Fostering ‘K-BioPharma Frontier Companies’: SMEs Ministry and Health Ministry Discuss End-to-End Support for Drug Development

The Ministry of SMEs and Startups and the Ministry of Health and Welfare held an on-site meeting with small and midsize pharmaceutical and biotech companies to hear about challenges across the drug development process as they work to develop a plan to foster “K-BioPharma Frontier Companies.”

The two ministries said they held the meeting on the 17th at Lunit Inc. in Gangnam-gu, Seoul. Attendees included Noh Yong-seok, first vice minister of SMEs and Startups; Lee Hyeong-hun, second vice minister of Health and Welfare; and eight representatives of small and midsize companies in drug development, digital health, medical devices, biomaterials and production technology.

The ministries shared key elements of the plan they are jointly developing to respond to the rapidly changing global pharmaceutical and biotech market and secure future growth engines, and gathered feedback from companies.

Because drug development takes a long time, from identifying candidate compounds through nonclinical studies, Phase 1-3 clinical trials, regulatory approval and commercialization, participants discussed ways to coordinate support for research and development (R&D), clinical trials, investment and commercialization at each stage.

Participants said support for technology development, testing and validation is needed during candidate development and the nonclinical stage, while large-scale funding, specialized personnel and collaboration with hospitals and clinical institutions become increasingly important as development advances to clinical trials. They also called for stronger coordination among policies covering regulatory approval, technology transfer, follow-on investment and global expansion after clinical trials.

The ministries plan to identify promising small and midsize companies with growth potential and technological capabilities, and establish a system to coordinate and provide policy support based on each company’s stage of growth and needs. They will flesh out the plan by linking the ministries’ policy tools along a growth pathway from technology development to clinical trials and validation, commercialization, investment and guarantees, and global expansion, rather than limiting support to a single R&D project.

The ministries also jointly announced a “Full-Cycle Collaboration Plan for Pharmaceutical and Biotech Ventures” in March. The plan is to build a collaborative support system by combining the Ministry of SMEs and Startups’ capabilities in identifying and fostering promising companies and supporting startups, R&D, investment and commercialization with the Ministry of Health and Welfare’s pharmaceutical and biotech expertise and clinical and commercialization infrastructure.

First Vice Minister Noh Yong-seok said, “Pharmaceuticals and biotech is a field that requires considerable time and funding to bring a product to market through clinical trials and commercialization, even when a company has secured promising candidate compounds and technologies. We will faithfully incorporate feedback from today’s meeting into the plan and support promising companies as they grow from technology development to entry into global markets.”

Second Vice Minister Lee Hyeong-hun said, “Working closely with the Ministry of SMEs and Startups and drawing on the voices of companies, we will establish an effective support system to address the challenges promising companies face as they grow.”