A total of 40 novel drugs were approved by Seoul‘s pharmaceutical authorities in 2020, but none were developed by South Korean companies, according to a survey released by the Ministry of Food and Drug Safety on Monday.

According to the Korean drug safety agency, local companies failed to introduce novel drugs domestically for the second consecutive year. In 2018, there were two novel drugs developed by local pharmaceutical companies that received approvals from the agency.

“Launching a novel drug is still difficult for local companies as it takes a large amount of investment and requires a lengthy period of time,” an official from the agency said.

Despite the Korean government’s efforts to back up local companies’ research and development of novel drugs, there are few that can manage developing new drugs, the official added.

“It usually takes more than 10 years to finish clinical trials and receive an approval for a novel drug,” the official explained. “Pharmaceutical companies, during the process, go through many trials and errors, which cost a great deal.”

An industry source said the domestic drug market has not matured enough to launch many novel drugs. Also, Korean pharmaceutical companies still lack experience and resources to develop novel drugs.

“It is not that development of novel drugs has suddenly stopped in recent years,” an official from one of the country‘s major pharmaceutical companies said in response to the survey’s findings.

“The history of drug discovery in the pharmaceutical industry here is not long enough, compared with those of foreign countries.” the source said.

Ever since SK Chemicals introduced the country’s first new drug Sunpla in 1999, 40 Korean-made drugs have been approved to date.

With the relatively short history of developing its own drugs, Korea remains a latecomer in the global pharmaceutical market in terms of data and resources, according to the industry source.

“The foreign players, who have accumulated data for many decades, have now grown bigger. They now have more resources and experience in developing new drugs, which means higher chances of being successful in launching new drugs.”

Local companies are, however, making a “meaningful” progress, the industry source said. “Starting with Hanmi Pharmaceutical’s mega deal in 2015 to export its technology for the company‘s new diabetes treatment, many local pharmaceutical players now export their technologies or launch their own biosimilar products, garnering global attention,” the source said.

In 2015, Hanmi Pharmaceutical signed a contract to export a diabetes treatment technology for 5 trillion won ($4.4 billion), the highest value in the history of the Korean pharmaceutical industry.

By Shim Woo-hyun (ws@heraldcorp.com)