R & D PIPELINE

Our Portfolio

ONIVYDE®

ONIVYDE® (PEP02, MM-398, nal-IRI) has received marketing authorizations in Taiwan, US, Europe and other countries for the treatment of metastatic pancreatic cancer patients who progressed on gemcitabine.

PEP503

PEP503 (Hensify®, NBTXR3), a radio-enhancer, has received CE Mark enabling commercialization in 27 European Union countries for the treatment of locally advanced soft tissue sarcoma. Other studies including a Phase I/II trial in head and neck cancer and a phase I/II trial in rectal cancer are being conducted in Taiwan.

PEP06

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

Indications & Stages

  • RESEARCH
  • PRECLINICAL
  • PHASE I
  • PHASE II
  • PHASE III
  • NDA

ONIVYDE®Irinotecan liposomal injection

Pancreatic Cancer (2nd-line)
APPROVED
MORE INDICATIONS
Pancreatic Cancer (1st-line)
PHASE II/III TRIAL ONGOING
Small Cell Lung Cancer (2nd-line)
PHASE II/III TRIAL ONGOING
Various ISTs
ONGOING PHASE I OR PHASE II DESIGNS

PEP503Crystalline hafnium oxide

Soft Tissue Sarcoma*
CE MARK
MORE INDICATIONS
Head & Neck Cancer (RTx alone)**
PHASE I/II TRIAL ONGOING
Liver Cancer (RTx alone)**
PHASE I/II TRIAL ONGOING
Prostate Cancer (RTx alone)**
PHASE II/III TRIAL ONGOING
Head & Neck Cancer (RTx + chemo)
PHASE II/III TRIAL ONGOING
Rectal Cancer (RTx + chemo)
PHASE II/III TRIAL ONGOING
H&N & Lung Cancer (RTx + anti-PD-1/PD-L1)**
IND APPROVED

*Collaboration with Nanobiotix **Nanobiotix clinical study

PEP06PEP06

Solid Tumor
ONGOING

Glossary & Links

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.

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.

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.

Go To Top