国内首备案！合成生物上市龙头，押注“人体软黄金”

智药局2025-08-11

近日，合成生物上市龙头华熙生物宣布完成国内首个发酵法软骨素钠医疗器械主文档备案（登记号：M2025264-000）。据悉，软骨素钠可用于II类、III类医疗器械，如医美注射、骨科填充或修复及眼部护理等终端医疗器械产品。而华熙生物的发酵法技术主要通过微生物定向发酵直接合成软骨素钠，具备100%无动物源引入、100%生物基碳源、生产过程中不使用有毒试剂等优势，且产品纯度达95%以上，生物相容性良好。...

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