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大消费渠道脉搏:国内重组蛋白表达技术仍处于起步阶段,海外押注再生材料

Investment Rating - The report does not explicitly provide an investment rating for the recombinant collagen industry or specific companies within it [6]. Core Insights - The domestic recombinant collagen expression technology is still in its infancy, facing two main technical bottlenecks: achieving a spatial structure consistent with human collagen and transitioning from laboratory to mass production [2][8]. - The overseas market currently shows low attention to recombinant collagen, with a focus on regenerative materials instead. The domestic market is more engaged due to regulatory advantages and brand effects from companies like Jinbo Bio-pharmaceutical [3][9]. - Regulatory challenges exist in obtaining Class III medical device approval for recombinant collagen, with most companies following Jinbo's approval path [4][10]. Summary by Sections Technical Bottlenecks - The first bottleneck involves forming a spatial structure that mimics human collagen, which may take an additional 3 to 5 years to resolve. The second bottleneck is the limited number of companies capable of stable mass production, currently fewer than 10 [2][8]. Market Focus - Overseas companies prioritize regenerative materials and high-end products, while the domestic market is more focused on recombinant collagen due to regulatory advantages and brand recognition [3][9]. Regulatory Environment - The approval process for recombinant collagen varies significantly between domestic and international markets, with stricter regulations in China. Companies face challenges in obtaining necessary approvals, particularly for high-risk applications [4][10]. Production Variability - Different companies utilize varying amino acid sequences and host cells for protein production, affecting the biological activity and efficacy of their products. The choice of host cells, such as E. coli or mammalian cells, significantly impacts the protein's activity and application [5][11][13].