GIANT BIOGENE obtains Class III medical device certification for recombinant collagen, potentially challenging Jinbo's exclusive position

The market for recombinant collagen injection materials is welcoming more players.

On October 23, GIANT BIOGENE (2367.HK) announced that its three types of medical devices, "recombinant type I collagen freeze-dried fibers," have been approved for market launch by the drug regulatory authority. The indications are for facial dermal tissue filling to correct dynamic wrinkles in the forehead, including frown lines, forehead lines, and crow's feet.

Specifically, GIANT BIOGENE's product is composed of recombinant type I collagen, selected from the 305th to the 1057th amino acid positions of the human natural type I alpha1 amino acid sequence, totaling 753 amino acids, and does not have a triple helix structure.

According to GIANT BIOGENE's explanation to Xinfeng, type I collagen mainly provides support and elasticity in the skin.

"Collagen accounts for about 25-35% of the total protein content in the human body, while type I collagen accounts for 80-90% of the total collagen in the body. Type I collagen makes up about 80% of the collagen in the skin, being the most abundant, and provides the main support and elasticity in the skin," GIANT BIOGENE stated. "The natural sequence collagen we have been approved for means that the sequence is identical to that of human collagen, covering all functional domains of type I collagen, without any modifications (such as splicing or repetition). Experimental verification shows low immunogenic risk, high biocompatibility, high safety, and biological functions close to human collagen."

This may break the monopoly of JINBO BIOLOGY (920982.BJ).

Previously, only JINBO BIOLOGY had obtained the Class III medical device certification for recombinant collagen injection materials, which has become an important asset for its soaring performance—2024 revenue is projected to be 1.443 billion yuan, a year-on-year increase of over 80%.

However, the material compositions of the two are slightly different.

GIANT BIOGENE's product belongs to recombinant type I collagen, while JINBO BIOLOGY's core material is recombinant type III collagen, which has a triple helix structure.

According to an industry insider in the medical beauty sector in Beijing, type I collagen mainly provides structural support, while type III collagen is primarily responsible for elastic repair.

However, from the perspective of approved indications, there is no difference between the two.

The approved indication for JINBO BIOLOGY's "recombinant type III humanized collagen injection solution" is "for facial dermal tissue filling to correct dynamic wrinkles in the forehead (including frown lines, forehead lines, and crow's feet)."

It is foreseeable that as the number of approved Class III recombinant collagen products increases, market competition may become even more intense