萬邦德(002082.SZ):子公司甲鈷胺治療肌萎縮側索硬化適應症獲得FDA孤兒藥資格認定
格隆匯2月17日丨萬邦德(002082.SZ)公佈,公司全資子公司萬邦德製藥集團有限公司於2025年2月13日收到美國食品藥品監督管理局(簡稱“FDA”)的認定函,甲鈷胺用於治療肌萎縮側索硬化(ALS,也稱漸凍症)獲得FDA授予的孤兒藥資格認定。
甲鈷胺是甲硫氨酸合成酶的輔酶,催化同型半胱氨酸轉化為甲硫氨酸,從而維持甲基化循環平衡並降低同型半胱氨酸的神經毒性。臨牀證據顯示ALS患者腦脊液中同型半胱氨酸水平顯著升高。甲鈷胺通過代謝調控減少同型半胱氨酸蓄積,同時直接保護神經元免受穀氨酸毒性,並在動物模型中促進神經再生與修復,如改善坐骨神經損傷和糖尿病神經病變中的傳導功能,突顯其雙重神經保護機制及在治療神經退行性疾病中的潛在價值。
甲鈷胺凍乾粉針劑於2024年9月在日本獲批用於漸凍症的治療。美國尚無甲鈷胺藥品上市。
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