Indication Expansion Dynamics and Trial Characteristics of Novel Multi-Indication Anti-Cancer Drugs in China (2000–2024): A Cross-Sectional Study

Regulatory reforms facilitated the approval of novel multi-indication anti-cancer drugs, although NRDL inclusion has not kept pace. Targeted therapies dominate, while ICIs, though fewer, show the broadest indication expansion. Most drugs are approved for two to three indications, mainly in solid tumors, and later approvals were associated with different regulatory pathways than earlier ones.

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Publication Details

Journal
Drug Design Development and Therapy
Published
2026-01-01
DOI
https://doi.org/10.2147/dddt.s551402
Primary Topic
Statistical Methods in Clinical Trials
Type
article
Field-Weighted Citation Impact
0.00

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article

Indication Expansion Dynamics and Trial Characteristics of Novel Multi-Indication Anti-Cancer Drugs in China (2000–2024): A Cross-Sectional Study

Dongni Zheng, H. Li, Qian Jiang, Zhisan He et al.
Drug Design Development and Therapy
Statistical Methods in Clinical Trials
article

Indication Expansion Dynamics and Trial Characteristics of Novel Multi-Indication Anti-Cancer Drugs in China (2000–2024): A Cross-Sectional Study

Dongni Zheng, H. Li, Qian Jiang, Zhisan He, Shunlong Ou, Jing Luo, Xiaoyi Chen
article en

Abstract

Regulatory reforms facilitated the approval of novel multi-indication anti-cancer drugs, although NRDL inclusion has not kept pace. Targeted therapies dominate, while ICIs, though fewer, show the broadest indication expansion. Most drugs are approved for two to three indications, mainly in solid tumors, and later approvals were associated with different regulatory pathways than earlier ones.

Drug Design Development and TherapyVol. Volume 20
Sichuan Cancer Hospital (CN), Chengdu Fifth People's Hospital (CN), Second People’s Hospital of Yibin (CN)
National Natural Science Foundation of China, Wu Jieping Medical Foundation
Good health and well-being
Openalex Percentile: Top 95%
Statistical Methods in Clinical Trials
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