PharmaEngine and GNTbm have both reported positive developments. PharmaEngine announced on the 17th that its oncology drug ONIVYDE has been approved by the National Health Insurance Administration (NHIA) for reimbursement as part of a first-line combination therapy for the treatment of metastatic pancreatic cancer, with an approved reimbursement price of NT$14,621 per vial. Meanwhile, GNTbm’s novel anti-breast cancer drug Tucidinostat (marketed in Taiwan under the brand name Kepida®) has also recently been approved for NHI reimbursement, with an approved price of NT$630 per tablet. Both reimbursement approvals will take effect on December 1. Institutional investors expect these inclusions to become an important driver of revenue growth next year.
ONIVYDE, PharmaEngine’s cancer drug, was first approved for NHI reimbursement in 2018 as a second-line treatment for patients with metastatic pancreatic cancer who had failed standard gemcitabine therapy. In 2024, ONIVYDE generated NT$279 million in sales in Taiwan, while sales for the first three quarters of this year reached NT$197 million, representing a year-on-year decline of 7%.
PharmaEngine noted that the decision to include ONIVYDE in NHI reimbursement for first-line combination therapy in metastatic pancreatic cancer was primarily based on data from the global, multi-country, multicenter Phase III clinical trial NAPOLI-3. This regimen has already been adopted as a first-line treatment for metastatic pancreatic cancer in multiple regions, including the United States, Europe, and the United Kingdom. According to the NHIA under the Ministry of Health and Welfare, ONIVYDE has been approved for NHI reimbursement as a first-line treatment for metastatic pancreatic cancer at a reimbursement price of NT$14,621 per vial, effective December 1, 2025.
GNTbm also recently announced that its domestically developed novel anti-breast cancer drug Tucidinostat (Taiwan brand name: Kepida®) has received support from the NHIA and expert review committees and has been approved for NHI reimbursement. Inclusion of Kepida® under the NHI program is expected to reduce the financial burden on patients and provide a new treatment option for patients with hormone receptor–positive, HER2-negative advanced breast cancer. Kepida® will be covered by NHI starting December 1. Based on the NHI reimbursement price of NT$630 per tablet, first-year drug expenditure is estimated at NT$65.47 million.
Kepida® is a new drug that GNTbm developed over a decade in Taiwan after obtaining patent licensing, in collaboration with well-known domestic active pharmaceutical ingredient and formulation manufacturers. The drug enrolled patients with advanced breast cancer from eight medical centers across Taiwan and completed a five-year pivotal Phase III clinical trial. In 2013, it received approval from the Taiwan Food and Drug Administration (TFDA) and was granted marketing authorization for a breast cancer indication. GNTbm submitted its application for NHI reimbursement for Kepida® in 2024 and subsequently received approval from the NHIA and expert committees, clearing the way for its inclusion in NHI coverage.
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