港股異動 | 諾誠健華-B(9969.HK)大漲9%創歷史新高 市值超430億港元
格隆匯6月28日丨諾誠健華-B(9969.HK)高開高走,盤中高見29港元創歷史新高,現漲9.09%報28.8港元,暫成交5629萬港元,最新市值432億港元,該股今年迄今已累漲超1.1倍。諾誠健華今日宣佈,公司自主研發的布魯頓酪氨酸激酶(BTK)抑制劑奧布替尼獲得美國食品藥品監督管理局(FDA)授予突破性療法認定,用於治療復發/難治性套細胞淋巴瘤(R/R MCL)。去年年底,奧布替尼治療MCL獲得美國FDA孤兒藥資格認定。突破性療法認定是美國FDA加速藥品研發和審評的重要審評程序,獲得這些資格不僅意味着FDA對這些創新藥治療潛力的認可,也意味着醫藥公司可以和FDA有更多的溝通交流機會,加快整個進程。

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