HLB Life Science announced on the 2nd that its developed single-use syringe "Softjek" has received pre-market approval (510k) from the U.S. Food and Drug Administration (FDA). The 510k pre-market approval is an FDA certification system that confirms the device has effectiveness and safety equivalent to existing marketed devices. Following this approval, the company plans to export the human-use syringe to the U.S. through Allison Medical, a medical device specialist in the U.S., starting this month. HLB Life Science formed a partnership with Allison Medical early last year and has previously supplied veterinary syringes.
Genewon Science announced on the 2nd that it has recruited two new executives, Byung-ok Ahn, head of the research and development division, and Ho-jun Yang, head of the Jecheon plant. Both are experts with over 30 years of experience in their respective fields. They began their careers at Dong-A Pharmaceutical and have served as directors in the development department and representatives at SL Bexigen and ImmuneMed. Genewon established the research and development division to enhance the efficiency of the central research institute and the development headquarters while creating synergy. Vice President Ahn will focus on strengthening Genewon's research and development capabilities and securing new growth engines. Executive Director Yang, who joined as head of the Jecheon plant, was responsible for technology transfer for the launch of Dong-A Pharmaceutical's first-generation biopharmaceuticals and has formerly served in various roles including head of production management at Dong-A EST and plant manager in Daegu and Cheonan, eventually rising to head of production headquarters. Executive Director Yang plans to enhance productivity and optimize drug production while focusing on strengthening production indicator management systems and cost efficiency. Genewon CEO Ji-hoon Son noted, "This appointment is a strategic decision aimed at enhancing drug research and development capabilities and improving production efficiency."
Kainos Medicine announced on the 2nd that the payment date for its planned 16.5 billion won third-party allocation capital increase has been changed to the 17th. The initial payment date was set for the 30th of last month. According to the company, Chiron Global Group, a major investor committed to investing 14.3 billion won, stated that the approval timing for overseas remittance from its government has been delayed due to unstable domestic circumstances and plans to make the payment before the 17th. Chiron Global Group also confirmed that the previously announced new share issuance price of 2,545 won per share will proceed without changes. They will use capital from the Intergovernmental Organization (IGO) under the United Nations (UN) for their investment.
JLK, a medical artificial intelligence company, announced on the 2nd that it has completed the application for approval from the U.S. Food and Drug Administration (FDA) for its developed medical AI hub platform. This is an integrated AI software platform capable of managing medical imaging and data analysis in one place. It supports analysis, storage, visualization, and mobile communication of various medical images. It can manage data generated from various medical devices, such as CT, MR, and ultrasound, on a single platform and is also usable on mobile. The platform can utilize both its own solutions and third-party AI solutions and can be integrated with hospital information systems (HIS) and picture archiving and communication systems (PACS).
JW Pharmaceutical announced on the 2nd that it has launched a new single-use artificial tear product, "Friends Eye One Cool." According to the company, this product does not contain preservatives, including benzalkonium chloride, an additive for enhancing preservatives, making it usable even while wearing contact lenses. It contains L-menthol for a cooling sensation and is packaged in a single-use container for easy portability.
Genome & Company announced on the 2nd that its microbiome cosmetic brand "Yuke" has launched a functional product, "Biome Barrier Pantensive Cream," which helps improve the skin barrier. According to the company, the Pantensive Cream has obtained the "skin barrier improvement function" designation, which corresponds to just 1% of the numerous functional cosmetics reviewed by the Korea Food and Drug Administration. Clinical test results demonstrated that the cream improved skin barrier moisture levels by over 40% and provided lasting hydration for 24 hours, proving its strong moisturizing effect without stickiness, with a 322% improvement in skin moisture immediately after one use.