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港股异动 | 和誉-B(02256)再涨超4% 月内涨超30% ABSK012获得美国FDA的临床试验许可

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和誉-B(02256)再涨超4%,月内涨超30%。截至发稿,涨3.22%,报3.85港元,成交额2143.1万港元。

消息面上,和誉-B发布公告,其自主研发的抗耐药突变小分子成纤维细胞生长因子受体4(“FGFR4”)抑制剂ABSK012获美国食品药品监督管理局(“FDA”)批准可开展其单药在晚期实体瘤患者中的首次人体(FIH) I期临床试验。

据悉,和誉医药近日在CTOS年会上公布自主研发的新一代CSF-1R抑制剂pimicotinib (ABSK021)的两项重要临床试验进展,与2022年CTOS上报告的6个月早期数据相比,pimicotinib一年随访的疗效数据得到持续改善。

此外,和誉医药新一代EGFR-Exon20ins抑制剂ABSK112获得国家药品监督管理局(NMPA)的IND批准,即将开展针对非小细胞肺癌(NSCLC)的国内首次人体I期临床试验。

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