Email Alert RSS
Volume 13 Issue 6
Nov.  2022
Turn off MathJax
Article Contents
Abstract
References
Related Articles
SUN Wenjuan, ZHANG Bo. Current Situation and Implications of Novel Antitumer Drugs in China[J]. Medical Journal of Peking Union Medical College Hospital, 2022, 13(6): 1036-1044. DOI: 10.12290/xhyxzz.2021-0521
Citation: SUN Wenjuan, ZHANG Bo. Current Situation and Implications of Novel Antitumer Drugs in China[J]. Medical Journal of Peking Union Medical College Hospital, 2022, 13(6): 1036-1044. DOI: 10.12290/xhyxzz.2021-0521
shu

Current Situation and Implications of Novel Antitumer Drugs in China

  • 1.

    Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China

  • 2.

    State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China

Funds: 

National High Level Hospital Clinical Research Funding 2022-PUMCH-B-059

More Information
  • Corresponding author:

    ZHANG Bo, E-mail: zhangbopumchpumch@163.com

  • Received Date: July 08, 2021
  • Accepted Date: September 12, 2021
  • Issue Publish Date: November 29, 2022
    Graphical Abstract
    • Abstract
  •   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.
    • FullText(HTML)
    • References (30)
  • [1]
    WHO. Data visualization tools for exploring the global cancer burden in 2020[EB/OL]. (2020-01-01)[2021-06-16]. https://gco.iarc.fr/today/home.
    [2]
    孙可欣, 郑荣寿, 张思维, 等. 2015年中国分地区恶性肿瘤发病和死亡分析[J]. 中国肿瘤, 2019, 2: 1-11. https://www.cnki.com.cn/Article/CJFDTOTAL-ZHLU201901001.htm
    [3]
    中华人民共和国国家卫生健康委员会. 关于印发新型抗肿瘤药物临床应用指导原则(2018年版)的通知[EB/OL]. (2018-09-21)[2021-06-08]. http://www.nhc.gov.cn.
    [4]
    American Jonit Committee on Cancer. Cancer Staging Manual Eighth Edition[M]. Springer Nature, 2016.
    [5]
    WHO. Global Cancer Observatary[EB/OL]. (2020-01-01)[2021-06-06]. https://gco.iarc.fr/.
    [6]
    国家药品监督管理局. 关于解决药品注册申请积压实行优先审评审批的意见[EB/OL]. (2016-02-26)[2021-06-16]. https://www.nmpa.gov.cn.
    [7]
    国家药品监督管理局. 关于临床急需境外新药审评审批相关事宜的公告[EB/OL]. (2018-10-23)[2021-06-16]. https://www.nmpa.gov.cn.
    [8]
    Gauzy-Lazo L, Sassoon I, Brun MP. Advances in Antibody-Drug Conjugate Design: Current Clinical Landscape and Future Innovations[J]. SLAS Discov, 2020, 25: 843-868. DOI: 10.1177/2472555220912955
    [9]
    于丝雨, 刘晓东, 刘李. 抗体药物偶联物药动学研究进展[J]. 药学进展, 2021, 45: 188-195. https://www.cnki.com.cn/Article/CJFDTOTAL-YXJZ202103006.htm
    [10]
    Von Minckwitz G, Huang CS, Mano MS, et al. Trastu-zumab Emtansine for Residual Invasive HER2-Positive Breast Cancer[J]. N Engl J Med, 2019, 380: 617-628. DOI: 10.1056/NEJMoa1814017
    [11]
    Denevault-Sabourin C, Joubert N, Beck A, et al. Antibody-Drug Conjugates: The Last Decade[J]. Pharmaceuticals, 2020, 13: 245. DOI: 10.3390/ph13090245
    [12]
    Theocharopoulos C, Lialios PP, Gogas H, et al. An over-view of antibody-drug conjugates in oncological practice[J]. Ther Adv Med Oncol, 2020, 12: 1758835920962997.
    [13]
    National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Chronic lymphocytic leukemia/Small lymphocytic leukemia[EB/OL]. (2021-04-29)[2021-06-06]. https://www.nccn.org/professionals/default.aspx.
    [14]
    Awan FT, Schuh A, Brown JR, et al. Acalabrutinib mono-therapy in patients with chronic lymphocytic leukemia who are intolerant to ibrutinib[J]. Blood Adv, 2019, 3: 1553-1562. DOI: 10.1182/bloodadvances.2018030007
    [15]
    Shah A, Barrientos JC. Oral PI3K-δ, γ Inhibitor for the Management of People with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma: A Narrative Review on Duvelisib[J]. Onco Targets Ther, 2021, 14: 2109-2119. DOI: 10.2147/OTT.S189032
    [16]
    National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Chronic myeloid leukemia[EB/OL]. (2021-01-13)[2021-06-06]. https://www.nccn.org/professionals/default.aspx.
    [17]
    Cortes J, Lang F. Third-line therapy for chronic myeloid leukemia: current status and future directions[J]. J Hematol Oncol, 2021, 14: 2-18. DOI: 10.1186/s13045-020-01026-6
    [18]
    Issa GC, DiNardo CD. Acute myeloid leukemia with IDH1 and IDH2 mutations: 2021 treatment algorithm[J]. Blood Cancer J, 2021, 11: 2-7. DOI: 10.1038/s41408-020-00404-0
    [19]
    Paik PK, Felip E, Veillon R, et al. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations[J]. N Engl J Med, 2020, 383: 931-943. DOI: 10.1056/NEJMoa2004407
    [20]
    Wolf J, Seto T, Han J Y, et al. Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer[J]. N Engl J Med, 2020, 383: 944-957. DOI: 10.1056/NEJMoa2002787
    [21]
    National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Non-small cell lung cancer[EB/OL]. (2021-03-03)[2021-06-26]. https://www.nccn.org/professionals/default.aspx.
    [22]
    Drilon A, Clark JW, Weiss J, et al. Antitumor activity of crizotinib in lung cancers harboring a MET exon 14 alteration[J]. Nat Med, 2020, 26: 47-51. DOI: 10.1038/s41591-019-0716-8
    [23]
    Camidge DR, Kim HR, Ahn MJ, et al. Brigatinib versus Crizotinib in ALK-Positive Non-Small-Cell Lung Cancer[J]. N Engl J Med, 2018, 379: 2027-2039. DOI: 10.1056/NEJMoa1810171
    [24]
    Besse B, Solomon BJ, Felip E, et al. Lorlatinib in patients (Pts) with previously treated ALK+ advanced non-small cell lung cancer (NSCLC): Updated efficacy and safety[J]. J Clin Oncol, 2018, 36: 9032-9032. DOI: 10.1200/JCO.2018.36.15_suppl.9032
    [25]
    Murthy RK, Loi S, Okines A, et al. Tucatinib, trastuzumab and capecitabine for HER2positive metastatic breast cancer[J]. N Engl J Med, 2019, 382: 597609.
    [26]
    Rugo HS, Im SA, Cardoso F, et al. Efficacy of Marge-tuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer: A Phase 3 Randomized Clinical Trial[J]. JAMA Oncol, 2021, 7: 573-584. DOI: 10.1001/jamaoncol.2020.7932
    [27]
    National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Breast cancer[EB/OL]. (2021-04-28)[2021-06-26]. https://www.nccn.org/professionals/default.aspx.
    [28]
    André F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer[J]. N Engl J Med, 2019, 380: 1929-1940. DOI: 10.1056/NEJMoa1813904
    [29]
    赵秋玲, 杨琳, 谢瑞祥. 9种获批上市的抗PD-1/PD-L1单抗药物的特征综述[J]. 中国药房, 2020, 31: 2294-2299. https://www.cnki.com.cn/Article/CJFDTOTAL-ZGYA202018022.htm
    [30]
    Hong Y, Feng Y, Sun H, et al. Tislelizumab uniquely binds to the CC' loop of PD-1 with slow-dissociated rate and complete PD-L1 blockage[J]. FEBS Open Bio, 2021, 11: 782-792. DOI: 10.1002/2211-5463.13102
    • Related Articles

  • Related Articles

    [1]Chinese Society of Rare Diseases, Rare Diseases Society of Chinese Research Hospital Association, National Rare Diseases Committee, Beijing Rare Disease Diagnosis, Treatment and Protection Society. Expert Consensus for the Diagnosis and Treatment of Bartter Syndrome in China(2023)[J]. Medical Journal of Peking Union Medical College Hospital, 2023, 14(4): 744-757. DOI: 10.12290/xhyxzz.2023-0207
    [2]CHEN Chen, HAN Xiaohong. Clinical Trials of Rare Diseases in China over One Decade: Based on the Chinese First List of Rare Diseases[J]. Medical Journal of Peking Union Medical College Hospital, 2022, 13(6): 1028-1035. DOI: 10.12290/xhyxzz.2022-0010
    [3]HE Shan, GAO Shiqi, HE Xinyue, LIU Peng, JIN Ye, LI Xiangyan, ZHU Yicheng, CHEN Limeng, ZHU Weiguo, ZHANG Shuyang. Advances in Rare Diseases in China (2020—2021)[J]. Medical Journal of Peking Union Medical College Hospital, 2022, 13(1): 39-45. DOI: 10.12290/xhyxzz.2021-0248
    [4]Chinese Society of Surgery, Chinese Society of Anesthesiology. Clinical Practice Guidelines for ERAS in China(2021)(Ⅴ)[J]. Medical Journal of Peking Union Medical College Hospital, 2021, 12(5): 658-665. DOI: 10.12290/xhyxzz.20210005
    [5]Chinese Society of Surgery, Chinese Society of Anesthesiology. Clinical Practice Guidelines for ERAS in China(2021)(Ⅳ)[J]. Medical Journal of Peking Union Medical College Hospital, 2021, 12(5): 650-657. DOI: 10.12290/xhyxzz.20210004
    [6]Chinese Society of Surgery, Chinese Society of Anesthesiology. Clinical Practice Guidelines for ERAS in China(2021)(Ⅲ)[J]. Medical Journal of Peking Union Medical College Hospital, 2021, 12(5): 641-649. DOI: 10.12290/xhyxzz.20210003
    [7]Chinese Society of Surgery, Chinese Society of Anesthesiology. Clinical Practice Guidelines for ERAS in China (2021)(Ⅱ)[J]. Medical Journal of Peking Union Medical College Hospital, 2021, 12(5): 632-640. DOI: 10.12290/xhyxzz.20210002
    [8]Chinese Society of Surgery, Chinese Society of Anesthesiology. Clinical Practice Guidelines for ERAS in China (2021)(Ⅰ)[J]. Medical Journal of Peking Union Medical College Hospital, 2021, 12(5): 624-631. DOI: 10.12290/xhyxzz.20210001
    [9]Jing FAN, Xu-dong MA, Yan-hong GUO. Striking Improvements in the Technological Capability and the Quality of Healthcare in China[J]. Medical Journal of Peking Union Medical College Hospital, 2018, 9(4): 303-306. DOI: 10.3969/j.issn.1674-9081.2018.04.004
    [10]Hao-peng XU, Chong ZHU, Meng-chun GONG, Shu-yang ZHANG. Research of Rare Diseases in China: from the Past to the Future[J]. Medical Journal of Peking Union Medical College Hospital, 2018, 9(1): 5-9. DOI: 10.3969/j.issn.1674-9081.2018.01.002

  • Cited by

    Periodical cited type(7)

    1. 杨利伟. 同意原则的伦理向度:从生命伦理到多元实践. 道德与文明. 2025(01): 145-156 .
    2. 夏振兰，刘俊荣，刘泽炫，陈丽萍. 慢性伤口处理中的临床伦理困境探析——以1例产后脂肪液化合并线结反应的慢性伤口患者护理为例. 中国医学伦理学. 2024(02): 194-198 .
    3. 朱敏，陈昌林，李明. 老年患者麻醉知情同意的临床伦理分析. 中国当代医药. 2024(14): 124-128 .
    4. 王茜，夏曼. 知情同意权的伦理应用困境与对策. 江苏卫生事业管理. 2024(11): 1559-1562 .
    5. 陶应时，陈巧，刘红玉. 治疗型脑机接口的知情同意问题及其应对. 南华大学学报(社会科学版). 2023(01): 62-68 .
    6. 夏振兰，陈丽萍，杨林玲，廖绮霞，刘俊荣. 一例慢性伤口不愈合患者拒绝住院治疗的伦理剖析. 中国医学伦理学. 2022(09): 1012-1016 .
    7. 张曼. 脑隐私法律概念建构：路径、特性与贡献. 东方法学. 2022(05): 60-73 .

    Other cited types(4)

Catalog

    Get Citation
    PDF
    XML

    Article Metrics

    Article views (4664) PDF downloads (159) Cited by(11)
    Related
    Links: National Health Commission of the People's Republic of China Chinese Academy of Medical Sciences(CAMS) AMLC Check CNKI Database CNKI Term Online Chinese General Practice
    Address：Room 302,Third Floor,Building 7, No. 1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing 100730, China
    Tel：010-69154261/4262
    E - mail：medj@pumch.cn mjpumch@126.com
    Copyright of website：Editorial Office of Medical Journal of Peking Union Medical College Hospital

    Supported by: Beijing Renhe Information Technology Co., Ltd.  Baidu Analytics

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return
    x Close Forever Close