The company independently carries out the early toxicity exploration test of the drug candidates, which provides important decision basis for preclinical development; as the preclinical toxicology professional team of the company, it cooperates with the domestic first-class GLP preclinical drug safety Center to carry out the drug safety evaluation test required by the registration application.

Early toxicity exploration tests that can be conducted independently include: single and repeated dose toxicity experiments in rats, mice and beagles, special toxicity evaluation tests (allergic, hemolytic, irritant, etc.), toxicokinetic tests, etc.

The center has histopathology laboratory and clinical laboratory. The animal test is carried out by lay center, and the toxicant metabolism samples are analyzed on DMPK center.

The histopathology laboratory is equipped with a full set of Leica pathology equipment, which can carry out the pathological anatomy of animals, paraffin sections, frozen sections, HE staining and special staining, immunohistochemical staining, image acquisition and analysis of large and small animals. The clinical laboratory has Hitachi 7180E automatic biochemical analyzer, SYSMEX CA510 automatic hemagglutination analyzer, SYSMEX ST2000IV automatic blood analyzer, urine analyzer, etc., which can conduct blood, urine and other biological sample molecules.

We have set up a professional scientific research team composed of drug toxicology, animal pathology and experimental technicians. We have completed more than 100 toxicity exploration tests of dozens of candidate compounds, and supported the registration and clinical experiments of more than 10 class 1.1 innovative drugs of the company.

The center works closely with the company's own test lay center and DMPK center, and independently completes the comprehensive analysis and evaluation of the toxicity exploration test in the company without the help of any outsourcing services.

In the early stage of the project, we can fully conduct the toxicity screening and evaluation of drug candidates internally, as an important scientific basis for project decision-making, effectively improve the research and development efficiency, reduce development risks and development costs, and save development costs, and the early project is easy to confidential management.

And our preclinical toxicology team participated in the program formulation, trial implementation and result interpretation of the GLP test; effectively supervised and controlled the outsourcing GLP test, and independently conducted scientific analysis and evaluation of the conclusion of the GLP test results.

Safety evaluation of small molecule drugs ，and evaluation of macromolecule drugs (antibody drugs, antibody-drug conjugates, etc.).

The Preclinical Drug Safety Center works closely with the DMPK center to carry out more exploratory work in verifying animal disease models, exploring biomarkers, and evaluating in vivo and vitro animal efficacy, and establish an in vivo efficacy evaluation platform with company characteristics and certain technical barriers.