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低收入和中等收入国家的药物研发:新兴的印度模式能否引领东南亚地区?

Drug development in LMICs: could the emerging Indian model usher the southeast Asian region?

作者信息

Pant Bharat, Goda Jayant, Gota Vikram

机构信息

Department of Clinical Pharmacology, Advanced Centre for Treatment Research & Education in Cancer (ACTREC), Tata Memorial Centre, Kharghar, Navi Mumbai, Maharashtra, 410210, India.

Homi Bhabha National Institute, Anushakti Nagar, Mumbai, Maharashtra, 400094, India.

出版信息

Lancet Reg Health Southeast Asia. 2024 Aug 16;29:100464. doi: 10.1016/j.lansea.2024.100464. eCollection 2024 Oct.

Abstract

Low-income and middle-income countries (LMICs) of southeast Asia are passing through a similar phase as India in their tryst with the development of novel drugs. They are beginning to break away from their dependency on the institutions of our developed world. Over the past few years, Tata Memorial Centre-India's premier cancer centre-has shown the tenacity to develop drugs within the national frontiers. By collaborating with the domestic pharmaceutical industries, it has been able to have a steady pipeline of drugs under development, with two of them receiving marketing authorization recently. Lately, Indonesia and Vietnam have also shown an inclination towards public-private partnerships for similar motives. However, due to prolonged innovative stagnation, the entire drug development machinery faces challenges stretching all the way from arranging funds to persuading regulatory bodies. In this Viewpoint, we have tried to address a few of those issues and their potential solutions, with the intention to share our own experience which might be useful to other LMICs in connecting some adamant dots.

摘要

东南亚的低收入和中等收入国家(LMICs)在新药研发方面正经历着与印度类似的阶段。它们开始摆脱对发达国家机构的依赖。在过去几年里,印度顶尖的癌症中心——塔塔纪念中心展现出了在国内研发药物的坚韧决心。通过与国内制药行业合作,该中心已拥有一条稳定的在研药物产品线,其中两种药物最近获得了上市许可。最近,印度尼西亚和越南也出于类似动机表现出了对公私合作的倾向。然而,由于长期的创新停滞,整个药物研发机制面临着从筹集资金到说服监管机构等一系列挑战。在这篇观点文章中,我们试图探讨其中的一些问题及其潜在解决方案,目的是分享我们自己的经验,这可能有助于其他低收入和中等收入国家连接一些顽固的节点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/336a/11377148/e4f275bdca0f/gr1.jpg

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