NIBEC completes bone regeneration material study in China, seeks NMPA approval
Nano Intelligence Biomedical Engineering Corporation (NIBEC), a Kosdaq-listed biotech firm, said it has successfully completed a clinical trial in China for its flagship bone regeneration material, OCS-B Collagen, and has submitted a marketing authorization application to the National Medical Products Administration (NMPA).
The clinical trial was conducted at four major university hospitals, including Wuhan University Hospital, Nanjing University Hospital, and Xi’an Jiaotong University Hospital, enrolling a total of 192 patients. The study compared OCS-B Collagen against a leading global bone graft material.
All patients treated with OCS-B Collagen demonstrated positive therapeutic outcomes, with efficacy and safety proven to be statistically equivalent to the reference global product. Within 14 days post-surgery, the incision healing rate reached 96.84 percent, with no cases of infection or rejection.
Additional metrics, including bone fusion, bone density maintenance, and the absence of re-grafting requirements, also confirmed stable recovery, according to participating physicians.
NIBEC previously secured NMPA approval for its OCS-B bone graft material in 2020 following a clinical trial involving 280 patients across five university hospitals. The successful completion of the OCS-B Collagen trial strengthens the company’s bone regeneration portfolio and builds on its prior regulatory milestone.
“This clinical trial directly comparing our product to a leading global competitor has validated the competitiveness of OCS-B Collagen,” a NIBEC official said. “We plan to leverage this evidence to drive adoption across Chinese medical institutions and accelerate market penetration through strong collaborations with local hospitals.”
On the news of the clinical trial completion and planned marketing authorization application to the Chinese NMPA for OCS-B Collagen, NIBEC's shares stood at 22,800 won ($16.47) as of 14:25 on Monday, up 6.54 percent from the previous trading day.