#USA #Boston #FDA #Medicilon #R&D Excellence

Medicilon's Achievement: A Benchmark in Preclinical Research

On May 20, Medicilon Preclinical Research (Shanghai) LLC, known as Medicilon, announced successfully passing an on-site inspection by the FDA. This milestone not only affirms Medicilon’s reputation as a trusted leader in preclinical research services but also enhances its credibility within the global pharmaceutical industry.

A Comprehensive Review by FDA Officials

The inspection conducted by the FDA was thorough and meticulous. It evaluated various aspects of the company, including organizational structure, personnel qualifications, Standard Operating Procedures (SOPs), facility integrity, documentation processes, experimental workflows, quality assurance systems, and computer infrastructure. In addition, FDA inspectors reviewed multiple research projects submitted to them.

During the inspection, FDA officials commended Medicilon for its scientific discipline and operational excellence. They expressed expectations for the continuous submission of high-quality data, aligning with Medicilon’s guiding philosophy of "Quality First."

Strengthening Global R&D Impact

This was Medicilon's first FDA inspection in seven years, marking a significant moment for the company. The successful outcome significantly boosts its credibility with regulatory authorities. This achievement serves as a testament to Medicilon's strategic vision, which revolves around its motto: "Innovation Driven, Quality Focused."

Through the approvals obtained from China’s NMPA, the U.S. FDA, EU-EMA, Australia’s TGA, and South Korea’s KFDA, Medicilon has facilitated over 520 Investigational New Drug (IND) applications for clinical trial entry by the end of 2024. These INDs encompass innovative drugs in various fields, including 34 antibodies, 28 antibody-drug conjugates (ADCs), and 8 GLP-1 drugs, among others.

In the coming years, Medicilon is set to intensify its investments in technological innovations and preclinical research. The company aims to launch even more innovative and high-quality technology solutions to meet the diverse opportunities and challenges posed by the global pharmaceutical market, thereby contributing to the advancement of the global pharmaceutical industry.

About Medicilon

Since its establishment in 2004, Shanghai Medicilon Inc. (Stock Code: 688202.SH) has dedicated itself to providing comprehensive preclinical R&D services to pharmaceutical companies, research institutions, and other organizations within the preclinical sector. As of the end of 2024, Medicilon has delivered services to over 2,000 clients globally and has been involved in the research and development of over 520 new drugs and generic projects supported by IND applications for clinical trials.