Minister Jung Outlines Ambitious Goals for K-Bio Innovation
Aims for Three Blockbuster New Drugs and Doubling Exports in Five Years
Three Key Strategies: Stakeholder-Oriented Regulatory Reform,
Accelerating Growth Through Technology, Talent
The government has set a goal to become one of the world’s top five bio-industrial powerhouses within five years through the advancement of the domestic bio industry. It also pledged to improve inconveniences faced by the industry, not only in regulatory approval policies but also in drug price negotiations and the health insurance listing process.
President Lee Jae-myung is speaking at the Bio Innovation Forum held on the 5th at Songdo Convensia in Incheon. From left, Minister of Trade, Industry and Energy Kim Jung-kwan, Deputy Prime Minister and Minister of Economy and Finance Koo Yoon-chul, President Lee Jae-myung, Minister of Science and ICT Bae Kyung-hoon, Minister of Health and Welfare Jung Eun-kyung. Photo by Yonhap News
At the Bio Innovation Forum held at Songdo Convensia in Incheon on the 5th, with President Lee Jae-myung in attendance, Minister of Health and Welfare Jung Eun-kyung stated, “In just ten years, Korea has evolved from a domestic generics-focused market to possessing world-class contract development and manufacturing organization (CDMO) capabilities. Following the emergence of blockbuster biosimilars with annual sales exceeding 1 trillion won, the debut of innovative blockbuster new drugs is also becoming visible. Based on these capabilities, this is a golden time for a major leap forward, transitioning from a follower to a leader.”
The goals presented by Minister Jung include doubling biopharmaceutical exports within the next five years, creating three blockbuster-level new drugs, and ranking third globally in clinical trials. To achieve these, she outlined three key innovation tasks: improving regulations in ways that are tangible for stakeholders, accelerating growth by linking technology, talent, and capital, and strengthening global competitiveness by fostering the joint growth of companies.
Regarding regulatory reform, Minister Jung said, “Although technological change in the bio sector is rapid, clinical trial review periods remain long, and relevant laws and systems have not kept pace. Since speed is crucial in the competition for technological supremacy, we will reform regulations in the product development and approval processes.”
Specifically, she proposed establishing preemptive approval standards for artificial intelligence (AI)-driven drug development, introducing organoid-based alternative testing methods, exempting phase 3 clinical trials for biosimilars within a safe range, and adopting AI-based review processes. The ministry also plans to shorten the review period from 406 days to 295 days by operating dedicated approval review teams and significantly increasing personnel, while enhancing transparency by making the approval process public.
Minister Jung also said, “To enhance the global competitiveness of domestic products, we will expand the dual pricing system and conduct approval, evaluation, and negotiation processes simultaneously to reduce the insurance listing period to 150 days.” The government also plans to enact a special law to support CDMO expansion overseas and operate a regulatory reform forum under the Biohealth Innovation Committee to continuously identify and resolve on-site regulatory issues.
In the area of linking technology, talent, and capital, she said, “We will support the entire cycle of AI drug development and establish AI- and robot-based autonomous laboratories. We will expand infrastructure so that companies and researchers can utilize data effectively, and we will actively foster 110,000 practical core professionals and attract top-tier global talent.” The government also intends to take the lead in establishing specialized new drug development funds at each stage to invigorate the bio-investment market.
Minister Jung promised, “For the joint growth of anchor and biotech companies, we will secure infrastructure for CDMO facility investment and fully support financing, tax, and talent development. We will provide comprehensive support for financing, consulting, and investment in bio ventures, as well as connections with global companies.” She added, “We will promote the localization of materials, components, and equipment to strengthen biosecurity, and support the establishment of overseas bases, networks with global pharmaceutical companies, and patent acquisition.”
Minister Jung emphasized, “The biopharmaceutical industry is a sector that simultaneously supports public health, national security, and economic growth. The government will accelerate the innovation of K-Bio.”
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