Out of 30 newly approved drugs in 2022, only 2 were made in Korea

Only two of the 30 new drugs approved last year in Korea were developed by domestic pharmaceutical companies, a government report showed.

The Ministry of Food and Drug Safety (MFDS) published the "2022 Drug Approval Report," which contains the status of drug approvals, on Friday.

According to the report, the number of drug approvals last year was 1,636, down 540 from 2,270 in 2021.

The two locally-developed new drugs were SK Bioscience's SKYCovione, a genetically recombinant Covid-19 vaccine, and Daewoong Pharmaceutical's Envlo, a diabetes drug.

In 2019 and 2020, no new drugs developed in Korea were approved, but in 2021, five were approved, followed by two last year.

Aside from locally-developed new drugs, the approval of generic drugs, which is a major source of revenue for Korean pharmaceutical companies, dropped from 1,614 in 2021 to 804 in 2022.

The MFDS attributed the decline in generic approval to the amendment to the Pharmaceutical Act in 2021, which limits the number of items that can share the same bioequivalence test to three.

Also, in response to the resurgence of Covid-19 cases due to the spread of omicron variants last year, the MFDS approved Covid-19 bivalent vaccines that express antigens from both the initial virus and the variant (omicron strain BA.1).

As a result, a total of eight Covid-19 vaccines received approval, including Covid-19 vaccines for infants (six months-four years) and children (five-11).

By vaccine type, six mRNA vaccines and two recombinant vaccines received marketing license.

Also, 29 orphan drugs received the permit last year.

The MFDS said has been approving various orphan drugs over the past four years thanks to the combination of national support for orphan drug development and pharmaceutical companies' strategies to capture unmet needs.

"Such high interest in orphan drugs has led to the expansion of treatment opportunities for patients with rare diseases such as incurable leukemia and relapsing-remitting multiple sclerosis, which has had limited access to medical care," the agency said.

By drug class, metabolic drugs, including diabetes drugs, accounted for the highest number of approvals, with 629 products, or 43.3 percent, surpassing circulatory system drugs, which took the top spot in 2021.

The MFDS explained that the increase in the number of approval of metabolic drugs is due to the expansion of the market, such as the recent decrease in the age of diabetic patients.