PharmaEngine announces Phase 1 clinical study of PEP07 has been approved by Taiwan Food and Drug Administration (TFDA)

PharmaEngine Inc. (4162.TWO) announces Phase 1 clinical study in hematological cancer (e.g., AML or MCL) of PEP07, our product under development, has been approved by Taiwan Food and Drug Administration (TFDA). 

PEP07 is a checkpoint kinase 1 (CHK1) inhibitor featuring high kinase selectivity, brain penetrating and oral bioavailability which targets the DNA Damage Response (DDR) network. PEP07 has demonstrated significant single-agent activity and combination potential with standard treatments in preclinical models. 

PharmaEngine applied for first-in-human clinical trials for PEP07 in December 2022 and the application has been approved by Australia HREC in March 2023. Today, the Company received TFDA confirmation on Phase 1 clinical trial in Taiwan shows we continue to hold true to our vision and strive to develop new cancer drugs. We work to improve patients' well-being, enhance quality of life, and extend lives through innovation. 

Per the report published by Datamonitor, the acute myeloid leukemia (AML) drug market is expected to nearly triple in size over the 10-year forecast period (2021-2031), growing from US$1.3bn in 2021 to nearly US$3.6bn in 2031, at a CAGR of 10.3%. 



Chihsing Chang
Vice President, Finance and Administration
TEL +886 2 2515 8228, ext. 700
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