CGBio's NOVO Factory Receives Construction Approval, Establishes Production System Targeting U.S. and Japanese Markets

Establishment of Dedicated Production Base for NOVOSIS PUTTY and OS Products

CGBio, a company specializing in regenerative medicine, announced on March 4 that its second plant, the 'NOVO Factory,' established in Hyangnam, Hwaseong, Gyeonggi Province, recently received construction approval, and has officially begun operating as a dedicated facility exclusively manufacturing NOVOSIS PUTTY and orthopedic surgery (OS, Orthopedic Surgery) products. With the completion of the facility, the company has secured a strategic production base to accelerate its entry into advanced markets such as the United States and Japan.

While CGBio’s existing first production plant, the 'S-Campus' in Hyangnam, is a smart factory specializing in filler production, the NOVO Factory serves as a strategic production base for regenerative medicine products designed to comply with the U.S. FDA’s manufacturing and quality standards. In particular, NOVO Factory has been established as a core production base dedicated to the global supply of 'NOVOSIS PUTTY' and 'NOVOSIS OS' among the NOVOSIS product lineup, further adding significance to its completion.

S Biopharmaceutical's 'Novofactory' (right) and the existing 'S-Campus' (left) panorama. S Biopharmaceutical

NOVOSIS PUTTY is a key strategic product aimed at entering advanced markets such as the United States and Japan, based on its U.S. FDA Investigational Device Exemption (IDE) clinical approval. The completion of NOVO Factory is symbolic in that it provides the actual production infrastructure needed to expand overseas supply of this product. The United States and Japan are markets with high standards for medical device quality and clinical data, and securing stable production capacity is regarded as a prerequisite for business expansion.

NOVOSIS is CGBio's flagship bone substitute brand, featuring a range of products that apply bone morphogenetic protein (rhBMP-2) to a hydroxyapatite (HA) ceramic scaffold that mimics the structure of human bone. Among them, 'NOVOSIS PUTTY' is a semi-solid (putty) product with viscosity, developed based on this technology and designed for easy handling during surgery. 'NOVOSIS OS' is a bone substitute product used in the orthopedic surgery sector and is produced according to specifications and quality standards tailored to global clinical settings. NOVO Factory is equipped with the capacity to produce up to 1 million syringes of NOVOSIS PUTTY per year, based on the 3mg dosage.

The synthetic bone production area incorporates CGBio’s core technologies. It features forming and coating equipment capable of precisely creating porous structures, grinding systems optimized for CGBio’s processes, and high-capacity sintering equipment to significantly increase output compared to existing facilities, thereby ensuring both mass production and product uniformity. As a result, NOVOSIS and BONGROWTH can initially be manufactured at a scale of 400,000 units per year, with potential for phased expansion. The foundational infrastructure has also been established for the stable production of major product lines, including NOVOSIS PUTTY, EXCELLOUS INJECT, and NOVOMAX FUSION. On the medical device production lines, products such as CURASYS, CURAVAC, BELLUNA, and CELLUNIT can be manufactured via automated equipment. These improvements not only enhance the work environment and production efficiency but also significantly strengthen supply chain stability compared to previous operations.

Additionally, NOVO Factory now houses 'CGMaterials,' a raw materials specialist subsidiary established last year. CGMaterials directly synthesizes hydroxyapatite (HAP), beta-tricalcium phosphate (β-TCP), and BGS-7 (a bioactive glass ceramic material), and processes and supplies these as raw materials for the manufacture of products such as the bone substitute NOVOSIS and the premium collagen stimulator DECLASSE CaHA (export name 'Facetem'). With this, CGBio has established a vertically integrated structure covering everything from core raw material synthesis to finished product manufacturing, achieving both quality consistency and cost competitiveness.

NOVO Factory was designed from the outset to meet the requirements of the U.S. FDA’s cGMP (Current Good Manufacturing Practice) inspection and Japan’s PMDA (Pharmaceuticals and Medical Devices Agency) review. It complies with medical device manufacturing and quality control regulations, as well as international medical device quality management standards (21 CFR Part 820 (QSR), QMSR, ISO 13485, etc.). Cleanrooms and automated production facilities have been installed to minimize contamination risk, and operational systems such as document management, quality improvement (CAPA), and environmental monitoring—suitable for U.S. FDA inspections—have been applied throughout the production system. Sterilization and packaging processes have also completed internal validation in accordance with international standards, and a global regulatory compliance framework has been established.

Hyunseung Yoo, CEO of CGBio, stated, "NOVO Factory is more than just a production facility; it is a strategic production base aimed at actively targeting advanced regulated markets such as the United States and Japan, with NOVOSIS PUTTY at its core." He added, "We will accelerate our entry into advanced markets such as the U.S. and Japan, leveraging a manufacturing infrastructure capable of meeting U.S. FDA cGMP and Japan PMDA inspections."

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