documented safety profile of ILUMYA. No new safety signals were identified in the INSPIRE-1 and INSPIRE-2 studies. ILUMYA may increase the risk of infection. Patients should be evaluated for tuberculosis (TB) infection prior to initiating treatment.

研究中的安全性数据与ILUMYA已充分记录的安全性特征一致。在INSPIRE-1和INSPIRE-2研究中未发现新的安全性信号。ILUMYA可能会增加感染风险。在开始治疗前，应对患者进行结核病（TB）感染评估。

Most common adverse reactions are: Plaque Psoriasis (≥1%): upper respiratory infections, injection site reactions, and diarrhea. Psoriatic Arthritis (≥3%): upper respiratory tract infections and COVID-19..

最常见的不良反应包括：斑块状银屑病（≥1%）：上呼吸道感染、注射部位反应和腹泻。银屑病关节炎（≥3%）：上呼吸道感染和COVID-19。

About the INSPIRE-1 and INSPIRE-2 Phase 3 Studies

关于INSPIRE-1和INSPIRE-2的III期研究

INSPIRE-1 and INSPIRE-2 are 52-week, global, multicenter, randomized, double-blind, placebo-controlled Phase 3 studies evaluating the efficacy and safety of tildrakizumab 100 mg (ILUMYA) in adults with active psoriatic arthritis.

INSPIRE-1 和 INSPIRE-2 是为期 52 周、全球性、多中心、随机、双盲、安慰剂对照的 III 期研究，旨在评估替达鲁珠单抗 100 mg（ILUMYA）在活动性银屑病关节炎成人患者中的疗效和安全性。

Learn more about the studies at clinicaltrials.gov (INSPIRE-1 NCT04314544 and INSPIRE-2 NCT04314531).

了解更多关于在clinicaltrials.gov上的研究（INSPIRE-1 NCT04314544 和 INSPIRE-2 NCT04314531）。

About Psoriatic Arthritis (PsA)

关于银屑病关节炎（PsA）

Psoriatic arthritis (PsA) is a chronic (long-lasting or recurring) disease related to the immune system. It causes swelling, pain, and stiffness in joints and entheses (places where tendons and ligaments connect to bones).

银屑病关节炎（PsA）是一种与免疫系统相关的慢性（持久或复发性）疾病。它会导致关节和附着点（肌腱和韧带与骨骼连接处）出现肿胀、疼痛和僵硬。

Psoriatic arthritis can develop at any age.

银屑病关节炎可在任何年龄发病。

Psoriatic arthritis can occur regardless of the severity of psoriasis (mild, moderate, or severe). Roughly 1 in 3 people living with psoriasis also have psoriatic arthritis

银屑病关节炎的发生与银屑病的严重程度（轻度、中度或重度）无关。大约三分之一的银屑病患者同时患有银屑病关节炎。

; typically, with psoriasis developing before psoriatic arthritis.

；通常，银屑病先于银屑病性关节炎发生。

While as many as 2.4 million Americans live with psoriatic arthritis, more than 15% of people living with psoriasis may also have undiagnosed psoriatic arthritis.

尽管多达240万美国人患有银屑病关节炎，但超过15%的银屑病患者可能还患有未确诊的银屑病关节炎。

About ILUMYA

关于 ILUMYA

(tildrakizumab-asmn)

（替达利珠单抗-asmn）

ILUMYA (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and for the treatment of adults with active psoriatic arthritis, in the United States.

ILUMYA（tildrakizumab-asmn）是一种人源化IgG1/k单克隆抗体，旨在选择性结合白细胞介素-23（IL-23）的p19亚基，并抑制其与IL-23受体的相互作用，从而抑制促炎性细胞因子和趋化因子的释放。在美国，ILUMYA适用于接受系统性治疗或光疗的中重度斑块状银屑病成人患者，以及活动性银屑病关节炎成人患者的治疗。

ILUMYA has also been approved for moderate-to-severe plaque psoriasis in India, Australia, Canada, China and Japan, and under the brand name ILUMETRI.

ILUMYA 也在印度、澳大利亚、加拿大、中国和日本获批用于治疗中重度斑块状银屑病，品牌名为 ILUMETRI。

in Europe, where it is marketed by Almirall.

在欧洲，由Almirall公司负责销售。

ILUMYA is the 1

ILUMYA 是第 1

第一

biologic to earn the National Psoriasis Foundation (NPF) Seal of Recognition. The NPF Seal recognizes products that meet the Foundation's established review criteria and reflects Sun's continued commitment to supporting people living with psoriatic disease.

生物制剂荣获美国国家银屑病基金会（NPF）认可印章。NPF认可印章授予符合该基金会既定审查标准的产品，体现了Sun公司持续致力于支持银屑病患者的承诺。

INDICATION

适应症

ILUMYA

伊鲁米亚

is indicated for the treatment of:

适用于治疗：

moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

适用于有系统治疗或光疗指征的成人中度至重度斑块状银屑病。

active psoriatic arthritis in adult patients.

成人患者的活动性银屑病关节炎。

IMPORTANT SAFETY INFORMATION

重要安全信息

CONTRAINDICATIONS

禁忌症

ILUMYA is contraindicated in patients with a history of serious hypersensitivity reaction to tildrakizumab or to any of the excipients.

ILUMYA 禁用于对 tildrakizumab 或任何辅料有严重超敏反应史的患者。

WARNINGS AND PRECAUTIONS

警告与注意事项

Hypersensitivity:

超敏反应：

Cases of angioedema and urticaria occurred in ILUMYA treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy.

在临床试验中，接受 ILUMYA 治疗的受试者出现了血管性水肿和荨麻疹病例。如果发生严重过敏反应，应立即停用 ILUMYA 并开始适当的治疗。

Infections:

感染：

ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing ILUMYA.

ILUMYA 可能会增加感染风险。对于患有任何临床意义重大的活动性感染的患者，应在感染消退或得到充分治疗后再开始使用 ILUMYA 进行治疗。对于患有慢性感染或有复发性感染病史的患者，在处方 ILUMYA 之前应权衡其风险与获益。

Instruct patients to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection or is not responding to standard therapy, monitor the patient closely and consider discontinuation of ILUMYA until the infection resolves..

指导患者在出现具有临床意义的慢性或急性感染的体征或症状时寻求医疗帮助。如果患者发生具有临床意义或严重的感染，或对标准治疗无反应，应密切监测患者，并考虑停用ILUMYA，直至感染消退。

Tuberculosis:

结核病：

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Monitor patients for signs and symptoms of active TB during and after ILUMYA treatment.

在开始使用 ILUMYA 治疗前，应对患者进行结核病（TB）感染评估。对于患有活动性结核病的患者，不得给予 ILUMYA。在给予 ILUMYA 之前，应先开始对潜伏性结核病进行治疗。在 ILUMYA 治疗期间及治疗后，应监测患者是否出现活动性结核病的体征和症状。

Consider anti-TB therapy prior to initiation of ILUMYA in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed..

对于有潜伏性或活动性结核病史且无法确认已接受充分疗程治疗的患者，在开始使用ILUMYA之前应考虑进行抗结核治疗。

Immunizations:

免疫接种：

Prior to initiating therapy with ILUMYA, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with ILUMYA.

在开始ILUMYA治疗之前，应根据当前的免疫接种指南完成所有适合年龄的疫苗接种。避免在接受ILUMYA治疗的患者中使用活疫苗。

ADVERSE REACTIONS

不良反应

Most common adverse reactions associated with ILUMYA treatment are:

与 ILUMYA 治疗相关的最常见不良反应包括：

Plaque Psoriasis

斑块型银屑病

(≥1%): upper respiratory infections, injection site reactions, and diarrhea.

（≥1%）：上呼吸道感染、注射部位反应和腹泻。

Psoriatic Arthritis

银屑病关节炎

(≥3%): upper respiratory tract infections and COVID-19.

（≥3%）：上呼吸道感染和 COVID-19。

USE IN SPECIFIC POPULATIONS

在特定人群中的使用

Pregnancy

怀孕

Advise patients that there is a pregnancy exposure registry that monitors outcomes in women exposed to ILUMYA during pregnancy.

告知患者，存在一个妊娠暴露登记系统，用于监测妊娠期间暴露于ILUMYA的女性的妊娠结局。

Patients can enroll by calling MotherToBaby at 1-866-626-6847 or by visiting

患者可以通过拨打 MotherToBaby 电话 1-866-626-6847 或访问

https://mothertobaby.org/ongoing-study/ilumya-tildrakizumab-asmn

。

Please see

请参见

Full Prescribing Information

完整处方信息

。

About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050):

关于太阳制药工业有限公司（CIN - L24230GJ1993PLC019050）：

Sun Pharma is the world's leading specialty generics company with a presence in innovative medicines, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global Emerging Markets. Sun Pharma's high-growth global Innovative Medicines portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for about 20% of company sales.

太阳制药是全球领先的专业仿制药公司，业务涵盖创新药、仿制药和消费者健康产品。它是印度最大的制药公司，也是美国及全球新兴市场中领先的仿制药企业。太阳制药的高增长全球创新药产品组合涵盖皮肤科、眼科和肿瘤皮肤科领域的创新产品，约占公司销售额的20%。

The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit .

公司的垂直整合运营提供高品质药品，深受全球100多个国家的医生和消费者信赖。其制造设施遍布六大洲。Sun Pharma 为其来自50多个国家的多元化员工队伍感到自豪。如需更多信息，请访问。

www.sunpharma.com

and follow us on LinkedIn & X (Formerly Twitter).

并在 LinkedIn 和 X（原 Twitter）上关注我们。

Disclaimer

免责声明

Statements in this 'Document' describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be 'forward looking statements' within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.

本“文件”中描述公司目标、预测、估计、预期、计划或预判，或行业状况或事件的陈述，可能构成适用证券法律法规所定义的“前瞻性陈述”。实际结果、表现或成就可能与明示或暗示的内容存在重大差异。

The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof..

本公司不承担更新或修订前瞻性陈述以反映此后出现的事态发展或情况，或反映发生意外事态发展/情况的义务。

Contacts: Sun Pharma

联系人：Sun Pharma

Investors:

投资者：

Dr. Abhishek Sharma

阿比谢克·夏尔马博士

Tel + 91 22 4324 4324, Ext 2929

电话 +91 22 4324 4324，分机号 2929

Tel Direct + 91 22 43242929

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