History & Milestones

Positive Topline Results from Phase III NAPOLI-3 trial of ONIVYDE® regimen (NALIRIFOX) as a first-line treatment for previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC)

PharmaEngine exercised option for a worldwide exclusive license agreement to Sentinel Oncology Limited’s CHK1 inhibitor

ONIVYDE® in combination with fluorouracil (5-FU) and leucovorin (LV) has been approved by China National Medical Products Administration (NMPA).

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

PharmaEngine and Nanobiotix mutually agreed to terminate the exclusive license and collaboration agreement for PEP503(NBTXR3).

The aggregate net sales of Onivyde in the Europe and Asia regions in 2020 reached the first sales milestone. PharmaEngine received the first sales milestone payment, US$20 million.

PharmaEngine presented the clinical results of phase I study for PEP503 (NBTXR3) in rectal cancer at ASCO-GI 2021.

US FDA granted Fast Track designation to ONIVYDE® as an investigational second-line monotherapy treatment for small cell lung cancer.

PharmaEngine and Sentinel Oncology entered into an exclusive collaboration and license agreement for SOL-578, a Chk1 inhibitor

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.

Ipsen, PharmaEngine’s partner , announced that US FDA granted Fast Track designation to ONIVYDE® as the first-line combination treatment for metastatic pancreatic cancer.

Nanobiotix, PharmaEngine’s partner, presented positive results of Phase I expansion study for PEP503 (HENSIFY ®, NBTXR3) in locally advanced head and neck cancer at ASCO 2020.

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 the Ministry of Health, Labor and Welfare(MHLW), Japan.

U.S. Food and Drug Administration (FDA) granted Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy.

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.

The preliminary study results from phase II/III trial of ONIVYDE® in second-line small cell lung cancer and phase I/II trial of PEP503 (NBTXR3) in head and neck cancer were presented by Ipsen and Nanobiotix, respectively, at ASCO Annual Meeting 2019.

PEP503 (NBTXR3) received CE Mark approval for the treatment of locally advanced soft tissue sarcoma.

Positive phase II/III results for PEP503 (NBTXR3) in soft tissue sarcoma were presented orally at ESMO 2018 Congress and 2018 ASTRO Annual Meeting.

ONIVYDE® obtained reimbursement from Taiwan’s National Health Insurance Administration.

ONIVYDE® launched in the third major European country.

Positive topline results from global pivotal trial of PEP503 (NBTXR3) in soft tissue sarcoma.

The Singapore Health Sciences Authority approved ONIVYDE® for the treatment of metastatic pancreatic adenocarcinoma.

The study recruitment of PEP503 (NBTXR3) of phase II/III pivotal global trial for soft tissue sarcoma was completed.

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.

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.

The independent data monitoring committee recommended the continuation of the ongoing phase II/III pivotal global trial of PEP503(NBTXR3) for soft tissue sarcoma.

PharmaEngine treated the first patient of phase Ib/II trial of PEP503 (NBTXR3) for head and neck cancer in Taiwan.

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.

Submission for CE Marking of PEP503 (NBTXR3) in Europe by Nanobiotix was accepted.

PharmaEngine won the Go-Global Gold Medal Award of Taipei Biotech Award 2016 hosted by Taipei City Government.

PharmaEngine gained the Gold Medal Award of BioTaiwan 2016.

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.

PharmaEngine initiated the pivotal global trial of PEP503 (NBTXR3) in soft tissue sarcoma in Asia Pacific region.

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.

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.

Taiwan FDA approved the product license of ONIVYDE®.

PharmaEngine won the Gold Prize of the Pharmaceutical and Technology Research Bioaward from Taiwan Ministry of Health & Welfare and Ministry of Economic Affairs.

The result of ONIVYDE® phase III NAPOLI-1 study was published in The Lancet.

PharmaEngine established a wholly owned subsidiary, PharmaEngine Europe SARL in Paris, France.

US FDA and TFDA approved ONIVYDE® (irinotecan liposome injection) for the treatment of metastatic pancreatic adenocarcinoma.

Marketing Authorization Application for MM-398 (PEP02) was filed to EMA. PharmaEngine received the milestone payment of US$11 million.

US FDA accepted New Drug Application (NDA) of ONIVYDE®. PharmaEngine received the milestone payment of US$5 million.

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.

PharmaEngine and Nanobiotix launched a pivotal global trial of PEP503 (NBTXR3) for soft tissue sarcoma.

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.

Full data of ONIVYDE® phase III NAPOLI-1 study for metastatic pancreatic adenocarcinoma were presented orally at ESMO World Congress on Gastrointestinal Cancer 2014.

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.

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.

PharmaEngine and Merrimack completed patient enrollment of MM-398 (PEP02) phase III NAPOLI-1 study for metastatic pancreatic adenocarcinoma.

ParmaEngine completed patient enrollment of PEP02 in combination with 5-FU/LV in phase II PEPCOL study for unresectable metastatic colorectal cancer.

PharmaEngine published the result of nanoliposomal irinotecan (PEP02, MM-398) phase II study for late-stage pancreatic adenocarcinoma in British Journal of Cancer.

PharmaEngine published the result of nanoliposomal irinotecan (PEP02, MM-398) phase II study for late-stage gastric cancer in Annals of Oncology.

PharmaEngine and Guangzhou BeBetter Medicine Technology signed a Collaboration and Research Agreement.

PharmaEngine debuted IPO on Taipei Exchange Securities Market and began trading under the ticker “4162.TT” on Sept. 18, 2012.

PharmaEngine won Technology Transfer Gold Medal for the PEP02 project at the Taipei Biotech Award 2012.

PharmaEngine and Nanobiotix S.A. entered into an Asia-Pacific Exclusive License and Collaboration Agreement for NBTXR3, a radio-enhancer.

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.

PharmaEngine presented the phase I study of biweekly PEP02 in metastatic colorectal cancer at the ASCO Gastrointestinal Cancers Symposium 2012.

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.

EMA granted orphan drug status to PEP02 (MM-398) for the treatment of pancreatic adenocarcinoma.

PharmaEngine debuted on Taiwan’s emerging stock market on Sept. 1, 2011.

PharmaEngine completed patient enrollment of PEP02 phase I study (PIST-CRC-01) for colorectal cancer in Taiwan.

US FDA granted orphan drug status to PEP02 (MM-398) for the treatment of pancreatic cancer.

Taiwan Securities & Futures Bureau (SFB) approved PharmaEngine stock to go public.

PharmaEngine presented a poster “Phase II study of PEP02 for patients with gemcitabine-refractory metastatic pancreatic cancer” at ASCO Annual Meeting 2011.

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.

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.

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

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

PharmaEngine completed patient enrollment for a combination of PEP02 with 5-FU/LV phase I study (PEP0203) in solid tumor.

PharmaEngine presented a poster Phase I study of liposome encapsulated irinotecan (PEP02) in advanced solid tumor patients at ASCO Annual Meeting 2008.

PharmaEngine completed a PEP02 single-agent phase I study.

PharmaEngine expanded PEP02 license to the European territory.

PharmaEngine completed PEP02 process scale-up and preclinical studies. PharmaEngine filed IND in Taiwan.

PharmaEngine completed the first round of fundraising with NTD630 million (~US$20 million).

PharmaEngine licensed liposomal irinotecan (PEP02) for Asia territory, including Japan, from Hermes Biosciences, Inc.

PharmaEngine began operation on Feb. 6, 2003.