PharmaEngine, Inc. (TWO:4162) announces commercial product ONIVYDE® in combination with oxaliplatin, fluorouracil and leucovorin will be included in Taiwan National Health Insurance (NHI) reimbursements for first-line metastatic pancreatic adenocarcinoma treatment effective on Dec. 1st, 2025.

 

The evaluation for including ONIVYDE® in NHI reimbursement for first-line metastatic pancreatic adenocarcinoma treatment was primarily based on the Phase III global NAPOLI-3 trial NCT04083235, a total enrollment of 770 patients, which assessed ONIVYDE® in combination with oxaliplatin, fluorouracil, and leucovorin. In previously untreated metastatic pancreatic adenocarcinoma patients, this regimen demonstrated manageable safety profile and statistically significant improvements in overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) compared to patients with the gemcitabine/nab-paclitaxel treatment, without compromising quality of life. This combination is already approved as a first-line treatment for metastatic pancreatic adenocarcinoma in multiple countries including the US, EU and the UK.

 

PharmaEngine President and CEO, Hong-Ren Wang, Ph.D., stated “PharmaEngine supports the government's Healthy Taiwan Cultivation Plan which aims to provide patients in Taiwan with more medical options and ensures the accessibility and fair distribution of medical resources.” He added “ONIVYDE® is evidence-based and utilizes a standardized treatment model. While first-line treatment options for metastatic pancreatic adenocarcinoma remain limited, the inclusion of ONIVYDE® in Taiwan National Health Insurance coverage not only broadens therapeutic options but also alleviates the financial burden on patients, enabling access to timely and appropriate treatment.”

 

According to the 2022 Cancer Registry Report by the Ministry of Health and Welfare, there were 2,774 pancreatic cancer patients in Taiwan. Latest data from the Ministry of Health and Welfare showed that in 2024 pancreatic cancer ranked seventh among the top ten causes of cancer death in Taiwan.

 

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About ONIVYDE®

ONIVYDE® is a cancer medicine that blocks an enzyme called topoisomerase I, which is involved in copying cell DNA needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and eventually die. In ONIVYDE®, irinotecan is enclosed in tiny fat particles called ‘liposomes’, which accumulate in the tumor and release slowly over time.

 

ONIVYDE® is currently approved in most major markets including the U.S., Europe and Asia in combination with fluorouracil and leucovorin for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy. On 13 February 2024, the U.S. Food and Drug Administration approved ONIVYDE® in combination with oxaliplatin, fluorouracil and leucovorin (NALIRIFOX), for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma in the U.S. In March 2024, ONIVYDE® in combination with oxaliplatin, fluorouracil and leucovorin (NALIRIFOX), for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma also obtained approvals from Taiwan’s TFDA and other countries.

 

PharmaEngine is responsible for the commercialization of ONIVYDE® in Taiwan. Ipsen, has exclusive commercialization rights for the current and potential future indications for ONIVYDE® in the U.S. and Canada. Servier is responsible for the commercialization of ONIVYDE® outside of the U.S., Canada and Taiwan.

 

About PharmaEngine, Inc.

PharmaEngine, Inc., headquartered in Taipei, began operations in February 2003. PharmaEngine focuses on new drug development by adopting “Virtual Pharmaceutical Company Business Model”. PharmaEngine has one commercial product, ONIVYDE®, which is currently approved for the treatment of adult patients with metastatic pancreatic adenocarcinoma. PharmaEngine also conducts, collaborates or licenses-in new drug discovery and development projects. With extensive experience in drug development and project management, we continue to expand our pipeline and accelerate drug development and the subsequent commercialization of new medicines.

 

Media Contact: ChiHsing Chang, Spokesperson/Vice President (info@pharmaengine.com)