2014年全球新药研发报告_第一部分_新药和生物药品_GraulAI.pdf

PROGRESS IN PHARMACEUTICAL SCIENCES 2015,3939 2 :126-142 126 G L O B A L P H A R M A C E U T I C A L I N F O R M AT I O N  A Report of New Drugs Research and Development in 2014——Part I:New Drugs Biologics (I) Graul A I, Cruces E, Stringer M 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 fi rst markets in 2014 (as of December 23,2014). Additionally, 29 important new line extensions (new formulations, new combinations or new indications for previously marketed products) also reached their fi rst 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 fi rst 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 Qualifi ed Infectious Disease Product (QIDP) status. Another 19 products were approved for the fi rst time during the year but not yet launched by close of this article, most are slated for launch in the fi rst months of the new year. new drug launch; new drug approval; line extension; fi rst-in-class drug