Nuvation Bio宣布从第一三共收购Safusidenib的日本权利-动脉网

Nuvation Bio Announces Acquisition of Japan Rights to Safusidenib from Daiichi Sankyo

PR Newswire 等信源发布 2026-04-01 20:00

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With acquisition of Japan rights, Nuvation Bio now has global development and commercialization rights for

随着日本权利的获得，Nuvation Bio现在拥有全球开发和商业化权利。

safusidenib

萨福西尼布

Agreement provides Nuvation Bio ownership of global clinical development program, inclusive of clinical trials, past and current data generation, and future publications

协议规定，Nuvation Bio拥有全球临床开发计划的所有权，包括临床试验、过去和当前的数据生成以及未来的出版物。

NEW YORK

纽约

，

April 1, 2026

2026年4月1日

/PRNewswire/ -- Nuvation Bio Inc. (NYSE:

/PRNewswire/ -- Nuvation Bio Inc.（纽约证券交易所：

NUVB

), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced the company has amended its existing exclusive license agreement for safusidenib with Daiichi Sankyo (TSE :4568) to include Japan rights, effectively securing exclusive global development and commercialization rights of the investigational medicine.

），一家专注于应对癌症治疗中最严峻挑战的全球肿瘤学公司，今天宣布该公司已修改与第一三共（TSE:4568）就沙呋西尼达成的现有独家许可协议，将日本权利纳入其中，从而全面获得该研究药物的独家全球开发和商业化权利。

The agreement, as amended, enables Nuvation Bio to expand its ongoing pivotal SIGMA study of safusidenib into Japan, and provides rights to all previously generated and future data to support further publication of safusidenib results in .

该协议经修订后，使Nuvation Bio能够将其正在进行的关于safusidenib的关键SIGMA研究扩展到日本，并赋予其所有先前生成的数据和未来数据的权利，以支持进一步发布safusidenib的结果。

IDH1-

mutant glioma.

突变型胶质瘤。

Safusidenib is a novel, oral, potent, brain-penetrant, selective inhibitor of mutant IDH1 that is currently being evaluated in the ongoing Phase 3 SIGMA study for the maintenance treatment of patients with

萨菲西尼是一种新型、口服、高效、可穿透血脑屏障的突变IDH1选择性抑制剂，目前正在正在进行的3期SIGMA研究中评估其对患者的维持治疗效果。

IDH1

-mutant astrocytoma who have high-risk features following standard-of-care.

具有高危特征的突变型星形细胞瘤患者在标准治疗后。

In Phase 1 and Phase 2 single arm studies, safusidenib has shown encouraging efficacy signals across all

在1期和2期单臂研究中，Safusidenib 已经显示出了令人鼓舞的疗效信号，涵盖了所有方面。

IDH1

异柠檬酸脱氢酶1

-mutant glioma grades and treatment lines, including durable responses and prolonged progression-free survival that show tumor shrinkage and disease control. In the Phase 1 study in Japan of 47 participants with recurrent or progressive

-突变型胶质瘤的分级和治疗方案，包括持久的反应和延长的无进展生存期，显示出肿瘤缩小和疾病控制。在日本进行的针对47名复发或进展性患者的1期研究中

IDH1

-mutant glioma with enhancing (predominantly high-grade) and non-enhancing (predominantly low-grade) tumors, safusidenib showed clinical activity in both populations. Data from a Phase 2 study in Japan of safusidenib in 27 patients with chemotherapy- and radiotherapy-naïve grade 2

- 在增强（主要为高级别）和非增强（主要为低级别）的突变型胶质瘤中，safusidenib 在两类患者群体中均显示出临床活性。来自日本一项针对 27 名未接受过化疗和放疗的 2 级胶质瘤患者的 safusidenib 二期研究的数据。

IDH1

-mutant glioma was

-突变型胶质瘤是

published online

在线发布

in the November 2025 issue of

2025年11月刊

Neuro-Oncology

神经肿瘤学

. The data published reflected a March 10, 2023 data cut-off. As of February 2026, 12 patients in the study remain on treatment with safusidenib with a median follow-up of over 5 years. Nuvation Bio plans to present longer-term data from the Phase 2 study at a future medical meeting.

数据截止日期为2023年3月10日。截至2026年2月，研究中仍有12名患者继续接受safusidenib治疗，中位随访时间超过5年。Nuvation Bio计划在未来的医学会议上展示这项二期研究的长期数据。

'We believe safusidenib has immense potential to address significant patient needs in

“我们相信safusidenib在满足患者重大需求方面具有巨大的潜力

IDH1

-mutant glioma, and our current development plan focuses on patient groups with limited or no FDA-approved targeted treatment options. We are thrilled to now have the exclusive global development and commercialization rights to explore this investigational medicine's potential across these devastating brain tumors,' said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio.

“我们的研究性药物针对的是突变型胶质瘤，我们当前的开发计划聚焦于那些FDA批准的靶向治疗选择有限或没有的患者群体。我们非常激动现在拥有了在全球范围内独家开发和商业化这种研究性药物的权利，以探索其在这些毁灭性脑肿瘤中的潜力，”Nuvation Bio的创始人、总裁兼首席执行官David Hung博士说道。

'With this agreement now final, we plan to expand the pivotal Phase 3 SIGMA study into Japan, continue to advance the robust global development of safusidenib, and pursue presentation and publication of longer-term data from the Phase 2 study to ensure the scientific community is up to date on these findings.'.

“随着该协议的最终敲定，我们计划将关键的三期SIGMA研究扩展到日本，继续推进Safusidenib的全球开发，并追求发布和发表二期研究的长期数据，以确保科学界对这些发现保持最新了解。”

'The invention of new medicines is at the core of what we do at Daiichi Sankyo and safusidenib is a strong example of our expertise in science and technology,' said Yuki Abe, Ph.D., Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. 'We continuously evaluate the best approach to accelerate the delivery of promising medicines to patients and we are confident that Nuvation Bio will carry this program forward, utilizing their strong expertise in clinical development and commercialization to explore the full potential of safusidenib for patients with .

“发明新药是我们第一三共的核心工作，而safusidenib正是我们在科学和技术方面专业能力的有力例证，”第一三共日本研发部门负责人兼研发主管Yuki Abe博士说道，“我们不断评估最佳方法，以加速将有希望的药物带给患者。我们相信Nuvation Bio将会推动这一项目的发展，凭借他们在临床开发和商业化方面的强大专业知识，充分挖掘safusidenib对患者的潜力。”

IDH1

-mutant glioma.'

“-突变型胶质瘤。”

About

关于

IDH1

-Mutant Glioma

-突变型胶质瘤

Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,500 people are diagnosed with IDH1-mutant gliomas each year, of which more than 95% harbor a mutation in the IDH1 gene. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, gliomas are not currently curable and prognosis worsens for those with high-risk features, including high grade tumors..

胶质瘤是全球成人中最常见的脑癌类型。在美国，每年约有2500人被诊断出患有IDH1突变型胶质瘤，其中超过95%携带IDH1基因突变。大多数患者在30至40岁之间被诊断出来。尽管具有IDH1突变的患者通常比IDH1野生型患者的生存时间更长，但胶质瘤目前尚无法治愈，且对于具有高风险特征（包括高级别肿瘤）的患者，预后会更差。

About Safusidenib

关于Safusidenib

Safusidenib is a novel, oral, potent, brain-penetrant, selective inhibitor of mutant IDH1. In Phase 1 and Phase 2 clinical studies, safusidenib delayed disease progression and provided durable responses across grades and risk groups with a favorable risk-benefit profile.

Safusidenib是一种新型、口服、高效、可穿透血脑屏障的突变型IDH1选择性抑制剂。在I期和II期临床研究中，Safusidenib延缓了疾病进展，并在不同级别和风险组中提供了持久的响应，且具有良好的风险收益特征。

About the SIGMA (G203) Study

关于SIGMA（G203）研究

SIGMA is a pivotal Phase 3 study that will evaluate safusidenib compared to placebo as a maintenance therapy after standard-of-care in

SIGMA 是一项关键的 III 期研究，将评估 Safusidenib 与安慰剂相比作为标准治疗后的维持疗法。

IDH1

异柠檬酸脱氢酶1

-mutant astrocytoma with high-risk features. The pivotal portion of the study will enroll approximately 300 patients. Data is anticipated to be available in 2029.

-具有高危特征的突变型星形细胞瘤。该研究的关键部分将招募大约300名患者。预计数据将在2029年公布。

A separate, exploratory, non-pivotal cohort will evaluate safusidenib in participants with grade 3

一个独立的、探索性的、非关键队列将评估safusidenib在3级参与者中的情况

IDH1

异柠檬酸脱氢酶1

-mutant oligodendroglioma who have not yet received chemotherapy or radiotherapy. The primary endpoint is objective response rate. This cohort is expected to enroll approximately 40 patients. Data is anticipated to be available in 2027.

- 突变型少突胶质细胞瘤患者，尚未接受化疗或放疗。主要终点是客观缓解率。该队列预计招募约40名患者。数据预计将于2027年公布。

About Nuvation Bio

关于Nuvation Bio

Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib (IBTROZI

Nuvation Bio是一家全球肿瘤学公司，专注于应对癌症治疗中一些最棘手的挑战，目标是开发对患者生活产生深远积极影响的疗法。我们多样化的研发管线包括塔莱曲塞替尼（IBTROZI）。

), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and an innovative drug-drug conjugate (DDC) program.

），一种下一代ROS1抑制剂；safusidenib，一种可穿透大脑的IDH1抑制剂；以及一项创新的药物-药物偶联（DDC）项目。

Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit .

Nuvation Bio 由生物制药行业资深人士 David Hung 博士于2018年创立，他曾创立 Medivation, Inc.，该公司为患者带来了世界上领先的前列腺癌药物之一。Nuvation Bio 在纽约、旧金山、波士顿和上海设有办事处。欲了解更多信息，请访问。

www.nuvationbio.com

or follow the company on

或关注公司

领英

and X (

和 X （

@nuvationbioinc

）。

Forward-Looking Statements

前瞻性声明

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as 'believe,' 'may,' 'will,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'expect,' 'should,' 'would,' 'plan,' 'predict,' 'potential,' 'seem,' 'seek,' 'future,' 'outlook' and similar expressions that predict or indicate future events or trends or that are not statements of historical matters.

本新闻稿中包含的某些非历史事实的陈述，根据1995年美国私人证券诉讼改革法案的避风港条款，属于前瞻性陈述。前瞻性陈述有时会伴随诸如“相信”、“可能”、“将”、“估计”、“继续”、“预期”、“打算”、“预计”、“应该”、“会”、“计划”、“预测”、“潜力”、“似乎”、“寻求”、“未来”、“展望”等词语以及类似的表达，这些词语预测或表明未来事件或趋势，或并非历史事实的陈述。

These forward-looking statements include, but are not limited to, statements regarding safusidenib's therapeutic potential, development plans, and plans to present new data. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance.

这些前瞻性声明包括但不限于关于safusidenib的治疗潜力、开发计划以及展示新数据的计划。这些声明基于各种假设，无论是否在本新闻稿中提及，并基于Nuvation Bio管理团队的当前预期，而非实际业绩的预测。

These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and commercialization, and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; physician and patient behavior; and competitive developments.

这些前瞻性陈述受多种风险和不确定因素的影响，可能导致实际结果与前瞻性陈述中预期的结果不同，包括但不限于与药物发现和商业化相关的挑战，以及由于监管过程中的困难或延迟、受试者招募、必要产品的生产或获取等原因导致启动或进行临床研究的困难；不良事件的出现或恶化以及其他不希望的副作用；与初步和中期数据相关的风险，这些数据可能无法代表更成熟的数据；医生和患者的行为；以及竞争动态的发展。

Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-K.

Nuvation Bio 在其 Form 10-K 中更全面地描述了所面临的风险和不确定性。

Media and Investor Contacts

媒体和投资者联系方式

Nuvation Bio Investor Contact

Nuvation Bio 投资者联系人

JR DeVita

[email protected]

电子邮件地址

Nuvation Bio Media Contact

Nuvation Bio媒体联系人

Kaitlyn Nealy