INTRO

INTRO
KOR
CHN

GemVax & KAEL

GemVax & KAEL is dedicated to healthy lives and improved quality of human life

PRODUCT

ABOUT RIAVAX™ inj.

RIAVAX™ inj. (Tertomotide HCl, code name GV1001™), the 21st Korean New Drug, is the immunotherapeutic peptide which received a marketing authorization from Korea MFDS on 15th September 2015, for the treatment of locally advanced or metastatic pancreatic cancer patients whose serum eotaxin level is higher than 81.02pg/mL

  • RIAVAX™ manufacturing & supply

    As GemVax & KAEL had not been provided with domestic manufacturing facilities, Korea MFDS approved NDA (new drug application) on the condition of possession of such facilities in September 2014. Since then, GemVax & KAEL acquired SAMSUNG Pharm and its manufacturing facilities, so marketing authorization was given by Korea MFDS in April 2015 accordingly and RIAVAX is currently supplied in a domestic market.

  • RIAVAX™ inj Prescribing Process

    One of the conditions of RIAVAX approval by Korea MFDS required that every single patient injected with RIAVAX has to be enrolled in Registry Program under the actual practice of medicine for thorough safety management of new drug after marketing. Only doctors and pharmacists who are trained for RIAVAX and registered with the Registry Program can prescribe and dispense RIAVAX. Therefore, patients have to enroll in the Registry Program after consulting a specialist in order to be prescribed with RIAVAX. If you have any question about this, please call +82 070-4367-2775 (PVPMS team).

Mechanism of Action

A foreign peptide (GV1001) is engulfed by Antigen Presenting Cells (APCs). APCs are specialized in initiating immune responses against “foreign” material. Thus, the GV1001 uptaken by the APCs in the skin is processed intracellularly, and the APCs presents the peptide/HLA complexes to the T-cells. Then, the activation of T cells takes place in the lymph nodes. The activated T-cells will circulate in the body to search for tumor cells displaying peptide/HLA complexes identical to the complexes presented to them by the APCs. The cancer cells will be killed when they are detected by the activated T-cells