華潤醫藥(03320.HK)藥品NIP292獲美國藥監局授予孤兒藥資格
華潤醫藥(03320.HK)公布,NIP292獲得美國食品藥品監督管理局(FDA)授予的治療特發性肺纖維化(IPF)孤兒藥資格。
是次藥物被認定為孤兒藥資格,集團將享有罕見病藥物臨床開發的各項激勵措施,包括美國臨床試驗費用相關稅費的抵免、FDA費用減免、藥物上市後針對所認定適應症為期7年的市場獨佔期等。
IPF是一種病因和發病機制尚不明確的、慢性進行性纖維化性間質性肺炎,主要表現為進行性加重的呼吸困難,伴限制性通氣功能障礙和氣體交換障礙,導致低氧血症、甚至呼吸衰竭,預後差,死亡率高,嚴重危害人類生命健康。
針對IPF,華潤醫藥研發的NIP292是一種具有抗炎、抗纖維化、擴張血管、修復血管內皮損傷等多重機制的全新小分子藥物。目前NIP292臨床一期研究正在美國順利進行。而孤兒藥是指用於預防、治療、診斷罕見病的藥品。由於罕見病患病人群少、市場需求少、研發成本高,很少有製藥企業關注其治療藥物的研發,因此這些藥被形象的稱為「孤兒藥」。
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