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创新驱动与战略转型背景下新药研发趋势及其对卫生健康发展格局的影响
Tendency of new drug research and development and its effect on health development pattern under the background of innovation⁃driven and strategic transformation

广西医学 页码:769-775

作者机构:

DOI:10.11675/j.issn.0253⁃4304.2026.06.01

  • 中文简介
  • 英文简介
  • 参考文献

在健康中国战略持续深入推进的背景下,我国卫生健康事业正在加快实现从“以治病为中心”向“以人民健康为中心”的深刻转变。在此期间,新药研发的内涵和外延也发生了明显变化,不再是单纯的实验室技术创新或企业产品开发问题,而是与国家公共卫生安全、医药产业升级、医疗服务体系重构、医保支付机制完善及人民群众健康福祉改善密切相关的系统性战略议题。“十四五”以来,国家围绕健康中国建设、医药工业高质量发展、药品监管改革、创新药全链条支持、创新药医保准入与多层次支付体系建设等方面持续出台政策,推动我国创新药发展从“数量增长”逐步转向“质量提升、价值导向和体系协同”。从现实基础看,我国人口老龄化持续加快,疾病谱持续向慢性非传染性疾病(慢性病)主导转变。这意味着卫生健康治理重点已由急性传染病防控和单病种救治,逐步拓展为全生命周期健康管理、重大慢性病综合防控和高水平临床创新转化的协同推进。本文立足中国政策体系和制度实践,从国家战略、产业基础、技术趋势、临床转化、医保支付和患者可及性等维度,系统分析新时代新药研发趋势及其如何重塑我国卫生健康发展格局。

Under the background of the continuous and in⁃depth promotion of the Healthy China Initiative, China's health service is accelerating the realization of a profound transformation from “putting disease treatment at the center” to “putting people's health at the center”. In line with this change, the connotation and extension of new drug research and development have also changed significantly. It is no longer a simple problem of laboratory technology innovation or enterprise product development, but a systematic strategic issue closely related to national public health security, the upgrading of the pharmaceutical industry, the reconstruction of the medical service system, the improvement of the medical insurance payment mechanism, and the improvement of people's health and well⁃being. Since the 14th Five⁃Year Plan, the national level has continuously introduced policies around the construction of Healthy China, high⁃quality development of the pharmaceutical industry, drug regulatory reform, full⁃chain support for new drugs, medical insurance access for new drugs and the construction of a multi⁃level payment system, promoting the development of new drugs in China to gradually shift from “quantitative growth” to “quality improvement, value orientation and system synergy”. On the basis of reality, China's population aging continues to accelerate, and chronic non⁃communicable diseases (hereinafter referred to as chronic diseases) continue to dominate the disease spectrum in China. This means that the focus of health governance has gradually expanded from the prevention and control of acute infectious diseases and single disease treatment to the coordinated promotion of life⁃cycle health management, comprehensive prevention and control of major chronic diseases, and high⁃level clinical innovation and translation. Based on China's policy system and institutional practice, this paper systematically analyzes the tendency of new drug research and development in the new era and how to reshape China's health development pattern from the dimensions of national strategy, industrial base, technology trends, clinical translation, medical insurance payment and patient accessibility.

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