Characteristics and future development of modified new drugs in China
10.13220/j.cnki.jipr.2017.06.011
- VernacularTitle:中国改良型新药的特点及未来发展
- Author:
Yang YANG
;
Jin ZHAO
;
Aiping ZHENG
;
Junwen MAO
- Keywords:
modified new drugs;
registry classification;
monitoring period of new drugs;
characteristics
- From:
Journal of International Pharmaceutical Research
2017;44(6):522-526
- CountryChina
- Language:Chinese
-
Abstract:
New registry classifications of chemical drugs redefined the concepts of new drugs and generic drugs. New drugs emphasize the international innovation including innovate new drugs and modified new drugs. Modified new drugs are improvement of drugs already on the market to achieve superior efficacy. With the advantages of high success rate,high return,low risk and long life cycle,modified new drugs have become the mainstream of new drugs research and development in the world. Modified new drugs R&D in China should be based on clinical demand and focused on the differentiation research in order to obtain new preparations with signif-icant clinical advantages to better serve the clinical practise. This paper states the concept and characteristics of modified new drugs in China,makes case analysis and shares the development history of blockbuster modified new drugs in the world,clarifies the opportuni-ties and challenges and provides ideas for the future development of modified new drugs in China.
