Sep.
TFDA approved PEP07 Phase I clinical trial for solid tumor
2023
Aug.
PharmaEngine announces first patient dosed in Phase I trial of PEP07 for hematological cancers
Jul.
PharmaEngine receives US$2 million of sublicense revenue following Europe EMA's acceptance of Type II Variation application for ONIVYDE®
Jun.
PharmaEngine files post-approval change application for a new indication of ONIVYDE® to Taiwan's TFDA
Jun.
Phase I clinical study of PEP07 has been approved by Taiwan's TFDA
Mar.
Phase I clinical study of PEP07 has been approved by Australia's HREC and acknowledged by Australia's TGA
Mar.
PharmaEngine was approved by the Taiwan's Ministry of Economic Affairs as a "Biotech and Pharmaceutical Company"
Jan.
Poster presentation of preclinical data of PEP07 at the 6th Annual DDR Inhibitors Summit 2023
Jan.
ONIVYDE® regimen (NALIRIFOX) demonstrated statistically significant improvement in overall survival in 1L PDAC (supplementary information)
2022
Nov.
ONIVYDE® regimen (NALIRIFOX) demonstrated statistically significant improvement in overall survival in 1L PDAC
Sep.
PharmaEngine exercised option for a Worldwide Exclusive License Agreement to Sentinel Oncology Limited's CHK1 inhibitor (PEP07)
Aug.
Phase III RESILIENT trial evaluating ONIVYDE® in second-line monotherapy for small cell lung cancer did not meet its primary endpoint
Apr.
ONIVYDE® in combination with fluorouracil (5-FU) and leucovorin (LV) has been approved by China's National Medical Products Administration (NMPA)
Jan.
PharmaEngine released the preliminary data of Phase I clinical studies of ONIVYDE® in combination with LONSURF® in treating multiple solid tumors in ASCO-GI 2022
2021
Jul.
IPSEN, PharmaEngine's partner, achieved patient enrollment goal for Phase III 1L PDAC study and 2L SCLC study of ONIVYDE®
Jun.
PharmaEngine released the data of Phase II clinical studies of ONIVYDE® combination therapy in squamous cell carcinoma of the head and neck and the esophagus that has failed prior platinum-based chemotherapy or concurrent chemoradiotherapy in 2021 ASCO symposium (2021 ASCO)
Mar.
PharmaEngine and Nanobiotix mutually agreed to terminate the exclusive license and collaboration agreement for PEP503 (NBTXR3)
Feb.
The aggregate net sales of ONIVYDE® in the Europe and Asia regions in 2020 reached the first sales milestone and PharmaEngine received the first sales milestone payment of US$20 million
Jan.
PharmaEngine presented the study results of Phase I rectal cancer trial of PEP503 (NBTXR3) at ASCO-GI 2021
2020
Nov.
US FDA granted Fast Track designation to ONIVYDE® as an investigational second-line monotherapy treatment for small cell lung cancer
Nov.
PharmaEngine and Sentinel Oncology entered into an exclusive collaboration and license agreement for SOL-578, a CHK1 inhibitor
Oct.
The rectal study of PEP503 (NBTXR3) entered into Phase II stage and initiated the patient recruitment
Jul.
IPSEN, PharmaEngine's partner, presented Phase I/II clinical data evaluating ONIVYDE® as an investigational first-line combination treatment for metastatic pancreatic cancer at the ESMO World Congress on Gastrointestinal Cancer
Jun.
US FDA granted Fast Track designation to ONIVYDE® as the first-line combination treatment for metastatic pancreatic cancer
Mar.
ONIVYDE® in combination with 5-fluorouracil (5-FU) and leucovorin (LV) 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 Japan's Ministry of Health, Labor and Welfare (MHLW)
2019
Sep.
PharmaEngine's partners IPSEN and Servier announced positive initial results for ONIVYDE® as a second-line treatment for Phase II/III small cell lung cancer, and announced that the trial had entered Phase II patient enrollment
Apr.
PEP503 (NBTXR3) received CE Mark enabling commercialization in 27 European Union countries under the brand name of Hensify® for the treatment of locally advanced soft tissue sarcoma
2018
Oct.
PharmaEngine's partner, Nanobiotix, presented positive results from the global pivotal trial of PEP503 (NBTXR3) in patients with soft tissue sarcoma in oral presentation at ESMO 2018 Congress and 2018 ASTRO Annual Meeting
Jul.
ONIVYDE® obtained reimbursement from Taiwan's National Health Insurance Administration, effective on August 1, 2018
Jul.
ONIVYDE® was launched in the third major European country, and PharmaEngine received milestone payment of US$3 million
Jun.
The global pivotal trial of PEP503 (NBTXR3) demonstrated statistically significant improvement in soft tissue sarcoma
Jan.
Singapore's Health Sciences Authority (HSA) approved ONIVYDE® for the treatment of metastatic pancreatic cancer
2017
Oct.
Patient enrollment for Phase II/III trial of PEP503 (NBTXR3) in soft tissue sarcoma was completed
Sep.
South Korea's MFDS approved ONIVYDE® for the treatment of metastatic pancreatic cancer, and PharmaEngine received milestone payment of US$25 million
2016
Oct.
The first patient was dosed in a Phase Ib/II trial of PEP503 (NBTXR3) of head and neck cancer
Oct.
ONIVYDE® 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 by EU's EMA, PharmaEngine received the milestone payment of US$25.5 million
Jul.
PharmaEngine won the Go-Global Gold Medal Award of 2016 Taipei Biotech Awards sponsored by Taipei City Government
Jul.
PharmaEngine gained the Gold Medal Award of 2016 BIO Taiwan sponsored by Taiwan Biotechnology Industry Organization
May
First patient dosed in a global pivotal trial of PEP503 (NBTXR3) in soft tissue sarcoma in Asia Pacific region
May
South Korea's Ministry of Food and Drug Safety (MFDS) accepted the submission of new drug application (NDA) of ONIVYDE®, PharmaEngine received the milestone payment of US$10 million
Mar.
The ONIVYDE® regimen was recognized as a category 1 second-line therapy in 2016 US National Comprehensive Cancer Network (NCCN) guidelines for patients with metastatic adenocarcinoma of the pancreas who have previously been treated with gemcitabine-based therapy
Mar.
Taiwan's TFDA approved the product license of ONIVYDE®
2015
Dec.
ONIVYDE® won the Gold Prize of the Pharmaceutical and Technology Research Bio Award from Taiwan Ministry of Health & Welfare and Ministry of Economic Affairs
Nov.
Published the ONIVYDE® Phase III NAPOLI-1 study data in The Lancet
Oct.
US FDA and Taiwan TFDA approved ONIVYDE® (formerly known as PEP02 and MM-398) for the treatment of metastatic pancreatic cancer
May
Filed Marketing Authorization Application for PEP02 (MM-398) with EMA, PharmaEngine received the milestone payment of US$11 million
Apr.
US FDA accepted New Drug Application (NDA) for PEP02 (MM-398), PharmaEngine received the milestone payment of US$5 million
Jan.
Presented expanded analyses of Phase III PEP02 (MM-398) NAPOLI-1 study at the 2015 ASCO GI substantiated the positive results of PEP02 (MM-398) in combination with 5-FU/LV
2014
Oct.
PharmaEngine and Nanobiotix launched a pivotal global trial of PEP503 (NBTXR3) for soft tissue sarcoma
Sep.
PharmaEngine and Merrimack amended PEP02 (MM-398) License Agreement; PharmaEngine received US$7 million and was eligible for up to US$39.5 million in sublicense revenues
Jun.
Global phase III (NAPOLI-1) full data of PEP02 (MM-398) for metastasis pancreatic cancer study was presented orally at ESMO World Congress on Gastrointestinal Cancer
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
The PEP02 (MM-398) in combination with 5-FU/LV met the primary endpoint for overall survival in Phase III post-gemcitabine metastatic pancreatic cancer study
2013
Aug.
Achieved patient enrollment goal for Phase III metastatic pancreatic cancer study of PEP02 (MM-398)
Aug.
Completed patient enrollment of PEP02 (MM-398) in combination with 5-FU/LV in Phase II PEPCOL study for unresectable metastatic colorectal cancer
Jul.
Published studies of nanoliposomal irinotecan PEP02 (MM-398) in late stage pancreatic cancer in British Journal of Cancer
Feb.
Published studies of nanoliposomal irinotecan PEP02 (MM-398) in gastric cancer in Annals of Oncology
Jan.
PharmaEngine and Guangzhou BeBetter Medicine Technology signed a Collaboration and Research Agreement
2012
Sep.
PharmaEngine, Inc. debuted IPO on Taipei Exchange Securities Market and began trading under the ticker "4162.TT" on September 18, 2012
Sep.
PharmaEngine won Technology Transfer Gold Medal for PEP02 project at the 2012 Taipei Biotech Award
Aug.
PharmaEngine, Inc. and Nanobiotix S.A. entered into an Asia-Pacific Exclusive License and Collaboration Agreement for NBTXR3, a radioenhancer
Jan.
Initiated global Phase III study on PEP02 (MM-398) with metastatic pancreatic cancer; the first patient was dosed, PharmaEngine received the milestone payment of US$5 million
Jan.
PharmaEngine presented the Phase I study of biweekly PEP02 (MM-398) in metastatic colorectal cancer at the ASCO Gastrointestinal Cancers Symposium 2012
2011
Dec.
Received Research & Development Innovation Prize from the Dept. of Industrial Technology (DoIT) of Ministry of Economic Affairs for PEP02 project in Phase II gastric cancer study
Dec.
EU EMA granted orphan drug status to PEP02 (MM-398) for the treatment of pancreatic adenocarcinoma
Sep.
PharmaEngine, Inc. debuted on Taiwan's emerging stock market on September 1, 2011
Aug.
Completed patient enrollment of PEP02 (MM-398) 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 public offering of PharmaEngine stocks
Jun.
Presented "Phase II study of PEP02 (MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer" by poster presentation at 2011 ASCO Annual Meeting
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 upfront payment of US$10 million
Jan.
PEP02 Phase II studies for both gastric cancer and pancreatic cancer met the primary endpoints and the results were orally presented at the ASCO Gastrointestinal Cancers Symposium 2011
2010
Sep.
Completed patient enrollment for a single agent Phase II study as a second line therapy for metastatic pancreatic cancer in US and Taiwan
Jun.
Cooperated with GERCOR, a famous French cancer research institute, to execute PEP02 metastatic colorectal cancer Phase II trial
2009
Sep.
Completed patient enrollment of PEP02 as a single agent in a randomized Phase II study in gastric cancer in Asia and Europe (PEP0206)
Jun.
Cooperated with Taiwan National Health Research Institution to execute PEP02 colorectal cancer Phase I trial (PIST-CRC-01)
Apr.
PharmaEngine was approved by the Ministry of Economic Affairs as a "Biotech Company"
2008
May
Completed patient enrollment for a combination of PEP02 with 5-FU/LV Phase I study
2007
Feb.
PEP02 manufacturing facility and material suppliers passed inspections from European Medicines Agency (EMA) which allows PEP02 to be able to implement clinical trials in Europe
2006
Jan.
Completed PEP02 single agent Phase I study (PEP0201)
2005
Jul.
Expanded PEP02 license to the European territory
2004
Dec.
Received government grant for PEP02 Phase I study
Dec.
Completed PEP02 process scale-up and preclinical studies; filed IND in Taiwan
Sep.
Completed fund raising of NT$630 million
2003
Jun.
Licensed PEP02 for Asia territory (including Japan) from Hermes Biosciences, Inc.
Feb.
PharmaEngine, Inc. began operation on Feb. 6, 2003