On November 14, 2022, the registration application was approved by the State Drug Administration;
On November 22, 2022, the production license of medical devices was issued;
On November 24, 2022, WH production base officially started mass production.
Recently, WHYZ Biomaterial Technology Corporation has sent good news one after another. The artificial bone repair materials independently developed by the company will soon move from clinical trials to large-scale clinical use, providing new options for patients with bone diseases that are both economical and safe.
Independent innovation promotes domestic substitution
The price of highly active artificial bone materials will be greatly reduced
Bone cement, artificial bone and other orthopaedic biomaterials are indispensable key materials in the surgical treatment of orthopaedic diseases, and are used to fill the autologous bone defects of patients with fractures and bone tumors.
Statistics show that more than 70% of the Chinese orthopaedic biomaterials market has been recognized by Johnson&Johnson, Medtronic, B Braun Global and other foreign manufacturers occupy. Take the imported high activity artificial bone materials as an example. The price per gram is as high as 4000 to 6000 yuan, which has become an important factor leading to high treatment costs.
WHYZ focuses on the fields of biomedical materials such as bone repair materials, oral biomaterials, artificial blood vessels, and artificial skin, and accelerates the realization of domestic substitution.
The highly active artificial bone material, which was approved for listing this month, is the first highly active multi-stage structure artificial bone repair material in China. It has full independent intellectual property rights and has won several invention patents in China and the United States.
"Through independent control of key raw materials and large-scale production of products, we can reduce the cost of highly active artificial bone materials to less than half of the imported products." Dr. Zhang Shengmin, Chief Scientist of National Key R&D Program, Professor of Huazhong University of Science and Technology, and Chief Scientific Advisor of WHYZ, said.
Since 2016, WHYZ has carried out multi center clinical trials nationwide. In 8 years, a large number of clinical results have proved that the "bone graft fusion rate" has reached 100%. "This is a very rare achievement in the industry, indicating that we can provide patients with more affordable, safe and reliable diagnosis and treatment programs."
In addition to the newly approved high activity artificial bone materials, two new generation of high activity artificial bone materials being developed by WHYZ are accelerating the marketing process.
WHYZ has reserved a number of key projects with clear transformation prospects. In the next three to five years, 5-6 Class III implant and interventional medical devices are expected to be approved for listing, helping China's biomedical materials and devices to achieve high level of scientific and technological self-reliance.
In November 2018, the biomedical materials and devices research institute jointly established by WHZY and Wuhan Industrial Innovation and Development Research Institute was officially put into operation, aiming to promote the multi subject and cross regional collaborative innovation of "government, industry, university, research and use" of biomedical materials and devices.