中国新型抗肿瘤药物现状分析及启示

Current Situation and Implications of Novel Antitumer Drugs in China

目的以美国为参照,对中国上市的新型抗肿瘤药物现状进行分析,探索抗肿瘤药物发展趋势,以期为抗肿瘤药品遴选提供依据。方法检索美国食品药品监督管理局和我国国家药品监督管理局数据库,提取中国进口(美国上市)与国产自主研发的新型抗肿瘤药物的药品名称、上市时间、适应证等信息(时间截至2021年4月30日),并计算中国上市比例。结果截至2021年4月30日,美国上市122种新型抗肿瘤药物,共覆盖14个疾病类型。其中中国进口51种,中国上市比例为41.80%。大分子单抗类药物中国上市比例最高(46.15%),其次为小分子靶向药物(44.58%),抗体药物偶联物中国上市比例最低(15.38%)。我国自2015年以来,进口新型抗肿瘤药物数量显著增多(70.59%,36/51),2015—2021年中国上市比例为50.70%(36/71),而2010—2014年中国上市比例仅为19.35%(6/31)。中国进口新型抗肿瘤药物共覆盖13个疾病类型,适应证为中国发病率前5位瘤种的新型抗肿瘤药物的中国上市比例均值为62.15%。国内自主研发的新型抗肿瘤药物共14种,包括大分子单抗类药物7种、小分子靶向药物7种,占我国现有新型抗肿瘤药物的21.54%(14/65)。其中,2015年以来上市11种(78.57%,11/14)。国内自主研发的新型抗肿瘤药物共覆盖8个疾病类型(57.14%,8/14)。结论虽然中国新型抗肿瘤药物上市数量与美国仍有一定差距,但基本可满足临床用药需求。2015年以来,我国在加速审批、自主创新等方面持续改进。未来应从安全、疗效、经济、临床必要性等多角度对我国已上市药品与未上市药品进行考量,从而为药品遴选提供依据。

Objective To explore the trend of antitumor drugs by comparing and analyzing the novel antitumor drugs of China and US, in order to provide a basis for the selection of antitumor drugs.Methods US Food and Drug Administration and China National Medical Products Administration databases were searched, and the drug name, marketing time, indication and other information were collected(as of April 30, 2021). The proportion of listed drugs in China were calculated. Results As of April 30, 2021, there were 122 novel antitumor drugs marketed in the US, covering 14 disease types. Among them, 41.80%(51/122) were marketedin China. The proportion of monoclonal drugs was the highest(46.15%), followed by the small molecule targeted drugs(44.58%), and antibody-drug conjugate(15.38%). The number of novel antitumor drugs increased significantly(70.59%, 36/51) since 2015, and the proportion of listed drug in China from 2015 to 2021 was 50.70%(36/71), while that from 2010 to 2014 was only 19.35%(6/31). China has imported novel antitumor drugs covering 13 disease types. The average proportion of imported novel antitumor drugs for the top 5 tumors in China was 62.15%. A total of 14 novel antitumor drugs have been independently developed in China, including 7 monoclonal drugs and 7 small molecule targeted drugs, accounting for 21.54%(14/65) of the available novel antitumor drugs in China. Among them, 11 drugs(78.57%, 11/14) have been listed since 2015. The indications of novel antitumor drugs independently developed in China cover 8 disease types(57.14%, 8/14). Conclusions There are still gaps between China and US in terms of novel antitumor drugs, but these drugs can basically meet the clinical needs in China. Since 2015, China has made progress in accelerating approval and independent innovation. We should consider the safety, effectiveness, economic and clinical necessity of the listed and unlisted drugs, so as to provide a basis for drug selection in the future.