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为准备第二阶段的研究,右脑生物公司与苏文制药签署RB-190制造协议,针对帕金森病的根源

In preparation of Phase II studies, Right Brain Bio signs Manufacturing Agreement with Suven Pharmaceuticals for RB-190 to Target the Root Cause of Parkinson's Disease

CISION 等信源发布 2025-03-11 20:45

可切换为仅中文


WESTCHESTER COUNTY, N.Y.

纽约州威彻斯特县

and

MONMOUTH JUNCTION, N.J.

新泽西州蒙茅斯交界处

,

March 11, 2025

2025年3月11日

/PRNewswire/ -- Right

/PRNewswire/ -- 右

Brain Bio

脑生物

, a biotechnology company pioneering treatments for complex diseases, today announced a manufacturing agreement with Suven Pharmaceuticals, a technology-driven global Contract Development and Manufacturing Organization (CDMO), for the production of its lead drug candidate, RB-190, targeting the root cause of Parkinson's disease..

,一家致力于复杂疾病治疗的生物技术公司,今日宣布与技术驱动的全球合同开发和制造组织(CDMO)Suven Pharmaceuticals达成生产协议,为其针对帕金森病根源的主导候选药物RB-190进行生产。

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RB-190 represents a groundbreaking approach to Parkinson's disease, aiming to modify the disease progression rather than merely alleviating symptoms. The drug is a repurposed form of metyrosine, based on Right Brain Bio Founder and CEO Dr.

RB-190 代表了一种针对帕金森病的突破性方法,旨在改变疾病进展而不仅仅是缓解症状。该药物是基于 Right Brain Bio 创始人兼首席执行官博士的研究,对甲基酪胺进行重新利用。

Jonathan Sackner-Bernstein's

乔纳森·萨克纳-伯恩斯坦的

discovery that excessive dopamine exposure leads to the neurotoxicity driving Parkinson's disease. Preclinical studies in nine different models of Parkinson's demonstrate RB-190's potential to reverse disease pathology, offering a promising new avenue for patients.

发现过度暴露于多巴胺会导致引发帕金森病的神经毒性。在帕金森病的九种不同模型中进行的临床前研究表明,RB-190有潜力逆转疾病病理,为患者提供了充满希望的新途径。

Advancing a breakthrough discovery to conquer Parkinson's disease

推进一项突破性发现以战胜帕金森病

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'We are excited to collaborate with Suven Pharma as we move RB-190 toward clinical trials,' said Dr. Sackner-Bernstein, Founder and CEO of Right Brain Bio. 'Bringing a novel therapy to clinical trials requires manufacturing excellence and stringent regulatory compliance. With Suven's expertise, cutting-edge facilities, and recent successful FDA review, we are confident in delivering RB-190 at the highest quality standards for our upcoming trials.'.

“我们很高兴与苏文制药合作,共同推动RB-190进入临床试验,”右脑生物公司创始人兼首席执行官萨克纳-伯恩斯坦博士表示。“将一种新型疗法引入临床试验需要卓越的制造工艺和严格的法规遵从性。凭借苏文的专业知识、尖端设施以及最近成功的FDA审查,我们有信心在即将到来的试验中以最高质量标准交付RB-190。”

Parkinson's disease affects over 1 million Americans, making it the second most prevalent neurodegenerative disorder after Alzheimer's. With an aging population, cases are expected to double by 2030, underscoring the urgent need for transformative treatments like RB-190.

帕金森病影响着超过100万美国人,是仅次于阿尔茨海默病的第二大神经退行性疾病。随着人口老龄化,预计到2030年病例将翻倍,凸显了对RB-190等变革性治疗手段的迫切需求。

'At Suven, we are thrilled to be part of this breakthrough initiative with Right Brain Bio,' said

“在Suven,我们很高兴能与右脑生物公司一起参与这项突破性的倡议,”

Vivek Sharma

维韦克·夏尔马

, Executive Chairman of Suven Pharmaceuticals. 'Our team is dedicated to manufacturing the highest-quality API for RB-190, ensuring that this innovative therapy meets global quality and regulatory standards. The potential of RB-190 to redefine Parkinson's treatment is truly inspiring, and we are proud to contribute our expertise in drug manufacturing to support its development.'.

苏文制药的执行主席表示:“我们的团队致力于为RB-190制造最高质量的原料药,确保这种创新疗法符合全球质量和监管标准。RB-190重新定义帕金森病治疗的潜力确实令人鼓舞,我们很自豪能够贡献我们在药物制造方面的专业知识来支持其发展。”

With a legacy spanning over three decades and a team of 1,000+ employees across

拥有跨越三十多年的传承,并在各地拥有一千多名员工的团队

India

印度

and

New Jersey

新泽西州

, Suven Pharma is a trusted partner in contract drug development and manufacturing. Having completed over 1,000 projects, Suven operates a network of US FDA-audited facilities, delivering innovative solutions to over 25 major global pharmaceutical companies.

,苏文药业是合同药物开发和制造的可靠合作伙伴。已完成1000多个项目,苏文运营着经美国FDA审核的设施网络,为全球25家主要制药公司提供创新解决方案。

ABOUT RIGHT BRAIN BIO:

关于右脑生物:

Founded in 2018, Right Brain Bio has pioneered the development of RB-190 using its proprietary 'First Principles-Based Gap Analysis' to identify novel therapeutic applications. The FDA has reviewed the scientific and operational foundation for RB-190 and confirmed the next step is an IND submission for a Phase 2 clinical trial.

右脑生物公司成立于2018年,利用其专有的“基于第一性原理的差距分析”率先开发了RB-190,并确定了新的治疗应用。美国食品药品监督管理局(FDA)已经审查了RB-190的科学和运营基础,并确认下一步是提交新药临床试验申请(IND),以进行二期临床试验。

While current treatments provide symptomatic relief, no existing therapy reverses Parkinson's disease progression. Right .

虽然目前的治疗方法可以缓解症状,但尚无任何现有疗法能够逆转帕金森病的进展。

Brain Bio

脑生物

seeks to change that paradigm.

寻求改变这一范式。

ABOUT SUVEN PHARMACEUTICALS:

关于SUVEN制药:

Suven Pharma and Cohance Life Sciences have announced their amalgamation, securing key regulatory approvals from NSE, BSE, SEBI, and minority shareholders, with the NCLT hearing pending. This merger creates a leading technology-driven CDMO, providing integrated solutions in custom synthesis, process R&D, and manufacturing for global innovators.

苏文制药与科瀚生命科学宣布合并,已获得印度国家证券交易所(NSE)、孟买证券交易所(BSE)、印度证券交易委员会(SEBI)及少数股东的关键监管批准,目前正等待国家公司法法庭(NCLT)的听证。此次合并打造了一家领先的技术驱动型合同开发与生产组织(CDMO),为全球创新者提供定制合成、工艺研发和生产的综合解决方案。

With over 100 active projects and a strong pipeline of late-stage molecules, Suven has built a reputation for delivering complex solutions at a scale with precision. Strengthening its technology expertise through strategic acquisitions—Sapala (.

拥有100多个活跃项目和强大的后期分子研发管线,Suven以精确性和规模交付复杂解决方案而赢得了声誉。通过战略性收购Sapala,进一步加强了其技术专长。

June 2024

2024年6月

) for oligonucleotides and NJ Bio for ADC technology (December 2024)—the platform has achieved consolidated revenue of

`) 寡核苷酸和 NJ Bio 的 ADC 技术(2024 年 12 月)——该平台实现了 consolidated revenue of`

US$315 million

3.15亿美元

(LTM) while maintaining industry-leading margins and ROCEs over the past five years.

(LTM)在过去五年中保持了行业领先的利润率和资本回报率。

Visit us for more information:

欲了解更多信息,请访问我们:

https://RightBrainBio.com

https://右脑生物.com

https://ParkinsonsDisease.blog

https://帕金森病.blog

SOURCE Right Brain Bio, Inc.

来源:右脑生物公司

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