• The Korean Society of Law and Medicine
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• v.21 no.1
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• pp.223-259
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• 2020

With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

• Korean Journal of Food Science and Technology
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• v.40 no.6
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• pp.707-711
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• 2008

The principal objective of the current study was to isolate a purpurogallin derivative as an oxidation product from gallic acid, in an effort to assess the anti-inflammatory effects of this compound. Purpurogallin derivative is known to be the one of the oxidation products of gallic acid. This compound has been identified as a minor chemical component in fermented tea products. It has been previously demonstrated that theaflavins, the oxidation products of catechins found in fermented tea products, exert profound antioxidant and anti-inflammatory effects. However, the biological activities of a minor chemical component in fermented teas have yet to be evaluated. Purpurogallin carboxylic acid (PCA) was identified as a major oxidation product of gallic acid from a peroxidase/hydrogen peroxide oxidation model system. The identity of the PCA was verified by $^{1}H$ NMR, $^{13}C$ NMR and MS techniques. PCA treatment significantly suppressed the generation of pro-inflammatory mediators including nitric oxide and IL-6 in lipopolysaccharide (LPS)-stimulated RAW264.7 murine macrophages. According to the nitrite assay, PCA 100, 75, and $50{\mu}g/mL$ treatment dose-dependently inhibited NO production by 57.6, 41.5, and 21.8%, respectively, in LPS-stimulated RAW264.7 murine macrophage cells. Moreover, IL-6 production was inhibited to a significant degree with PCA treatment of 100 and $75{\mu}g/mL$ at 43.1 and 23.9%, respectively. PCA treatment also significantly suppressed $PGE_2$ production at levels of 100 and $75{\mu}g/mL$. These results showed that PCA exerts inhibitory effects on the production of inflammatory mediators.

• Journal of Life Science
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• v.31 no.1
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• pp.17-27
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• 2021

This study was performed to investigate the antioxidant activities of subfractions of Peucedanum insolens Kitagawa root in various organic solvents and their anti-inflammatory effects on LPS-treated RAW264.7 cells. First, P. insolens Kitagawa roots were dried at room temperature for one week, chopped, and extracted with 70% ethanol. The resulting extracts were successively sub-fractionated with hexane, chloroform, ethyl acetate, and water. The antioxidant potential of the fractions was evaluated using a DPPH (1,1-diphenyl-2-picrylhydrazyl) radical scavenging assay and by measuring total polyphenol and flavonoid contents. The anti-inflammatory potency of the fractions was evaluated by measuring the inhibition levels of the expressions of inflammatory-mediated genes and proteins (e.g., iNOS, COX-2, IL-1β, and IL-6) in RAW264.7 cells. The results clearly showed that the ethyl acetate fraction of the P. insolens Kitagawa root contained relatively high total flavonoid (34.08±1.68 ㎍ of quercetin equivalents per mg) and total polyphenol (154.1±3.2 ㎍ of gallic acid equivalents per mg) contents. The DPPH assay results showed that the P. insolens Kitagawa root possessed strong free radical scavenging activity in the ethyl acetate fraction. Both the ethyl acetate and hexane fractions showed strong inhibitory potencies to nitric oxide production induced by lipopolysaccharide (1 ㎍/ml) treatment for 24 hr in RAW264.7 cells. The results also showed that both the hexane and ethyl acetate fractions of the P. insolens Kitagawa root strongly inhibited mRNA levels of iNOS, IL-1β, and IL-6, which were overexpressed by LPS treatment for 24 hr in the RAW264.7 cells. These results suggest that P. insolens Kitagawa root may contain compounds that possess strong potency for anti-inflammatory activity. Further studies are needed to discover more detailed modes of action of P. insolens Kitagawa root fractions against inflammation modulation, such as the regulation of cytokine signaling and inflammatory signaling pathways.

• Journal of Life Science
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• v.33 no.2
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• pp.138-148
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• 2023

This study compared and analyzed the antioxidant activities of various organic solvent fractions from the leaves and roots of Peucedanum insolens Kitagawa. For this study, the dried leaves and roots of P. insolens Kitagawa were first extracted using 70% ethanol. The extracts were sequentially sub-fractionated in the order of hexane, chloroform, ethyl acetate, n-butanol, and water. The results revealed that the distribution of total phenolic contents by organic solvent fractions showed the same pattern in both the leaves and roots, with the highest in the ethyl acetate fraction (101.1±1.0 mg vs 71.2±3.4 mg of GAE/mg), but the lowest content in the hexane fraction (9.5±0.2 mg vs 7.5±2.1 mg of GAE/mg). The distribution of total flavonoid content in the organic solvent fractions showed the same pattern as that of total phenolic content. The results of DPPH, ABTS, and FRAP assays showed that the leaf and root extracts exhibited free radical scavenging activity in the same pattern, particularly, the ethyl acetate fraction had the highest activity. These results indicate that not only the roots of P. insolens Kitagawa but also the leaves possess potential substances that exhibit strong antioxidant activity. Significant correlations (R=0.903, p<0.0001, DPPH radical; R=0.891, p<0.001, ABTS radical; R=0.745, p<0.05, FRAP radical) between total phenolics and radical scavenging activities, but also significant correlations (R=0.867, p<0.001, DPPH vs. ABTS radicals; R=0.882, p<0.0001, DPPH vs. FRAP radicals; R=0.973, p<0.0001, ABTS vs. FRAP radicals) between radical scavenging activities were found in the organic solvent fractions. Therefore, as in the roots of P. insolens Kitagawa, the leaves possess strong antioxidant capacity and can be used as the main antioxidant material.

• Asia-Pacific Journal of Business Venturing and Entrepreneurship
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• v.19 no.1
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• pp.55-73
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• 2024

Unicorn companies are attracting attention around the world as they are recognized for their high corporate value in a short period of time as an innovative business models. Their growth process presents good lessons for the startup ecosystem and have a positive impact on national economic development and job creation. However, previous studies related to unicorn companies are focused on 'event studies' and 'case studies' such as characteristics of founders, environmental factors, business models and success/failure cases of companies already recognized as unicorns rather than a multifaceted approach. The occurrence of unicorn companies and Macroscopic analysis of related factors is lacking. Against this background, this study are considering the characteristics of unicorns examined through previous research and the current status unicorns with a high proportion of technology companies, the purpose was to analyze the impact of the country's technological competitiveness, such as 'technology human resource index', 'R&D index', and 'technology infrastructure index', on the increase in unicorn companies. For statistical analysis, data published by various international organizations, the Bank of Korea, and Statistics Korea from 2017 to 2020 and unicorn company data compiled by CB Insights were used as panel data for 44 countries to be tested by multiple regression analysis. As a result of the study, it was confirmed that the number of science majors had a positive (+) effect on the increase of unicorn companies in the case of technology human resource index, and in the case of R&D index, the total amount of R&D investment had a positive (+) effect on the increase of unicorn companies, while the number of Triad Patents Families and the number of scientific and technological papers published had a negative (-) effect on the increase of unicorn companies. Finally, in the case of technology infrastructure index, it was confirmed that the number of the world's 500th-ranked universities had a positive (+) effect on the increase of unicorn companies. This study is the first to reveal the causal relationship between national technological competitiveness and unicorn company growth based on country-specific and time-series empirical data, which were insufficiently covered in previous studies. and compared to the UN's ranking of the global industrial competitiveness index and the OECD's total R&D investment by country, Korea is considered to have technological and growth potential, while the number of unicorn companies driving growth as leaders of the innovative economy is relatively small, so the research results can be used when establishing policies to discover and foster unicorn companies in the future.