South Korea’s Ministry of Food and Drug Safety (MFDS) has given innovative medical device designation for Te Bios Co. Ltd.’s artificial cornea, C-Clear, bringing it one step closer to becoming the first artificial cornea to be approved in the country.
South Korea plans to create a bio data dam, a step toward generating the necessary industrial ecosystem in the country’s bid to become one of the top seven players in the global medical device market by 2025.
SD Biosensor Inc. made a splash in its KOSPI board debut on July 16, raising a total ₩776.4 billion (US$679.26 million). The company will now use the funds to mass-produce and promote the company’s diagnostic machines for various indications, including COVID-19.
South Korea plans to create a bio data dam, a step toward generating the necessary industrial ecosystem in the country’s bid to become one of the top seven players in the global medical device market by 2025.
KT Corp. took its first step into the digital therapies space by entering into an agreement with Neurosigma Inc. to develop electronic therapies to treat neurological and neuropsychological disorders, including attention deficit hyperactivity disorder (ADHD), depression and epilepsy. KT will support the design and development of Neurosigma’s next-generation versions of external trigeminal nerve stimulation (eTNS) products that incorporate artificial intelligence (AI), big data and cloud capabilities.
New phase III data on Celltrion Inc.'s COVID-19 therapy, regdanvimab, showed it reduced the risk of hospitalization or death related to the disease for high-risk patients to 3.1% vs. 11.1% for placebo by day 28 of the study. The treatment also proved beneficial to participants across all risk categories, reducing their risk of hospitalization or death to 2.4% vs. 8% for placebo at the same time point.
HONG KONG – Mitoimmune Therapeutics Inc., a company that earlier this year completed a ?27.5 billion (US$24.41 million) series B financing led by Korea Development Bank, has received investigational new drug approval in the U.S. for MIT-001, its anti-inflammatory and anti-necrotic agent, moving the company a step closer to entering the clinic.
HONG KONG – South Korea’s securities exchange operator, Korea Exchange Inc., has relaxed the procedure for tech companies, including biopharma firms, to list on its KOSDAQ board. Under the simplified listing standard, which came into effect on April 26, companies with a market capitalization of ₩500 billion (US$449.26 million) and above will now need to submit only one assessment, with a result of “A” or higher, from a professional evaluation agency.
Soulbrain Holdings Co. Ltd. ramped up its unusual diversification program with the acquisition of Pixcell Medical Technologies Ltd. as part of the semiconductor company's shift into health care and in vitro diagnostics. The acquisition of Pixcell follows Soulbrain’s acquisition of Ark Diagnostics Inc. in 2018 as the company looks to the bio-health care industry as its "engine for new growth."
HONG KONG – Celltrion Inc. has received the European CE mark for Tekitrust, its COVID-19 tests kit developed with Mico Biomed Co. Ltd. “Mico, which is a diagnostic device specialist, partnered with Celltrion to combine both companies’ strengths in the test kit sector,” a Celltrion spokesperson told BioWorld. Mico will manufacture the kits, while Celltrion handles marketing and sales.