我国创业板制药企业药物研发现状与成果分析

目的分析我国创业板制药企业的药物研发现状与成果。方法选择创业板制药企业中年度营业收入达10亿元的20家企业,从研发投入、专利产出、1类新药产出和仿制药一致性评价现状4个角度分析其药物研发现状与成果。结果在纳入分析的20家企业中,40%研发投入金额不足1亿元,45%研发强度不到5%;19家企业获得了专利授权,但仅8家企业有专利获得了不少于3个国家的授权;仅半数企业有1类新药产出,大多处于临床研究阶段,过去10年内仅有1个1类新药获批上市;7家企业共计21个仿制药处于一致性评价审评中,仅1个产品通过了一致性评价;26项获得不少于3个国家授权的专利和23个在研或上市的1类新药中,分别有15项(57.69%)和9个(39.13%)来自贝达药业。结论我国创业板制药企业大多创新投入少,近半数企业研发强度较低,具有高潜在市场价值的专利储备较少,技术含量高的1类新药较缺乏,一致性评价成果也不足,总体研发实力较弱。虽整体创新实力不足,但也有个别企业创新成果丰硕。

Status and Outputs of Drug Research and Development Among Companies Listed on the Second-Board Market

Objective To analyze the status and outputs of drug research and development among companies listed on the second-board market.Methods Twenty companies with an operation revenue of RMB 1 billion yuan were selected from those listed on the second-board market,and their research input,patients,Class 1 new drugs and consistency evaluation of generic drugs were described and analyzed.Results Among the 20 companies included in the analysis,40%input less than 100 million yuan per year in the research and development(R&D)of drugs,45%didn't achieve an R&D intensity of 5%;19 companies had been authorized with granted patents,but only 8 companies had patents granted by 3 or more countries;only half of the companies had Class 1 new drugs in development,with only one launched in the past ten years;there were altogether 21 generic drugs by 7 companies that had been submitted for consistency evaluation,with only one passed the evaluation.It is worth mentioning that 15(57.69%)of the 26 patents granted by≥3 countries and 9(39.13%)of the 23 Class 1 new drugs are from Betta Pharmaceuticals.Conclusion Most of the companies listed on the second-board market didn't input enough fees in the R&D of drugs and only a few patents with high potential market value have been accumulated;Class 1 new drugs are lacking,and the output of consistency evaluation is relatively poor.In spite that the overall R&D strength is weak,a few companies have already obtained fruitful innovation achievements.