OSAKA, Japan, October 10, 2025

日本大阪，2025年10月10日

- Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.) hereby announces that its group company, Torii Pharmaceutical Co., Ltd. (Head Office: Chuo-ku, Tokyo, Japan; President and Chief Executive Officer: Nobumasa Kondo), has issued a press release regarding a new drug application for JTE-061 Cream, aryl hydrocarbon receptor modulating agent, for the treatment of pediatric atopic dermatitis in Japan..

－盐野义制药株式会社（总部：日本大阪；首席执行官：手代木功博士）在此宣布，其集团公司鸟居制药株式会社（总部：日本东京都中央区；总裁兼首席执行官：近藤伸正）已发布新闻稿，内容涉及在日本提交用于治疗儿童特应性皮炎的JTE-061乳膏（芳烃受体调节剂）的新药申请。

Below is the announcement released by Torii Pharmaceutical.

以下是鸟居制药发布的公告。

Japan Tobacco Inc. (JT) (TSE:2914) and Torii Pharmaceutical Co., Ltd. (Torii) announced today that JT has filed a New Drug Application for JTE-061 (generic name: tapinarof) cream 0.5%, a therapeutic aryl hydrocarbon receptor modulating agent, for the treatment of pediatric patients aged 2 to <12 years with atopic dermatitis..

日本烟草公司（JT）（东京证券交易所代码：2914）和鸟居制药株式会社（Torii）今天宣布，JT已提交JTE-061（通用名：tapinarof）乳膏0.5%的新药申请，这是一种治疗2至12岁以下特应性皮炎儿童患者的芳烃受体调节剂。

In 2020, JT previously entered into an exclusive license agreement with Dermavant Sciences GmbH (which was later acquired by Organon & Co.) for the development and commercialization of tapinarof for dermatological diseases and conditions in Japan. JT also signed an exclusive license agreement with Torii for the co-development and commercialization of tapinarof in Japan.

2020年，JT此前与Dermavant Sciences GmbH（后被Organon＆Co.收购）签订了独家许可协议，用于在日本开发和商业化治疗皮肤病的tapinarof。JT还与鸟居制药签署了独家许可协议，共同开发和商业化tapinarof在日本的使用。

Under this agreement, JT and Torii are jointly developing tapinarof cream 0.5% for pediatric patients with atopic dermatitis, and Torii will be responsible for marketing the product in Japan subsequent to JT's obtaining manufacturing and marketing approval..

根据该协议，JT和鸟居将联合开发用于治疗特应性皮炎的儿科患者的0.5%浓度的塔皮纳罗夫乳膏，且在JT获得生产和销售许可后，鸟居将负责在日本市场推广该产品。

In the Phase 3 clinical study conducted in Japan in pediatric patients aged 2 to <12 years with atopic dermatitis, tapinarof cream 0.5% met the primary efficacy endpoint, demonstrating superiority over vehicle. Furthermore, the safety of tapinarof cream 0.5% was confirmed during long-term treatment.

在日本针对2至<12岁特应性皮炎儿童患者开展的3期临床研究中，0.5%的tapinarof乳膏达到了主要疗效终点，显示出优于赋形剂的效果。此外，在长期治疗中也证实了0.5%的tapinarof乳膏的安全性。

JT and Torii expect that tapinarof cream 0.5% will offer a new treatment option for pediatric patients with atopic dermatitis in Japan..

JT和Torii预计，0.5%的tapinarof乳膏将为日本的特应性皮炎儿童患者提供一种新的治疗选择。

In addition, in June 2024, JT received manufacturing and marketing approval in Japan for tapinaorf cream 1% (VTAMA® Cream 1%) for the treatment of atopic dermatitis in patients aged 12 years and older and plaque psoriasis in adults. VTAMA® Cream 1% has been distributed in Japan by Torii since October 2024..

此外，在2024年6月，JT公司获得了在日本生产和销售1%塔匹那罗乳膏（VTAMA® Cream 1%）的批准，用于治疗12岁及以上患者的特应性皮炎和成人的斑块状银屑病。自2024年10月起，该药已由鸟居制药公司在日本分销。

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 in 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瘙痒性炎症性皮肤病。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，通过暴露于各种刺激物或过敏原而发生的。

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预期，这些假设受风险和不确定性的影响，可能导致实际结果与这些陈述有重大差异。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；对产品安全性和有效性的主张和担忧；技术进步；重要诉讼的不利结果；国内外医疗保健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。公司否认任何更新或修改任何前瞻性声明的意图或义务，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 :

盐野义制药网站咨询表：

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

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