OSAKA, Japan, September 19, 2025

日本大阪，2025年9月19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 the approval in Japan for the manufacture and marketing of YCANTH® topical Solution 0.71% for the treatment of molluscum contagiosum, a dermatological disease..

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，其集团子公司鸟居制药株式会社（总部：日本东京中央区；总裁兼首席执行官：近藤伸昌）已发布新闻稿，宣布在日本获得批准生产和销售YCANTH®外用溶液0.71%，用于治疗传染性软疣这一皮肤病。

Below is the announcement released by Torii Pharmaceutical.

以下是鸟居制药发布的公告。

Torii Pharmaceutical Co., Ltd. (Torii) announced that Torii has today received manufacturing and marketing approval of YCANTH

鸟居制药株式会社（Torii）宣布，公司今日已获得YCANTH的生产和上市批准。

®

®

(cantharidin) topical solution 0.71% for the treatment of Molluscum Contagiosum in Japan.

0.71%的（斑蝥素）外用溶液，用于治疗日本的传染性软疣。

YCANTH

YCANTH

®

®

(cantharidin) topical solution 0.71% is a skin disease treatment drug containing cantharidin as an active ingredient. In the Phase 3 clinical study of YCANTH

(cantharidin) 外用溶液 0.71% 是一种含斑蝥素作为活性成分的皮肤病治疗药物。在 YCANTH 的 3 期临床研究中

®

®

(cantharidin) topical solution 0.71% in patients with molluscum contagiosum (≥2 years old) in Japan, the primary endpoint of efficacy has met superiority to the vehicle. Furthermore, the safety of YCANTH

(cantharidin) 0.71%外用溶液在日本针对传染性软疣（≥2岁）患者的疗效主要终点已证明优于安慰剂。此外，YCANTH的安全性

®

®

(cantharidin) topical solution 0.71% was confirmed and there were no observed issues of tolerability for the application.

确认了0.71%的斑蝥素局部溶液，应用时未观察到耐受性问题。

Torii expects YCANTH

鸟居期待YCANTH

®

®

(cantharidin) topical solution 0.71% to be a new option for the treatment of molluscum contagiosum patients (≥2 years old) in Japan.

0.71%的（斑蝥素）外用溶液将成为日本治疗传染性软疣患者（≥2岁）的新选择。

Separately, Verrica received approval from the U.S. Food and Drug Administration in July 2023 for the topical treatment of molluscum contagiosum in adult and pediatric patients (≥2 years old) and launched YCANTH in the US in August 2023. Verrica and Torii are in process of further developing YCANTH

此外，Verrica于2023年7月获得美国食品药品监督管理局（FDA）批准，用于成人和两岁及以上儿童传染性软疣的局部治疗，并于2023年8月在美国推出YCANTH。Verrica和Torii正在进一步开发YCANTH。

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®

for additional indications, including a planned global clinical program in common warts, targeted to begin enrollment in the US by the end of 2025.

针对更多的适应症，包括计划开展的全球临床项目，针对常见疣，预计于2025年底前开始在美国招募患者。

Product name

产品名称

YCANTH

YCANTH

®

®

topical solution 0.71%

局部溶液 0.71%

Japanese Accepted Name

日文接受名称

Cantharidin

斑蝥素

Indications

适应症

Molluscum Contagiosum

传染性软疣

Dosage and

剂量和

administration

管理

For adults and pediatric patients (≥2 years old), apply an appropriate amount of solution to the affected area once every 3 weeks during treatment. 16 to 24 hours after application, washing affected area with soap.

对于成人和儿科患者（≥2岁），在治疗期间每3周向患处涂抹适量溶液一次。涂抹后16至24小时，用肥皂清洗患处。

ABOUT Molluscum Contagiosum

关于传染性软疣

Molluscum contagiosum is a highly prevalent, contagious dermatologic disease that often occurs in children due to infection with the molluscum contagiosum virus, a member of the poxviridae family, and is commonly referred to as 'water warts.' Many shiny papules with a diameter of 1 to 4 mm are seen on the trunk and extremities..

传染性软疣是一种高度流行、具有传染性的皮肤病，常因感染属于痘病毒科的传染性软疣病毒而在儿童中发生，通常被称为“水瘊子”。躯干和四肢可见许多直径1至4毫米的光滑丘疹。

ABOUT Common Warts

关于寻常疣

Common warts (Verruca vulgaris) is a common dermatologic disease caused by infection with the human papillomavirus, and is commonly called “warts”. Keratinized raised lesions measuring several mm to 1 cm are seen mainly on the hands and feet.

普通疣（Verruca vulgaris）是一种由人乳头瘤病毒感染引起的常见皮肤病，常被称为“瘊子”。主要在手部和脚部出现数毫米至1厘米大小的角化隆起性病灶。

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、在预期的基础上作出的，这些假设受到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：临床试验的完成和中止；获得监管批准；关于产品安全性和有效性的声明和担忧；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，其中包括但不限于无法建立产能以满足需求、原材料供应不足以及竞争产品进入市场。公司否认任何更新或修改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 :

SHIONOGI网站咨询表：

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

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