Huang Huiyao, Zhu Qi, Ga Man, Wu Dawei, Meng Xinyu, Wang Shuhang, Fang Hong, Tang Yu, Li Ning
Department of Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, China.
Front Oncol. 2022 Jul 22;12:930846. doi: 10.3389/fonc.2022.930846. eCollection 2022.
To systematically summarize the landscape and characteristics of all approved new anticancer drugs for the last 10 years in China and the United States (US) to further inform the trend, current state, and existing gap in the availability and affordability of cancer medicine between the two countries.
Mainly based on the Pharmcube database, a list and detailed information of anticancer drugs approved in China and the United States were acquired. The annual number, time lag, and basic characteristics, including drug type, mechanism, enterprise type, indication population, drug target, and cancer type of approved drugs were compared.
Eighty-seven and 118 new anticancer drugs were approved in China and the US, respectively, showing a stable trend in the US, while a significant increase was observed after 2016 in China. Of the 42 cancer medicines launched in both countries, the US took precedence, and the median time lag markedly decreased, from 6.53 years in 2012 to 0.88 years in 2020. A total of 14.4% of drugs were applicable to children in the US, while only 2.3% were applicable in China, and there was no difference in drug type and enterprise. Thirty-one and 43 targets were explored, with respect to 27 and 36 cancer types in China and the US, respectively, during the period. In addition, the expenditure of drugs on PD-1 and PD-L1 in China was generally lower than that in America.
The availability of new anticancer drugs has increased dramatically in the past decade, particularly in China. Compared with the US, the launch of new anticancer drugs in China lags behind, but the time lag has been shortened significantly, and better affordability is observed in immune drugs. More attention should be given to differentiated innovation, and unmet medical needs in special populations like childhood tumors, which are important directions of new drug R&D in China.
系统总结过去10年中美两国所有获批的新型抗癌药物的情况和特点，以进一步了解两国抗癌药物可及性和可负担性的趋势、现状及存在的差距。
主要基于Pharmcube数据库，获取中美两国获批的抗癌药物清单及详细信息。比较获批药物的年度数量、时间间隔以及基本特征，包括药物类型、作用机制、企业类型、适用人群、药物靶点和癌症类型。
中国和美国分别批准了87种和118种新型抗癌药物，美国呈稳定趋势，而中国在2016年后有显著增长。在两国均上市的42种抗癌药物中，美国占先，且中位时间间隔显著缩短，从2012年的6.53年降至2020年的0.88年。美国共有14.4%的药物适用于儿童，而中国仅为2.3%，在药物类型和企业方面无差异。在此期间，中国和美国分别探索了31个和43个靶点，涉及27种和36种癌症类型。此外，中国PD-1和PD-L1药物的支出总体低于美国。
在过去十年中，新型抗癌药物的可及性显著提高，尤其是在中国。与美国相比，中国新型抗癌药物的上市滞后，但时间间隔已显著缩短，免疫药物的可负担性更好。应更加关注差异化创新以及儿童肿瘤等特殊人群未满足的医疗需求，这是中国新药研发的重要方向。
