HONG KONG – South Korea’s Bridge Biotherapeutics Inc. wrapped up the week by announcing its awaited IND clearance for its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, BBT-176, for non-small-cell lung cancer (NSCLC) from the country’s Ministry of Food and Drug Safety (MFDS) on May 7.
HONG KONG – South Korea’s Osang Healthcare Co. Ltd. became the first Korean company to receive the U.S. FDA’s emergency use authorization (EUA) for its COVID-19 test kit.
HONG KONG – South Korea’s Osang Healthcare Co. Ltd. became the first Korean company to receive the U.S. FDA’s emergency use authorization (EUA) for its COVID-19 test kit. In a letter dated April 18, 2020, the FDA informed Osang of its authorization for the company’s Genefinder COVID-19 Plus Realamp Kit.
The Korea Export Import Bank (KEXIM) took a step toward fulfilling its mandate to finance Korean companies’ overseas expansion by seeking managers for a new ₩400 billion (US$328 million) fund.
HONG KONG – Korean biopharma Celltrion Inc. said it’s halfway through the process of creating a super antibody to reign in the COVID-19 novel coronavirus that has claimed almost 13,000 lives globally.
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention. Two diagnostic kits made by domestic companies Seegene Inc.and Kogene Biotech Co. Ltd. are currently preparing to apply for U.S FDA approval.
HONG KONG – Korean biopharma Celltrion Inc. said it’s halfway through the process of creating a super antibody to reign in the COVID-19 novel coronavirus that has claimed almost 13,000 lives globally.
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic kits to battle the pandemic in the country, which is home to one of the largest outbreaks in the world outside of China.
U.S. FDA commissioner Stephen Hahn appeared before a congressional panel to discuss the administration’s budget proposal for the agency, but the outbreak of COVID-19 predictably dominated the proceedings.
HONG KONG – South Korea’s AI-based biotech venture, Kaipharm Co. Ltd. has secured ₩5 billion (US$4.22 million) in series A funding. Founded in 2018, the firm has attracted a total of ₩7 billion in investments. Kaipharm will generate a reference dataset of 2,000 drugs (KMAP_2K) using next-generation sequencing (NGS). The dataset will include all the FDA-approved drugs to date.