2018年全球新药研发报告--第1部分:新药和生物制剂(Ⅰ)

A Keport of New Drugs Kesearch and Development in 2018-Part I: New Drugs & Biologies (Ⅰ)

2018年全球首次获批或上市的新药和生物制剂共64种,达近10年来最大数量。同年,还有19种产品线拓展产品(即新适应证、新联合用药和新制剂等)获批,以及23种新产品和产品线拓展产品获批但在2018年12月31日前尚未上市。作为近年来的发展趋势,抗肿瘤是上市药物最活跃的治疗领域,抗癌药物占2018年全球获批或上市新药及生物制剂的25%。2018年首次上市8个同类首创新药(firstin-class),包括首个RNA干扰剂,3种不同类型的非血管收缩性抗偏头痛药物和抗降钙素基因相关肽(CGRP)单克隆抗体。2018年29种指定孤儿药的获批反映了被忽视疾病领域投资的持续增长。这在美国尤为突出,因为2018年美国有25种孤儿药获批上市。总体而言,美国是新药和生物制剂最活跃的市场,占2018年所有新上市产品的2/3。

Sixty-four new drugs and biologies reached their first global markets in 2018, the greatest number in at least a decade. In addition, 19 important new line extensions (new indications, new combinations or new formulations of previously marketed drugs) were introduced over the course of 2018. Twenty-three other new products and new line extensions were approved but not launched before December 31. As has been the trend in recent years, oncology was the most active therapeutic area in terms of new launches, with cancer drugs accounting for 25% of all novel drugs and biologies introduced worldwide last year. Eight first-in-class agents were launched for the first time in 2018, including the first RNA interference agent as well as the photo-finish approval and rollout of the first three members of a radically different class of nonvasoconstricting antimigraine agents, the anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies. Twenty-nine of the drugs launched last year were designated orphan drugs, reflecting the continued upswing in investment in the area of neglected diseases. This is especially true in the U.S., which welcomed 25 of the newly launched orphan drugs. Overall, the U.S. was the most active market for new drugs and biologies, accounting for two-thirds of all new launches in 2018.