2019年全球新药研发报告(Ⅰ)

A Report of New Drugs Research and Development in 2019(Ⅰ)

通过对全球药品市场新获批和新上市的药物进行年度综述,重点内容包括:截至目前,在囊性纤维化治疗中应用最广泛的Trikafta的获批和上市;首款常规(非应急)接种用的埃博拉疫苗的获批;全球首款疟疾疫苗在3个非洲国家的试点推广;一种新型多药耐药细菌感染治疗药物的获批;首款阿尔茨海默病原研药在中国的获批上市,结束全球10余年来相关领域无新药上市的历史。随着多款新型免疫检查点抑制剂和抗体药物偶联物的恶性肿瘤适应证相继获批,证实了生物制药行业对恶性肿瘤免疫疗法的投入热情持续上涨。2019年最引人瞩目的趋势是美国FDA授予了创纪录数量的加速审批,其中多项审评的批准早于预期批准日期多达数月。

Highlights of our annual review of new approvals and launches on global drug markets include the approval and launch of Trikafta,the most widely applicable treatment to date for cystic fibrosis;approval of the first Ebola vaccine for general(rather than emergency)use;the pilot rollout in three African countries of the world’s first malaria vaccine;approval of a new treatment option for multidrug-resistant bacterial infections;and the approval and launch in China of the first new drug to treat Alzheimer’s disease in more than a decade.Several new immune checkpoint inhibitors and antibody-drug conjugates were approved for cancer indications,confirming continued industry enthusiasm for cancer immunotherapy.The most notable trend of 2019 was the granting by the Food and Drug Administration(FDA)of a record number of accelerated approvals,many of which were issued several months ahead of the expected action date.