止吐药研发现状及发展趋势.docVIP

止吐药研发现状及发展趋势 　　（江苏太平洋美诺克生物药业有限公司 常州 213022） 　　摘 要 通过查询CFDA、FDA数据库，汇总分析国内外已上市止吐药的种类、生产批件数量、销售金额以及近3年产品注册申报情况，发现国内止吐药生产批件众多，且有不少企业仍在仿制，临床用药高度集中于5-HT3受体拮抗剂类品种，其销售金额占据止吐药98%的市场份额，市场呈平稳增长态势。然而，近年来随着新作用机理的NK-1受体拮抗剂类止吐药成功上市，止吐药市场格局将迎来新的变化，也给企业带来了新的机遇和挑战。因此，企业在抢夺市场先机之时应注意防范过度仿制带来的产品风险。 　　关键词 止吐药 5-HT3受体拮抗剂 NK-1受体拮抗剂 　　中图分类号：R975.4 文献标识码：C 文章编号：1006-1533（2014）17-0075-06 　　Marketing and RD trends of antiemesis agents 　　WANG Mengjun* 　　（Jiangsu Pacific-Meinuoke Bio-pharmaceutical Co. Ltd.， Changzhou 213022， China） 　　ABSTRACT It is found that there are many domestic production approvals in anti-emesis agents， and many domestic enterprises have been working on the production of this kind of generic drug by querying CFDA and FDA database， summarizing and analyzing the types of anti-emesis agents already on the international and domestic markets， the number of production license， sales and the applications of production registration in three years. Clinical medication is highly focused on 5-HT3 receptor antagonist， the sales of which account for 98% market share of anti-emesis agents and the marketing trend has been steadily increasing. However， antiemetic market pattern will also usher in a new change and the pharmaceutical enterprises will be faced with new opportunities and challenges with NK-1 receptor antagonists as new anti-emesis being successfully marketed in recent years. Therefore， enterprises should pay attention to the risks resulting from the excessive imitation production while capturing the market. 　　KEY WORDS anti-emesis agents； 5-HT3 receptor antagonist； NK-1 receptor antagonist 　　美国NCCN止吐临床实践指南（V.1.2013）（简称美国NCCN指南）对癌症患者在预防化疗引起的恶性呕吐（chemotherapy-induced nausea and vomiting，CINV）用药方面提出了新建议，为各国医生在临床用药选择时提供了依据。由于其极强的权威性，不仅对临床用药选择产生了很大的影响，也对新药研发和市场销售起到了方向性的指导作用。统计近几年国内止吐药新品研发和市场销售情况，发现大多数国内企业止吐药新品研发仍以仿制为主，热点集中在5-HT3受体拮抗剂和NK-1受体拮抗剂类药物。临床用药和市场销售以5-HT3受体拮抗剂类药物为主，其销售额呈逐年增长趋势并占据98%的绝对优势。整体表现为研发品种比较集中，同品种生产批件众多，市场销售平稳增长但竞争激烈，品种研发及市场销售趋势与美国NCCN指南有很好的相关性。随着NK-1