2019冠状病毒病药物研发

2019冠状病毒病药物研发是指人们开发2019冠状病毒病处方药的过程,目的是治疗2019冠状病毒病的患者,减轻患者痛苦。从2020年初到2021年,几百家制药公司生物技术公司、大学研究小组、和卫生组织在临床前或临床研究的各个阶段开发COVID-19疾病的候选治疗药物(2021年4月共有506个候选药物),截至2021年4月 ,有419个候选药物正在进行临床试验[1]

早在2020年3月,世界卫生组织 (WHO)[2]欧洲药品管理局 (EMA)[3]美国食品药品监督管理局 (FDA)[4] 、 以及中国政府和药品制造商[5][6] 正在与学术和行业研究人员协调,以加快疫苗、抗病毒药物、和感染后疗法的开发[7][8][9][10]世界卫生组织国际临床试验注册平台英语International Clinical Trials Registry Platform(ICTRP)已经记录了536项临床研究,以开发针对 COVID-19 感染的感染后疗法[11][12], 许多已确定的抗病毒化合物用于治疗临床研究中的其他感染,将被重新利用英语COVID-19 drug repurposing research[7][13][14][15]

2019冠状病毒病药物研发的方式主要有两种:一种是药物再利用研究英语COVID-19 drug repurposing research,即考察已被批准用于治疗其他疾病的药物,研究是否可用于治疗2019冠状病毒病。通过这一途径开发的比较有代表性的药物有瑞德西韦地塞米松。另一策略是针对新冠病毒感染机制及感染后症状开发全新的新药。用这种方法已经开发出的新药,包括Paxlovid莫纳皮拉韦沙利姆单抗英语SotrovimabBebtelovimab英语BebtelovimabEvusheld抗体组合英语Tixagevimab/cilgavimab

目前经由临床试验证明有较明确疗效的新冠药物,主要分两大类:一类是以沙利姆单抗、Bebtelovimab、Evusheld等为代表,通过生物技术开发出的抗体类生物大分子药物;另一类为小分子药物,如地塞米松、帕克斯洛维德及莫纳皮拉韦。

药物开发是一个多步骤的过程,通常需要五年以上的时间才能确保新化合物的安全性和有效性[16] 。 一些国家监管机构,如欧洲药品管理局 (EMA)和美国食品药品监督管理局 (FDA),批准了加快临床试验的程序[4][17]。 到2021年6月,数十种潜在的感染后疗法已进入人体试验的最后阶段 – III-IV 期临床试验[18]。根据最近的杰富瑞集团有限公司估计,一种有效、方便的COVID-19治疗方法的年销售额可能超过$100亿美元[19]

参见

参考文献

  1. ^ COVID-19 vaccine and therapeutics tracker. BioRender. 5 April 2021 [21 June 2021]. (原始内容存档于2020-10-03). 
  2. ^ Kupferschmidt K, Cohen J. WHO launches global megatrial of the four most promising coronavirus treatments. Science Magazine. 22 March 2020 [27 March 2020]. S2CID 216325781. doi:10.1126/science.abb8497. (原始内容存档于14 September 2020). 
  3. ^ First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development. European Medicines Agency. 18 March 2020 [21 March 2020]. (原始内容存档于20 March 2020). 
  4. ^ 4.0 4.1 Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments (新闻稿). U.S. Food and Drug Administration (FDA). 19 March 2020 [21 March 2020]. (原始内容存档于20 March 2020). 
  5. ^ China approves first anti-viral drug against coronavirus Covid-19. Clinical Trials Arena. 18 February 2020 [21 March 2020]. (原始内容存档于21 March 2020). 
  6. ^ Chinese Vaccine Approved for Human Testing at Virus Epicenter. Bloomberg News. 19 March 2020 [21 March 2020]. (原始内容存档于21 March 2020). 
  7. ^ 7.0 7.1 Dhama K, Sharun K, Tiwari R, Dadar M, Malik YS, Singh KP, Chaicumpa W. COVID-19, an emerging coronavirus infection: advances and prospects in designing and developing vaccines, immunotherapeutics, and therapeutics. Human Vaccines & Immunotherapeutics. June 2020, 16 (6): 1232–1238. PMC 7103671 . PMID 32186952. doi:10.1080/21645515.2020.1735227 . 
  8. ^ Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. Journal of Medical Virology. May 2020, 92 (5): 479–490. PMC 7166986 . PMID 32052466. doi:10.1002/jmv.25707 . 
  9. ^ Fox M. Drug makers are racing to develop immune therapies for Covid-19. Will they be ready in time?. Stat. 19 March 2020 [21 March 2020]. (原始内容存档于22 March 2020). 
  10. ^ Chan M. Chinese military scientists ordered to win global race to develop coronavirus vaccine. South China Morning Post. 19 March 2020 [22 March 2020]. (原始内容存档于22 March 2020). 
  11. ^ COVID-19 Clinical Research Coalition. Global coalition to accelerate COVID-19 clinical research in resource-limited settings. Lancet. April 2020, 395 (10233): 1322–1325. PMC 7270833 . PMID 32247324. doi:10.1016/s0140-6736(20)30798-4 . 
  12. ^ Maguire BJ, Guérin PJ. A living systematic review protocol for COVID-19 clinical trial registrations. Wellcome Open Research. 2 April 2020, 5: 60. PMC 7141164 . PMID 32292826. doi:10.12688/wellcomeopenres.15821.1 . 
  13. ^ Li G, De Clercq E. Therapeutic options for the 2019 novel coronavirus (2019-nCoV). Nature Reviews. Drug Discovery. March 2020, 19 (3): 149–150. PMID 32127666. doi:10.1038/d41573-020-00016-0 . 
  14. ^ Dong L, Hu S, Gao J. Discovering drugs to treat coronavirus disease 2019 (COVID-19). Drug Discoveries & Therapeutics. 29 February 2020, 14 (1): 58–60 [21 March 2020]. PMID 32147628. doi:10.5582/ddt.2020.01012 . (原始内容存档于20 March 2020). 
  15. ^ Harrison C. Coronavirus puts drug repurposing on the fast track. Nature Biotechnology. April 2020, 38 (4): 379–381. PMID 32205870. doi:10.1038/d41587-020-00003-1 . 
  16. ^ The Drug Development Process. U.S. Food and Drug Administration (FDA). 4 January 2018 [21 March 2020]. (原始内容存档于22 February 2020). 
  17. ^ Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments. European Medicines Agency. 19 March 2020 [21 March 2020]. (原始内容存档于21 March 2020). 
  18. ^ COVID-19 vaccine and treatments tracker (Choose vaccines or treatments tab, apply filters to view select data). Milken Institute. 21 June 2021 [11 June 2021]. (原始内容存档于24 June 2021). 
  19. ^ Beasley, Deena. COVID-19 pill developers aim to top Merck, Pfizer efforts. Reuters (Reuters). 28 September 2021 [4 October 2021]. (原始内容存档于4 October 2021) (英语).