Accelerating Global New Drug Development through Open Innovation

In an effort to strengthen the global competitiveness of Korea’s pharmaceutical and biotech industries and secure pharmaceutical sovereignty a key to public health the government has been promoting an open innovation strategy that brings together pharmaceutical companies academia research institutions and medical centers. Since 2011 in response to the limitations of fragmented support systems three ministries—Ministry of Science and ICT (Minister Yoo Sang-im) Ministry of Trade Industry and Energy (Minister Ahn Deok-geun) and Ministry of Health and Welfare (Minister Cho Kyu-hong)—have collaborated to support the entire cycle of new drug development from basic research to clinical trials and commercialization through a cross-ministerial national R&D initiative.

On August 20 (U.S. local time) Johnson & Johnson Innovative Medicine (formerly Janssen) a subsidiary of Johnson & Johnson (J&J) obtained U.S. Food and Drug Administration (FDA) approval for the combination therapy of Leclaza (ingredient: lazertinib) a lung cancer treatment licensed from Korea’s Yuhan Corporation and Rybrevant. This is a success story of open innovation in global new drug development with government R&D support playing a foundational role.

The development of this new drug involved a candidate substance originally developed by Genosco a subsidiary of the Korean biotech company Oscotec which was transferred to Yuhan Corporation. Yuhan led domestic clinical trials with government R&D support facilitating the production of clinical trial drugs stability testing and other key aspects of the clinical process. This collaboration enabled Yuhan to generate the critical data necessary for technology exports culminating in the successful licensing of Leclaza to Janssen and its subsequent global clinical trials and final FDA approval. This is recognized as a successful example of an open innovation strategy in new drug development.

The global lung cancer treatment market valued at approximately KRW 45.6 trillion in 2023 is the largest segment within oncology. With AstraZenecas competing product Tagrisso achieving sales of approximately KRW 7.7 trillion in 2023 Leclaza is poised to become Korea’s first blockbuster drug expected to surpass annual sales of KRW 1 trillion.
※ Clinical trial results for Leclaza showed a 30% reduction in the risk of disease progression or death compared to Tagrisso.

The government plans to designate advanced biotechnology alongside artificial intelligence (AI) and quantum technology as one of the three major game-changers with increased investment to support innovations like this successful global new drug development.

In particular as a national strategy to lead the advanced biotechnology sector the government established the Advanced Bio Initiative in April. Based on this initiative the government has allocated approximately KRW 2.1 trillion (KRW 1.8 trillion for 2024) in R&D funding for 2025. The investment will support various advanced biotechnology areas including regenerative medicine the convergence of data and AI and pandemic preparedness through cross-ministerial collaboration.
※ Based on the 2025 Budget Proposal and 2024–2028 National Fiscal Management Plan approved by the Cabinet on August 27.

Additionally the government aims to shorten the drug development process and increase success rates by applying AI and data technologies to the field of new drug development aligning with the bio-digital transformation trend in the sector.

Looking ahead the government will continue to focus on open innovation in the new drug development field reinforcing R&D support. By eliminating silos between ministries the government will support the entire cycle of new drug development from basic research and drug discovery to clinical trials and commercialization involving industry academia research institutions and medical centers. The government also seeks to encourage collaboration through joint research and the establishment of domestic and international networks. Furthermore by closely linking R&D infrastructure with consulting services commercialization efforts chemistry manufacturing and controls (CMC) and technology transfer contracts the government aims to increase success rates at every stage of new drug development.

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