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樂普生物(02157.HK)MRG004A用於治療胰腺癌適應症獲FDA孤兒藥認定
阿思達克 12-14 17:29
樂普生物(02157.HK)公布,候選藥物MRG004A用於治療胰腺癌適應症,近日獲美國食品藥品監督管理局(FDA)授予孤兒藥資格認定,預料將有助於MRG004A在美國的後續研發、註冊及商業化過程中享受若干激勵,包括合格臨床試驗的稅收抵免、用戶收費豁免及獲批後享有七年的潛在市場獨佔權。 MRG004A是一種新型靶向組織因子的運用定點偶聯技術進行偶聯的特異性抗體藥物偶聯物,目前樂普生物在美國及中國進行I/II期臨床研究。公司表示,已觀察到胰腺癌、三陰性乳腺癌及宮頸癌的抗腫瘤活性信號。
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