Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Transcend Therapeutics, Inc. (Transcend) announce that the two companies entered into an agreement today, under which Otsuka, through its wholly owned subsidiary Otsuka America, Inc., will fully acquire Transcend. The acquisition is expected to be completed in the second quarter of 2026, subject to the fulfillment of customary closing conditions and required procedures..

大塚制药株式会社（Otsuka）和Transcend Therapeutics, Inc.（Transcend）宣布，两家公司已于今日达成协议，根据该协议，大塚将通过其全资子公司大塚美国公司（Otsuka America, Inc.）全面收购Transcend。此次收购预计将于2026年第二季度完成，但需满足惯例的交割条件及所需程序。

Under the terms of the agreement, Otsuka will pay USD 700 million to Transcend shareholders upon closing of the acquisition, and up to USD 525 million in additional contingent consideration based on future sales milestones related to assets in development, for a total potential consideration of USD $1.225 billion..

根据协议条款，大冢将在收购完成时向Transcend股东支付7亿美元，并基于未来与在研资产相关的销售里程碑，支付最高达5.25亿美元的额外有条件对价，潜在总对价为12.25亿美元。

Transcend, founded in 2021, is a clinical stage biotechnology company developing rapid-acting treatments for neuropsychiatric diseases. TSND-201 (methylone), which the company is developing, is a rapid-acting neuroplastogen--an agent that induces rapid and durable neural plasticity in the brain--and is being advanced as a potential treatment for post-traumatic stress disorder (PTSD) and other psychiatric conditions.

Transcend成立于2021年，是一家临床阶段的生物技术公司，致力于开发治疗神经精神疾病的速效疗法。该公司正在研发的TSND-201（甲基酮）是一种速效神经塑化剂——一种能够在大脑中诱导快速且持久的神经可塑性的药物——并正被推进作为治疗创伤后应激障碍（PTSD）及其他精神疾病的潜在疗法。

In the United States, more than 13 million individuals are estimated to be affected by PTSD each year,¹ yet no new treatments have been approved for 25 years, underscoring the significant unmet medical need..

在美国，每年估计有超过 1300 万人受到 PTSD 的影响，¹ 但 25 年来一直没有新的治疗方法获批，凸显了显著未满足的医疗需求。

Recent research has demonstrated that changes in neuroplasticity in the brain are deeply involved in both the onset and persistence of PTSD symptoms. Neuroplasticity, the brain's ability to reorganize neural circuits, supports memory formation and emotional regulation. In PTSD, alterations in fear-related pathways impair the ability to relearn safety ('overwriting fear'), driving growing interest in interventions that restore or enhance neuroplasticity.².

最近的研究表明，大脑中神经可塑性的变化与 PTSD 症状的发作和持续密切相关。神经可塑性是指大脑重新组织神经回路的能力，它支持记忆形成和情绪调节。在 PTSD 中，与恐惧相关的通路改变会削弱重新学习安全的能力（“覆盖恐惧”），这促使人们日益关注恢复或增强神经可塑性的干预措施。

TSND-201 (methylone) acts on monoamine transporters in the brain--including those for serotonin, norepinephrine, and dopamine. By promoting monoamine release, it increases monoamine concentrations within the synaptic cleft, resulting in rapid and sustained enhancement of neuroplasticity.

TSND-201（甲基酮）作用于大脑中的单胺转运蛋白——包括血清素、去甲肾上腺素和多巴胺的转运蛋白。通过促进单胺释放，它增加了突触间隙中的单胺浓度，从而快速且持续地增强神经可塑性。

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Importantly, TSND-201 does not act on the serotonin 5-HT2A receptor, which mediates hallucinogenic effects, and is therefore considered a non-hallucinogenic compound.

重要的是，TSND-201 不作用于介导致幻效果的血清素 5-HT2A 受体，因此被认为是一种非致幻化合物。

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Transcend is also conducting research and development on novel prodrugs--classified as new chemical entities--to further improve the balance of efficacy, safety, and tolerability of TSND‑201. The company has selected a development candidate and is currently performing non‑clinical studies in preparation for an Investigational New Drug application to the U.S.

Transcend 还在进行新型前药的研究与开发——这些前药被归类为新化学实体——以进一步改善 TSND-201 的疗效、安全性和耐受性之间的平衡。该公司已选定一个开发候选药物，目前正在开展非临床研究，为向美国提交试验性新药申请做准备。

Food and Drug Administration (FDA)..

食品和药物管理局 (FDA)。

TSND‑201 demonstrated favorable results in the Phase 2 clinical trial IMPACT‑1, which enrolled adults with PTSD, and study findings were published in

TSND‑201 在纳入 PTSD 成人的 2 期临床试验 IMPACT‑1 中展示了良好的结果，研究结果已发表在

JAMA Psychiatry

《美国医学会杂志》精神病学分册

in February 2026.

2026年2月。

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Due to its rapid onset of activity and robust effects, TSND‑201 was granted Breakthrough Therapy designation by the FDA in July 2025. Transcend met with the FDA in September 2025, to discuss company plans to expedite the development of TSND-201 and confirm the design of the Phase 3 study. Patient recruitment for the Phase 3 trial is underway in the U.S..

由于其快速起效和显著效果，TSND-201于2025年7月获得FDA授予的突破性疗法认定。Transcend公司于2025年9月与FDA会面，讨论公司加快TSND-201开发的计划，并确认了三期研究的设计。三期试验的患者招募正在美国进行中。

Makoto Inoue, president and representative director of Otsuka, commented, 'We are very pleased to welcome Transcend Therapeutics into the Otsuka group. Although treatment options for PTSD remain limited, TSND‑201 is generating expectations as a potential paradigm‑shifting therapy in the field of psychiatry.

大冢总裁兼代表董事井上诚评论道：“我们非常高兴欢迎Transcend Therapeutics加入大冢集团。尽管PTSD的治疗选择仍然有限，但TSND‑201作为一种潜在的范式转变疗法在精神病学领域备受期待。”

By combining Otsuka's long‑standing expertise in the psychiatric and neurological fields with Transcend's innovative approach, we will advance the development of TSND-201 in close collaboration with regulatory authorities to bring this new treatment option to patients.'.

通过结合大冢在精神科和神经学领域的长期专业知识与Transcend的创新方法，我们将与监管机构密切合作，推动TSND-201的开发，为患者带来这一新的治疗选择。

Blake Mandell, CEO and co-founder at Transcend Therapeutics, noted, 'We founded Transcend to bring a fundamentally new treatment to patients with PTSD-one that is rapid-acting and accessible. Otsuka's leadership and longstanding commitment in neuroscience reflect the same dedication to patients that has driven our team from day one, and we are proud to continue advancing TSND-201 together in service of that shared mission.'.

布莱克·曼德尔，超越治疗公司的首席执行官和联合创始人指出：“我们创立超越治疗公司是为了给PTSD患者带来一种根本上的全新治疗方案——一种快速起效且易于获取的疗法。大冢在神经科学领域的领导地位和长期承诺反映了与我们团队自始至终对患者的专注相同的奉献精神，我们很自豪能够继续共同推进TSND-201，以服务于这一共同使命。”

Since the 1970s, Otsuka Pharmaceutical has focused on the psychiatric and neurological fields, working to provide new treatment options for disorders such as schizophrenia, bipolar disorder, depression and PTSD, for which therapeutic choices remain limited. In recent years, with the aim of creating next-generation therapies for psychiatric disorders, Otsuka has expanded its global network through partnerships and collaborations, as well as by the acquisition of Mindset Pharma, Inc., a company with innovative, serotonin 5-HT2A agonist discovery technology.

自20世纪70年代以来，大冢制药一直专注于精神和神经领域，致力于为精神分裂症、双相情感障碍、抑郁症和创伤后应激障碍等治疗选择仍然有限的疾病提供新的治疗方案。近年来，为了创造下一代精神疾病疗法，大冢通过合作伙伴关系和合作扩大了其全球网络，并收购了拥有创新性血清素5-HT2A激动剂发现技术的公司Mindset Pharma, Inc.

Through these efforts, the company is actively working to broaden future treatment options..

通过这些努力，该公司正在积极努力拓宽未来的治疗选择。

By acquiring TSND‑201--a novel investigational asset with a mechanism of action distinct from Otsuka's existing medicines and development programs--the company will further accelerate the expansion of its portfolio in the psychiatric and neurological fields. In the U.S. in particular, despite the very large number of individuals living with PTSD, treatment options remain limited to psychotherapy and antidepressants, underscoring the need for new therapeutic approaches supported by scientific evidence of efficacy and safety.

通过收购TSND-201——一种具有与大冢现有药物和开发项目不同作用机制的新型研究资产——该公司将进一步加速其在精神科和神经学领域的产品组合扩展。特别是在美国，尽管有大量患有创伤后应激障碍（PTSD）的人群，但治疗选择仍然仅限于心理治疗和抗抑郁药物，这凸显了对新治疗方法的需求，这些方法需要有科学证据支持其有效性和安全性。

By welcoming Transcend into the Otsuka group, the company aims to strengthen its position as a global leader in the psychiatric and neurological fields and to accelerate the development of next‑generation treatments, including those for PTSD, with the goal to expand future treatment options..

通过将Transcend引入大冢集团，该公司旨在加强其在精神科和神经学领域的全球领导地位，并加速包括PTSD治疗在内的下一代治疗方法的开发，以扩大未来的治疗选择。

About the Phase 2 IMPACT-1 Study

关于第2阶段IMPACT-1研究

IMPACT‑1 was a randomized, double‑blind, placebo‑controlled trial that evaluated the efficacy, safety, and tolerability of TSND‑201 in adults with PTSD. A total of 65 patients with severe PTSD, defined as having a CAPS‑5 (Clinician‑Administered PTSD Scale for DSM‑5) total severity score of 35 or higher, were enrolled across 16 sites in the U.S., the U.K., and Ireland (mean age: 43.7 years; 26 males and 39 females).

IMPACT-1 是一项随机、双盲、安慰剂对照试验，评估了TSND-201在患有创伤后应激障碍（PTSD）的成人中的疗效、安全性和耐受性。研究共纳入65名严重PTSD患者，定义为CAPS-5（DSM-5临床医生施用的PTSD量表）总严重程度评分达到35分或更高，分布在美国、英国和爱尔兰的16个研究中心（平均年龄：43.7岁；26名男性和39名女性）。

Participants received blinded study drug (orally administered TSND-201 or placebo) once a week for four weeks and were followed for an additional six weeks..

参与者每周一次接受盲法研究药物（口服TSND-201或安慰剂），持续四周，并在随后的六周内进行随访。

The IMPACT‑1 study met its primary endpoint, with the TSND‑201 group demonstrating rapid improvements in CAPS‑5 total severity scores from baseline through Day 64 compared with placebo. Notably, from Day 10 onward, the TSND‑201 group showed statistically significant greater improvement in CAPS‑5 scores relative to the placebo group..

IMPACT‑1 研究达到了其主要终点，与安慰剂相比，TSND‑201 组从基线到第 64 天的 CAPS‑5 总严重程度评分显示出快速改善。值得注意的是，从第 10 天起，TSND‑201 组相较于安慰剂组在 CAPS‑5 评分上表现出统计学上显著更大的改善。

TSND‑201 was generally well tolerated. The most frequently reported treatment‑emergent adverse events included headache, decreased appetite, nausea, dizziness, increased blood pressure, dry mouth, and insomnia. These events were typically transient, occurred on the day of dosing, and resolved within one day..

TSND‑201 通常耐受性良好。最常见的治疗中出现的不良事件包括头痛、食欲减退、恶心、头晕、血压升高、口干和失眠。这些事件通常是短暂的，发生在给药当天，并在一天内得到缓解。

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About PTSD

关于 PTSD

Post‑traumatic stress disorder is a serious mental health condition that develops after experiencing or witnessing a life‑threatening event or a deeply traumatic experience. Common symptoms include flashbacks, nightmares, severe anxiety, and uncontrollable thoughts related to the traumatic event.

创伤后应激障碍是一种严重的心理健康状况，通常在经历或目睹危及生命的事情或深度创伤经历后发展而来。常见症状包括闪回、噩梦、严重焦虑以及与创伤事件相关的无法控制的思绪。

In the U.S., it is estimated that more than 13 million people live with PTSD each year,¹ and nearly 6 out of every 100 individuals are expected to be diagnosed with PTSD at some point in their lives. Only two medications are FDA-approved for the treatment of PTSD (sertraline and paroxetine), and novel treatments for PTSD are urgently needed..

在美国，据估计每年有超过 1300 万人患有 PTSD，¹ 而且几乎每 100 人中就有近 6 人预计在生命中的某个阶段会被诊断出患有 PTSD。目前只有两种药物获得 FDA 批准用于治疗 PTSD（舍曲林和帕罗西汀），因此迫切需要新的 PTSD 治疗方法。

About TSND-201

关于TSND-201

TSND-201 (methylone) is a rapid-acting neuroplastogen developed by Transcend. TSND-201 has well-characterized primary pharmacology, with its primary site of action at the monoamine transporters, and no activity at 5-HT2A receptors (i.e., not hallucinogenic). Transcend is developing TSND-201 as a rapid-acting and durable treatment for PTSD and other central nervous system (CNS) indications.

TSND-201（甲基酮）是一种由Transcend开发的速效神经塑化剂。TSND-201的主要药理特性已被充分研究，其主要作用位点位于单胺转运蛋白，并且在5-HT2A受体上无活性（即不具致幻性）。Transcend正在开发TSND-201作为一种速效且持久的治疗PTSD及其他中枢神经系统（CNS）相关适应症的药物。

TSND-201 is an investigational medication..

TSND-201 是一种研究性药物。

About Transcend Therapeutics

关于Transcend Therapeutics

Transcend, founded in 2021 and based in New York City, is a clinical-stage, neuroscience-focused company developing rapid-acting treatments for neuropsychiatric diseases. The company's mission is to develop new drugs for the millions of people for whom current psychiatric medicines have not worked.

Transcend成立于2021年，总部位于纽约市，是一家临床阶段、专注于神经科学的公司，致力于开发快速起效的神经精神疾病治疗方法。该公司的使命是为数百万现有精神药物无效的患者研发新药。

Visit

访问

http://www.transcendtherapeutics.com

http://www.transcendtherapeutics.com

for more information.

更多信息，请参阅。

About Otsuka

关于大冢制药

Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement.

大冢制药株式会社是一家全方位的医疗保健公司，专注于激发每个人的潜能以提升其健康水平。我们的医药相关业务提供针对身体和心理健康的治疗与诊断方案。我们的营养保健品业务则支持日常健康维护与改善。

Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: .

大冢的独特产品和服务基于科学研究证据，在我们企业理念的指导下：。

Otsuka-people creating new products for better health worldwide.

大冢——为全球健康创造新产品的团队。

For further information, please visit

欲了解更多信息，请访问

www.otsuka.co.jp/en/

www.otsuka.co.jp/en/