来源:新京报 | 2022-12-22 12:37:13 |
【资料图】
讯(记者张兆慧)12月22日,东诚药业(002675)发布公告,控股子公司蓝纳成收到国家药监局核准签发关于氟[18F]纤抑素注射液的《药物临床试验批准通知书》,将开展临床试验。
氟[18F]纤抑素注射液是一种靶向FAP的放射性体内诊断药物,为全新靶点药物,国内尚无同靶点治疗或诊断药物上市或在研,注册分类为化学药品1类。
成纤维细胞激活蛋白(FAP)为Ⅱ型跨膜丝氨酸蛋白酶,属于脯氨酰寡肽酶家族,高表达于许多上皮性肿瘤相关成纤维细胞(CAF)中,如胃癌、食管癌、肺癌、结直肠癌、卵巢癌等肿瘤中,而在正常组织、良性肿瘤间质中无表达或表达较低。FAP抑制素(FAPI)能特异性地与CAF膜表面的FAP结合,靶向FAP核素成像可用于诊断多种肿瘤及非肿瘤性疾病。
氟[18F]纤抑素与FAP蛋白具有较高的特异性和亲和力,可在FAP高表达的肿瘤中高度浓聚,从而可以将氟[18F]带至晚期实体瘤患者FAP表达阳性的部位,适用于实体肿瘤患者成纤维细胞激活蛋白(FAP)阳性病灶的正电子发射断层扫描(PET)成像。
截至目前,东诚药业对氟[18F]纤抑素注射液相关项目累计已投入研发费用约1486.9万元。
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