The Korean regenerative biopharmaceutical firm CGBIO said on November 2, 2020 that India’s Central Drugs Standard Control Organization (CDSCO) authorized the sale of recombinant human bone morphogenetic protein-2 (rhBMP-2), NOVOSIS.

Indian medical device market is regarded as having a big potential. India’s population is estimated at 1.4 billion people. India is the second most populated country following China. The Drug Control Department of India forecasts that India’s medical device market is growing at more than 10% CAGR every year.

According to Indian Ministry of Health and Family Welfare, Indian healthcare market size is estimated at $280 billion. India has more than 75% import dependency on medical devices. CGBIO expects that the approval of NOVOSIS in India will become a new engine for propelling the rapid growth of the company. Eris Life Science, which has already formed a partnership with CGBIO, will be responsible for NOVOSIS distribution in India.

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.

CGBIO’s bioactive ceramic supporter is a platform technology in which rhBMP-2 is loaded more effectively than general supporters. It is slowly released, with an integrated bioreaction and less side effects. CGBIO has filed a patent cooperation treaty (PCT) application for rhBMP-2 formulation technology. CGBIO received a World Class Product of Korea for recognition of NOVOSIS development in 2017 and won Jang Young Sil Award in 2019. Now that NOVOSIS is approved for spinal fusion, CGBIO plans to acquire another indication for its dental application.

“With marketing authorization of NOVOSIS by India’s CDSCO, this product will be successfully landed in the rapidly growing medical device market in India,”, said CGBIO CEO Hyun Seung Yu. “We will endeavor to increase the presence of NOVOSIS in India through our aggressive marketing tactics.”.

“We will acquire marketing authorization of NOVOSIS from Therapeutic Goods Administration (TGA) in Australia for successful launching, where CCBIO has reached an agreement with LifeHealthcare in Australia for supplying NOVOSIS,” Yu added.