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華熙生物(688363.SH):發酵法軟骨素鈉完成醫療器械主文檔登記

格隆匯8月11日丨華熙生物(688363.SH)公佈,自主研發的發酵法軟骨素鈉原料(簡稱“軟骨素鈉”)成功通過國家藥品監督管理局醫療器械技術審評中心(CMDE)的主文檔備案登記(登記號:M2025264-000),成爲我國首個實現發酵法軟骨素鈉合規化備案的企業。本次完成備案的軟骨素鈉作爲公司醫藥級原料的新品種,可應用於II類、III類醫療器械,未來有望爲高端醫療器械提供核心原料。

傳統硫痠軟骨素主要從動物軟骨(如豬、牛、雞、鯊魚)中提取,存在動物免疫原性、原料來源不可持續、提取工藝污染高等問題。下一步,公司將以發酵法得到的軟骨素鈉爲基礎,利用合成生物學技術開發硫痠軟骨素原料,應用於眼科、骨科、醫美等領域。

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