从研发到产业落地贝捷迈 ® 申报受理助力和誉医药进阶

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贝捷迈®由和誉医药自主研发，并授权默克公司负责其在全球的商业化。2025年12月，贝捷迈®获中国国家药品监督管理局(NMPA)批准上市，用于手术切除可能会导致功能受限或出现较严重并发症的症状性TGCT成年患者。目前，该产品在其他市场的上市申请正由相关监管机构审评中。此次贝捷迈®NDA获FDA受理，主要基于全球多中心、随机、双盲、安慰剂对照III期MANEUVER研究的积极结果。研究显示，每日一次...

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从研发到产业落地 贝捷迈 ® 申报受理助力和誉医药进阶

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从研发到产业落地贝捷迈 ® 申报受理助力和誉医药进阶