Medicilon Passes FDA Inspection, Reinforcing Global R&D Excellence

BOSTON, May 29, 2025 /PRNewswire/ -- On May 20, Medicilon Preclinical Research (Shanghai) 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 .

A Milestone of Compliance and Capability 

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 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."

Strategic Validation of Global R&D Impact

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."

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

About Medicilon

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