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《大行報告》建銀國際:內地就仿製藥一致性評價徵求意見 可推動藥企創新
建銀國際發表研究報告指,內地就仿製藥品質和療效一致性評估受理審查指南徵求意見,即如果一間公司品種通過了一致性評價,有關當局將在三年內不再接受其他公司對同一仿製藥品種的申請。該行相信,這項新政策是藥監局推動中國藥物開發和評價市場成為真正創新藥物的舉措的一部分,這些藥物與市場上現有藥物相比具有臨床獨特性和更優越的療效。 該行提到,此前中國的藥品市場過於擠擁,令醫療資源未能良好運用。隨著帶量採購(VBP)成為目前醫院採購藥品的主要管道,通過一致性評價認證是仿製藥企業進入VBP招標流程的入場券。最近透過一致性評價的藥品將優先納入VBP招標,無法參與VBP招標將嚴重阻礙收入嚴重依賴仿製藥銷售的公司。 該行表示,目前中國的藥品審批申請變得愈來愈困難,仿製藥製造商的稀缺溢價亦愈來愈高。在這種環境下,獲得一致性評價認證最多的上市公司將具有優勢。而上半年獲批最多的藥物開發商是石四藥集團(02005.HK),佔17款;而石藥集團(01093.HK)亦有8款。
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