Xu W F
Drug Discov Ther. 2007 Aug;1(1):3.
China appears to consistently lag behind developed countries like the US, Japan, and the nations of Europe in the development of pharmaceuticals, putting China in an embarrassing situation. In fact, China is still dependent on foreign imports for most highly effective cures to major diseases such as cancer, diabetes, hepatitis, and neurodegenerative disease. There is no denying the fact that governmental support, and especially a signifi cant amount of fi nancial support and political assistance to include government restructuring, is needed for the establishment of new drug Research and Development (R&D). Fortunately, China's authorities have recently recognized the importance of new drug development and have committed to implementing strong measures to help establish new drug R&D. This improvement in the government's status is showing immediate and substantial promise in the field of pharmaceuticals. On January 4, 2007, a research group directed by Wang Ming-Wei, Head of the National Center for Drug Screening, Shanghai Institute of Materia Medica (SIMM), made a breakthrough in the development of novel category I anti-diabetes drugs with the support of the Ministry of Science & Technology of China, the National Natural Science Foundation (NSFC) of China, and the Shanghai municipal government. Taking almost four years, the group finally developed a nonpeptide agonist of small molecule glucagon-like peptide 1 receptors with effi cacy in diabetic db/db mice (Proc Natl Acad Sci U S A 2007;104:943-948). As an antidiabetes drug, a peptide hormone traditionally had to be taken as an injection, which greatly limited its clinical application. In contrast, the new compound can be taken orally. This offers hope for the development of a new field of peptidomimetics for orally-available nonpeptide small molecules. Today, the ever-growing prevalence of major diseases worldwide is driving growth in new drug spending, encouraging the marketing of newly developed and effi cacious therapies. This achievement appears to have significantly boosted the field of new drug research in China. While "China's pharmaceutical firms lag far behind [their Western counterparts] in terms of biological preparations" "today's achievement, with the attention it has garnered, has important scientific signifi cance and potential social and economic value," said Chen Zhu, the minister of health PRC and also the former associate dean of the China Academy of Sciences (http://www.simm.ac.cn/News/20071417649.htm , available as of January 4, 2007). Other encouraging news came from the Shanghai Life Sciences Institute. A novel anti-HIV compound named Nifeviroc was developed with the support of the municipal government and licensed for clinical trials on April 17, 2007 (Shanghai Daily, April 17, 2007). This is expected to become the world's first oral HIV entryinhibitor. Thus far, applications to patent Nifeviroc have been submitted in 14 countries and regions, including the United States, Japan, and the European Union. Recently, Shanghai Targetdrug Pharmaceutical Company and Avexa, a Melbourne-based drug-research company in Australian, announced that they will jointly develop Nifeviroc for global distribution. Avexa will handle post-research expenses, develop the drug in the international marketplace, and share global profits with Targetdrug. Thus, China may have justified rationale and confidence to believe that the day will come when China's pharmaceutical products will boast a strong presence in the global market.
在制药领域的发展上,中国似乎一直落后于美国、日本以及欧洲国家等发达国家,这使中国陷入尴尬境地。事实上,对于癌症、糖尿病、肝炎和神经退行性疾病等重大疾病的多数高效治疗药物,中国仍依赖进口。不可否认,建立新药研发体系需要政府支持,尤其是大量的资金支持以及包括政府机构改革在内的政策扶持。幸运的是,中国政府部门最近已认识到新药研发的重要性,并致力于采取有力措施推动新药研发体系的建立。政府这一态度的转变在制药领域已初见成效且前景可观。2007年1月4日,在中华人民共和国科学技术部、中国国家自然科学基金委以及上海市政府的支持下,由上海药物研究所国家新药筛选中心主任王明伟领导的研究小组,在一类新型抗糖尿病药物研发方面取得突破。该小组历时近四年,最终研制出一种小分子胰高血糖素样肽-1受体非肽激动剂,对糖尿病db/db小鼠有效(《美国国家科学院院刊》2007年;104:943 - 948)。作为一种抗糖尿病药物,传统的肽类激素必须注射使用,这极大地限制了其临床应用。相比之下,新化合物可以口服。这为口服非肽小分子拟肽药物新领域的发展带来了希望。如今,全球重大疾病发病率不断攀升,推动了新药研发投入的增长,促使新研发的有效治疗方法进入市场。这一成果似乎极大地推动了中国新药研究领域的发展。中国卫生部部长、中国科学院前副院长陈竺表示:“尽管中国制药企业在生物制剂方面远远落后于(西方同行),但‘今天的这一成果,因其受到的关注,具有重要的科学意义和潜在的社会经济价值’”(http://www.simm.ac.cn/News/20071417649.htm获取时间:2007年1月4日)。另一个令人鼓舞的消息来自上海生命科学研究院。一种名为Nifeviroc的新型抗艾滋病毒化合物在市政府支持下研制成功,并于2007年4月17日获得临床试验许可(《上海日报》2007年4月17日)。预计这将成为全球首个口服艾滋病毒进入抑制剂。截至目前,Nifeviroc已在包括美国、日本和欧盟在内的14个国家和地区提交专利申请。最近,上海靶点药物制药公司与澳大利亚墨尔本的药物研发公司Avexa宣布,双方将联合开发Nifeviroc并在全球销售。Avexa将承担研发后的费用,在国际市场开发该药物,并与靶点药物分享全球利润。因此,中国有理由相信,中国制药产品在全球市场占据重要地位的那一天终将到来。