关于新药DPP-4抑制剂市场表现及国内企业该药研发立项的思考建议.docVIP

关于新药DPP-4抑制剂市场表现及国内企业该药研发立项的思考建议 　　摘 要 近年来随着新型降糖药的出现，糖尿病药物市场呈现快速增长趋势，目前仅次于肿瘤用药，居全球药品销售排行第二位。DPP-4抑制剂作为一种治疗糖尿病的较新型药物，目前主要用于2型糖尿病的治疗。该类产品凭借其耐受性及安全性较好、低血糖发生率低、可口服等优势，在国内外临床指南中逐步得到充分认可，治疗地位不断提升，逐渐成为降糖药物市场的主力之一。因此，DPP-4抑制剂国内市场方兴未艾，其进医保后将释放更大市场空间，也是各大国内药企研发抢仿的热点所在。本文建议国内企业在研发立项DPP-4抑制剂这类新药时，不应盲目跟从热点，还需关注其临床需求、新药安全性评价、剂型优化选择并结合企业自身情况等进行综合评估。 　　关键词 DPP-4抑制剂 2型糖尿病 市场情况 　　中图分类号：R977.15； R713.52 文献标识码：C 文章编号：1006-1533（2017）23-0076-04 　　Suggestions on market performance of new drug DPP-4 inhibitor and domestic enterprises’ RD project 　　LIU Jianhui* 　　（Department of Marketing， Shanghai Shyndec Pharmaceutical Co.， Ltd.， Shanghai 200041， China） 　　ABSTRACT With the emergence of some new antidiabetic drugs， their market has shown a trend of rapid growth in recent years and has now become the second largest in the world. DPP-4 inhibitor as a new type of antidiabetic drug is mainly used for the treatment of type 2 diabetes mellitus. Because of its advantages of good tolerability and safety， low incidence of hypoglycemia and oral administration， it has been gradually recognized in clinical guidelines both at home and abroad and become one of the main hypoglycemic drugs， and meanwhile its treatment status has also been continuously improved. However， we considered that domestic enterprises should not blindly follow the hot spots in the research and development of this new DPP-4 inhibitor， and great attention should be also paid to their clinical needs， safety evaluation of new drugs， optimization of dosage forms so that enterprises can comprehensively evaluate such RD project based on the enterprise’s own situation. 　　KEY WORDS DPP-4 inhibitor； type 2 diabetes； market condition 　　糖尿病已成?槿?球最严重的公共卫生问题之一，2015年国际糖尿病联盟公布的数据显示，全球成年糖尿病患者人数已达4.15亿，其中亚洲地区的糖尿病患者占全球患者的60%以上[1]。中国糖尿病患者位居世界首位，患者人数约1.1亿[2]。我国糖尿病药的用药群体量大，逐渐呈现年轻化趋势。近年来随着新型降糖药的出现，糖尿病药物市场呈现快速增长趋势，目前仅次于肿瘤用药，居全球药品销售排行第二位[3]。 　　DPP-4抑制剂作为一种治疗糖尿病的较新型药物[4]，目前主要用于2型糖尿病的治疗。该类产品凭借其耐受性及安全性较好、低血糖发生率低、可口服等优势，在国内外临床指南中逐步得到充分认可，治疗地位不断提升，逐渐