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PharmaEngine focuses on the development of new drugs for the treatment of cancer diseases. There are 3 projects in the pipeline. ONIVYDE® (PEP02, MM-398, nal-IRI), a new formulation of an anti-cancer drug (irinotecan) for the patients with gemcitabine-treated metastatic pancreatic cancer, was approved by both the US FDA and Taiwan FDA in 2015,
European Medicines Agency (EMA) in 2016, Korea MFDS and Singapore HAS in 2017. PEP503 (NBTXR3), a nanoparticle working as a radio-enhancer, is in a positive global pivotal trial of soft tissue sarcoma, the other ongoing studies are in Phase I/II trial in head and neck cancerand rectal cancer in Taiwan. PEP06, a new chemical entity (NCE) for cancer treatment, is currently in the pre-clinical stage.