Haihe Biopharma and 3D Medicines announced on April 28 that the two parties have reached a strategic cooperation on the FGFR inhibitor (code-named "HH185") project of Haihe Biopharma. 3D Medicines can conduct R&D, production and commercialization of HH185 in Mainland China, Hong Kong and Macau Special Administrative Regions and Taiwan for the treatment of tumors and pulmonary fibrosis.
HH185 was synthesized by Shanghai Medicilon and completed some preclinical pharmacokinetic studies and safety evaluation. Medicilon warmly congratulates HaiHe Biopharma and 3D Medicine for reaching a strategic cooperation, which will be another step in the research and development of new anti-tumor drugs.
Medicilon has extensive experience in the evaluation of non-clinical pharmacokinetic studies. The Medicilon pharmacokinetic laboratory has passed the GLP certification of CFDA, and can provide high-quality in vivo and in vitro pharmacokinetic research and evaluation technical services from small molecules to large molecules (proteins and antibodies). The laboratory is equipped with more than ten advanced LC-MS/MS, and uses Watson LIMS software and WinNolin software to manage the laboratory and data respectively. The animal species involved in the research evaluation include non-human primates, dogs, mice, rats, rabbits, guinea pigs, etc. Among them, the non-human primate platform and the isotope protein/antibody experiment platform have been identified as important laboratory platforms by the Shanghai Municipal Science and Technology Commission.
Our Preclinical Pharmacokinetics Department has a number of professionals with rich theoretical knowledge and experimental experience for experiment design, experiment implementation, bioanalysis and data analysis. Our Pharmacokinetics Lab has passed the GLP certification by NMPA. Following the guiding principles of ICH, NMPA and FDA. The lab offers in vivo and in vitro pharmacokinetic tests according to the needs of our clients and provide them with complete sets of pharmacokinetic evaluation and optimization services. Our acclaimed quality data collection and efficient experiment can meet our clients’ needs from early drug discovery to new drug filing.
Medicilon has a quality management system for drug safety evaluation based on the internationally certified AAALAC quality standard and compliance with international and domestic GLP regulations.
Since 2008, we have continued to meet international standards and completed high-quality GLP safety evaluation services, establishing a long-term brand effect. Medicilon can perform systematic evaluation services covering multiple toxicity endpoints and has internationally recognized pathology studies to support our safety evaluation studies.
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