复旦张江(01349.HK):奥贝胆酸片获得药物临床试验申请受理通知书
格隆汇 4 月 23日丨复旦张江(01349.HK)发布公告,公司的附属公司泰州复旦张江药业有限公司收到国家药品监督管理局核准签发的《受理通知书》,奥贝胆酸片(规格:5mg、10mg)的临床试验申请获得受理。
根据披露,该药物属于法尼酯 X 受体(“FXR”)激动剂。FXR 是一种在肝脏和肠道中高水平表达的核受体,在胆酸代谢调节中起关键性作用。该药物是化学药品3类仿制药,其首个目标适应症为原发性胆汁性胆管炎(PBC),目前已完成与原研药的人体生物等效性研究,下一步将开展一项小规模验证性桥接临床研究,支持仿制药批准上市。
中国作为肝胆疾病高发的国家,市场容量非常庞大。集团对于原研药物的专利限制进行了突破,并在中国大陆获得了相应的专利授权。2021年3月15日,国家卫健委联合科技部、工业和信息化部、国家医保局、国家药监局、国家知识产权局六部门,组织专家对国内专利即将到期尚未提出注册申请及临床供应短缺(竞争不充分)的药品进行遴选论证,制定了《第二批鼓励仿制药品目录》,明确了鼓励仿制的十七种药品及剂型,其中包括奥贝胆酸片。
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