Celltrion’s Corona 19 new drug ‘Lekrona’ is an example of how difficult it is to stand alone for a domestic new drug. Although it received conditional approval in Korea in February, it was not properly treated in the medical field. It was because they did not listen well to seriously ill patients admitted to the hospital. They were even treated as ‘potions’.
It has been clinically proven that Lekkorina has the effect of preventing the development of severe cases in mild patients. However, there was not enough opportunity to be used properly for patients in need of Rekkona. This is because living treatment centers that accommodate mildly ill patients do not have a medical environment to inject lekkona.
Rekkona’s competitiveness, which had been neglected in Korea, stood out during the European licensing process. As it received the approval review alongside US pharmaceutical and bio companies such as Regeneron, the fact that it is effective against the delta mutant virus was highlighted. Finally, on the 12th, it was approved by the European Union (EU) as ‘Europe’s No. 1 Corona Antibody Treatment’. It had only been a month since I applied for a permit.
Domestic new drugs that are neglected in Korea
Obtaining approval for European sales of Rekkona is a splendid achievement that marked a significant milestone in the history of Korean pharmaceuticals and biotechnology. There are domestic drugs that have penetrated the US and European markets, but all were synthetic drugs or generic drugs. Rekkona is the first biopharmaceutical with high added value. This is why the bio industry is cheering.
Celltrion’s new drug challenge didn’t happen overnight. It is the product of years of experience and failure. Celltrion started preclinical testing (animal testing) to develop a new flu drug in May 2012. Although 10 years have passed, it has only just completed phase 2 clinical trials. went through many ups and downs. However, the experience accumulated in this process became the foundation for developing Rekkona in just one year.
Rekkona is just the beginning. It must be properly recognized in Europe and cross the threshold of the Food and Drug Administration (FDA) in the United States. It has to survive competition with ‘edible medicines’ developed by Merck (MSD) and Pfizer, respectively. The fact that a strong competitor such as Tamiflu, which puts the H1N1 flu to sleep with a ‘oriental shot’, has not yet appeared is an opportunity for Rekkona.
New drug challenge must not be stopped
There is another mountain that Rekkona has to climb. It is a deep-rooted prejudice against domestic new drugs. The view of the bio industry is that this prejudice must have played a role in the treatment of Recklona in the field of Corona 19 treatment. In fact, out of 33 domestic new drugs, only Zemiglo (LG Chem) and Kanarb (Boryung Pharmaceutical) have sales exceeding 100 billion won. There are many factors, but it is not unrelated to the trend of favoring foreign drugs.
A lack of understanding of the world’s karma is also an obstacle. The reason was cited as the reason that domestic securities companies had recently lowered the target price of Celltrion and neglected its ‘main business’. The competition in the market for biosimilars (biopharmaceuticals), which is the main business, is getting fierce. Celltrion received domestic approval in July 2012 for Remsima, a treatment for rheumatoid arthritis. It was the world’s first biosimilar. It was approved in Europe the following year and in the United States in 2016.
Celltrion has grown into a leading biotechnology company in Korea by creating a new market that did not exist. However, it is difficult for a biosimilar to be Celltrion’s main business. If it cannot compete with new drugs, it is difficult to grow into a global pharmaceutical/bio company. There is no pharmaceutical or biotechnology company that has grown into a global company only with generic drugs. This is why Celltrion, as well as domestic pharmaceutical and bio companies, should not stop trying new drugs.
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