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Lyndra Therapeutics

Lyndra Therapeutics公司

, a clinical-stage biopharmaceutical company pioneering long-acting oral therapies, today announced a strategic collaboration with Thermo Fisher Scientific Inc., the world leader in serving science, in which Thermo Fisher will provide global clinical research and commercial manufacturing services to Lyndra for its long-acting oral therapies..

，一家开创长效口服疗法的临床阶段生物制药公司，今天宣布与全球领先的服务科学公司Thermo Fisher Scientific Inc.进行战略合作，Thermo Fisher将为Lyndra的长效口服疗法提供全球临床研究和商业制造服务。。

Lyndra’s long-acting oral therapies, including lead investigational product oral weekly risperidone (LYN-005), are designed to deliver medication for a week or longer with a single oral dose. LYN-005

Lyndra的长效口服疗法，包括主要研究产品口服利培酮（LYN-005），旨在单次口服给药一周或更长时间。LYN-005

met its primary endpoint in the phase 3 pivotal STARLYNG-1 study

在第三阶段关键的STARLYNG-1研究中达到了其主要终点

, demonstrating efficacy compared to daily Risperdal. The phase 3 pivotal safety study of oral weekly risperidone is planned to be initiated in 1H 2025.

，与每日利培酮相比显示出疗效。每周口服利培酮的第三阶段关键安全性研究计划于2025年上半年启动。

“Lyndra’s clinical research and manufacturing collaboration with Thermo Fisher is a critical step in our mission to transform how patients take medicine, providing the capabilities and scale to bring long-acting oral therapies to broad markets,” said Dr. Richard Scranton, M.D., M.P.H., President of Global Product Development and Chief Medical Officer of Lyndra Therapeutics.

Lyndra全球产品开发总裁兼Lyndra Therapeutics首席医疗官Richard Scranton博士表示：“Lyndra与Thermo Fisher的临床研究和生产合作是我们转变患者服药方式、提供将长效口服疗法推向广阔市场的能力和规模的使命中的关键一步。”。

“Thermo Fisher will be part of our ecosystem of best-in-class partners as we execute on our go-to-market strategy, allowing Lyndra to focus on what we do best – R&D for innovative long-acting oral therapeutic solutions – while ensuring reliable, scalable manufacturing and clinical trial operations.”.

“当我们执行上市战略时，赛默飞世尔将成为我们一流合作伙伴生态系统的一部分，使Lyndra专注于我们最擅长的领域——创新长效口服治疗方案的研发，同时确保可靠、可扩展的制造和临床试验运营。”。

The collaboration leverages Thermo Fisher’s Accelerator™ Drug Development services, 360° Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) drug development solutions. Accelerator™ Drug Development provides a customizable suite of manufacturing, clinical research and clinical supply chain services for emerging biotechs and large pharmaceutical companies at every stage from pre-clinical to commercialization..

该合作利用了Thermo Fisher的Accelerator™药物开发服务、360°合同开发和制造组织（CDMO）和合同研究组织（CRO）药物开发解决方案。Accelerator™药物开发为新兴生物技术和大型制药公司从临床前到商业化的各个阶段提供了一套可定制的制造、临床研究和临床供应链服务。。

As part of the collaboration, Lyndra plans to utilize Thermo Fisher’s end-to-end advanced pharmaceutical manufacturing capabilities in Cincinnati, Ohio, including Lyndra’s LYNX drug delivery platform commercial line, to manufacture commercial materials at scale.

作为合作的一部分，Lyndra计划利用Thermo Fisher在俄亥俄州辛辛那提的端到端先进制药制造能力，包括Lyndra的LYNX药物输送平台商业线，大规模生产商业材料。

“Thermo Fisher is pleased to collaborate with Lyndra on its revolutionary drug delivery platform, and we look forward to helping bring these groundbreaking, long-acting oral therapies to patients,” said Michael Shafer, Executive Vice President and President, Biopharma Services at Thermo Fisher. “Leveraging Accelerator™ Drug Development, our comprehensive CDMO and CRO drug development solutions, exemplifies our commitment to help speed and simplify the complex journey of clinical development.”.

Thermo Fisher执行副总裁兼生物制药服务总裁Michael Shafer表示：“Thermo Fisher很高兴与Lyndra在其革命性的药物输送平台上合作，我们期待着为患者带来这些开创性的长效口服疗法。”。“利用Accelerator™药物开发，我们全面的CDMO和CRO药物开发解决方案，证明了我们致力于帮助加速和简化复杂的临床开发过程。”。

Pharmaceutical partners seeking to utilize Lyndra’s LYNX platform technology to create long-acting oral therapies may also benefit from the collaboration with Thermo Fisher and its clinical research and manufacturing services, helping to accelerate development pathways and supporting commercialization..

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About the LYNX

关于山猫

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Drug Delivery Platform

The

The

LYNX

山猫

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drug delivery platform

药物输送平台

aims to improve clinical outcomes by optimizing how oral medicines are delivered and taken. The LYNX platform technology enables the stable and sustained delivery of medicine in a target therapeutic window for a week or longer in a single oral dose. This is made possible by more than 50 patented innovations in design, engineering and materials science.

旨在通过优化口服药物的递送和服用方式来改善临床结果。LYNX平台技术能够在单次口服剂量下在目标治疗窗口中稳定持续地递送药物一周或更长时间。这是由设计、工程和材料科学领域的50多项专利创新实现的。

The technology for the LYNX platform originated in the Traverso and Langer Laboratories, with which Lyndra has an exclusive technology license. With broad applicability across multiple therapeutic areas, the LYNX platform has the potential to revolutionize oral drug delivery, enhancing the patient experience and providing meaningful value to the healthcare system..

LYNX平台的技术起源于Traverso和Langer实验室，Lyndra拥有专有技术许可证。LYNX平台在多个治疗领域具有广泛的适用性，有可能彻底改变口服给药方式，增强患者体验，并为医疗保健系统提供有意义的价值。。

About Lyndra Therapeutics

关于Lyndra Therapeutics

Lyndra Therapeutics is a clinical-stage biopharmaceutical company partnering to create and commercialize long-acting oral therapies. Lyndra’s LYNX

Lyndra Therapeutics是一家临床阶段的生物制药公司，合作创建长效口服疗法并将其商业化。琳德拉的猞猁

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drug delivery platform delivers medicine for a week or longer in a single oral dose. The LYNX drug delivery platform aims to optimize the way we take and deliver medicines: less frequent dosing with more stable drug exposure, enhancing the patient experience. The LYNX platform's versatility has been demonstrated through clinical proof-of-concept research across five therapeutic areas and 25 APIs.

药物递送平台以单次口服剂量递送药物一周或更长时间。LYNX药物输送平台旨在优化我们服用和输送药物的方式：减少频率，更稳定的药物暴露，增强患者体验。LYNX平台的多功能性已通过跨越五个治疗领域和25个API的临床概念验证研究得到证明。

For more information on Lyndra and partnership opportunities, visit .

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https://lyndra.com

https://lyndra.com

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