24 drugmakers extend their state-designated "innovative pharma" title until 2027
The Ministry of Health and Welfare (MOHW) announced on Thursday that 24 "innovative pharmaceutical enterprises" have had their certification status extended until 2027, bringing the total number of certified enterprises to 42.
This decision followed recent discussions by the Pharmaceutical Industry Promotion and Support Committee.
Under the Special Act on Fostering and Support of the Pharmaceutical Industry, which has been in effect since 2012, the Health Ministry evaluates companies based on their substantial investments in research and development and their achievements in new drug development to certify them as "innovative pharmaceutical enterprises."
Certified enterprises receive incentives such as tax breaks, regulatory relief, and priority reviews to foster a conducive environment for pharmaceutical innovation. Certifications are renewed every two years, allowing certified companies to maintain their status for three years upon each recertification.
A total of 27 general pharmaceutical companies have retained their status, including GC Biopharma, DongKoo Bio&Pharma, Dongkook Pharmaceutical, Dong Wha Pharm, Daewoong Pharmaceutical, Daewon Pharmaceutical, Daehwa Pharmaceutical, Boryung, Bukwang Pharmaceutical, Samyang Biopharm, Celltrion, Shinpoong Pharmaceutical, ST Pharm, HK inno.N, Yuhan, ISU Abxis, Ildong Pharmaceutical, Taejoon Pharmaceutical, Pharmicell, BMI Korea, Pharmbio Korea, Handok, Hanlim Pharmaceutical, Hanmi Pharmaceutical, Hyundai Pharmaceutical, LG Chem, and SK Chemicals.
In the bio venture sector, a total of 12 companies were recognized, including Bridge Biotherapeutics, Medytox, BC World Pharm, Alteogen, Olmix, ABLE Biott, Genexine, GI Innovation, Corestem, Qurient, Tego Science, and Helixmith.
Additionally, three foreign pharmaceutical companies were listed: AstraZeneca Korea, Janssen Korea, and Korea Otsuka Pharmaceutical.
Four companies did not pass the re-certification process for innovative pharmaceutical enterprises. These companies include CrystalGenomics, Korea United Pharm, Genuonesciences, and Chong Kun Dang (CKD).
MOHW did not disclose specific reasons for their exclusion, citing confidentiality concerns regarding their internal processes.
For "innovative pharmaceutical companies," the minimum threshold for research and development (R&D) spending is set at 7 percent of sales for enterprises with less than 100 billion won ($100 million) in revenue, and at least 5 percent for those with sales exceeding 100 billion won. Additionally, companies must obtain Good Manufacturing Practice (GMP) certification from either the U.S. or Europe to qualify for investing at least 3 percent of their revenue in R&D expenses.
Jung Eun-young, Director General of the Bureau of Health Industry at MOHW, emphasized the significant role that innovative pharmaceutical enterprises have played in advancing the domestic pharmaceutical industry since the introduction of the system.
"We will continue to gather practical and expert opinions to develop rational improvements to the system in alignment with global standards, enhancing innovation and competitiveness in the pharmaceutical industry,” she said.