相关实验视频

Updated: Jan 7, 2026

An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules

An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules

Published on: November 4, 2022

中国创新药物的专利期限延长:2021年至2024年的队列研究

Xuefang Yao¹, Yan Zhang², Jin Zhou²

¹School of Health Economics and Management, Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, China. sarina_yao@126.com.

Therapeutic innovation & regulatory science

|December 11, 2025

概括

中国中国中国中国.

科学领域:

制药政策制药政策
知识产权法知识产权法
药物可访问性药物可访问性

背景情况:

中国于2024年1月对2021年6月1日之后批准的创新药物实施了专利期限延期 (PTE) 制度.
该系统旨在补偿药物批准过程中丢失的专利期限.
了解PTE的影响对于中国的药物创新和市场准入至关重要.

研究的目的:

分析中国专利期限延期 (PTE) 制度的结果.
评估PTE对中国创新药物可获得性的潜在影响.
将中国的PTE系统与美国和欧盟的PTE系统进行比较.

主要方法:

对PTE持续时间和上市后有效专利寿命 (EPLL) 的模拟分析.
利用来自中国市场药物专利注册平台和其他公共数据库的数据.
包括2021年6月至2024年12月中国监管机构批准的创新药物.

主要成果:

在148种创新药中,有61%含有获得PTE的创新药物,平均持续时间为5年.
经过PTE后,EPLL的中位数从9年增加到14年,增加了55.6%.
在不同类型的药物和治疗领域中观察到PTE持续时间和EPLL的显著变化.

结论:

中国的中位数PTE持续时间比美国和欧盟更长,但中位数EPLL仅显示边际延伸.
国内外的利益相关者都必须考虑增量PTE期和整体EPLL.
需要进行战略评估,以应对中国药物专利政策不断变化的局面.

关键词:

获得药品的机会中国中国中国中国.在上市后的有效专利期限.创新药是一种创新药物.专利期限的延期是专利的延期.

更多相关视频

Author Spotlight: Optimization of Processing Technology for Tiebangchui with Zanba Based on CRITIC Combined with Box-Behnken Response Surface Method

Author Spotlight: Optimization of Processing Technology for Tiebangchui with Zanba Based on CRITIC Combined with Box-Behnken Response Surface Method

Published on: May 12, 2023

Author Spotlight: Streamlining Protein Target Prediction and Validation via Molecular Docking and CETSA

Author Spotlight: Streamlining Protein Target Prediction and Validation via Molecular Docking and CETSA

Published on: February 23, 2024

相关概念视频

FDA Approved Drugs: Changes to Approved Drugs

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

Clinical Trials: Overview

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

Drug Products: Biologics, Biosimilars and Interchangeables

Drug Products: Biologics, Biosimilars and Interchangeables

Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...

Bioavailability Enhancement: Drug Stability Enhancement and GI Retention

Bioavailability Enhancement: Drug Stability Enhancement and GI Retention

Body:Improving a drug's stability in the gastrointestinal (GI) tract is paramount for enhancing its bioavailability and therapeutic effectiveness. Various strategies are employed to protect the drug from the harsh gastric milieu and to ensure its release and absorption at the desired site within the GI tract.Polymer coatings are one such method used to shield drugs from the stomach's acidic environment. By preventing premature drug release, these coatings improve the bioavailability of unstable...

Bioequivalence studies: Biowaivers

Bioequivalence studies: Biowaivers

Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...

Bioavailability Enhancement: Drug Permeability Enhancement

Bioavailability Enhancement: Drug Permeability Enhancement

Body:After oral administration, poor permeability often limits the rate at which drugs are absorbed through the intestinal epithelium. Enhancing drug permeability is crucial for effective therapy, and several strategies have been developed to overcome this challenge.One effective strategy involves the use of lipid-based formulations. These formulations enhance dissolution and solubility, targeting physiological mechanisms to increase drug absorption. This includes stimulating bile salt...