OSAKA, Japan, February 27, 2026 -

日本大阪，2026年2月27日 -

Shionogi & Co., Ltd.  (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter 'Shionogi') and Torii Pharmaceutical Co., Ltd. (Head office: Tokyo, Japan; President and CEO: Nobumasa Kondo; hereinafter 'Torii'), a wholly owned subsidiary of the SHIONOGI Group, are pleased to announce the submission of an application for manufacturing and marketing approval for a 0.5% lotion formulation (hereinafter 'this product') of the atopic dermatitis treatment CORECTIM.

盐野义制药株式会社（总公司：日本大阪；首席执行官：手代木功博士；以下简称“盐野义”）及其全资子公司鸟居制药株式会社（总公司：日本东京；总裁兼首席执行官：近藤伸正；以下简称“鸟居”）很高兴宣布，已提交关于治疗特应性皮炎的药物CORECTIM的0.5%洗剂配方（以下简称“本产品”）的生产和上市许可申请。

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(generic name: delgocitinib), which we are jointly developing.

（通用名：delgocitinib），我们正在联合开发。

CORECTIM

正确性

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is a non-steroidal, JAK inhibitors that are expected to improve autoimmune and allergic diseases by inhibiting the action of JAKs, which play key roles in immune activation signaling in cells, by suppressing the overactivation of immune responses. In Japan, the ointment formulation has been approved for the treatment of atopic dermatitis in adults and children.

是一种非甾体类JAK抑制剂，通过抑制在细胞免疫激活信号中起关键作用的JAKs，来抑制免疫反应的过度活化，从而有望改善自身免疫和过敏性疾病。在日本，该药膏已被批准用于治疗成人和儿童的特应性皮炎。

1,2

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and is now also available for use in infants

现在也可用于婴儿

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3

.

。

Atopic dermatitis is a chronic disease that repeatedly worsens and improves, making stable symptom control over the long term essential. Therefore, a therapeutic drug that can be used over the long term and can control symptoms is needed. This application for approval of the additional formulation is based on the positive results of a Phase 1 skin safety study (.

特应性皮炎是一种慢性疾病，症状反复加重和缓解，因此长期稳定控制症状至关重要。所以，需要一种可长期使用并能控制症状的治疗药物。此次申请批准新增制剂正是基于1期皮肤安全性研究的积极结果。

jRCT2031230570

jRCT2031230570

) and a Phase 3 bioequivalence study (

）以及一项三期生物等效性研究（

jRCT2031230713

jRCT2031230713

). The Phase 1 skin safety study confirmed safety, while the Phase 3 bioequivalence study confirmed bioequivalence to CORECTIM

）。第一阶段的皮肤安全性研究证实了其安全性，而第三阶段的生物等效性研究则证实了其与CORECTIM的生物等效性。

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0.5% Ointment and safety.

0.5%软膏和安全性。

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Generally speaking, the lotion formulation can be easily applied to the scalp and other hairy areas where ointments are difficult to use. Its low greasiness and pleasant, lightweight texture are expected to support improved patient adherence to treatment.

一般来说，乳液制剂可以轻松应用于头皮和其他多毛区域，而这些地方软膏很难使用。其低油腻性和令人愉悦的轻盈质地有望提高患者对治疗的依从性。

Shionogi has identified 'contributing to a healthy and prosperous life' as a key materiality and is committed to building a society where everyone can live longer, healthier, and more fulfilling lives in their own way. Shionogi and Torii Pharmaceutical will continue to work hard to deliver this drug as soon as possible to contribute to the treatment and improvement of the quality of life of patients suffering from atopic dermatitis..

盐野义制药将“助力健康繁荣生活”确定为关键要务，并致力于打造一个让每个人都能以自己的方式更长寿、更健康、更充实生活的社会。盐野义制药和鸟居制药将继续努力，尽快推出这款药物，为治疗和改善特应性皮炎患者的生活质量做出贡献。

About Atopic Dermatitis

关于特应性皮炎

Atopic dermatitis is a chronic and pruritic inflammatory skin disease. It is thought to develop through exposure to various irritants or allergens for patients with a physiological abnormality of the skin (dry skin and abnormal skin barrier function).

特应性皮炎是一种慢性且瘙痒性的炎症性皮肤病。它被认为是在皮肤有生理异常（干燥和皮肤屏障功能异常）的患者中，通过接触各种刺激物或过敏原而引发的。

About Delgocitinib

关于Delgocitinib

Delgocitinib, under the product name 'CORECTIM

德尔戈西替尼，商品名为“CORECTIM”

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Ointment,' was approved in Japan in January 2020 as the world's first non-steroidal topical JAK inhibitor. Currently, Shionogi is the manufacturer and distributor, and Torii Pharmaceutical is the distributor, with both companies co-promoting the drug in Japan. In 2014, LEO Pharma signed a license agreement for the exclusive development and commercialization of topical skin preparations worldwide except for Japan.

“软膏”于2020年1月在日本获批，成为全球首款非甾体类局部JAK抑制剂。目前，盐野义制药为生产商和经销商，鸟居制药为经销商，两家公司共同在日本推广该药物。2014年，LEO制药签署了独家开发和商业化局部皮肤制剂的许可协议，范围涵盖日本以外的全球市场。

LEO Pharma has obtained approval for the treatment of chronic hand eczema in Europe and the United States, and is selling the product under the name 'Anzupgo.

丹麦利奥制药公司已经获得在欧洲和美国用于治疗慢性手部湿疹的许可，并以“Anzupgo”的名称销售该产品。

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Cream.'

奶油。

Reference:

参考：

1.

1.

Torii Pharmaceutical Co., Ltd. Press Release: January 23, 2020

鸟居制药株式会社新闻稿：2020年1月23日

2.

2.

Torii Pharmaceutical Co., Ltd. Press Release: March 23, 2021

鸟居制药株式会社新闻稿：2021年3月23日

3.

3.

Torii Pharmaceutical Co., Ltd. Press Release: December 14, 2021

鸟居制药株式会社新闻稿：2021年12月14日

4.

4.

Torii Pharmaceutical Co., Ltd. Press Release: May 14, 2025

鸟居制药株式会社新闻稿：2025年5月14日

Forward-Looking Statements

前瞻性声明

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate.

本公告包含前瞻性陈述。这些陈述是基于当前可获得的信息和可能引起实际结果与这些陈述有重大差异的风险和不确定性假设下的预期。风险和不确定性包括一般国内和国际经济状况，如一般行业和市场状况，以及利率和货币汇率的变化。

These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations.

这些风险和不确定性尤其适用于与产品相关的前瞻性声明。产品风险和不确定性包括但不限于：临床试验的完成和终止；获得监管批准；有关产品安全性和有效性的索赔和担忧；技术进步；重要诉讼的不利结果；国内外医疗改革以及法律法规的变更。

Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise..

对于现有产品，也存在生产和营销风险，包括但不限于无法建立满足需求的生产能力、原材料供应不足以及竞争产品的进入。公司否认有任何意图或义务更新或修改任何前瞻性声明，无论是否由于新信息、未来事件或其他原因。

For Further Information, Contact:

如需更多信息，请联系：

SHIONOGI Website Inquiry Form:

SHIONOGI网站咨询表：

https://www.shionogi.com/global/en/contact.html

https://www.shionogi.com/global/en/contact.html