2018

  • Jul. ONIVYDE® obtained reimbursement from Taiwan’s National Health Insurance Administration.
  • Jul. ONIVYDE® launched in the third major European country.
  • Jun. Positive topline results from global pivotal trial of PEP503 (NBTXR3) in soft tissue sarcoma.

2017

  • Dec. The Singapore Health Sciences Authority approved ONIVYDE® for the treatment of metastatic pancreatic adenocarcinoma.
  • Oct. The study recruitment of PEP503 (NBTXR3) of phase II/III pivotal global trial for soft tissue sarcoma was completed.
  • Sep. The Korea Ministry of Food and Drug Safety approved ONIVYDE® for the treatment of metastatic pancreatic adenocarcinoma. PharmaEngine received the milestone payment of US$25 million.
  • Jun. The study results of phase I/II trial of PEP503 (NBTXR3) for head and neck cancer was presented by Nanobiotix at ASCO Annual Meeting 2017.
  • Mar. The independent data monitoring committee recommended the continuation of the ongoing phase II/III pivotal global trial of PEP503(NBTXR3) for soft tissue sarcoma.

2016

  • Oct. PharmaEngine treated the first patient of phase Ib/II trial of PEP503 (NBTXR3) for head and neck cancer in Taiwan.
  • Oct. European Medicines Agency (EMA) granted the marketing authorization of ONIVYDE® in combination with 5-fluorouracil and leucovorin for the treatment of metastatic pancreatic adenocarcinoma patients who have progressed following gemcitabine-based therapy. PharmaEngine received the milestone payment of US$25.5 million.
  • Sep. Submission for CE Marking of PEP503 (NBTXR3) in Europe by Nanobiotix was accepted.
  • Jul. PharmaEngine won the Go-Global Gold Medal Award of Taipei Biotech Award 2016 hosted by Taipei City Government.
  • Jul. PharmaEngine gained the Gold Medal Award of BioTaiwan 2016.
  • Jul. ONIVYDE® regimen received a positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for the treatment of metastatic pancreatic adenocarcinoma. 
  • May PharmaEngine initiated the pivotal global trial of PEP503 (NBTXR3) in soft tissue sarcoma in Asia Pacific region.
  • May Korean Ministry of Food and Drug Safety (MFDS) accepted the submission of new drug application (NDA) of ONIVYDE®. PharmaEngine acquired the milestone payment of US$10 million.
  • Mar. US National Comprehensive Cancer Network (NCCN) recognized the ONIVYDE® regimen as a category 1 second-line therapy in 2016 guidelines for metastatic pancreatic adenocarcinoma patients who have progressed following gemcitabine-based therapy.
  • Mar. Taiwan FDA approved the product license of ONIVYDE®.

2015

  • Dec. PharmaEngine won the Gold Prize of the Pharmaceutical and Technology Research Bioaward from Taiwan Ministry of Health & Welfare and Ministry of Economic Affairs.
  • Nov. The result of ONIVYDE® phase III NAPOLI-1 study was published in The Lancet.
  • Nov. PharmaEngine established a wholly owned subsidiary, PharmaEngine Europe SARL in Paris, France.
  • Oct. US FDA and TFDA approved ONIVYDE® (irinotecan liposome injection) for the treatment of metastatic pancreatic adenocarcinoma.
  • May Marketing Authorization Application for MM-398 (PEP02) was filed to EMA. PharmaEngine received the milestone payment of US$11 million.
  • Apr. US FDA accepted New Drug Application (NDA) of ONIVYDE®. PharmaEngine received the milestone payment of US$5 million.
  • Jan. Expanded analyses of Phase III MM-398 NAPOLI-1 study showed the sustained positive finding of MM-398 in combination with 5-FU/LV, which was reported at the ASCO GI Cancer Symposium 2015.

2014

  • Oct. PharmaEngine and Nanobiotix launched a pivotal global trial of PEP503 (NBTXR3) for soft tissue sarcoma.
  • Sep. PharmaEngine and Merrimack amended MM-398 License Agreement. PharmaEngine received US$7 Million and was eligible for up to US$39.5 Million in sublicense revenues.
  • Jun. Full data of ONIVYDE® phase III NAPOLI-1 study for metastatic pancreatic adenocarcinoma were presented orally at ESMO World Congress on Gastrointestinal Cancer 2014.
  • Jun. The result of Phase I trial of NBTXR3 (PEP503) for soft tissue sarcoma was presented by our licensing partner Nanobiotix at ASCO Annual Meeting 2014.
  • May PharmaEngine announced that MM-398 (PEP02) in combination with 5-FU/LV met the primary endpoint for overall survival in phase III NAPOLI-1 study for metastatic pancreatic adenocarcinoma post-gemcitabine metastatic treatment.

2013

  • Aug. PharmaEngine and Merrimack completed patient enrollment of MM-398 (PEP02) phase III NAPOLI-1 study for metastatic pancreatic adenocarcinoma.
  • Aug. ParmaEngine completed patient enrollment of PEP02 in combination with 5-FU/LV in phase II PEPCOL study for unresectable metastatic colorectal cancer.
  • Jul. PharmaEngine published the result of nanoliposomal irinotecan (PEP02, MM-398) phase II study for late-stage pancreatic adenocarcinoma in British Journal of Cancer. 
  • Feb. PharmaEngine published the result of nanoliposomal irinotecan (PEP02, MM-398) phase II study for late-stage gastric cancer in Annals of Oncology.
  • Jan. PharmaEngine and Guangzhou BeBetter Medicine Technology signed a Collaboration and Research Agreement.

2012

  • Sep. PharmaEngine debuted IPO on Taipei Exchange Securities Market and began trading under the ticker “4162.TT” on Sept. 18, 2012.
  • Sep. PharmaEngine won Technology Transfer Gold Medal for the PEP02 project at the Taipei Biotech Award 2012. 
  • Aug. PharmaEngine and Nanobiotix S.A. entered into an Asia-Pacific Exclusive License and Collaboration Agreement for NBTXR3, a radio-enhancer.
  • Jan. PharmeEngine and Merrimack initiated global phase III study on PEP02/MM-398 for metastatic pancreatic adenocarcinoma. PharmaEngine received the milestone payment of US$5 million after the first patient was dosed.
  • Jan. PharmaEngine presented the phase I study of biweekly PEP02 in metastatic colorectal cancer at the ASCO Gastrointestinal Cancers Symposium 2012. 

2011

  • Dec. PharmaEngine received Research & Development Innovation Prize from the Department of Industrial Technology of Ministry of Economic Affairs for the PEP02 project in phase II gastric cancer study.
  • Dec. EMA granted orphan drug status to PEP02 (MM-398) for the treatment of pancreatic adenocarcinoma.
  • Sep. PharmaEngine debuted on Taiwan’s emerging stock market on Sept. 1, 2011. 
  • Aug. PharmaEngine completed patient enrollment of PEP02 phase I study (PIST-CRC-01) for colorectal cancer in Taiwan.
  • Jul. US FDA granted orphan drug status to PEP02 (MM-398) for the treatment of pancreatic cancer.
  • Jul. Taiwan Securities & Futures Bureau (SFB) approved PharmaEngine stock to go public.
  • Jun. PharmaEngine presented a poster “Phase II study of PEP02 for patients with gemcitabine-refractory metastatic pancreatic cancer” at ASCO Annual Meeting 2011. 
  • May PharmaEngine, Inc. and Merrimack Pharmaceuticals, Inc. entered into a Licensing and Collaboration Agreement on PEP02 (MM-398, Nanoliposomal Irinotecan) for US$220 million plus tiered royalties. PharmaEngine received an upfront payment of US$10 million.
  • Jan. PEP02 phase II studies for both gastric cancer and pancreatic cancer met the primary endpoints. The results were orally presented at the ASCO Gastrointestinal Cancers Symposium 2011.

2010

  • Sep. PharmaEngine completed patient enrollment of PEP02 single-agent phase II study (PEP0208) for second-line metastatic pancreatic adenocarcinoma in the US and Taiwan.

2009

  • Sep. PharmaEngine completed patient enrollment of PEP02 single-agent phase II study (PEP0206) for advanced gastric cancer in Asia and Europe. 

2008

  • May PharmaEngine completed patient enrollment for a combination of PEP02 with 5-FU/LV phase I study (PEP0203) in solid tumor. 
  • Jun. PharmaEngine presented a poster Phase I study of liposome encapsulated irinotecan (PEP02) in advanced solid tumor patients at ASCO Annual Meeting 2008.

2006

  • Jan. PharmaEngine completed a PEP02 single-agent phase I study.

2005

  • Sep. PharmaEngine expanded PEP02 license to the European territory.

2004

  • Dec. PharmaEngine completed PEP02 process scale-up and preclinical studies. PharmaEngine filed IND in Taiwan.
  • Sep. PharmaEngine completed the first round of fundraising with NTD630 million (~US$20 million).

2003

  • Jun. PharmaEngine licensed liposomal irinotecan (PEP02) for Asia territory, including Japan, from Hermes Biosciences, Inc.
  • Feb. PharmaEngine began operation on Feb. 6, 2003.