■描述和比较2020年中国和美国癌症新药和新批准药物的研发(R&D)管道,从而为相关利益相关者提供决策依据。
■中国和美国的临床试验和测试癌症新药信息分别从药物临床研究信息公开平台和试验数据库获得。从官方发布开始跟踪药物批准。在两个国家之间进行了启动试验和药物方面的亚组比较。
■2020年,在中国注册了335种癌症新药的577项试验,占所有临床药物试验的22.6%,而在美国,共捕获了678项癌症新药试验的916项试验,占总数的19.9%。相对而言,较早阶段的比例较低(76.9%对87.4%),全球(17.7%对39.0%),在中国启动的癌症药物试验中发现了前20名药物贡献(15.8%对43.2%)。对抗实体瘤的斗争在这两个国家都占据了首位,并且还观察到与癌症谱相关的癌症适应症的不同分布。与美国相比,更多的目标代理(87.5%和77.0%,P<0.001)和较少的免疫剂(30.7%vs41.6%,P<0.001)在中国进行了测试。此外,在中国和美国批准了16和18种抗癌新药,有6种(37.5%)和17种(94.4%)药物在全球范围内首次获得批准,分别。其中,至少一项加急计划批准了32种药物,根据替代终点的证据,批准了31种药物.总共涵盖了17种癌症类型,只有一种药物是针对消化系统癌症的,包括胃,肝脏,和食道癌。
■抗癌新药的研发是实质性的,2020年中美两国都取得了很大进展。中美之间的差异和差距突出表明,应该在创新药物和中国人群特有的癌症方面进行更多的抗癌药物研发。以及促进中国的全球同步研发。
UNASSIGNED: To describe and compare the research and development (R&D) pipeline of cancer new drugs and newly approved drugs in China and the USA in 2020, thus to provide decision-making evidence for related stakeholders.
UNASSIGNED: Clinical trials and tested cancer new drugs information in
China and the
USA were respectively acquired from Information Disclosure Platform for Drug Clinical Studies and Trialtrove database. Drug approval was tracked from the official release. Subgroup comparison in terms of initiated trials and drugs were conducted between the two countries.
UNASSIGNED: In 2020, 577 trials on 335 cancer new drugs were registered in China, accounting for 22.6% of all clinical drug trials, while in the USA, 916 trials on 678 cancer new drug trials were captured, accounting for 19.9% of the total. Relatively, a lower proportion of earlier phase (76.9% vs 87.4%), global (17.7% vs 39.0%), and top 20 pharmaceutics contribution (15.8% vs 43.2%) were found for cancer drug trials initiated in China. The fight against solid tumor took top billing in both countries, and the different distribution of cancer indications associated with cancer spectrum was also observed. Compared with the USA, more targeted agents (87.5% vs 77.0%, P < 0.001) and less immune agents (30.7% vs 41.6%, P < 0.001) were tested in
China. In addition, 16 and 18 anticancer new drugs were approved in
China and the
USA, with 6 (37.5%) and 17 (94.4%) drugs being firstly approved worldwide, respectively. Among them, 32 drugs were granted by at least one expedited program, and 31 drugs were approved based on evidence from surrogate endpoints. A total of 17 cancer types were covered, and only one drug was targeted on digestive cancers, including gastric, liver, and esophageal cancers.
UNASSIGNED: R&D of anticancer new drugs is substantial, and great progress has been made in both China and the
USA in 2020. The difference and gap between
China and the
USA highlight that more efforts should be paid to anticancer drug R&D on innovative agents and cancers unique to Chinese populations, as well as to facilitate global synchronous R&D in China.