[Reporter’s View] Next year wishes for the industry

“Last year, not one of Korean-made new drug was approved by the U.S.

 

Food and Drug Administration (FDA).

 

Ever since hemophilia treatment Aftyla was passed in 2016, Korean drugs have not been able to get a green light from the U.S.

 

health regulator for two consecutive years.

 

However, the industry is expected to bring a series of good news this year about Korean drugs entering the U.S.

 

market.” In the beginning for the year, Daily Pharm had opened an article with the lead.

 

And as predicted, Korean pharmaceutical and bio companies had a year filled with good news.

 

Starting from Yuhan closing a license-out deal with Gilead Sciences on candidate medicine for non-alcoholic steatohepatitis (NASH), SK Biopharmaceuticals, OliX Pharmaceuticals, LegoChem Biosciences, Bridge Biotherapeutics, JW Pharmaceutical and Alteogen also scored license-out deals.

 

Total nine license-out deals from January to November this year were closed by Korean pharmaceutical and biotechnology companies for 290 billion won.

 

Also, other good news reported new pipelines developed with Korean-made technology have been approved in global markets.

 

The U.S.

 

FDA gave a nod respectively on treatment for excessive daytime sleepiness associated with narcolepsy, Sunosi (solriamfetol), and for partial-onset seizure, Xcopri (cenobamate) that SK Biopharmaceuticals licensed out to Jazz Pharmaceuticals.

 

Led by botulinum toxin medicine Nabota developed by Daewoong Pharmaceutical, Samsung Bioepis and Celltrion’s biosimilars also had a notable achievement of grabbing foreign regulators’ approval this year.

 

Although they were not first-in-class breakthrough drugs, Nabota and the biosimilars have been making profits from global markets in competition against other blockbuster drugs.

 

Celltrion Healthcare has generated total of 800 billion won up to the third quarter with three biosimilars, Resima, Truxima and Herzuma.

 

The volume surged by 60 percent from the same time last year.

 

Samsung Bioepis selling three biosimilars—Benepali, Flixabi and Imraldi—in European market is expected to turn around for the first time in the year with accumulated net profit of 97.2 billion won up to the third quarter.

 

Unfortunately, the industry had to endure a number of setbacks as well.

 

Following the sales ban on Kolon Life Science’ Invossa, emerging biotechnology companies like Sillajen, Helixmith, and HLB Life Science released regretful news of failed clinical trials and left the public doubtful of the pharmaceutical and bio industry.

 

Hanmi Pharmaceutical with the most aggressive R&D investment strategy in Korea had to give up on two R&D milestones from its license-out deal, whereas botulinum toxin companies like Medytox and Hugel stagnated with litigation over the source of strain and regulation on Chinese resellers.

 

In contrast, the sluggish bio stocks growth having to turn around recently gave a hint of hope for next year.

 

Investors are expecting the J.P.

 

Morgan Healthcare Conference 2020 in January to be a catalyst to drive up the bio stocks.

 

The J.P.

 

Morgan Healthcare Conference is the one of the world’s most renowned conferences for the bio sector.

 

It has been reported major pharmaceutical and biosimilar companies from Korea, such as Hanmi Pharmaceutical, Yuhan, Daewoong Pharmaceutical, JW Pharmaceutical, Dong-A ST, Celltrion and Samsung Biologics, as well as other bio companies like Medytox, Hugel and ABL Bio are planning to participate in the event.

 

Moreover, the industry predicts SK Biopharmaceuticals going public in the first half of next year would also boost investors’ confidence.

 

Hopefully, Korean pharmaceutical and bio industry would achieve even more R&D milestones in year 2020.