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Investing.com -- Giant Biogene has received a certificate from China’s National Medical Products Administration (NMPA) for its recombinant Type I collagen facial injectable with native human sequence, making it the first such product in China.
The approval came after a joint review by the Center for Medical Device Evaluation (CMDE) and Center for Drug Evaluation (CDE). The announcement was made during the Hong Kong market lunch break on Thursday.
The newly approved product is primarily composed of recombinant collagen and is designed for dermal tissue filling in facial areas to correct dynamic wrinkles on the forehead, including glabellar lines, forehead lines, and crow’s feet.
This facial injectable differs from Giant Biogene’s RC injection gel, which mainly targets moderate to severe neck wrinkles and was granted priority review in December last year.
According to Jefferies, "this Class-III certificate approval has come as a surprise to the market and earlier than market consensus, and indicates GB’s strong R&D capabilities."
Jefferies noted that during Giant Biogene’s first half 2025 earnings call, management had indicated that the Class-III certificate application was still a work in process and that commercialized layout was under preparation.
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