我国已上市治疗用提取分离类和菌体制剂类产品分析

目的：分析我国已上市治疗用提取分离类和菌体制剂类产品存在的差距，明确努力方向。方法：基于我国已上市治疗用提取分离类和菌体制剂类产品批准数据进行统计分析和对比分析。结果：对我国已上市治疗用提取分离类产品中的血液制品和多组分生化药物以及菌体制剂类产品的批准数量、企业数量进行了梳理，并与FDA批准情况进行对比分析。结论：治疗用提取分离类和菌体制剂类产品都是早期的治疗用生物药物，血液制品目前仍发挥着重要的临床价值，但重复申报情况严重。多组分生化药物和菌体制剂重复申报情况很少，但在临床上应用很少。FDA批准的两类产品数量较少。

Analysis of Listed Biological Extraction-separation Products and Bacterial Preparation Products for Therapeutic Use in China

Objective:To analyze the shortcomings of listed biological extraction-separation products and bacterial preparation products for therapeutic use in China and clarify the direction of efforts. Methods:Based on the approval data of biological extraction-separation products and bacterial preparation products for therapeutic use, the statistical analysis and comparative analysis were conducted. Results:The approved number of blood products and multi-component biochemical drugs of extraction-separation products and bacterial preparation products and the number of enterprises were sorted out and compared with the approved number of FDA. Conclusion:The biological extraction-separation products and the bacterial preparation products are both early therapeutic biological drugs. The blood products still have an important clinical value, but the repeated application is a serious problem. The repeated application of the multi-component biochemical drugs and bacterial preparations is rare, but they are rarely used clinically. The number of the two types of products approved by the FDA is small.