George R.Bolger，张 泓

    (美国拜尔麦德生物医药公司，美国洛克维尔 20855)

    Ever since the synthesis of the B-chain of insulin by Chinese scientists in 1964[1]，the discovery of the first restriction enzyme in 1968[2]and the developmentofrecombinantDNA technology in 1973[3]by U.S.scientists，biotechnology and biopharmaceuticals have dramatically changed the pharmaceutical industry，and become economic growth engines and the best hope for fighting many lifethreatening illnesses such as cancers，cardiovascular diseases and HIV/AIDS.Hundreds of biopharmaceuticals and vaccines have been approved by regulatory agencies since the first recombinant protein，human insulin(Humulin)，was approved by U.S.Food and Drug Administration(FDA)in 1982，which have helped millions of people worldwide.The top three worldwide best-selling drugs of 2012 were all biopharmaceuticals[4-5]and the stock market values for some big biopharmaceutical companies are already higher than some big pharmaceutical companies.According to Pharmaceutical Research and Manufacturers of America＇s 2013 Report，U.S.biopharmaceutical companies are currently developing 907 biopharmaceuticals through biological manufacturing processes which target more than 100 diseases including cancers ......