Dr. Nguyen Hong Vu, formerly of the City of Hope research institute in California, explained that Pembroria contains the active ingredient Pembrolizumab, with a concentration of 100mg/4mL. This compound is also the key component in Keytruda - a globally recognized cancer immunotherapy developed by Merck.

Pembrolizumab is a humanized monoclonal antibody targeting the PD-1 protein. This mechanism works by "reawakening" the patient’s immune system to identify and attack cancer cells. The antibody is developed in mice genetically modified with human genes and then mass-produced using CHO (Chinese hamster ovary) cells.

Keytruda underwent extensive preclinical and clinical trials (phases I, II, and III) and was first approved by the U.S. Food and Drug Administration in 2014 for treating malignant melanoma. Its use has since been expanded to over 15 different cancer indications.

As for Pembroria, Dr. Vu emphasized that there is not yet sufficient publicly available clinical data to confirm its full equivalency to Keytruda.

In its approval decision, the Drug Administration of Vietnam required that the manufacturer submit updates on the progress of phase III immunogenicity studies every three months. Upon completion, they must also submit updated clinical data as part of the regulatory review process.

Based on the drug registration documents, Pembrolizumab is currently approved for more than 14 types of cancer, including non-small cell lung cancer, melanoma, colorectal cancer, cervical cancer, renal cell carcinoma, and breast cancer.

Phuong Thuy