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Medicilon Passes FDA Inspection: A Testament to Excellence

On May 20, 2025, Medicilon Preclinical Research (Shanghai) LLC experienced a pivotal moment in its journey by successfully passing a rigorous on-site inspection conducted by the FDA. This achievement marks an important milestone in the company's mission to uphold the highest standards of research and development services in the pharmaceutical sector. The inspection culminated in the issuance of an official Establishment Inspection Report (EIR), reinforcing Medicilon's status as a trusted leader in preclinical R&D services.

A Thorough Examination

The FDA inspection was a meticulous process, assessing various aspects of Medicilon's operations. Inspectors examined the company's organizational structure, personnel qualifications, standard operating procedures (SOPs), facility integrity, documentation practices, experimental methodologies, quality assurance systems, and advanced computerized infrastructures. Additionally, several research projects pending approval were thoroughly reviewed, showcasing Medicilon's commitment to scientific rigor.

FDA officials commended Medicilon for its scientific discipline and operational excellence, expressing optimism for continued high-quality data submissions in the future. This recognition exemplifies the company's unwavering dedication to its guiding philosophy of "Quality First," emphasizing the importance of maintaining stringent oversight and innovative practices within the R&D ecosystem.

Strategic Validation and Global Impact

This FDA inspection represented Medicilon's first on-site assessment in seven years, making its success even more significant. The favorable outcome not only boosts Medicilon's regulatory credibility but also serves as a strategic validation of its vision, which is fundamentally driven by innovation and a steadfast focus on quality.

Throughout its history, Medicilon has played a crucial role in the global pharmaceutical landscape. By the end of 2024, the company had facilitated 520 Investigational New Drug (IND) applications, allowing innovative therapies to progress into clinical trials across major regulatory bodies, including the US FDA, China's NMPA, the EU EMA, the Australian TGA, and South Korea's KFDA. These submissions encompass a wide array of innovative drugs, including 34 antibody therapies, 28 antibody-drug conjugates (ADCs), 8 GLP-1 agents, and more. This breadth of expertise indicates Medicilon's capacity to operate at the forefront of drug development across multiple therapeutic domains.

Looking Ahead: Commitment to Innovation

In light of recent developments, Medicilon plans to continue investing heavily in technological advancements and research efforts. The company is committed to delivering more innovative and high-quality technology and service solutions, enabling it to navigate the complexities of the evolving global pharmaceutical market. As challenges and opportunities arise, Medicilon remains steadfast in its commitment to fostering the development of the global pharmaceutical industry.

About Medicilon

Founded in 2004, Shanghai Medicilon Inc. (stock code 688202.SH) has dedicated itself to providing comprehensive R&D services tailored to meet the needs of pharmaceutical companies, research institutions, and organizations involved in preclinical activities. With a track record of serving over 2,000 global clients and contributing to the development of 520 new drugs and generic projects, Medicilon's influence in the industry continues to grow, underscoring its essential role in advancing healthcare solutions worldwide.