CGBio announced on Wednesday that its second factory, Novo Factory, in Hyangnam, Hwaseong, Gyeonggi Province, has received construction approval. This dedicated facility will now officially produce the bone substitute Novosis Putty and orthopedic surgical products. The completion of this factory marks a significant milestone, securing a strategic production base to intensify efforts in advanced markets like the U.S. and Japan.
The Novo Factory establishes a production hub for the bone substitute brand Novosis. While CGBio’s existing S-Campus in Hyangnam specializes in filler production, the Novo Factory is designed to produce regenerative medical products that meet U.S. Food and Drug Administration (FDA) manufacturing and quality standards.
Within the Novosis product line, the Novo Factory is specifically designed as a core production center for the global supply of Novosis Putty and Novosis OS.
Novosis Putty, a key strategic product, is pursuing entry into advanced markets such as the U.S. and Japan, backed by FDA Investigational Device Exemption (IDE) approval. The completion of the Novo Factory is symbolic, representing the establishment of practical production infrastructure to expand the product’s international supply. In markets like the U.S. and Japan, where standards for medical device quality and clinical data are exceptionally high, securing stable production capacity is crucial for business expansion.
Novosis (NOVOSIS) is CGBio’s flagship bone substitute brand. It features products that apply bone-forming protein (rhBMP-2) to a hydroxyapatite (HA) ceramic scaffold mimicking human bone structure. Novosis Putty, part of this line, is formulated as a viscous semi-solid to facilitate easier handling during surgical procedures.
Novosis OS is a bone substitute product for orthopedic surgeries, produced to meet global clinical standards. The Novo Factory has the capacity to produce up to 1 million syringes annually of Novosis Putty, based on a 3 mg standard.
CGBio’s Core Technologies Consolidated… Preparing for Regulatory Review
The facility features precision molding and coating equipment for creating porous structures, optimized crushing equipment, and high-capacity sintering equipment. This setup ensures both mass production capabilities and consistent quality.
The production system for Novosis and Bone Gross starts with an annual capacity of 400,000 units, with room for phased expansion. The facility is also equipped to reliably produce other key products like Novosis Putty, Excelos Inject, and Novomax Fusion.
The medical device production line incorporates automated equipment to manufacture products such as Curasis, Curaback, Belluna, and Cellunit. This automation enhances the working environment and boosts production efficiency, significantly improving supply stability.
The Novo Factory houses CG Materials, a raw material subsidiary established last year.
CG Materials directly synthesizes materials like Hydroxyapatite (HAP), beta-tricalcium phosphate (β-TCP), and bioactive glass ceramic (BGS-7). These are then processed and supplied as raw materials for products including the bone substitute Novosis and the premium collagen stimulator D-Classi CaHA (marketed internationally as Facestem).
This integration completes CGBio’s vertically integrated structure, encompassing everything from core raw material synthesis to finished product manufacturing. This approach ensures both quality consistency and cost competitiveness.
From its initial design phase, the Novo Factory was built to meet FDA Good Manufacturing Practice (GMP) inspection requirements and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) drug assessment standards. It complies with medical device manufacturing and quality management regulations as well as international medical device quality management standards.
The facility minimizes contamination risks through cleanroom technology and automated production equipment. It also implements comprehensive operational systems to prepare for FDA audits, covering areas such as document management, quality improvement, and environmental monitoring. Sterilization and packaging processes have undergone internal validation to meet international standards, establishing a framework for global regulatory compliance.
CGBio’s CEO, Yu Hyun-seung, stated that the Novo Factory is more than just a production facility; it’s a strategic base for aggressively targeting advanced regulatory markets like the U.S. and Japan, with Novosis Putty at the forefront. With its manufacturing infrastructure now capable of meeting FDA Current Good Manufacturing Practice (cGMP) inspections and Pharmaceuticals and Medical Devices Agency (PMDA) assessments, they’re poised to make significant inroads into these advanced markets.
