OSAKA, Japan, April 25, 2025 -

日本大阪，2025年4月25日 -

Shionogi & Co., Ltd.  (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter 'Shionogi') announced that it has entered into an agreement with Apnimed, Inc. (Head Office: Massachusetts, USA; Chief Executive Officer: Lawrence G. Miller, MD; hereafter 'Apnimed') for the introduction of sulthiame* and a new drug development program..

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”）宣布，已与Apnimed公司（总公司：美国马萨诸塞州；首席执行官：Lawrence G. Miller医学博士；以下简称“Apnimed”）达成协议，引进舒噻胺*并开展新药开发计划。

* Sulthiame: A carbonic anhydrase inhibitor approved as an antiepileptic drug in certain regions. Sulthiame has successfully completed two Phase 2 trials in over 300 obstructive sleep apnea (OSA) patients studied for up to 3 months in Europe.1

* 苏噻胺：一种碳酸酐酶抑制剂，在某些地区被批准作为抗癫痫药物。苏噻胺已在欧洲成功完成了两项针对超过300名阻塞性睡眠呼吸暂停（OSA）患者的二期临床试验，研究时间长达3个月。1

With the conclusion of this agreement, Shionogi acquired a joint ownership interest in the intellectual property rights related to the use of sulthiame in the field of sleep apnea and also in other intellectual property rights related to a different drug development program of Apnimed by paying a one-time fee to Apnimed..

通过达成此项协议，盐野义制药支付了一次性费用给Apnimed，从而获得了与磺胺乙胺在睡眠呼吸暂停领域的使用相关的知识产权权利的共同所有权，同时也获得了Apnimed另一个药物开发项目相关其他知识产权权利的共同所有权。

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Furthermore, Shionogi and Apnimed have already equally contributed this intellectual property to SASS, which will now conduct thefuture research and development of sulthiame and the other drug development program.

此外，盐野义制药和 Apnimed 已经将这一知识产权平等地转让给了 SASS，SASS 现在将开展对磺噻胺及其他药物开发项目的研究与开发。

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Note: Shionogi retains exclusive negotiation rights for the development and sales rights in Japan, Korea, Taiwan, and China.

注意：盐野义保留日本、韩国、台湾和中国开发及销售权的独家谈判权。

“We are pleased to add new assets to the SASS OSA pipeline,” said John Keller, Ph.D., Senior Executive Officer, Senior Vice President, R&D Supervisory Unit at Shionogi. “Our joint venture, combining the scientific and medical resources of Apnimed and Shionogi, represents the most robust global effort to bring new pharmacologic treatments for people with sleep apnea and related disorders.”.

“我们很高兴为SASS OSA管线增添新的资产，”盐野义制药研发监管单位高级执行官、高级副总裁John Keller博士表示，“我们的合资企业结合了Apnimed和盐野义的科研与医学资源，代表了为睡眠呼吸暂停及相关疾病患者带来新药物治疗的最强全球努力。”

“We are delighted to announce that this transaction further strengthened our SASS pipeline,” commented Larry Miller, MD, Chief Executive Officer of Apnimed. “The 80 million people with OSA in the US, and hundreds of millions more around the globe, need more convenient options that directly treat the root causes of OSA.”.

“我们很高兴地宣布，此次收购进一步加强了我们的SASS产品线，”Apnimed首席执行官Larry Miller博士表示。“美国有8000万OSA患者，全球还有数亿患者，他们需要更便捷的选择来直接治疗OSA的根源。”

Shionogi has identified Contributing to a Healthy and Prosperous Life as one of our material focus area. We are committed to creating a society where everyone can lead a longer, more vibrant life, realizing their goals. Through the partnership with Apnimed, Shionogi continues to strive to deliver innovative treatments for diseases with high unmet medical needs, including sleep apnea and related disorders, to patients as quickly as possible..

盐野义制药已将“为健康繁荣的生活做出贡献”确定为我们的重点领域之一。我们致力于创造一个让每个人都能更长寿、更有活力地生活，实现自己目标的社会。通过与Apnimed的合作，盐野义将继续努力尽快为患者提供包括睡眠呼吸暂停及相关疾病在内的、具有高度未满足医疗需求的创新疗法。

About Apnimed

关于Apnimed

Apnimed, based in Cambridge, Massachusetts, is a pharmaceutical company with exceptional expertise in sleep disorders. The company is building a portfolio of novel drug treatments for sleep-related breathing disorders, including Sleep Apnea Syndrome (SAS). Apnimed's lead development candidate, AD109, aims to maintain upper airway patency during sleep with a once-daily oral medication for the treatment of OSA, which, if approved, could bring a dramatic change to conventional therapies for OSA.

总部位于马萨诸塞州剑桥的 Apnimed 是一家在睡眠障碍领域具有卓越专业知识的制药公司。该公司正在构建一系列针对睡眠相关呼吸障碍（包括睡眠呼吸暂停综合征 (SAS)）的新型药物治疗产品组合。Apnimed 的主要开发候选药物 AD109 旨在通过每日一次的口服药物在睡眠期间保持上呼吸道通畅，用于治疗阻塞性睡眠呼吸暂停 (OSA)，若获批准，可能为 OSA 的传统疗法带来重大变革。

For more details, please visit apnimed.com, X, or LinkedIn..

有关更多详细信息，请访问 apnimed.com、X 或 LinkedIn。

About Shionogi-Apnimed Sleep Science, LLC

关于盐野义-Apnimed睡眠科学有限公司

In November 2023, Shionogi and Apnimed established a joint venture, Shionogi-Apnimed Sleep Science, LLC, with each company holding a 50% stake.

2023年11月，盐野义和Apnimed成立了一家合资企业——盐野义-Apnimed睡眠科学有限责任公司，两家公司各持股50%。

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The aim of SASS is to provide promising solutions to meet the unmet needs in the field of sleep disorders. SASS combines Shionogi's capabilities in small molecule drug discovery, first-in-class and best-in-class compound creation with Apnimed's advanced expertise in the field of sleep disorders, including a highly experienced clinical-stage drug development team and a strong network with clinical facilities.

SASS 的目标是为睡眠障碍领域未满足的需求提供有前景的解决方案。SASS 结合了盐野义在小分子药物发现、首创和最佳化合物创造方面的能力，以及 Apnimed 在睡眠障碍领域的先进专业知识，包括经验丰富的临床阶段药物开发团队和与临床机构的强大网络。

This collaboration leverages superior translational research to create promising solutions in the field of sleep disorders more rapidly than either company could achieve alone..

此次合作利用卓越的转化研究，能够比任何一家公司单独行动更快速地在睡眠障碍领域创造有前景的解决方案。

References:

参考文献：

1.       Hedner et al. Efficacy, Safety, and Tolerability of Three Doses of Sulthiame in Patients With Obstructive Sleep Apnea. A Randomized, Double-blind, Placebo Controlled, Dose-ranging Study (STM-042/K). B14. American Thoracic Society Annual Meeting 2024.

1.       Hedner 等人。三种剂量的苏噻胺在阻塞性睡眠呼吸暂停患者中的疗效、安全性和耐受性。一项随机、双盲、安慰剂对照、剂量范围研究（STM-042/K）。B14。美国胸科学会2024年年会。

2.       Press Release: November 1, 2023 - Establishment of a Joint Venture Company with Apnimed for Solving Challenges in Sleep Disorders

新闻发布：2023年11月1日 - 与Apnimed成立合资企业，解决睡眠障碍问题

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、预期以及一些假设，这些假设受到风险和不确定性的制约，可能导致实际结果与这些陈述存在重大差异。风险和不确定性包括一般的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；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:

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