The Korean regenerative biopharmaceutical firm CGBIO announced an agreement with Australia’s leading independent medical device distributor, LifeHealthcare, on September 16, 2020 that could lead to KRW 200 billion in revenue. Under the contract, CGBIO will supply LIfeHealthcare a recombinant human bone morphogenetic protein-2 (rhBMP-2), NOVOSIS.
This agreement marks the third time for NOVOSIS following Japan’s Nippon Zoki (KRW 600 billion contract) and India’s Eris Lifesciences (KRW 36 billion contract). NOVOSIS will be launched in Australia and New Zealand in the latter half of 2021.
NOVOSIS is a composite bone graft material consisting of 100% hydroxyapatite ceramic with rhBMP-2. In a damaged bone, sustained release of rhBMP-2 from NOVOSIS can effectively contribute to the differentiation of stem cells into osteogenic cells.
NOVOSIS was co-developed by CGBIO and Daewoong Pharma. Thanks to the recognized technology and originality, rhBMP-2 has acquired ‘Nebotermin’ as an International Nonproprietary Name from the Word Health Organization.
CGBIO’s bioactive ceramic supporter is a platform technology in which rhBMP-2 is loaded more effectively than general supporters and slowly released, with an integrated bioreaction and less side effects. CGBIO has filed a patent cooperation treaty (PCT) application for rhBMP-2 formulation technology. NOVOSIS developed by CGBIO received a World Class Product of Korea in 2017 and won Jang Young Sil Award in 2019.
To date, some local companies have launched bone graft with rhBMP-2. However, their indication is limited to dentistry. Now that local clinical trials for NOVOSIS were successfully completed in patients undergoing spinal fusion, this medical device was approved for the use of orthopedics for the first time in Korea in 2017. CGBIO is expected to obtain an orthopedics-related indication from Therapeutic Goods Administration (TGA) in Australia in about September 2021.
“We have an aim to expand biopharmaceutical business in orthopedics and neurosurgery by strong sales of NOVOSIS,” said LifeHealthcare officials. “It is expected that our collaboration with CGBIO will provide better service and medical environments to doctors and patients in Australia and New Zealand.”
“NOVOSIS has been developed through a 13-year intensive R&D effort to catch up with global giant Medtronic’s Infuse Bone Graft,” said CGBIO CEO Hyun Seung Yu. “NOVOSIS is a bioinfusion medical device to increase the efficacy and maximize the safety through application of CGBIO’s sophisticated protein delivery technology. This is the reason why we have reached an agreement with LifeHealthare.”
“Our market entry into the U.S. plus Japan, India, and Australia is also underway. We will further expand our presence in countries around the world,” Yu added.
