Medicilon通过FDA检查，巩固全球研发卓越地位-动脉网

Medicilon Passes FDA Inspection, Reinforcing Global R&D Excellence

CISION 等信源发布 2025-05-29 20:30

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BOSTON

波士顿

，

May 29, 2025

2025年5月29日

/PRNewswire/ --

On May 20,

5月20日，

Medicilon Preclinical Research (

美迪西临床前研究 (

Shanghai

上海

) LLC ('Medicilon') announces that it has successfully passed an on-site inspection by the FDA. The company receives an official Establishment Inspection Report (EIR) reaffirming its position as a trusted leader in preclinical R&D services .

）LLC（'美迪西'）宣布，已成功通过美国食品药品监督管理局（FDA）的现场检查。公司收到一份官方的机构检查报告（EIR），再次证明了其在临床前研发服务领域的可信赖领导者地位。

A Milestone of Compliance and Capability

合规与能力的里程碑

The FDA inspection, conducted with meticulous detail, evaluated Medicilon's organizational structure, personnel qualifications, SOPs, facilities integrity, documentation processes, experimental operations, quality assurance systems, and computerized infrastructures. Inspectors also reviewed several research projects submitted to the FDA..

FDA的检查以细致入微的方式进行，评估了美迪西的组织结构、人员资质、标准操作规程（SOPs）、设施完整性、文件流程、实验操作、质量保证体系以及计算机化基础设施。检查员还审查了多个提交给FDA的研究项目。

FDA officials praised Medicilon for its scientific discipline and operational excellence, expressing anticipation for continued high-quality data submissions. This endorsement validated Medicilon's enduring commitment to its guiding philosophy of 'Quality First.'

FDA官员赞扬了美迪西的科学严谨性和卓越的运营能力，并期待其持续提交高质量的数据。这一认可验证了美迪西对其“质量第一”指导理念的长期承诺。

Strategic Validation of Global R&D Impact

全球研发影响的战略验证

This is Medicilon's first on-site FDA inspection in seven years, and the successful outcome significantly enhances its regulatory credibility. The milestone is a strong endorsement of its strategic vision, rooted in being 'Innovation Driven, Quality Focused.'

这是美迪西七年来首次接受FDA现场检查，成功的检查结果大大提升了其监管信誉。这一里程碑式的成功是对美迪西“创新为驱动，质量为核心”战略愿景的有力认可。

By the end of 2024, Medicilon has helped 520 INDs enter clinical trials, through the approval of

截至2024年底，美迪西已帮助520个IND进入临床试验，通过审批。

China's

中国的

NMPA, the US FDA, the EU EMA, the Australian TGA and the South Korean's KFDA. These INDs include innovative drugs in various fields, such as 34 antibodies, 28 ADC drugs, 8

中国国家药监局（NMPA）、美国食品药品监督管理局（FDA）、欧洲药品管理局（EMA）、澳大利亚治疗用品管理局（TGA）以及韩国食品医药品安全处（KFDA）。这些IND包括多个领域的创新药物，例如34种抗体、28种ADC药物、8种...

GLP-1

drugs, 6 PROTAC drugs, 3 botanical drugs, etc. Looking ahead, Medicilon will remain committed to increasing investment in technological innovation and R&D, and is committed to launching more innovative and more high-quality technology and service solutions, embracing the broad opportunities and challenges of the global pharmaceutical market, and promoting the development of the global pharmaceutical industry!.

药物、6个PROTAC药物、3个植物药等。展望未来，美迪西将继续加大技术创新和研发投入，致力于推出更多创新、更高质量的技术和服务解决方案，拥抱全球医药市场的广阔机遇与挑战，推动全球医药产业的发展！

About Medicilon

关于美迪西

From its inception in 2004, Shanghai Medicilon Inc. (stock code: 688202.SH) has been committed to providing comprehensive R&D services to pharmaceutical companies, research institutions, and any organizations working in the preclinical space. By the end of 2024, Medicilon has provided drug development services to over 2,000 clients worldwide, and has been involved in the research and development of .

自2004年成立以来，上海美迪西生物医药股份有限公司（股票代码：688202.SH）一直致力于为制药公司、研究机构以及任何从事临床前研究的组织提供全面的研发服务。截至2024年底，美迪西已为全球超过2000家客户提供药物开发服务，并参与了多项研发项目。

520

new drugs and generic drug projects that have been approved for clinical trials with IND applications.

新药和已获IND申请批准进行临床试验的仿制药项目。

SOURCE Medicilon Inc.

源：美迪西生物医药股份有限公司

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