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兆科眼科-B(06622.HK):用於治療兒童視網膜母細胞瘤的美法侖取得美國FDA孤兒藥資格認證
格隆匯 07-30 19:09

格隆匯7月30日丨兆科眼科-B(06622.HK)公吿,美國食品藥品監督管理局(FDA)已向公司擁有專利配方、用於治療兒童視網膜母細胞瘤(RB,一種罕見的兒童眼癌)的美法侖授出孤兒藥資格認證(Orphan Drug Designation,「ODD」)。

取得ODD為在美國提交新藥臨牀試驗申請建立清晰的監管路徑。再者,如果美法侖獲成功研發並獲批准,公司將在新藥上市申請批准後享有七年美國市場獨家權利。此項完善保護涵蓋上市許可持有人(marketing authorization holder,「MAH」)地位及數據獨家權利,尤其重要的是,即使配方有所創新,FDA亦不得批准任何其他以美法侖為基礎的RB適應症產品。

美法侖是一種烷化劑類抗腫瘤藥物,通過與DNA作用並干擾DNA複製和細胞分裂,阻斷癌細胞在體內生長擴散。現時,美法侖應用主要作為多發性骨髓瘤患者自體造血幹細胞移植前的預處理治療,或口服療法不適用的多發性骨髓瘤的緩和治療等。

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