The government said the “pan-governmental full-cycle new drug development project” has supported 153 programs at academic, industrial, and research institutions and achieved 7.36 trillion won ($6.51 billion) worth license deals since 2011.
The new drug development project involves the Ministry of Health and Welfare, the Ministry of Science and ICT, and the Ministry of Trade, Industry and Energy.
The Korea Drug Development Fund (KDDF) was established in September 2011 to efficiently carry out the pan-governmental full-cycle new drug development project, removing barriers between government agencies at each stage of research support.
KDDF has provided 193.7 billion won for the pharmaceutical industry, universities, and research labs to develop new drugs in 153 programs.
KDDF has doctoral-level professionals experienced in new drug development. Through the management of monthly milestone-based tasks for a higher chance of new drug development, the fund is accelerating efforts to license out Korean drug candidates to foreign firms.
Since the launch of the KDDF, the government’s support program yielded 17 license deals with foreign firms, and 23, with domestic companies. The 40 deals are worth 7.36 trillion won.
Major license deals include Hanmi Pharmaceutical’s antidiabetic treatment (Sanofi of France, 3.6 trillion won), Yuhan Corp’s lung cancer drug (Janssen Biotech of the U.S., 1.4 trillion won), SK Biopharmaceuticals’ epilepsy medication (Arvelle Therapeutics of Switzerland, 600 billion won), and HanAll BioPharma’s autoimmune disease drug (Roivant Science of Switzerland, 540 billion won).
Among the 40 drugs, seven obtained the U.S. Food and Drug Administration’s orphan drug status. CJ HealthCare’s K-Cab won the marketing license from the Ministry of Food and Drug Safety. Two of them were listed on the nation’s top 100 excellent research and development projects.
The 40 drug development cases also led to 638 patent applications and registrations.
The seven treatments that won the FDA’s orphan drug designation are an anti-tuberculosis drug by Qurient, a growth hormone by Genexin, a treatment for children with infantile spasms by BioPharm Solutions, an infectious disease drug by LegoChem Biosciences, a neutropenia treatment by Enzychem Lifesciences, and an anticancer drug by PharmAbcine and Alteogen.
The FDA is reviewing SK Biopharmaceuticals’ epilepsy drug Cenobamate for marketing approval. The Korean company is expecting to reap over 1 trillion won sales per year from the nation’s first global blockbuster drug.