Platform & Pipeline

Platform & Pipeline

Biomarkers

Biomarker driven drug development starts from the traditional drug target to the genome big data of a large number of tumor patients. Through the research, biomarkers are found to guide drug development and improve the success rate of clinical trials.

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The successful development of targeted tumor drugs based on biomarkers in history includes Gleevec for leukemia, gefitinib and crizotinib for lung cancer, olaparib for ovarian cancer, etc. In particular, gefitinib and olaparib failed in the clinical trials of the unselected population, then restarted the biomarker driven clinical trials, and finally approved.

In 2017, for the first time, US FDA granted tumor-agonistic indication for pembrolizumab based on presence of MSI-H/dMMR, marking the beginning of molecular diagnostic subtyping era for targeted cancer therapy.

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This pipeline diagram is updated to September 2019

Envafolimab’s Competitive Advantages:

Safety:

~700 patients dosed globally;

Similar safety profile to other PD-(L)1 antibodies but without infusion reactions

Efficacy:

>400 patients dosed with envafolimab monotherapy in global phase I studies;

Similar efficacy to other PD-(L)1 antibodies

Convenience:

Stable at room temperature for up to 6 months;

Improved patient satisfaction and compliance with less time spent in clinic compared with IV administration

Cost-saving:

Higher yield with lower production cost compared with regular antibodies

Reduced cost, lower resource use compared with IV administration

2019 ESMO

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2019 ASCO

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