高端制剂的临床可及性研究

Study on Clinical Accessibility of High-end Drug Products

高端制剂具有普通制剂所不具备的临床优势,如改善药物安全性、提高药物生物利用度、长效给药降低给药次数、避免首过效应、直接病灶给药以及提高患者依从性等。但由于这类制剂存在难以攻克的技术壁垒,且研究周期长、研发费用高昂,导致市场竞争不充分进而影响其临床可及性。因此,国内急需制定相关鼓励政策以加大对这类制剂的支持力度,从而推动高端制剂的研发、审评审批,进而提高其临床可及性,使患者早日获益。本研究梳理了高端制剂开发所面临的困难与挑战,结合高端制剂的产业技术特点以及现状,对提升高端制剂的开发提出相应的思考与建议,旨在推动我国高端制剂产业的发展,更好地满足临床用药需求。

High-end drug products have some clinical advantages that ordinary ones do not have,such as improving drug safety,enhancing drug bioavailability,reducing dosing frequency for long acting drugs,avoiding first-pass effect of gastrointestinal administration,administrating on the lesion site directly,and improving patient compliance.However,due to high technical barriers,long research cycle,and high research and development costs of such products,the market competition for these high-end drug products is extremely insufficient,which affects their clinical accessibility.Therefore,there is an urgent need to formulate the relevant incentive policies in China to increase supports for such drug products,so as to promote the research and development,as well as review and approval of such drug products,thereby expanding the clinical accessibility of those products and benefiting patients at an early date.This study examined the difficulties and challenges faced by the development of high-end drug products,and put forward the corresponding thoughts and suggestions on improving the development of these drug products based on the technical characteristics of the industry and its current status,which aims to promote the development of high-end drug products in China and better meet clinical drug demand.