摘要
Abstract
Improved new drugs are applied and evaluated according to the US 505(b)(2)pathway,and the market of 505(b)(2)products is about 1.7 times that of generic drugs in the USA.While meeting clinical needs,the 505(b)(2)products present significant economic benefits due to less competition.In recent years,due to the slow growth of the Chinese generic drug market,more and more generic pharmaceutical companies are looking to improved new drugs for new growth points.In addition,with the rapid growth of innovative drugs,many innovative pharmaceutical companies are starting to apply this pathway to increase the potential patient population or extend the product lifecycle.However,developing improved new drug is a challenging field for Chinese pharmaceutical companies,with high approval standards and immature product design concepts and experience,resulting in a high failure rate of development or unsatisfactory market returns.In contrast,the US 505(b)(2)has a forty-year history,over 2500 approvals,and many products have obtained successful market performance.Therefore,the design and development,clinical evaluation,and market expansion of the US 505(b)(2)pathway are valuable for reference.This article systematically compares the similarities and differences between China's improved new drugs and the US 505(b)(2)pathway,reviews 505(b)(2)approvals,including their market performance,design ideas,and highlights,to provide references for the industrial planning,project design,and product development of improved new drugs in China.关键词
505(b)(2)/改良型新药/设计/开发/市场Key words
505(b)(2)/improved new drugs/design/development/market分类
医药卫生
