[FOCUS] 10 ‘global new drugs’ promised 10 years ago

In 2011, the government formed Korea Drug Development Fund (KDDF) to provide inter-ministerial level support for developing new drug.

 

Ministry of Science and ICT (MSIT), Ministry of Trade, Industry and Energy (MOTIE) and Ministry of Health and Welfare (MOHW) laid down a plan to develop more than ten global-level new drugs by investing on R&D together.

 

The initial plan was to invest 1.6 trillion won for ten years until 2020 (530 billion won by the government, 530 billion won by private investment).

 

According to the plan, Korea should be able to release ten new drugs by the end of this year.

 

But it seems unrealistic at the moment.

 

Considering Korea’s pharmaceutical and bio industry’s reality, the barrier of global market was too high.

 

When Hanmi Pharmaceutical signed a series of giant license-out deals on investigational technology in 2015, the Korean pharmaceutical and bio industry was exhilarated.

 

Everyone celebrated the advancement Korea has achieved in pharmaceutical and bio sector.

 

But the excitement did not last long.

 

For a long while, no other news of notable out licensing deals was reported.

 

And when a few of licenses were returned to Hanmi Pharmaceutical, the industry’s rosy dream subsided.

 

In fact, many were skeptical about the exaggerated expectation on the industry.

 

Only then, more voices spoke out about keeping the head cool.

 

In hindsight, more realized the Korean pharmaceutical and bio industry’s landscape has not been progressing, except for the exceptional performance by Hanmi Pharmaceutical.

 

Since then, not only traditional pharmaceutical companies, but also bio ventures, such as Dong-A ST, Yuhan, SK Chemicals, SK Biopharmaceuticals, Legochem Biosciences, BridgeBio Pharma, Alteogen, and iNtRON Biotechnology, inked out licensing deals.

 

Global pharmaceutical giants like AbbVie, Janssen, and Boehringer Ingel Heim shook hands with Korean companies.

 

And Celltrion and Samsung Bioepis are now leading the global biosimilar market.

 

Now the Korean industry is yet again dreaming on about drawing level with global pharmaceutical powerhouses.

 

But the truth is we still have a long way to go.

 

Last year, the U.S.

 

Food and Drug Administration (FDA) cleared two new drugs by SK Biopharmaceuticals, but only five investigational drugs developed with Korean-made technology have passed the U.S.

 

health authority so far.

 

None of them reached the level, what would be viewed as ‘global commercialization success.’ Finished pharmaceutical product export in 2018 generated 3.40 trillion won, which was not even 20 percent of overall manufactured volume of 18.54 trillion won.

 

Contrastingly, 4.89 trillion won of overseas finished products, significantly higher than the export, were imported in the same year.

 

Finished product made in Korea used in Korea has gone down lower than the previous year to 75.6 percent.

 

Some of Korean pipelines transferred to other global companies were dropped before reaching the commercialization stage.

 

And in the near future, more out-licensed technologies are likely to be returned than successfully made into a finished product.

 

Recent global drug development trend has more progressive new drugs proceeding faster than Korean pipelines.

 

In some cases, technology development partner companies have lost interest in pursuing Korean companies’ pipeline with other similar candidate medicines available.

 

Even worse, many Korean bio companies reported disappointing news of failed pipeline and clinical trials to their investors last year.

 

Stock market was shaken by rumors spreading with mixed facts and hopes.

 

Share price fluctuated from maximum to minimum limit for days.

 

Obviously, it is possible for a Korean company to soon bring surprise news of making a big global success.

 

But even so, it would mean outstanding performance of the company and not the whole Korean corporate R&D landscape’s.

 

For last few years, Korean pharmaceutical and bio industry has experienced a series of trial and error.

 

The ‘world’s first gene therapy’ turned out to have switched out active ingredient in production and its approval was revoked.

 

Such ridiculous ‘trial and error’ should not be repeated again.

 

Hopefully, this year would be the time for the industry to grow further based on the rough experiences.

 

This year, probably, Korean companies would hear many stories of hopes and failures.

 

And the entire industry should not be agitated or swayed by them.

 

Instead of heightened anticipation, what we need is keeping it calm and moving forward.