#Shanghai #None #Medicilon #FDA Inspection #Preclinical R&D

Medicilon Celebrates Successful FDA Inspection

Medicilon Preclinical Research (Shanghai) LLC has recently achieved a significant landmark by successfully passing a comprehensive FDA inspection conducted on May 20. The inspection resulted in the issuance of an official Establishment Inspection Report (EIR), which not only affirms Medicilon's status as a leader in preclinical R&D services but also highlights its commitment to quality and operational excellence.

A Rigorous Evaluation of Capabilities

During the FDA's meticulous review, Medicilon was evaluated on various critical factors including its organizational structure, the qualifications of its personnel, the integrity of its facilities, and adherence to Standard Operating Procedures (SOPs). The FDA inspectors also scrutinized Medicilon’s documentation processes, experimental operations, and quality assurance systems, along with its computerized infrastructures. Notably, several research projects submitted for FDA review were also part of this rigorous inspection.

The favorable feedback from FDA officials praised Medicilon for its robust scientific discipline and operational excellence, setting high expectations for continued data submissions. This accolade confirms Medicilon's long-standing dedication to its guiding principle of "Quality First."

Enhancing Regulatory Credibility

This inspection marks Medicilon's first on-site evaluation in seven years. The positive outcome significantly boosts the company's regulatory standing and reputation, validating its strategic vision to remain "Innovation Driven, Quality Focused." By the end of 2024, Medicilon had already facilitated the entry of 520 Investigational New Drug Applications (INDs) into clinical trials, securing approvals from various regulatory bodies including China’s NMPA, the US FDA, the EU EMA, the Australian TGA, and South Korea’s KFDA. These INDs encapsulate a wide range of innovative drugs, including 34 antibody therapeutics, 28 antibody-drug conjugates (ADCs), and many more.

Looking Ahead: Commitment to Innovation

Medicilon is poised to ramp up its investment in research and development to further enhance its technological capabilities. The company plans to introduce more innovative and high-quality technology and service solutions in response to the evolving challenges and opportunities within the global pharmaceutical market. Medicilon's commitment to driving the advancement of the global pharmaceutical industry remains resolute.

About Medicilon

Founded in 2004, Shanghai Medicilon Inc. (stock code 688202.SH) has dedicated itself to offering a comprehensive range of R&D services to pharmaceutical companies, research institutions, and organizations engaged in preclinical research. By the close of 2024, Medicilon had successfully assisted over 2,000 clients worldwide and contributed to the development of 520 new drugs and generic drug projects that attained clinical trial approvals through IND applications.