China NMPA Approves ONIVYDE Regimen for the Treatment of Metastatic Pancreatic Cancer Following Gemcitabine Based Therapy

PharmaEngine (TWO: 4162), a global, science-driven biotechnology company focused on developing innovative medicines, today announced that ONIVYDE® in combination with fluorouracil (5-FU) and leucovorin (LV) has been approved by China National Medical Products Administration (NMPA) for the treatment of patients with metastatic pancreatic cancer after disease progression following gemcitabine-based therapy.

Pancreatic cancer remains one of the most lethal malignant diseases worldwide. It is commonly diagnosed at an advanced stage, when no curative options exist. Over the last decade, combination chemotherapy has shown a survival benefit compared with single-agent gemcitabine and has become established as first-line therapy in metastatic pancreatic cancer. However, almost all patients with advanced pancreatic cancer will experience disease progression after first-line therapy. ONIVYDE® regimen has been approved in multiple countries for standard of care as the second-line treatment since 2015.

The approval from NMPA is based on data from the phase III NAPOLI 1 study (NCT01494506). The NAPOLI 1 study demonstrated that ONIVYDE® in combination with 5 FU/LV extended overall survival, progression free survival and increased tumor response rate, without compromising quality of life as compared to 5 FU/LV alone in metastatic pancreatic cancer patients who have progressed after gemcitabine based therapy.

About PharmaEngine (TWO: 4162)

PharmaEngine, Inc. is a commercial stage oncology company headquartered in Taipei, focusing on the development of new medications for the treatment of cancer. PharmaEngine, Inc. has two ongoing projects: ONIVYDE® (Irinotecan Liposome Injection) has received marketing authorizations more than 40 countries worldwide, including Taiwan, US, EU, Australia, Canada, Japan, South Korea and Singapore, for the treatment of metastatic pancreatic cancer patients who have progressed on gemcitabine; PEP07, a CHK1 inhibitor, is under development at pre-clinical stage. For further information, please visit the company website (


ONIVYDE®, also known as nal-IRI, MM-398 or PEP02, is a novel encapsulation of irinotecan in a liposomal formulation. PharmaEngine, Inc. has Taiwan exclusive commercial rights, Ipsen (Euronext: IPN; ADR: IPSEY) acquired the US exclusive new indication development and commercial rights, the exclusive rights for rest of the world are owned by Servier. ONIVYDE® has been approved in Taiwan, US, EU, Australia, Canada, Japan, South Korea and Singapore since 2011. It also received orphan drug designations in the US, EU, and other countries.


Chihsing Chang
Vice President, Finance and Administration
TEL +886 2 2515 8228, ext. 700
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