CGBIO has secured approval for its calcium-based filler, Facetem, in Taiwan and is poised to enter the local market. The company aims to generate cumulative supply sales exceeding 5 billion KRW (about 3.7 million USD) over the next three years and plans to expand into the Greater China market, including mainland China.
CGBIO announced that Facetem received medical device approval from Taiwan’s Food and Drug Administration (TFDA) on May 6. This product, marketed in South Korea as DCLASSY CaHA, is approved for replenishing deep dermal layers and subcutaneous soft tissues.
This market entry stems from a licensing agreement CGBIO inked with Hong Kong’s HTDK Holdings in 2024 for the Taiwan region. Index International, HTDK’s Taiwanese distribution partner, will handle local approvals and distribution. The company collaborates with over 500 medical institutions across Taiwan.
The two firms plan to leverage their extensive network of medical institutions to boost product supply and conduct training and academic programs for healthcare professionals. Their goal is to enhance local medical staff’s understanding by providing comprehensive guidance on the product’s materials, structural features, and approved usage protocols.
Market research firm Grand View Research projects that Taiwan’s filler market will reach 41.8 million USD by 2025. The sector is expected to grow at an average annual rate of 12.4% from 2026 to 2033, potentially hitting 105.9 million USD by 2033.
Facetem incorporates CGBIO’s patented Lattice Pore Formation (LPF) technology, which creates a lattice pore structure within calcium hydroxyapatite (CaHA) particles.
Currently, CGBIO exports Facetem to 32 countries worldwide and aims to expand to over 50 by year-end. In China, the company is collaborating with HTDK on clinical trials and regulatory processes.
Chief Executive Officer (CEO) Yoo Hyun-seung stated that they’re set to expand the product supply by leveraging Taiwan’s network of medical institutions and providing comprehensive training for healthcare professionals. By securing regulatory approvals and establishing robust distribution channels in each country, it aims to enhance healthcare professionals’ understanding and experience with the products, paving the way for sustainable long-term growth.
CGBIO is a regenerative medicine specialist that develops and manufactures materials for tissue reconstruction. The company has diversified its portfolio to include bone graft materials, adhesion prevention products, and wound dressings.
In 2013, the company received U.S. Food and Drug Administration (FDA) approval for its negative pressure wound therapy device, CuraVAC, further solidifying its position in the medical device sector focused on wound treatment.