Record number of new homegrown drugs released this year

from Leclaza to Fexclu

New drugs from Yuhan Corp, Celltrion, Hanmi Pharmaceutical and Daewoong Pharmaceutical approved this year

Exceeded the record of three homegrown new drug approvals in 2011 and 2015

Major companies with annual sales record of 1 trillion won made the performance

Domestic pharmaceutical and biopharmaceutical companies this year had received approval for four new drugs.

 

This is the most amount of new drugs released in a single year since the first homegrown drug was introduced in 1999.

 

Major companies with an annual sales record of 1 trillion won such as Yuhan Corp, Celltrion, Hanmi Pharamcetucial, and Daewoong Pharmaceutical have made this performance.

 

According to the Ministry of Food and Drug Safety on the 31st, Daewoong Pharmaceutical’s gastroesophageal reflux disease (GERD) treatment ‘Fexclu,’ which contains fexuprazan, was approved as a new drug on the 30th.

 

Daewoong Pharmaceutical made this achievement in 14 years since it first started the development of Fexclu in 2007.

 

Fexclu is a potassium-competitive acid blocker (P-CAB) GERD treatment.

 

It has a faster onset of action than proton pump inhibitors (PPIs) and has the advantage of being able to be taken regardless of meal ingestion and the longer-lasting effect.

 

These types of drugs had quickly settled in the market since HK inno.N introduced its first P-CAB type of new drug ‘K-CAB’ in 2018.

 

With the approval of Fexclu, a total of 4 new homegrown drugs by local pharmaceutical and biopharmaceutical companies this year.

 

First was Yuhan Corp’s anticancer drug ‘Leclaza’ in January, followed by Celltrion’s COVID-19 treatment ‘Regkirona’ in February and March, and Hanmi Pharmaceutical’s neutropenia treatment ‘Rolontis.’ In January, Leclaza received conditional approval for the treatment of patients with advanced non-small-cell lung cancer who have a mutation in a specific gene (EGFR) who have previously received lung cancer treatment.

 

Leclaza is a targeted anticancer therapy that inhibits the signal transduction that is involved in lung cancer cell proliferation and growth.

 

It is an oral tyrosine kinase inhibitor (TKI) that has high selectivity against the EGFR T790M resistant mutation.

 

It showed superior efficacy and tolerability against lung cancer patients with brain metastasis as it can pass through the blood-brain-barrier (BBB).

 

Celltrion’s COVID-19 antibody treatment ‘Regkirona’ received conditional approval in February.

 

Regkirona Inj.

 

is a recombinant neutralizing antibody produced by selecting a neutralizing antibody gene in a COVID-19 convalescent patient's blood and inserting the selected gene into a host cell that is cultured for large-scale production.

 

Regkirona is the first locally developed COVID-19 treatment and the third COVID-19 antibody treatment in the world to be verified by the regulatory authority.

 

It received marketing approval based on its Phase III trial results in August and its indication was extended to the treatment of high-risk adult patients with mild and moderate symptoms who have been confirmed with COVID-19 according to the provisional pathway.

 

In March, Hanmi Pharmaceutical’s Rolontis Pre-filled Syringe inj.

 

was approved as a new locally developed new drug.

 

Rolontis uses recombinant technology to connect a specific protein to a human’s granulocyte-colony stimulating factor (G-CSF) analog to increase the sustainability of its effect.

 

It is used to treat chemotherapy-induced neutropenia.

 

It binds to the G-CSF receptor to stimulate neutrophil production.

 

This year, domestic pharmaceutical and biopharmaceutical companies have broken the record and received approval for the largest number of homegrown new drugs in a single year, and in three years since HK inno.N received approval for K-CAB in 2018.

 

That these new drugs were released after a long period of time by major companies that recorded annual sales exceeding 1 trillion won - Yuhan Corp, Celltrion, Hanmi Pharmaceutical, and Daewoong Pharmaceutical – is also being considered significant.

 

Yuhan Corp released its second novel drug this year in 16 years since ‘Revancex’ in 2005.

 

Regkirona was Celltrion’s first new drug.

 

Celltrion had focused on biosimilars, but with the spread of COVID-19 in earnest, the company had entered into the treatment development business and succeeded in the commercialization of the treatment within a year.

 

Rolontis is the first new biologic and the only new drug Hanmi Pharmaceutical succeeded in commercializing and is in sale.

 

Hanmi Pharmaceutical had received approval for its NSCLC treatment ‘Olita’ in 2016 but announced the discontinuation of its development after three years, based on the strategic judgment that stopping the development is more beneficial than bearing the cost of Phase 3 clinical trial.

 

Daewoong Pharmaceutical succeeded in developing a new drug in 20 years since Easyef in 2011.

 

It is evaluated that the potential of success of Fexclu is high as the same class drug K-CAB’s marketability was recognized in the industry.