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重组Ⅲ型人源化胶原蛋白溶液
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【锦波生物(832982.BJ)】首个胶原蛋白填充类三类械注册证获批,打开成长天花板——获得第三类医疗器械注册证事件点评(姜浩)
光大证券研究· 2025-04-11 09:02
Core Viewpoint - The company has received approval for its third-class medical device, "Injectable Recombinant Type III Humanized Collagen Gel," which reinforces its monopoly in the recombinant collagen aesthetic medicine industry [2][3]. Group 1: Regulatory Approval - The company announced on April 9 that it obtained a third-class medical device registration certificate from the National Medical Products Administration for "Injectable Recombinant Type III Humanized Collagen Gel" [2]. - This product is the third recombinant collagen product approved, following the approvals of "Recombinant Type III Humanized Collagen Freeze-Dried Fiber" in 2021 and "Recombinant Type III Humanized Collagen Solution" in 2023 [3]. Group 2: Market Position and Competitive Advantage - With all three third-class medical device certifications for recombinant collagen in China held by the company, it confirms its leading position in the domestic and global recombinant collagen industry [3]. - The company’s monopoly in the recombinant collagen aesthetic field is expected to continue, maintaining a leading edge even with potential new entrants in the market [3]. Group 3: Product Innovation and Market Expansion - The newly approved product is the first internationally to utilize self-assembly and self-crosslinking technology, produced via synthetic biology, suitable for correcting mid-facial volume loss and contour defects [4]. - The product expands the application of recombinant collagen from water-light treatments to support and filling, thus broadening its market potential in the aesthetic medicine sector [4]. - The higher market positioning, pricing, and profit margins of support and filling products indicate that the company is opening pathways to serve the high-end aesthetic market [4]. Group 4: Industry Growth Potential - According to Taiwan's Shuangmei's financial report, sales of animal-derived collagen in mainland China reached 370 million RMB, with a year-on-year growth of 8.5% [5]. - The compound annual growth rate (CAGR) for Shuangmei's revenue in mainland China from 2019 to 2024 is 27.1%, indicating rapid growth, which bodes well for the company's new product launch and operational prospects [5].