The Ministry of Health headquarters in Hà Nội. — VNA/VNS Photo

HÀ NỘI — Việt Nam’s Ministry of Health has granted market authorisation to Pembroria, a Russian-made anti-cancer drug containing the active ingredient pembrolizumab, along with 13 other vaccines and biological products.

Under Decision No. 628/QĐ-QLD, signed on October 31 by DAV Director Vũ Tuấn Cường, 14 vaccines and biologicals were approved for three-year circulation in Việt Nam as part of the ministry’s 57th registration round.

Pembroria (with the main active pharmaceutical ingredient being Pembrolizumab, at dosage 100mg/4ml packaged into one bottle), produced by the Russian company Limited Liability “PK-137” and registered through a firm based in the United Arab Emirates, is formulated as a concentrated solution for intravenous infusion. It has a shelf life of 24 months from the date of manufacture.

Notably, according to information provided by the registrant, pembrolizumab is used in treating more than 14 types of cancer, including lung carcinoma, melanoma, colorectal cancer, cervical cancer, renal cell carcinoma, and breast cancer.

Cancer remains a growing health burden in Việt Nam. The GLOBOCAN 2022 report estimated 180,480 new cancer cases and 120,184 deaths nationwide, with breast, liver, lung and colorectal cancers among the most common.

Current cancer treatments in Việt Nam include surgery, chemotherapy, radiotherapy, targeted therapy and immunotherapy – areas in which new-generation drugs like pembrolizumab play an increasingly important role.

Besides Pembroria, the latest authorisation round also includes vaccines and biologicals used in the treatment of stroke, lupus, osteoporosis, skin diseases, rheumatoid arthritis, ankylosing spondylitis, blood disorders, and multiple sclerosis.

Under the decision, manufacturers and registrants are required to guarantee that the production and supply of medicines conform to dossiers submitted to the Ministry of Health.

They must maintain compliance with Good Manufacturing Practices (GMP) standards and promptly report to the ministry within 15 days if the production licence is revoked or GMP certification withdrawn by the competent authority in the producing country.

The registrant must also coordinate with healthcare facilities to comply with existing regulations on prescription drugs, monitor the drug’s safety and efficacy among Vietnamese patients, and submit periodic reports on adverse effects and usage outcomes.

The drug administration further instructed the company to provide quarterly updates on the progress of its ongoing phase III immunogenicity studies and to submit supplementary data once the research is completed.

Prof. Dr. Lê Văn Quảng, Director of K (Cancer) Hospital, told Tiền Phong newspaper that the hospital will soon introduce this drug into treatment for patients.

According to Prof. Quang, this drug is not yet covered by health insurance.

Currently, the cost of Pembroria is about VNĐ18 million (US$580)/bottle. Patients usually use 2 bottles for 1 treatment course. — VNS