OSAKA, Japan, December 22, 2025 -

日本大阪，2025年12月22日 -

Shionogi & Co., Ltd.  (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter 'Shionogi') is pleased to announce that it has obtained manufacturing and marketing approval in Japan for “ZURZUVAE

盐野义制药公司（总部：日本大阪；首席执行官：手代木功博士；以下简称“盐野义”）很高兴地宣布，已获得“ZURZUVAE”在日本的生产和销售许可。

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Capsules 30 mg” (non-proprietary name: zuranolone; hereafter “ZURZUVAE”) as of [December 22, 2025], for the indication of depression and depressive state.

“胶囊 30 毫克”（非专利名称：祖拉诺酮；以下简称“ZURZUVAE”），截至[2025 年 12 月 22 日]，适用于抑郁症和抑郁状态的治疗。

The approval of ZURZUVAE is based on positive results from a Phase 3 randomized placebo-controlled clinical trial of Japanese adults with major depressive disorder conducted in Japan

ZURZUVAE的批准是基于在日本进行的一项针对日本成年重度抑郁症患者的第三阶段随机安慰剂对照临床试验的积极结果。

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. In this study, Oral administration of ZURZUVAE at 30 mg once daily for 14 consecutive days demonstrated efficacy and safety, showing rapid onset of symptom improvement from the early stages of treatment. Furthermore, efficacy and safety were confirmed even upon re-administration after a drug-free interval of six weeks or longer.

在这项研究中，口服ZURZUVAE每天一次30毫克，连续14天显示出有效性和安全性，从治疗的早期阶段就表现出症状迅速改善。此外，即使在停药六周或更长时间后再次给药，仍然确认了其有效性和安全性。

The primary endpoint was the change from baseline in the HAM-D17 total score at the end of the 14-day treatment period. The treatment group showed a mean change of -7.43, which was statistically significantly greater than the placebo group (-6.23), with a least-squares mean difference of -1.20 (95% CI, -2.32 to -0.08; p < 0.0365).

主要终点是14天治疗期结束时HAM-D17总分从基线的变化。治疗组的平均变化为-7.43，显著大于安慰剂组的-6.23，最小二乘均值差异为-1.20（95%置信区间，-2.32至-0.08；p < 0.0365）。

Based on these favorable results, ZURZUVAE has now been approved in Japan..

基于这些有利的结果，ZURZUVAE现已在日本获得批准。

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无法满足

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. ZURZUVAE is expected to address significant unmet needs in the field of depression by providing timely symptom relief for patients in need of 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，满足抑郁症领域显著未满足的需求。

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. We will continue striving to deliver this medicine—potentially capable of transforming the paradigm of depression treatment—to patients as quickly as possible..

盐野义制药将“助力健康繁荣的生活”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。我们将继续努力，尽快将这种有望转变抑郁症治疗模式的药物送到患者手中。

About zuranolone (

关于祖拉诺酮（

ZURZUVAE

祖鲁祖瓦埃

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)

)

Zuranolone is a novel oral antidepressant with a mechanism of action different from conventional therapies. It acts as a GABA-A receptor positive allosteric modulator (PAM) at both synaptic and extrasynaptic sites. Based on clinical trial results conducted by Shionogi, Oral administration of 30 mg once a day for 14 days has been shown to rapidly improve symptoms of major depressive disorder (MDD) without the need for dose adjustment. .

祖拉诺酮是一种新型的口服抗抑郁药，其作用机制不同于传统疗法。它在突触和突触外位点均作为GABA-A受体正向变构调节剂（PAM）发挥作用。根据盐野义制药开展的临床试验结果，每日一次口服30毫克，连续14天已被证明能够快速改善重度抑郁症（MDD）症状，且无需调整剂量。

About Shionogi

关于盐野义制药

Shionogi & Co., Ltd. is a leading global research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of 'supplying the best possible medicine to protect the health and well-being of the patients we serve.' Shionogi has discovered and developed novel antibiotics, medicines for HIV and influenza and currently markets medicines for infectious diseases and central nervous system disorders.

盐野义制药株式会社是一家全球领先的以研发为导向的制药公司，致力于根据其“为患者提供尽可能最好的药物，以保护我们所服务患者的健康与福祉”的企业理念造福患者。盐野义制药发现了并开发了新型抗生素、治疗艾滋病和流感的药物，目前销售用于治疗传染病和中枢神经系统疾病的药物。

Shionogi’s global pipeline includes research programs in infectious disease, pain/CNS, metabolic disorders, rare disease, oncology and stroke..

盐野义的全球研发管线包括传染病、疼痛/中枢神经系统、代谢紊乱、罕见病、肿瘤学和中风等研究项目。

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.       渡边宏一郎等。临床精神药理学。2008；11（12）：2295-2304。

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

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，而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，如整体行业和市场状况，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；有关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，这些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。