2014年全球新药研发报告——第二部分:趋势和挑战(Ⅴ)

A Report of New Drugs Research and Development in 2014——Part II: Trends & Challenges(Ⅴ)

2014年制药和生物技术行业继续保持着高活力。截至2014年12月23日,全球共有55个新的化学药物和生物制品首次进入市场,另有29个重要的延伸性新药获批,还有19个药物首次获批,但尚未来得及上市。此外,在传统的年底冲刺期间,一些国家的监管机构在年底最后一刻还批准了其他一些药物,因此,这些获批药物未能被收录在内,所以2014年实际获批的新药数量应该大于前面提到的数字。除了新药的成功开发、注册和上市外,还有其他一些可反映整个行业现状和发展趋势的风向标,例如,监管机构采取新措施以刺激难治性疾病药物的开发、制药公司定期并务实地对其研发项目进行甄选以及通过并购整合研发管线、投资项目和销售队伍。

2014 was a year of continued high activity in the pharma and biotech industry. As of December 23, 2014, a total of 55 new chemical and biological entities had reached their fi rst markets worldwide, together with another 29 important new line extensions. Another 19 products were approved for the fi rst time during the year but not yet launched by December 23. Furthermore, during the now-traditional year-end sprint, several regulatory agencies issued last-minute approvals for other compounds that missed the deadline for inclusion in that article, bringing the total of new approvals for the year to a somewhat higher number. In addition to the successful development, registration and launch of new drugs and biologics, there are various other trends and tendencies that serve as indicators of the overall health and status of the industry. These include the pursuit of novel programs designed by regulators to stimulate the development of drugs for diseases that are currently under-treated; the regular and pragmatic culling by companies of their RD pipelines; and the decision to unify pipelines, portfolios and sales forces through mergers and acquisitions.