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China’s active biological bone was approved by NMPA Hay:P01YTZH

On October 20, 2022, China's leading orthopedic repair material biotechnology company:

YTZH Biotechnology Corporation announces:

The active biological bone developed by the company has obtained the registration certificate of the State Drug Administration [NMPA]

Active biological bone is a kind of bone repair material, which is made of bone scaffold materials (mainly composed of hydroxyapatite and collagen) made of xenogeneic bone after a series of treatment, and combined with recombinant human bone morphogenetic protein (rhBMP-2) with specific binding capacity of collagen.

Among them, the bone scaffold material maintains the natural structure of bone, with appropriate pore size and porosity. The loose reticular space occupying structure of bone scaffold material can be used to fill bone defects, and support local cells and blood vessels to crawl inward, live in it, and gradually absorb and replace it

During the process of bone healing, rhBMP-2 can recruit mesenchymal cells and induce them to differentiate into osteoblasts or chondroblasts. At the same time, other regulatory factors of the system participate in the formation of bone tissue. Active biological bone can achieve the filling and repair of bone defects through the synergistic effect of bone scaffold materials and rhBMP-2.

Through clinical trials, the active biological bone can be used as a bone graft substitute to promote the repair of bone defects in the non weight bearing bone and joint surface bone defects. The product will eventually be replaced by new bone tissue after application.

Compared with other products that have been put on the market, active biological bone is composed of bone materials and BMP, which is unique in product communication and mechanism of action.

The benchmarking product of YTZH's active biological bone is Medtronic's InfuseBone. After its launch in 2002, the market share of Medtronic's active biological bone rose rapidly with its outstanding product quality advantages. The peak sales volume was close to US $1 billion, and the global market share exceeded 50%.

The active biological bone of the company has overcome the side effects of complications such as ectopic bone formation caused by the high concentration of BMP-2 of Medtronic InfuseBone, with better performance and better sales prospects.

At present, the international market is occupied by Medtronic and Stryker.

YTZH has invested in the research and development of active biological bone since 2005, and it has been nearly 20 years.

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