About Us

Our Portfolio

ONIVYDE®

ONIVYDE® (PEP02, MM-398, nal-IRI) was approved by the US FDA, Taiwan FDA, EMA and other regulatory agencies among 38 countries worldwide for patients with gemcitabine-treated metastatic pancreatic cancer.

PEP503

PEP503 (NBTXR3), a radio-enhancer, has completed the recruitment in a global pivotal clinical study of soft tissue sarcoma, and phase I/II studies of both rectal cancer and head and neck cancer in Taiwan.

PEP06

PEP06 is a new chemical entity (NCE) for cancer treatment in preclinical development.

Indications & Stages

ONIVYDE

(Irinotecan liposomal injection)

Pancreatic Cancer (2nd-line)
More Indications
Pancreatic Cancer (1st-line)
Small Cell Lung Cancer (2nd-line)
Various ISTs
PEP503

(Crystalline hafnium oxide)

More Indications

*Collaboration with Nanobiotix  **Nanobiotix clinical study

PEP06
Solid Tumor

Our Pipeline

 01. CLINICAL TRIAL DESIGN

The clinical trial or study design is a key aspect of the successful conduct of clinical trials. It involves deciding parameters such as the number of patients, the length of the trial, the comparator arm (in the case of randomized controlled trials) using information on current treatments, the anticipated effect of the therapeutic intervention being studied and applying biostatistics methods.

02. PIVOTAL CLINICAL TRIAL

Usually, a phase III study which presents the data that regulatory agencies use to decide whether or not to approve a drug.

A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind.

03. SAFETY VIGILANCE

Safety Vigilance or Pharmacovigilance (PV) is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
The aims of PV are to enhance patient care and patient safety in relation to the use of medicines and to support public health programs by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.

American Society of Clinical Oncology
Taiwan Joint Cancer Conference
ClinicalTrials.gov

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