Latest news with #YuHyun-seung
Korea Herald
21-04-2025
- Business
- Korea Herald
CGBio secures FDA nod for Novosis Putty clinical trial
Korean regenerative medicine company CGBio announced Monday that an investigational device exemption has been approved for CGBio's bone graft substitute, paving the way for pivotal clinical trials in the US. The approval by the US Food and Drug Administration marks a major milestone, making Novosis Putty the first Korean-developed bone graft substitute to enter pivotal clinical trials in the US. It also brings CGBio one step closer to achieving the premarket approval, or PMA, required for full commercialization in the global medical device market. Novosis Putty builds on CGBio's existing Novosis platform, combining hydroxyapatite and tricalcium phosphate to better replicate natural bone structure. Its putty-like consistency allows for easier handling, while the company's proprietary Slorel technology enables controlled, sustained release of recombinant human bone morphogenetic protein-2 (rhBMP-2), designed to maximize bone regeneration while minimizing side effects such as ectopic bone formation. Although classified as a medical device, the product underwent FDA review under standards equivalent to those for biopharmaceuticals. RhBMP-2, a key bone-forming protein, was successfully localized and mass-produced by Daewoong Pharmaceutical, CGBio's affiliate. The IDE review involved a rigorous assessment of chemistry, manufacturing, and controls data, with the two companies collaborating closely across research and development, production and quality management. CGBio is targeting the US BMP-2-based bone graft market, which is valued at approximately 1 trillion won ($705 million). The company also plans to expand into additional global markets, including Europe and Australia, following this regulatory milestone. Novosis Putty received Breakthrough Device Designation from the FDA in December 2023 and has already completed Phase 1 and 2 clinical trials in Japan. 'This approval is the result of nearly a decade of R&D and marks an important step in our global expansion,' said CGBio CEO Yu Hyun-seung. 'We remain committed to providing innovative regenerative solutions worldwide.'
Korea Herald
28-02-2025
- Business
- Korea Herald
CGBio secures deals worth W50b at Paris medical research conference
CGBio, a Korean medical device firm and an affiliate of Daewoong Pharmaceutical, said Friday it has secured contracts worth 50 billion won ($38 million) at the International Master Course on Aging Science 2025, a medical research conference held in Paris early this month. CGBio signed major supply agreements with partners across Latin America, Europe and the Middle East to supply the products it showcased at the IMCAS 2025, held in Paris from Jan. 31 to Feb. 1. In detail, the Korea firm inked a 15 billion won deal to provide surgical suture LUXX to the Cimed Group, the fourth-largest pharmaceutical firm in Brazil, for three years. A 17.3 billion won supply contract was also signed for CGBio's dermal fillers Faceteam, AiLEENE and Giselleligne with partners from 18 countries, including the UK, Italy, Portugal, Greece and Saudi Arabia. During the IMCAS Open Stage ― an industry sponsored lectures session ― the company introduced the latest full-body regeneration therapy technique with calcium hydroxyapatite fillers instructed by Renato Pazzini, a Brazilian dermatologist. The company also shared different medical treatment cases in the Euro-Middle Eastern program, 'Meet the Master,' penetrating state-of-the-art beauty and plastic surgery trends and aesthetic techniques. 'Through this event, we were able to witness our global competence,' said the CEO of CGBio, Yu Hyun-seung. 'We will continue to expand our scope in terms of research and development along with global network, leading the future cosmetic surgery market.' CGBio plans to scout new agents in the coming years, actively develop products tailored to the latest trends and strengthen marketing strategies.
