40 new drugs licensed last year

Licensed 24 rare drugs, more than doubled from the previous year

Last year, a total of 40 new drugs were licensed in Korea, with five items manufactured by domestic pharmaceutical companies.

 

One item of Yooyoung Pharmaceutical Co., Ltd.'s anti-arthritis treatment and four items of Hwanin Pharmaceutical Co., Ltd.

 

were listed as new drugs.

 

Rare drugs have also been licensed, up sharply from the previous year.

 

The expedited review of treatments such as Remdesivir was also made due to the epidemic of COVID-19 infectious diseases.

 

Domestic pharmaceutical companies were found to have been active in developing salt modified drugs for compounding drugs and patent avoidance purposes.

 

The MFDS announced that it published the "Approval report of 2020 drugs" on the 30th of last month, which contains the current status of drug approvals and reports for the previous year.

 

A total of 3,496 drugs were licensed and reported last year, with 40 new drugs, 24 rare drugs, 6 new drugs developed in Korea, and 2 equivalent biosimilar drugs developed in Korea.

 

Last year's major characteristics of licensed medicines include ▲ expedited review of COVID-19 treatments ▲ increase in rare drug permits ▲ increase in new drug product permits ▲ the largest proportion of licensed drugs.

 

In July last year, the MFDS quickly approved the COVID-19 treatment "Veklury (Remdesivir)" (Gilead Science Korea) as an imported medicine for stable treatment of domestic patients.

 

This is an example of a preemptive response to the national health crisis and establishing a system to supply medical supplies.

 

Rare drug approval has also increased significantly.

 

The number of rare drug item permits declined slightly from 34 items in 2016 to 11 items in 2019, but it turned upward last year and 24 items (14 active ingredients) were licensed.

 

This is believed to be due to the industry's sufficient compliance with the requirements for submission of item permits for rare drugs, which were strengthened under the revised regulations in July 2015, and the level of safety management for rare drugs has also increased.

 

The number of new drugs has been steadily increasing since 40 items were licensed last year, with 35 new imported drugs and five new domestically manufactured drugs being licensed.

 

The new drug was licensed from 15 items (12 ingredients) in 2018 to 35 items (21 ingredients) in 2019 and 40 items (20 ingredients) in 2020.

 

34 items of chemicals and 6 items of biological drugs (all imported) were licensed, and 13 items of anti-cancer drugs were licensed by the medicinal group, accounting for a high proportion of 32.5% of the total.

 

New drugs developed in Korea decreased from a year earlier to six items, but biosimilars were licensed for two items, similar to the previous year.

 

Five new chemo drugs in Korea are one treatment for slime arthritis and four anti-epidemic drugs, while six new biomedical drugs include PNH treatment and macular degeneration treatment.

 

Permits for "new products" were also increased last year.

 

Of the 326 items subject to the safety and validity review last year, 182 items (55.8%) were licensed and developed intensively, with 154 items (84.6%) containing Rosuvastatin calcium for hyperlipidemia.

 

The development of drugs using new salts or isomers ,which are used for patent avoidance purposes, also increased sharply from two items in 2019 to 74 items in 2020.

 

This is due to the development of a new salt for active ingredients used in diabetes drugs, which is analyzed to be due to the industry's strategy to preempt the diabetes drug market.

 

Of the total 3,110 licensed items, "blood circulation medicine," which includes "HTN treatment," was the most licensed item with 581, accounting for 18.7%.

 

This is similar to 902 items licensed in 2019, accounting for 18.8 percent of the total, and it is analyzed to be due to the continued expansion of the blood pressure drug market, including aging population.

 

554 fever, pain and anti-inflammatory drugs (17.8%), 425 digestive medicine (13.7%), 337 other metabolic and diabetic drugs (12.1%), 121 blood and body medicine (3.9%), 102 allergy drugs (3.3%), and 95 antibiotic drugs (3.1%) were licensed.