...药），主要包括活性成分的新酯或新盐、新剂型、新组合、新给药途径（new route of administration）、新适应症（new indication）等；第3通道是505（j），即仿制药[2]。
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该研究结果确立了一类二十多年前开发药物的新适应症。
The findings presented here identify a novel therapeutic application for a class of pharmacological compounds developed more than two decades ago.
数据独占权应当适用于所有的适应症和制剂，而非仅限于NCE(新的化学实体)的首次批准。
Data exclusivity should apply to all indications and formulations, not just the first approval of an NCE.
方法：通过文献考证、新器械研制以及临床实践介绍砭石疗法的操作手法和临床适应症。
Methods the manipulation methods and clinical indications of the Bian-stone therapy are introduced through literature, development of new medical instruments and clinical practice.
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