SijiBio Secures Taiwanese Regulatory Approval for Facetem Dermal Filler
SijiBio has obtained medical device marketing approval from the Taiwan Food and Drug Administration (TFDA) for its calcium hydroxylapatite (CaHA) based dermal filler, Facetem, on May 6. The clearance paves the way for the company to expand its aesthetic product footprint across the Greater China market utilizing established local medical networks.
Commercial Distribution and Local Partnerships in Taiwan
The regulatory clearance was pursued through a licensing agreement originally signed in 2024 with HTDK Holding (Hong Kong) Limited. Under this arrangement, local regulatory filing, distribution, and commercial sales are managed by Index International, HTDK’s designated Taiwanese distribution partner. Index International maintains a collaborative network spanning over 500 medical institutions across Taiwan.
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SijiBio plans to leverage this existing healthcare infrastructure to distribute the product while simultaneously executing targeted educational initiatives. Medical professionals will receive specialized training on the material composition, structural characteristics, and authorized application parameters of the filler.
Product Specifications and Clinical Applications
Marketed domestically under the brand name DClassy CaHA, Facetem is officially approved in Taiwan for deep dermal and subcutaneous soft tissue augmentation. The device incorporates SijiBio’s proprietary Lattice-Pore Formation (LPF) technology. This manufacturing method engineers a lattice-like porous architecture directly into the CaHA microspheres, governing both the internal physical structure and the in vivo degradation profile of the implant.
The commercial rollout targets a cumulative supply revenue exceeding 5 billion KRW over the next three years within the territory.
Global Expansion and Mainland China Regulatory Pipeline
Beyond the Taiwanese market, Facetem is currently exported to 32 countries worldwide. SijiBio intends to scale its international footprint by pushing the total number of export contract nations past 50 before the end of the year. In parallel, the company is collaborating with HTDK to advance local clinical trials and regulatory approval pathways within mainland China.
Yoo Hyun-seung, CEO of SijiBio, stated that the company plans to expand supply in Taiwan based on local medical institution networks and medical professional education, adding that by securing national approvals and distribution foundations while building medical practitioners’ understanding and user experience with the product, the company will connect this to long-term growth.
