“2022 Drug Approval Report: Highlights of New Medicines Approved by the Korean Ministry of Food and Drug Safety”

On the 27th, the Ministry of Food and Drug Safety (Minister Oh Yoo-gyeong) published the ‘2022 Drug Permission Report’, which contains the status of drug approval and notification last year.

Looking at the report, a total of 1,636 items were approved/notified as medicines last year. The main characteristics are △approval of 2 new drugs (corona 19 vaccine and diabetes treatment) △approval of 8 items of COVID-19 vaccine △treatment of intractable and rare diseases 29 items were approved for orphan drugs to expand opportunities △ ‘metabolite drugs’ such as diabetes drugs ranked first among drug efficacy groups △ generic drug approval continues to decline.

Last year, the Ministry of Food and Drug Safety approved a total of 30 items for 22 ingredients. Among them, domestically developed new drugs are two items (two ingredients): a COVID-19 vaccine that injects antigens made with genetic recombination technology and a new ingredient diabetes treatment.

In addition, in a situation where the number of confirmed cases of Corona 19 increased again due to the spread of Omicron mutation last year, the ‘Corona 19 bivalent vaccine’ that expresses each antigen of the initial virus and the mutant virus (Omicron BA.1) was approved. A total of 8 Corona 19 vaccines were approved, including Corona 19 vaccines for infants (6 months to 4 years old) and children (5 to 11 years old).

By type, 6 mRNA vaccines and 2 recombinant vaccines were approved, and 3 items were approved for domestic manufacturing.

In particular, ‘Skycobione Multi Inj.’ is a COVID-19 vaccine developed and manufactured by a domestic pharmaceutical manufacturer, approved by the Ministry of Food and Drug Safety for the first time in the world. As a result, Korea has the Corona 19 treatment’Leckironaju’ (permitted on February 5, 2021) and a vaccine at the same time.

Last year, a total of 29 items of 22 ingredients were approved for orphan drugs. As various orphan drug items and ingredients have been approved for the past four years, treatment opportunities for patients with rare diseases such as intractable leukemia and relapsing multiple sclerosis, which had low medical access, have expanded.

By efficacy group, circulatory drugs, which ranked first in 2021, and metabolic drugs, which ranked second, took first place with 629 items (43.3%) approved last year. Following that, last year, drugs for the nervous system, drugs for the circulatory system, and drugs for the digestive system were approved. We believe the expansion of the market, such as the recent decline in the age group of diabetic patients, has had an impact.

As for detailed classification, ‘diabetes concomitant drugs’ accounted for 41.3% of the total approved items with 599 items, antipyretic/pain reliever/anti-inflammatory drugs 8.3% (120 items), other vitamins 4.6% (67 items), and other circulatory system drugs. Drugs for the autonomic nervous system were 4.2% (61 items), and drugs for the autonomic nervous system were 3.0% (43 items), forming the top 5.

Last year, the number of approved/notified items (1636 items) decreased by 540 items (27.9%) compared to the previous year (2270 items). items) decreased by half.

The Ministry of Food and Drug Safety said, “We will continue to use the analysis data on drug approval and notification status for policy establishment, and continue to support drug product development by providing this information.”