Lan Yipeng, Lin Xiaofeng, Yu Jialin, Wang Li, Sun Lihua, Huang Zhe
School of Business Administration, Shenyang Pharmaceutical University, Shenyang, China.
Institute of Drug Regulatory Science, Shenyang Pharmaceutical University, Shenyang, China.
Front Pharmacol. 2024 Mar 18;15:1345672. doi: 10.3389/fphar.2024.1345672. eCollection 2024.
Since 2016, China has successively implemented Accelerated Drug Marketing Registration Procedures (ADMRPs) for drugs, including Breakthrough Therapy Drug (BTD), Conditional Approval (CA), and Priority Review and Approval (PRA), which have played an important role in promoting the development and review of clinically urgently needed drugs. In this study, we focused on the antineoplastic and immunomodulating agents approved for marketing through ADMRPs, to provide a reference for promoting the formation of a stable and mature regulatory system for the review and approval of antineoplastic drugs and immunomodulating agents in China.
Reviewed the National Medical Products Administration (NMPA) drug review reports for the years 2016-2022 and screened the antineoplastic and immunomodulating agents approved through ADMRPs. Then, with the help of the NMPA website and the Yaozhi Database, two researchers independently queried and entered the detailed information of the selected drugs, and checked with each other. The attribute classification and main characteristics of the drugs were then analyzed with descriptive statistics to obtain the trend of drug types, drug review and approval status, and timeliness.
A total of 206 antineoplastic and immunomodulating agents were approved for marketing through five accelerated marketing registration procedures (or procedure combinations), with the average review time shortened by about 81 days. Among them, imported drugs accounted for a larger proportion, the most drugs for treating non-small cell lung cancer and lymphoma, and the largest number of PD-1/PDL-1 inhibitors, but pediatric drugs and rare disease drugs accounted for a smaller proportion.
ADMRPs can promote the accessibility of antineoplastic and immunomodulating agents in China and safeguard the life and health rights of more patients. Nevertheless, it is necessary to pay attention to the expansion of the types of indications for medicines and to increase the development of drugs that are urgently needed by a small number of patients.
自2016年起，中国陆续实施了药品加速上市注册程序，包括突破性治疗药物（BTD）、附条件批准（CA）和优先审评审批（PRA），这些程序在促进临床急需药品的研发和审评方面发挥了重要作用。在本研究中，我们聚焦于通过加速上市注册程序获批上市的抗肿瘤和免疫调节药物，为推动中国抗肿瘤药物和免疫调节药物审评审批形成稳定、成熟的监管体系提供参考。
查阅国家药品监督管理局（NMPA）2016 - 2022年的药品审评报告，筛选出通过加速上市注册程序获批的抗肿瘤和免疫调节药物。然后，借助NMPA网站和药智数据库，两名研究人员独立查询并录入所选药物的详细信息，并相互核对。随后采用描述性统计分析药物的属性分类和主要特征，以获取药物类型趋势、药物审评审批状态及及时性。
共有206种抗肿瘤和免疫调节药物通过五项加速上市注册程序（或程序组合）获批上市，平均审评时间缩短了约81天。其中，进口药品占比更大，治疗非小细胞肺癌和淋巴瘤的药物最多，PD - 1/PDL - 1抑制剂数量最多，但儿科用药和罕见病用药占比更小。
加速上市注册程序可提高中国抗肿瘤和免疫调节药物的可及性，保障更多患者的生命健康权益。尽管如此，仍需关注药品适应证类型的拓展，并加大对少数患者急需药物的研发力度。
