基石药业-B(02616.HK)：avapritinib新药上市申请在香港地区获受理用于治疗PDGFRAD842V突变无法切除或转移性胃肠道间质瘤成人患者
格隆汇5月12日丨基石药业-B(02616.HK)公告，公司欣然宣布胃肠道间质瘤("胃肠道间质瘤")同类首创精准靶向药avapritinib香港地区的新药上市申请("NDA")已获受理，用于治疗携带PDGFRAD842V突变无法切除或转移性胃肠道间质瘤成人患者。Avapritinib由基石药业合作伙伴Blueprint Medicines Corporation (NASDAQ:BPMC) 开发，是一款强效、高选择性口服KIT和PDGFRA抑制剂。
基石药业首席医学官杨建新表示：“我们很高兴看到avapritinib的新药上市申请在香港地区获得受理，这是该产品走向中国患者的又一重要里程碑。由于现有疗法的获益极为有限，PDGFRAD842V突变的GIST患者具有高度未被满足的治疗需求。2020年中国临床肿瘤学会("CSCO")会议公布的数据显示，avapritinib治疗携带PDGFRAD842V突变的患者中，所有患者靶病灶均有缩小，并且安全性和耐受性良好，研究中报告的治疗相关不良事件大部分为1级或2级。我们期待avapritinib能够早日在香港地区获批上市，惠及更多胃肠道间质瘤患者。”
2020年CSCO会议上公布的avapritinib的研究数据来自一项开放标签、多中心的I/II期桥接研究，该研究旨在评估avapritinib治疗不可切除或转移性晚期胃肠道间质瘤中国患者的安全性、药代动力学特徵和抗肿瘤疗效。截至数据截止日期2020年3月31日，共计50例患者纳入avapritinib的安全性评估，8例携带PDGFRAD842V突变的胃肠道间质瘤患者疗效可评估，由研究者依据实体瘤疗效评价标准1.1版("RECIST")进行疗效评估。
基石药业与Blueprint Medicines达成独家合作和授权协议，获得了包括avapritinib在内的多款药物在大中华区地区(包括中国大陆、香港、澳门和台湾地区)的独家开发和商业化授权。Blueprint Medicines将保留全球其他地区的开发和商业化权利。
胃肠道间质瘤是发生于胃肠道("胃肠道")壁的肉瘤，肉瘤是发生在骨内或源自结缔组织的肿瘤。胃肠道间质瘤起源于胃肠道壁中的细胞，并且最常发生在胃或小肠中。大多数患者的确诊年龄在50至80岁间，通常在胃肠道出血、做手术或医学影像检查时发现，极少在肿瘤破裂或胃肠道发生梗阻后确诊。原发胃肠道间质瘤中，约有5％至6％的病例由PDGFRAD842V突变导致，这种突变是最常见的PDGFRA外显子18突变。
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