[Reporter's view] The goal of global new drug development

When the government announced the 'Third Five-Year Comprehensive Plan to Foster and Support the Pharmaceutical Bio Industry', it was emphasized that it would create three new blockbuster drugs that record global sales of more than 1 trillion won by 2030.

 

For this purpose, strategic R&D investment was selected as a key task.

 

In the development of new drugs, it is planned to significantly increase public and private R&D investment.

 

Looking at the detailed support measures, the government plans to promote R&D investment of a total of 25 trillion won jointly with the private sector for 5 years with 10 global new drug development goals.

 

The government also expects to invest 4 trillion won in government R&D and 21 trillion won in private R&D from this year to 2027.

 

Based on the national new drug development project that inherited the results of the pan-governmental new drug development project from 2011 to 2020, a joint public-private investment of 2.2 trillion won was invested to develop one new blockbuster drug and three new drugs by 2035.

 

A plan for development was also established.

 

The government's will to foster the industry is positive, but the problem with new drug development is that speed is not important.

 

As of last year, there were zero blockbuster new drugs recognized by the government.

 

The government expects to secure two by 2027.

 

Under the current circumstances, only Yuhan's non-small cell lung cancer drug Leclaza and SK Biopharmaceuticals' epilepsy drug Xcopri appear to be the only drugs developed by domestic biopharmaceutical companies by 2027 that have the potential to become global blockbusters.

 

Leclaza was transferred from Genosco/Oscotec to Yuhan Corporation in July 2015 when preclinical development was underway.

 

In November 2018, the technology was transferred from Yuhan to Janssen, a subsidiary of J&J, a global pharmaceutical company.

 

Yuhan received conditional approval for Leclaza as a treatment for secondary mutations in non-small cell lung cancer in Korea in 2021.

 

In other words, it took five and a half years from preclinical trials to conditional approval.

 

It seems that it will take more time for Leclaza to rise to prominence as a global blockbuster.

 

Janssen, which holds the global copyright, is conducting a phase 3 trial of Leclaza alone and Rybrevant as an indication for non-small cell lung cancer.

 

Cenobamate started with basic research in 2001, went through clinical trials and licensing, and was approved by the U.S.

 

Food and Drug Administration (FDA) in 2019.

 

It took 18 years from the first research to enter the large-scale US pharmaceutical market.

 

Last year, US sales of Cenobamate more than doubled from the previous year to 169.2 billion won, but it will take more time to get on the list of global blockbuster new drugs.

 

Moderna's Corona 19 mRNA vaccine, which recorded $18.4 billion in sales last year, was praised for succeeding in developing it in about a year, but the actual situation is different.

 

Moderna's COVID-19 mRNA vaccine is the product of 30 years of RNA research, 20 years of LNP development that protects mRNA, and 10 years of Moderna's own research and development.

 

The government recognized the biopharmaceutical industry as a 'future food in a low-growth period', a 'key field for securing jobs', and an 'essential national strategic industry for overcoming infectious diseases and other diseases and guaranteeing public health'.

 

In order to realize this, not only R&D support measures such as active support for global clinical trials but also support measures for basic research fields such as chemistry and biotechnology from a long-term perspective must be prepared.