Giant Biogene Holding Co., Ltd announced that its wholly owned subsidiary, Shaanxi Giant Biotechnology Co., Ltd, has obtained a Medical Device Registration Certificate (No. Guo Xie Zhu Zhun 20263131219) from the China National Medical Products Administration (NMPA) for the Cross-linked Recombinant Collagen Implant.
The newly approved product employs the full-length sequence of mature human type III collagen—comprising 1,068 amino acids—and uses a physical cross-linking method to create a stable three-dimensional mesh gel. Designed for intradermal injection into the dermis layer of the neck, the implant is indicated for correcting moderate to severe horizontal neck wrinkles.
Granted priority review status by the NMPA in December 2024, the device is now the world’s first cross-linked recombinant type III collagen filler approved for neck-wrinkle treatment. The certification positions Giant Biogene as the first company globally to hold both recombinant type I and type III collagen implant products, covering two main aesthetic indications—facial wrinkles and neck wrinkles.
In parallel with this regulatory milestone, the company recently launched the Collgene Reborn (可麗金芯生) Recombinant Type I α1 Subtype Collagen Freeze-dried Fibers, marking its entry into the high-end biological regeneration materials market. These developments align with China’s “15th Five-Year Plan,” which prioritizes biomanufacturing as a future growth industry, and underscore Giant Biogene’s more than 20-year track record in synthetic biology research and industrialization.
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