2014年全球新药研发报告——第一部分:新药和生物药品(Ⅰ)

A Report of New Drugs Research and Development in 2014——Part I:New Drugs & Biologics(I)

2014年的新药批准和上市年终报告显示医药行业的活跃性持续保持在高位。截至2014年12月23日,共有55个新药和生物制品首次上市。此外,29个重要的延伸性新药(新处方、新复方或已上市药物的新适应证)也在2014年首次上市。在这些新上市的药物中,最多的是抗感染药物,有11个新药和生物制品。它们大多用于多药耐药菌引发的感染或丙肝的治疗。美国再一次成为这些新上市药物最青睐的市场,该国是2014年半数以上新上市药物的首选地区。不过,日本在2014年开发上市新药的能力显著增强,多年来首次超越欧盟。另一重要成果是:2014年上市的新药和生物制品中有15个获得罕见病用药资格,5个获得突破性治疗药物资格,还有3个获得合格传染病产品(QIDP)资格。另外,2014年还有19个产品首度获批,将于2015年年初上市。

A year-end wrap-up of new drug approvals and launches reveals that activity in the pharmaceutical industry continues at a high level, with 55 new drugs and biologics introduced on their first markets in 2014 （as of December 23,2014）. Additionally, 29 important new line extensions （new tbrmulations, new combinations or new indications for previously marketed products） also reached their first markets during the year. The most active therapeutic group in terms of new launches was anti-infective therapies, with 11 new drugs and biologics launched, most for the treatment of multidrug-resistant bacterial infections or hepatitis C.The most active market for new launches was again the U.S., site of more than half of all new launches in 2014. However new launch activity increased considerably last year in Japan, which actually pulled ahead of the E.U. For the first time in many years. In another important new development, 15 of the new drugs and biologics launched last year had orphan drug status, 5 had breakthrough therapy designation and 3 had Qualified Infectious Disease Product （QIDP） status. Another 19 products were approved for the first time during the year but not yet launched by close of this article, most are slated for launch in the first months of the new year.