[Reporter’s View] Korean drugs go international this year

Wishes for homegrown new drugs to emerge and thrive on the international stage this year

Last year, new drugs developed by domestic pharmaceutical companies recorded remarkable achievements overseas.

 

Hanmi Pharmaceutical's Rolontis (U.S.

 

brand name Rolvedon) has continued to grow in the U.S.

 

market.

 

Rolontis is a neutropenia treatment developed by Hanmi Pharmaceutical and became the 33rd new domestic drug to be approved in Korea in March 2021.

 

The drug was also approved in the U.S.

 

in September of the same year.

 

Since its launch in the U.S.

 

in the fourth quarter of 2022, Rolontis has posted cumulative sales of USD 110.3 million (approximately KRW 155 billion).

 

SK Biopharm's epilepsy drug Xcopri has also shown success in the U.S.

 

market.

 

Officially launched in the U.S.

 

market in May 2020, Xcopri generated sales of KRW 78.2 billion in 2021, KRW 169.2 billion in 2022, and 270.8 billion in 2023.

 

SK Biopharm expects Xcopri’s sales to have exceeded the KRW 400 billion mark last year.

 

This year, Yuhan Corp’s new cancer drug Leclaza will be launched in the U.S.

 

and European markets.

 

Leclaza was approved in the U.S.

 

and Europe last year for the treatment of non-small cell lung cancer in combination with Janssen's targeted therapy Rybrevant.

 

The combination is currently recommended in the National Comprehensive Cancer Network (NCCN) guidelines.

 

Leclaza is expected will be able to break the dark history of domestic anti-cancer drugs.

 

In the past, SK Chemicals' Sunpla, the first new domestic drug, Hanmi Pharmaceutical's Olita, and Samsung Pharm’s Riavax have challenged the market dominated by foreign anticancer drugs, but they have left the market through cancelation or voluntary withdrawal.

 

In contrast, Leclaza has gone from strength to strength, receiving domestic approval, and then global approval.

 

HLB’s rivoceranib also seeking approval from global regulators this year.

 

In May of last year, the company and its Chinese partner Jiangsu Hengrui Medicine received a complete response letter (CRL) from the FDA, but a was found to have no deficiencies in the recent review.

 

The combination of rivoceranib and Jiangsu Hengrui Medicine’s immuno-oncology drug camrelizumab has shown the longest survival benefit among first-line liver cancer treatments.

 

Domestic new drugs that emerged last year are also eyeing the global market.

 

Onconic Therapeutics is in the process of licensing out its technology for its P-CAB-based gastroesophageal reflux disease drug Jaqbo.

 

Vivozon Pharmaceutical's non-narcotic painkiller Unafra is also emerging as an alternative to narcotic painkillers.

 

The domestic companies need to keep in mind not only the domestic market but also global expansions for survival.

 

Last year, the global pharmaceutical industry market was valued at USD 1.44 trillion (about KRW 1901.6 trillion).

 

Compared to Korea's market size of USD 18.2 billion (about KRW 25.5 trillion), the global market is about 79 times larger.

 

To put it bluntly, none of the homegrown new drugs developed to date can be called a “global blockbuster drug.” Global blockbuster drugs usually refer to products that post annual sales of more than KRW 1 trillion, but a sufficient market is required to achieve such sales.

 

A small market cannot generate KRW 1 trillion in sales.

 

In the end, going global is not an option but a necessity to grow further in the domestic pharmaceutical bio-industry.

 

It is necessary to consider various research institutions such as clinical sites with the global market in mind from the initial stages of development.

 

If homegrown new drugs successfully go global, this is expected to drive the performance of later drugs.

 

In addition, if the domestic pharmaceutical and biotech industry shows results overseas, a virtuous cycle of reinvestment in R&D and investment in promising biotech companies is expected to be established.

 

Currently, various domestic new drugs such as K-CAB and Fexuclue are conducting clinical studies to enter the global market.

 

If domestic pharmaceutical companies' new drugs pave the way this way, it will be easier for latecomers to enter the market.

 

I hope this year domestic drugs will show performance not only on the domestic stage but also on the international stage.