Medicilon Preclinical Research (Shanghai) LLC announced on May 20 that it has successfully passed a comprehensive on-site inspection by the FDA, receiving an official Establishment Inspection Report (EIR) that reaffirms its position as a trusted leader in preclinical R&D services. This marks the company's first FDA inspection in seven years and represents a significant milestone in validating its global regulatory compliance capabilities.
Comprehensive FDA Evaluation Process
The FDA inspection was conducted with meticulous detail, evaluating multiple critical aspects of Medicilon's operations. Inspectors assessed the company's organizational structure, personnel qualifications, standard operating procedures (SOPs), facilities integrity, documentation processes, experimental operations, quality assurance systems, and computerized infrastructures. Additionally, FDA officials reviewed several research projects that Medicilon had previously submitted to the agency.
FDA officials praised Medicilon for its scientific discipline and operational excellence, expressing anticipation for continued high-quality data submissions. This endorsement validates Medicilon's commitment to its guiding philosophy of "Quality First" and strategic vision of being "Innovation Driven, Quality Focused."
Global Regulatory Impact and Drug Development Portfolio
The successful inspection outcome significantly enhances Medicilon's regulatory credibility and validates its global R&D impact. By the end of 2024, Medicilon has helped 520 Investigational New Drug (IND) applications enter clinical trials through approvals from multiple international regulatory agencies, including China's NMPA, the US FDA, the EU EMA, the Australian TGA, and South Korea's KFDA.
The company's diverse drug development portfolio spans various therapeutic areas and innovative drug classes. Among the 520 INDs, the portfolio includes 34 antibodies, 28 antibody-drug conjugate (ADC) drugs, 8 GLP-1 drugs, 6 PROTAC drugs, and 3 botanical drugs, demonstrating the company's expertise across cutting-edge therapeutic modalities.
Established Track Record in Preclinical Services
Since 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 organizations working in the preclinical space. By the end of 2024, the company 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 received clinical trial approval through IND applications.
Looking ahead, Medicilon has committed to increasing investment in technological innovation and R&D, with plans to launch more innovative and high-quality technology and service solutions. The company aims to embrace the opportunities and challenges of the global pharmaceutical market while promoting the development of the global pharmaceutical industry.
