#Shanghai #USA #FDA #Medicilon #Preclinical Research

Medicilon's Success in the FDA Inspection

On May 20, 2025, Medicilon Preclinical Research (Shanghai) LLC announced a significant achievement: successfully passing a meticulous inspection conducted by the U.S. Food and Drug Administration (FDA) at its facility. This inspection marks the first of its kind in seven years and underscores Medicilon's commitment to excellence in the preclinical research and development sector.

Validation of Compliance and Capability

The FDA inspection comprehensively evaluated Medicilon’s organizational structure, staff qualifications, standard operating procedures (SOPs), equipment integrity, documentation practices, experimental operations, quality assurance systems, and IT infrastructure. Inspectors also reviewed several research projects submitted for FDA consideration.

The feedback from FDA officials was overwhelmingly positive. They acknowledged Medicilon's scientific discipline and operational excellence, expressing confidence in the company’s ability to continue delivering high-quality data. This recognition highlights the unwavering dedication of Medicilon to its core philosophy of "Quality First."

Strategic Confirmation of Global R&D Impact

Medicilon's successful FDA inspection significantly boosts its credibility in regulatory matters. This milestone confirms its strategic vision of innovation and quality orientation in its operations. As of the end of 2024, Medicilon had contributed to the submission of 520 Investigational New Drug (IND) applications recognized by major regulatory bodies, including China’s NMPA, the U.S. FDA, the European EMA, Australia’s TGA, and South Korea’s KFDA. These INDs encompass groundbreaking pharmaceuticals across a range of fields, including 34 antibody drugs, 28 ADCs (Antibody-Drug Conjugates), 8 GLP-1 medications, 6 PROTACs, and 3 botanical medicines.

Commitment to Innovation

With a track record dating back to its founding in 2004, Shanghai Medicilon Inc. (stock code 688202.SH) has devoted itself to providing comprehensive R&D services to pharmaceutical companies, research institutions, and organizations involved in preclinical activities. By the end of 2024, Medicilon had worked with over 2,000 clients worldwide and contributed significantly to the development of 520 new and generic drugs approved for clinical trials through IND applications.

Looking ahead, Medicilon remains resolute in enhancing its investment in technological innovations, research, and development. The company is committed to implementing innovative and higher-quality technological solutions and service offerings, capitalizing on the vast opportunities within the global pharmaceutical market, and facilitating the growth of the global pharmaceutical industry.

In summary, Medicilon's success in passing the FDA inspection serves as a testament to its continued pursuit of excellence in biopharmaceutical research and development, paving the way for further innovations that will benefit the healthcare landscape worldwide.