NaiVec Obtains IRB Approval for Bio Materials in China... "Expecting Improved Contribution to China-Centered Performance"

Naivek, a peptide fusion bio-specialized company, announced on the 26th that it has obtained Institutional Review Board (IRB) approval for clinical trials of collagen composite materials in China and will commence clinical trials. Collagen composite materials are the third product among Naivek's major bio-material products to undergo clinical trials in China, following the bone graft material ‘OCS-B’ and the periodontal tissue regeneration material ‘Gaidos’ membrane. It is expected that sales performance centered on the Chinese market will increase through sales approval after clinical trials.

Collagen composite materials are bio-products for bone tissue regeneration combined with collagen, helping to restore bone defects around teeth and promote bone tissue growth. The clinical trial in China will be conducted at four local hospitals, involving a total of 192 patients, observing efficacy and any adverse effects for 24 weeks after applying the collagen composite material. It is expected that sales approval can be obtained as early as 8 months to 1 year after the clinical trial ends.

Naivek has previously conducted clinical trials in China for the xenogeneic bone graft material OCS-B. Clinical trials were conducted on 280 patients at five large local hospitals, successfully proving efficacy. In 2020, Naivek received sales approval for OCS-B from the National Medical Products Administration (NMPA) of China and is currently selling the product. Clinical trials for the periodontal tissue regeneration collagen bio-material Gaidos membrane have also been completed, securing efficacy.

A Naivek representative stated, “We are thoroughly preparing to ensure that the clinical trial for collagen composite materials in China proceeds swiftly,” adding, “Since this is the third clinical trial in China, we have accumulated know-how related to clinical trials, and if this trial is successfully completed, we will be able to accelerate our entry into the Chinese implant market, which is showing the steepest growth worldwide.”

He continued, “Our core bio-material products, including collagen composite materials, received many order consultations from global companies at the world’s largest dental exhibition ‘IDS 2023’ held last March,” emphasizing, “Especially companies from the U.S. and the MENA (Middle East and North Africa) region showed great interest, and we expect overseas sales, which have been concentrated in Europe, to expand to various regions including China, the U.S., and South America.”

In January this year, Naivek obtained product sales approval for the xenogeneic bone graft material 'OCS-B' and collagen composite materials in Mexico and Colombia. In addition to these countries, Naivek is currently undergoing various procedures for individual product approvals in multiple global countries.

This content was produced with the assistance of AI translation services.