Naibec Advances Chinese Approval for Core Bio-Material Product 'Gaidos'

Naivec, a peptide fusion bio-specialized company, announced on the 24th that it has submitted a product approval application to the China National Medical Products Administration (NMPA) for its next-generation core product in the bio-material business division, the GuidOss barrier membrane (hereinafter referred to as GuidOss).

GuidOss is the second product for which approval has been applied following the bone regeneration bio-material ‘OCS-B,’ which is already being sold in China. It is expected to benefit from the rapidly growing Chinese implant market. This next-generation product is anticipated to make a significant contribution to the expansion of sales in the bio-material sector.

GuidOss is a barrier membrane containing collagen that induces periodontal tissue regeneration. It is a core bio-material that maintains space within the destroyed periodontal tissue, creating an environment where desired cells can proliferate.

A Naivec representative stated, “Since all statistical data have been secured after completing procedures on 180 patients over the past three years and conducting follow-up observations, we expect no difficulties in obtaining sales approval. We will actively enter the rapidly growing Chinese implant market with product lines necessary for implant placement, including the dental bone graft material OCS-B, the periodontal tissue regeneration material GuidOss, and collagen composite materials, accelerating our growth trajectory.”

Naivec was the first domestic company to receive product approval from China’s NMPA in 2020 for the bone regeneration bio-material OCS-B. OCS-B underwent large-scale clinical trials involving 280 patients at five major hospitals in China, proving its efficacy and successfully obtaining the stringent product approval certification. It is currently being sold in China.

Last month, Naivec obtained Institutional Review Board (IRB) approval for clinical trials of collagen composite materials in China, and clinical trials are scheduled to proceed. The clinical trials will be conducted at four local hospitals with 192 patients, observing efficacy and any adverse effects for 24 weeks after applying the collagen composite material. The collagen composite material is expected to obtain sales approval within one year after the completion of clinical trials.

A Naivec representative said, “Following the approval of our core bone regeneration bio-material product OCS-B, which is already sold in China, obtaining product approval for the next-generation core product, the GuidOss periodontal tissue regeneration barrier membrane, will significantly increase sales through synergy effects from expanding the implant bio-material product line in China.”

He added, “Besides China, since our bio-material products are being exported worldwide, including Europe and the United States, through global implant companies, we expect continued performance growth this year as well.”