mainPic
About Us - History & Milestones
  • 2015
    • The ONIVYDE™ phase III NAPOLI-1 study is published in The Lancet
    • The subsidiary PharmaEngine Europe SARL is established
    • ONIVYDE wins the Gold Prize of the pharmaceutical and technology research bioaward given by Taiwan MOHW and MOEA
    • US FDA and TFDA approve ONIVYDE (irinotecan liposome injection) for the treatment of metastatic pancreatic cancer
    • Marketing Authorization Application for MM-398 (PEP02) filed with TFDA / Marketing Authorization Application for MM-398 (PEP02) filed with EMA
    • US FDA grants Priority Review Designation to MM-398/ MM-398 (PEP02) New Drug Application submitted to U.S. FDA
    • Annual innovation prize awarded by Monte Jade Science and Technology Association of Taiwan
    • Phase 2 PEPCOL study presented at the 2015 ASCO GI of PEP02 (MM-398) in combination with 5-FU/LV in unresectable metastatic colorectal cancer / Expanded analyses of Phase 3 MM-398 NAPOLI-1 study presented at the 2015 ASCO GI Substantiate the Positive Results of MM-398 in combination with 5-FU/LV
  • 2014
    • US FDA grants Fast Track Designation for MM-398 in post-gemcitabine metastatic pancreatic cancer to Merrimack
    • PharmaEngine and Nanobiotix launch a global pivotal trial of PEP503 (NBTXR3) in soft tissue sarcoma
    • PharmaEngine and Merrimack amend MM-398 License Agreement; PharmaEngine receives US$12 Million and is eligible for up to US$39.5 Million in sublicense revenues
    • Global phase 3 (NAPOLI-1) full data of MM-398(PEP02) for metastasis pancreatic cancer study presented at ESMO World Congress on Gastrointestinal Cancer
    • Phase 1 results of NBTXR3 (PEP503) presented by our licensing partner Nanobiotix S.A. at 2014 ASCO Annual Meeting
    • PharmaEngine announces MM-398 (PEP02) in combination with 5-FU/LV meet the primary endpoint for overall survival in phase 3 post-gemcitabine metastatic pancreatic cancer study
  • 2013
    • Patient enrollment goal for phase III metastatic pancreatic cancer study of PEP02 (MM-398) achieved
    • Studies of Nanoliposomal Irinotecan (PEP02,MM-398) in late stage pancreatic cancer and gastric cancer are published in British Journal of Cancer and Annals of Oncology
    • PharmaEngine and Guangzhou BeBetter Medicine Technology sign a Collaboration and Research Agreement
  • 2012
    • PharmaEngine, Inc. IPO debuts on Taiwan GreTai Securities Market and begins trading under the ticker"4162.TT" on Sept. 18, 2012
    • Technology Transfer gold medal for PEP02 project received at the 2012 Taipei Biotech Award
    • PharmaEngine, Inc. and Nanobiotix S.A. enter into an Asia-Pacific Exclusive License and Collaboration Agreement for NBTXR3, a radioenhancer
    • Global phase 3 study on PEP02/MM-398 with metastatic pancreatic cancer is initiated; the first patient is dosed
    • Phase 1 study of biweekly PEP02 in metastatic colorectal cancer presented at the ASCO 2012 Gastrointestinal Cancers Symposium
  • 2011
    • Research & Development Innovation Prize received from the Dept. of Industrial Technology (DoIT) of MOEA for PEP02 project in phase II gastric cancer study
    • PharmaEngine, Inc. debuts on Taiwan's emerging stock market on Sept. 1, 2011
    • US FDA grants orphan drug status to PEP02 (Merrimack Pharmaceuticals’ MM-398) for the treatment of pancreatic cancer
    • PharmaEngine, Inc. approved by Taiwan Securities & Futures Bureau (SFB) for IPO
    • Pre-clinical study of PEP02 for three xenograft models of human lung tumors presented at 14th World Conference on Lung Cancer (WCLC)
    • "Phase II study of PEP02 for patients with gemcitabine-refractory metastatic pancreatic cancer" poster presentation at 2011 ASCO Annual Meeting
    • PharmaEngine, Inc. and Merrimack Pharmaceuticals, Inc. enter into a Licensing and Collaboration Agreement on PEP02 (MM-398), Nanoliposomal Irinotecan
    • PEP02 meet the primary endpoints in phase II studies in gastric cancer and pancreatic cancer; results presented at the 2011 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO)
  • 2010
    • Patient enrollment for a single agent phase II study as a second line therapy for metastatic pancreatic cancer in the US and Taiwan completed
    • China SFDA gives IND approval for a phase I/II colorectal cancer trial
  • 2009
    • Patient enrollment for a single agent randomized phase II study in gastric cancer in Asia and Europe completed
    • Phase II study as a second line therapy for metastatic pancreatic cancer initiated in the US and Taiwan
    • Government grant for PEP02 phase II pancreatic cancer study
    • Phase I investigator sponsored trial for colorectal cancer initiated in Taiwan
  • 2008
    • US FDA approves phase II pancreatic cancer trial
    • Research & Development Innovation bronze medal received for PEP02 project at the 5th Taipei Biotech Award
    • Patient enrollment for a combination phase I study completed
    • “Phase I study of liposome encapsulated irinotecan (PEP02) in advanced solid tumor patients” poster presentation at 2008 ASCO Annual Meeting
    • Phase II single agent study in gastric cancer initiated in Asia and Europe
  • 2007
    • Government grant for PEP02 phase II gastric cancer study
    • Phase I study in brain tumor is initiated in the US by Hermes, using Pharmaengine's PEP02 data
  • 2006
    • PEP02 single agent phase I study completed
    • 10th Golden Peak and 6th National Quality Assurance Golden Statue awards winner
  • 2005
    • PEP02 license extended to the European territory
    • Red Herring Asia 100 award winner
    • Licensing of PEP04 (TransMID) rights for China and Korea from Xenova
  • 2004
    • Fund raising completed; government grant for PEP02 phase I study
    • PEP02 process scale-up and preclinical studies completed; IND filed in Taiwan.
  • 2003
    • Licensing of PEP02 for Asia (including Japan) from Hermes Biosciences, Inc.
    • Licensing of PEP03 for Asia (including Japan) from Millennium Pharmaceuticals, Inc
    • PharmaEngine, Inc. begins operation on Feb. 6

TOP