HLB Life Science, which holds the copyright
of Rivoceranib in Korea, has been approved by the Registry of Food and Drug
Safety (MFDS) for the use of clinical trial medicines as a treatment at Korean
medical sites, apart from the approval process for new drugs.
On the 21st, MFDS registered Rivoceranib in
the 'approval for therapeutic use' status of the integrated drug information
system. This allows Rivoceranib to be prescribed at a licensed hospital for the
treatment of terminal gastric cancer patients. The ‘approval for therapeutic use’
status is a system that authorizes life-threatening patients to use drugs at
the development stage, which allows terminal gastric cancer patients to choose
Rivoceranib as a new treatment option.
HLB ended the third phase of global
clinical trials for terminal gastric cancer patients conducted at 88 general
hospitals in 12 countries around the world in June last year and is currently
preparing to apply for a marketing permit. In addition, the company is
conducting global clinical trials on various indications such as liver cancer, Adenoid
Cystic Carcinoma (ACC), and colon cancer.
An HLB official said, "We are very
pleased that the following approval will open the way for patients suffering
from lack of alternative treatments to be prescribed Rivoceranib," and
added, "with using the strengths as an oral drug with fewer side effects, we
expect Rivoceranib to raise the quality of the patients’ lives."