內地發布新指導原則 藥明生物(02269.HK)挫逾9%
國家藥品監督管理局藥品審評中心(CDE)上周五發布新通知,醫藥股顯著受壓。藥明生物(02269.HK)最多挫逾9%,低見124.5元,為表現最差藍籌,成交16億元;同系藥明康德(02359.HK)亦挫6.8%。康龍化成(03759.HK)跌7.7%,方達控股(01521.HK)瀉近一成;泰格醫藥(03347.HK)跌7.6%。
CDE日前發布徵求《以臨床價值為導向的抗腫瘤藥物臨床研發指導原則》意見的通知,該《指導原則》稱,藥物進行臨床對照試驗時,一是應盡量為受試者提供臨床實踐中最佳治療方式及藥物,而不應為提高臨床試驗成功率和試驗效率,選擇安全有效性不確定,或已被更優的藥物所替代的治療手段。
同時,新藥研發應以為患者提供更優治療選擇為最高目標,當選擇非最優的治療作為對照時,即使臨床試驗達到預設研究目標,也無法說明試驗藥物可滿足臨床中患者的實際需要,或無法證明該藥物對患者的價值。
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