[The influence of orphan drug policy on the development of anti-tumor drugs]

S Feng; M C Gong; H Bai; Y Shen; S Y Zhang

doi:10.3760/cma.j.cn112138-20200619-00601

[The influence of orphan drug policy on the development of anti-tumor drugs]

Zhonghua Nei Ke Za Zhi. 2021 Feb 1;60(2):171-174. doi: 10.3760/cma.j.cn112138-20200619-00601.

[Article in Chinese]

Authors

S Feng¹, M C Gong², H Bai³, Y Shen⁴, S Y Zhang³

Affiliations

¹ Peking Union Medical College, Chinese Academy of Medical Sciences , Beijing 100730, China.
² School of Health Management, Southern Medical University,Guangzhou 510515, China.
³ Department of Cardiology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences Beijing 100730, China.
⁴ Digital China Health, Beijing 100080, China.

PMID: 33503733
DOI: 10.3760/cma.j.cn112138-20200619-00601

Abstract

美国、欧洲、日本、中国相继出台政策鼓励孤儿药的研发，大量孤儿药获批上市，罕见肿瘤药物是其中重要的组成部分。孤儿药政策有力推动了罕见肿瘤新药的研发，也使得众多已获批药物的潜能被充分挖掘，并有望革新肿瘤及肿瘤药物分类观念。但是长达7年的市场独占期、政策的经济支持、低标准的上市前临床试验也使得罕见肿瘤药物存在定价、安全性、有效性等一系列问题，亟需更多医疗工作者的努力。.

MeSH terms

Antineoplastic Agents* / therapeutic use
Humans
Orphan Drug Production*
Policy
Rare Diseases

Substances

Antineoplastic Agents