新药研究是一项关系到国计民生、民族兴旺发达和造福人类,且具有重大社会效益和经济效益的事业。由于我国经济基础和技术力量都较薄弱,新药研制长期处于落后状态,致使我国医药工业和药品市场除传统医药外,主要靠无偿仿制国外医药产品以满足医疗保健的需要。目前我国已能生产的千余种原料药中97％为仿制品,虽有极少数几种创新药,亦难进入国际市场。面对当前知识产权制度和药物专利立法的实施,今后再难维持这种大量无偿仿制国外专利药品的局面,而高价购买国外专利进行全面生产,不仅为国力所不及,而且作为12亿人口的大 The study of new drugs is a business that has a significant social and economic benefit, which is related to the national economy and people’s livelihood, the prosperity of the nation, and the benefit to mankind. As China’s economic base and technical power are relatively weak, the development of new drugs has been lagging behind for a long time, resulting in China’s pharmaceutical industry and pharmaceutical market in addition to traditional medicine, mainly rely on foreign imitation of pharmaceutical products to meet the needs of medical care. At present, 97% of the more than 1,000 kinds of APIs that China can produce are imitations. Although there are very few innovative drugs, it is difficult to enter the international market. In the face of the current implementation of the intellectual property system and drug patent legislation, it will be difficult to maintain such a large amount of foreign patented drugs at no cost in the future. To purchase foreign patents at a high price for comprehensive production is not only beyond national power, but also as a population of 1.2 billion.