OSAKA, Japan, March 19, 2026 -

日本大阪，2026年3月19日 -

Shionogi & Co., Ltd.  (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter 'Shionogi') announced today that Shionogi launched ZURZUVAE

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”）今日宣布，盐野义已推出ZURZUVAE。

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Capsules 30 mg (generic name: zuranolone; hereafter “ZURZUVAE”), for the treatment of major depressive disorder (MDD).

30毫克胶囊（通用名：祖拉诺酮；以下简称“ZURZUVAE”），用于治疗重度抑郁症（MDD）。

ZURZUVAE is a novel oral antidepressant with a mechanism of action different from conventional therapies. It acts as a positive allosteric modulator of GABA

ZURZUVAE 是一种新型口服抗抑郁药，其作用机制不同于传统疗法。它是 GABA 的正向变构调节剂。

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receptors at both synaptic and extrasynaptic sites.

突触和突触外位点的受体。

In a Phase 3 randomized, placebo-controlled clinical trial

在一项三期随机、安慰剂对照临床试验中

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conducted in Japan involving adults with major depressive disorder, oral administration of ZURZUVAE at 30 mg once daily for 14 consecutive days demonstrated rapid improvement in depressive symptoms. Furthermore, no safety-related concerns were identified upon re-administration.

在日本进行的涉及重度抑郁症成人的研究中，连续14天每日一次口服30毫克ZURZUVAE显示抑郁症状迅速改善。此外，再次给药时未发现与安全性相关的问题。

Depression affects an estimated 5 million people in Japan, representing one of the most burdensome non-fatal diseases in terms of social and health impact

抑郁症影响着日本大约500万人，是社会和健康影响方面负担最重的非致命疾病之一。

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. Conventional antidepressants often require several weeks to achieve therapeutic effect

传统抗抑郁药通常需要数周才能达到治疗效果。

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, creating an unmet need for treatments with rapid onset

，导致对快速起效的治疗药物的需求得不到满足

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. ZURZUVAE is expected to address significant unmet needs in the treatment of depression by providing timely symptom relief for patients requiring therapeutic intervention.

ZURZUVAE 预计将通过为需要治疗干预的患者提供及时的症状缓解，满足抑郁症治疗中显著未被满足的需求。

Shionogi has identified “Contributing to a healthy and prosperous life” as a key materiality and is committed to the research and development, manufacturing, and commercialization of healthcare solutions addressing QOL diseases with high social impact*, building a society where everyone can live longer, healthier, and more fulfilling lives in their own way.

盐野义制药将“为健康和富足的生活做贡献”确定为关键要务，致力于研究、开发、制造和推广解决高社会影响生活质量类疾病（QOL疾病）的医疗保健方案，构建一个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。

Through the delivery of ZURZUVAE, which has the potential to transform the paradigm of depression treatment, we aim to address the unmet needs of patients with depression..

通过提供有可能改变抑郁症治疗模式的ZURZUVAE，我们的目标是满足抑郁症患者未被满足的需求。

*QOL diseases with high social impact: sleep disorders, hearing loss, rare pediatric diseases, Immunology/Allergy, etc.

*对社会影响较大的生活质量（QOL）疾病：睡眠障碍、听力损失、罕见儿科疾病、免疫学/过敏等。

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用信息的预期，假设存在风险和不确定性，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：临床试验的完成和终止；获得监管批准；有关产品安全性和有效性的索赔和顾虑；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化。

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

References

参考文献

1.  Psychiatry Clin Neurosci.2025 Nov 18.doi: 10.1111/pcn.13917.

1. 精神病学与临床神经科学。2025年11月18日。doi: 10.1111/pcn.13917。

2.  WHO, Depression and Other Common Mental Disorders Global Health Estimates

2. 世界卫生组织，《抑郁症和其他常见精神障碍全球健康估计》

3.  Japanese Society of Mood Disorders Treatment Guidelines

3. 日本情绪障碍治疗指南

4.  Watanabe, Koichiro et al. Clinical Psychopharmacology. 2008; 11(12): 2295-2304.

4. 渡边幸一郎等。《临床精神药理学》。2008年；11卷12期：2295-2304页。