Medicilon is the first CRO in China to provide a complete set of preclinical approval applications that comply with both Chinese GLP and US GLP standards. Since the establishment, Medicilon has steadily implemented its international strategic arrangement and has shown a trend of vertical integration. Since 2009, the Medicilon preclinical experimental base has established a research operation process and quality system that is benchmarked with international standards. Medicilon has successively passed the international AAALAC certification, CFDA (now NMPA) GLP certification, and has reached the international standards such as China's NMPA, the US FDA, Australia's TGA, and Europe's EMEA, providing global pharmaceutical companies and scientific research institutions with a full range of one-stop biopharmaceutical preclinical R&D services that meet China and international filing standards, including drug discovery, pharmaceutical research and preclinical research.
The standardization of GLP ensures the scientificity and reliability of drug toxicology research, and also accelerated the drug toxicology research of Medicilon to be in line with international standards. Currently, the Toxicology Research Department of Medicilon can provide research services for small molecule drugs and biotechnology drugs (including ADCs, antibodies, proteins, peptides, etc.). In addition to the common administration routes such as PO and IV, special evaluation platforms have also been established, such as inhalation administration, intrathecal administration, ophthalmic administration, and sublingual administration. Moreover, Medicilon has established data transformation platform called SEND, which is a comprehensive and mature platform in terms of software, technology, specifications and quality.
As Medicilon undertakes more and more new drug toxicology and registration application projects, the addition of Dr. Renzong Xie will give full play to his professional advantages, help Medicilon to further improve new drug toxicology research and registration application services, and to better serve the innovation and development of pharmaceutical industry.
Recently, Shanghai Medicilon Inc. (Medicilon) appointed Dr. Renzong Xie as the Vice President of Toxicology Research Department.
Dr. Renzong Xie, Ph.D. in Pharmacology and Toxicology, University of Mississippi, USA, Certified Toxicologist of the DABT, former member of the Drug Development Program Review Committee of the National Science Society of Taiwan, Ministry of Science and Technology and Ministry of Economic Affairs and the Professor of Taipei Medical University and Biotech Inudstrial Academy.
Dr. Xie has been rooted in the pharmaceutical industry for more than 30 years, including 12 years of working experience in CDE in Taiwan, China. Dr. Xie was responsible for reviewing the pharmacological and toxicological test reports of IND and NDA applications, writing review reports and conducting risk assessments. He reviewed more than 200 IND cases, including 70 biologics drugs and more than 150 NDA cases, of which about 40 biologics drugs. He has also drafted the guidelines for CDE non-clinical safety trials of Taiwan, ICH S9 and E14/S7B, and several guidelines for non-clinical safety trials of Taiwan. In addition, Dr. Xie is also experienced in pharmacology and toxicology research, establishment of disease animal models, and the whole process of new drug development. These experiences will further promote the development of Medicilon toxicology research and improve the quality, efficiency and successful rate of project submissions.
Before joining Medicilon, Dr. Xie served as a senior executive in Jiangxi Changpharma Inc., LongBio Pharma, and Oneness Biotech, and has excellent experience in new drug R&D and team management.
Dr Xie said, "It is an honor to join Medicilon. As a rare one-stop biopharmaceutical preclinical comprehensive R&D CRO in China, Medicilon's 18-year dedication to innovative R&D technology and the steady deployment of various technical service platforms impressed me deeply. In the future, I hope to lead the team in Medicilon to help global pharmaceutical communites in the development of new drugs to create high quality and help the development of Medicilon."
Dr. Chunlin Chen, Founder and CEO of Medicilon, said, "I am delighted that Dr. Xie has joined Medicilon. Dr. Xie's more than 30 years of toxicology research experience and outstanding achievements in filing and declaration will greatly empower Medicilon's toxicology research and declaration services. I believe that the addition of Dr. Xie will bring more high-level strategic insights and industry thinking to Medicilon, and I also expect more new and good drugs to move from Medicilon to clinical and to go worldwide."
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