Korea develops 2 new drugs and 2 biosimilars in 2022

Makes abundant R&D performance

SK Bioscience and Daewoong Pharmaceutical receives approval for the 35th and 36th homegrown new drugs... 6 drugs approved in 2 years

Celltrion, Samsung Bioepis, Chong Kun Dang, etc. succeed in commercializing biosimilars

In Korea, domestic pharmaceutical companies succeeded in developing 2 new drugs this year.

 

The new drugs developed by SK Bioscience and Daewoong Pharmaceuticals reached the commercialization stage.

 

This is the most amount of biosimilars developed in Korea in 7 years since 2015.

 

◆SK Bioscience receives approval for the first new homegrown COVID-19 vaccine...Daewoong receives marketing authorization for a new diabetes drug According to the Ministry of Food and Drug Safety on the 28th, domestic pharmaceutical and biohealth companies received approval for 2 new drugs this year.

 

In June, SK Bioscience’s COVID-19 prevention vaccine SKYCovione Multi inj received marketing authorization in Korea as the 35th homegrown new drug.

 

SKYCovione Multi Inj is a COVID-19 vaccine that induces an immunological response by administering the company’s proprietary gene recombination technology.

 

SK Bioscience first discovered the COVID-19 vaccine candidate jointly with the Institute for Protein Design at the University of Washington.

 

It was funded by Bill & Melinda Gates Foundation (BMGF) and Coalition for Epidemic Preparedness Innovation (CEPI), and the company succeeded in commercializing the drug after 2 years.

 

On the 30th of last month, Daewoong Pharmaceutical received approval for its diabetes treatment Envlo as the 36th new homegrown drug.

 

Envlo was approved as an adjunct to diet and exercise therapy in Type-2 diabetes patients.

 

Envlo may be used as monotherapy, metformin combination therapy, and metformin and gemigliptin combination therapy.

 

Envlo is the first SGLT-2 inhibitor class antidiabetic developed in Korea.

 

The drug reduces blood sugar levels by inhibiting the reabsorption of glucose in the kidneys and allowing it to be excreted as urine.

 

In October, Daewoong Pharmaceutical confirmed the blood sugar reduction effect and safety of the drug through a Phase III trial that was conducted on Type 2 diabetes patients.

 

Envlo was first developed by GC Corp, and Da Daewoong acquired its exclusive license in 2016.

 

With this, a total of 6 new drugs developed by Korean pharmaceutical companies were approved in the past 2 years, starting last year.

 

In January last year, Yuhan Corp’s anticancer drug ‘Leclaza’ was approved, and in February and March, Celltrion’s COVID-19 treatment ‘Regkirona’ and Hanmi Pharmamceutcial’s neutropenia treatment ‘Rolontis’ received MFDS approval, respectively.

 

In December last year, Daewoong Pharmaceutical’s ‘Fexclu’ was listed as the 34th new domestically developed drug.

 

◆3 homegrown biosimilars enter the market for the first time in 7 years since 2015 Korean pharmaceutical and bio companies have received approval for 3 biosimilars this year.

 

Celltrion, Samsung Bioepis, Chong Kun Dang etc.

 

succeeded in commercializing one biosimilar each this year.

 

In May, Samsung Bioepis received approval for its Lucentis biosimilar Amelivu in Korea.

 

Lucentis, which is being marketed by Roche and Novartis, is a drug used to treat macular degeneration and diabetic macular edema.

 

It is a blockbuster drug that made KRW 4.4 trillion in global sales last year.

 

Amelivu is the first biosimilar of Lucentis to be introduced to Korea.

 

In October, Chong Kun Dang received marketing authorization in Korea for its Lucentis biosimilar, LucenBS.

 

In September, Celltrion’s Avastin biosimilar, the anticancer drug Vegzelma was approved.

 

And in March last year, Samsung Bioepis received approval for the first Avastin biosimilar Onbevzi, followed by Celltrion.

 

No.

 

of approved biosimilars developed by Korean companies by year (Unit: product amount, Data: MFDS)

This is the first time in 7 years since 2015 that Korean pharma and bio companies received approval for 3 biosimilars.

 

In 2012, Celltrion first released its Remicade biosimilar Remsima and then a Herceptin biosimilar Herzuma in 2014.

 

In 2015, Celltrion developed 1 and Samsung Bioepis developed 2 biosimilars.

 

Celltrion received approval for Mabthera biosimilar Truxima, and Samsung Bioepis commercialized its Enbrel and Remicade biosimilar Etoloce and Remaloce.

 

In 2017, Samsung Bioepis received approval for Adaloce and Samfenet.

 

Their respective original drugs are Humira and Herceptin.

 

In 2018, LG Chem and Chong Kun Dang developed one biosimilar each, and last year, Samsung Bioepis and Celltrion received approval for one biosimilar each.

 

By company, Samsung Bioepis received approval for most biosimilars, with 6 approvals.

 

Celltrion follows with 5 approvals.