InnoStar's clinical development services mainly focus on the clinical bioanalysis and translational research, providing the development and full validation services of analytical methodologies for pharmacokinetics, immunogenicity, and biomarkers, as well as the biological sample analysis services, to support the clinical pharmacokinetics, pharmacodynamics, and safety evaluation of innovative drugs.

Drug candidates may enter the clinical development stage to assess their safety and efficacy in humans only after the approval of the initial applications for clinical trials of new drugs. Clinical stage generally includes the main clinical trials (Phases I, II, and III), as well as the corresponding patient recruitment, on-site management, clinical sample bioanalysis and biomarker detection, data management and statistical analysis, etc. The clinical trials (Phases I, II, and III), as the most important element in this stage, are conducted with drugs to evaluate their efficacy and safety in humans. After the required clinical trials with a drug candidate are completed, an NDA/BLA submission can be filed. The new drug can be marketed only after the approval from the relevant regulatory authority(ies) and continuous post-marketing surveillance on drug safety will be conducted if necessary.

Platform advantages

InnoStar has established diversified bioanalysis platforms, including:

● LC-MS/MS-based bioanalysis technology platforms for chemical drugs, traditional Chinese medicines, peptides, small nucleic acids and ADC drugs

● Ligand binding assay (LBA)-based bioanalysis platforms for large molecules such as monoclonal antibodies, polyclonal antibodies and ADCs and LBA- or cell-based evaluation platform of immunogenicity (including neutralizing antibodies)

● Analytical platforms based on flow cytometry, PCR and other technologies for nucleic acids as well as gene and cell therapy products

● Biomarker and translational research platforms based on immunohistochemistry and multi-omics

● Human mass balance and metabolites identification based on radioisotope labeling technology

Provide comprehensive and professional one-stop solutions for bioanalysis and biomarker translational research in new drug research and development to domestic and international companies