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About Us - History & Milestones
  • 2017
    • PharmaEngine was ranked the 2nd enterprise in the biotechnology service industry and the 5th enterprise regarding the business performance in the non-manufacturing corporations by CHINA CREDIT INFORMATION SERVICE, LTD. For “Top5000 of the Large Companies in Taiwan”
    • The study result regarding the phase I/II head and neck cancer trial of PEP503(NBTXR3) was presented at 2017 ASCO
    • The independent data monitoring committee recommends the continuation of the ongoing phase II/III trial of PEP503(NBTXR3) in soft tissue sarcoma
  • 2016
    • The PharmaEngine ONIVYDEâ R&D team gained the 2016 Technology Management Award hosted by Chinese Society for Management of Technology (CSMOT)
    • The first patient has been dosed in a phase 1b/2 trial of PEP503 (NBTXR3) of head and neck
    • Since ONIVYDEâ in combination with 5-fluorouracil and leucovorin for the treatment of metastatic adenocarcinoma of the pancreas in patients who have progressed following gemcitabine based therapy was granted the marketing authorization approval by the European Commission, PharmaEngine is eligible to receive US$25.5 million of the milestone payment.
    • Acceptance of submission for CE Marking approval of lead product PEP503 (NBTXR3) in Europe
    • Gained the Go-Global Gold Medal Award of 2016 Taipei Biotech Awards hosted by Taipei City Government
    • Gained the Gold Medal Awaord of BIO Taiwan 2016 hosted by Taiwan Bio Industry Organization
    • ONIVYDEâ regimen receives CHMP positive opinion for the treatment of metastatic pancreatic cancer
    • Initiation of global pivotal trial of PEP503 (NBTXR3) in soft tissue sarcoma in Asia Pacific region
    • MFDS accepted the submission of a new drug application (NDA) of ONIVYDEâ
    • Recognition of the ONIVYDEâ regimen as a category 1 second-line therapy in 2016 NCCN guideline for patients with metastatic adenocarcinoma of the pancreas who have previously been treated with gemcitabine-based therapy
    • Taiwan FDA approved the product license of ONIVYDEâ
  • 2015
    • The ONIVYDEâ phase III NAPOLI-1 study is published in The Lancet
    • The subsidiary PharmaEngine Europe SARL is established
    • ONIVYDEâ wins the Gold Prize of the pharmaceutical and technology research bioaward given by Taiwan MOHW and MOEA
    • US FDA and TFDA approve ONIVYDEâ (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

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