‘Will create first FDA-approved Korean drug by 2030’

“Beyond licensing deals…it’s time for fully finished Korean drugs that complete Phase III trials enter global markets independently”

KRW 150 billion Phase III–focused fund to be launched this year

Kang-seop Lim, “The establishment of a dedicated Division of Pharmaceutical and Bio Industry carries strong symbolic meaning…will show change”

Amid the Ministry of Health and Welfare's ambition to foster Korea’s pharmaceutical industry by establishing a new dedicated “Division of Pharmaceutical and Bio Industry,” Kang-Seop Lim, its first director, expressed his ambition. He said, “We will create cases where domestically developed new drugs independently obtain approval from the U.S. Food and Drug Administration (FDA).”

Rather than relying on licensing-out deals to global pharmaceutical companies for overseas market entry, what the government wants to do is support Korean pharmaceutical firms in completing Phase III clinical trials and securing FDA approval on their own, paving the way for direct global commercialization of Korean blockbuster drugs.

On the 18th, Director Lim met with the Ministry of Health and Welfare's press corps and stated, “Our goal is to create a successful case of a fully developed Korean drug completing Phase III trials, securing FDA approval, and being sold directly in the U.S. market within five years. We will make this year the starting point, with the aim of achieving this milestone by 2030.”

When asked what administrative priorities he would focus on this year as the inaugural head of the new division, Director Lim cited “developing a finished new drug that successfully completes Phase III clinical trials, secures FDA approval, and achieves direct sales” as the top priority.

While the ministry will continue to support technology licensing deals, Lim emphasized that the new policy direction is focused on enabling Korean-developed drugs to enter global markets independently, without relying on multinational pharmaceutical companies.

To this end, MOHW will operate a dedicated fund specifically supporting Phase III clinical trials for new drug candidates showing potential for final regulatory approval.

The Ministry has already allocated KRW 60 billion in government capital in this year's budget proposal for this purpose. Combined with matching funds from the Fund of Funds, it plans to establish a ‘Phase III Clinical Trial Specialized Fund’ totaling KRW 150 billion.

Lim said, “Last year, Korea recorded its highest-ever technology licensing exports, yet there are still very few cases of fully developed Korean drugs being launched overseas.  Now is the time for Korea to take the lead in completing Phase III clinical trials and securing FDA approval.”

“Looking at the K-Bio Vaccine Fund, roughly 50% went to preclinical research and 50% to Phase I–II trials, but there were virtually no Phase III investments. That gap is something we are now determined to fill, which is why we decided to establish a Phase III specialized fund based on this year's budget.”

He added, “Of the KRW 150 trillion National Growth Fund, KRW 11.6 trillion will be allocated to the pharmaceutical, bio, and vaccine sectors over five years. We are also considering connecting this funding to late-stage clinical investments. We will signal that pharmaceutical and biotech companies can secure funding even in late-stage clinical trials, enabling them to plan their clinical and business strategies.”

Lim added that the Ministry of Health and Welfare also plans to continue supporting technology licensing.

This means the Ministry will assist pharmaceutical and biotech ventures and startups in growing from small and medium-sized enterprises (SMEs) to mid-sized companies, and their search for opportunities for further expansion, using technology exports as a starting point.

The Ministry has allocated KRW 10.4 billion for its global open innovation budget and is developing collaboration plans to combine this with the Ministry of SMEs and Startups' budget to further expand the scale of the program.

In the first half of the year, MOHW will establish a consultative body with biotech venture companies to gather feedback on regulatory reform and policy support. These discussions will feed into regulatory modernization initiatives and next year’s budget planning.

Lim stated, “The number of companies to be supported through the global open innovation budget is around 32. For platform technology development R&D, we are considering planning it this year and including it in next year's budget. While existing R&D has primarily focused on candidate substances, preclinical studies, and clinical trials, we now intend to support investment in the platform technology itself.”

He further noted, “The establishment of a dedicated department under the name ‘Division of Pharmaceutical and Bio Industry’ carries significant symbolic meaning. I feel a sense of responsibility. The follow-up budget and administrative measures for the Pharmaceutical and Bio-Health Leap Strategy unveiled last September will be fully implemented starting this year. We will present a changed approach to the industry, and the first message will be the announcement of the revised Innovative Pharmaceutical Company Certification System.”