In a significant development, Giant Biogene (02367) has announced that its wholly-owned subsidiary, Shaanxi Giant Biogene Technology Co., Ltd., has obtained a Medical Device Registration Certificate from China's National Medical Products Administration for its cross-linked recombinant collagen implant. The product, utilizing the full-length sequence of human mature type III collagen with 1,068 amino acids, retains the natural functional domains of collagen. It employs a physical cross-linking process free from chemical cross-linker residue risks, forming a stable three-dimensional network gel for intradermal injection into the neck to correct moderate to severe horizontal neck lines. This implant was included in the NMPA's priority review pathway for medical devices in December 2024. Following this approval, it has become the world's first cross-linked recombinant type III collagen filler specifically for neck line correction.
Following the approval of two previous implant products, the successful registration of this product will further diversify and enhance the company's product portfolio. This achievement makes Giant Biogene the first company globally to possess both recombinant type I and type III collagen implant products, with indications covering facial wrinkles and neck wrinkles. This milestone underscores the company's deep research, innovation, and industrial application capabilities, enabling it to continuously expand into new market segments.
Recently, the company's Coregenxin recombinant type I α1 subtype collagen lyophilized fiber product, under the 'Curgine' brand, has been launched, marking the company's official entry into the commercialization of high-end bioregenerative materials. The national "15th Five-Year Plan" proposal calls for the forward-looking layout of six future industries, including biomanufacturing. Moving forward, the company will leverage its over two decades of synthetic biology research to advance the market promotion of its approved products and the research and development of its pipeline products. This strategy aims to support the domestic biomanufacturing and regenerative materials industry in accelerating its transition towards a new phase of standardized, high-end, and technologically advanced high-quality development.
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