沛嘉医疗-B(09996):SeQuent® Please CIS获国家药监局注册批准

公告速递
4 hours ago

2026年9月25日,沛嘉医疗-B(09996)发布自愿公告称,其神经介入产品——神普畅™ SeQuent® Please CIS紫杉醇药物涂层颅内球囊扩张导管已获国家药品监督管理局注册批准。该产品由贝朗医疗(苏州)有限公司注册,基于贝朗医疗成熟的药物涂层球囊技术开发,可在机械扩张病变血管时将紫杉醇准确释放至血管壁,以抑制内膜增生并降低再狭窄风险,适用于具备纤细、迂曲解剖特征的颅内血管病变,提供“无植入物”治疗方案。

公司提醒,2026年6月1日,旗下子公司上海加奇生物科技苏州有限公司已取得该产品在中国内地的独家分销权。本次批准进一步丰富了沛嘉医疗-B在神经介入领域的产品组合,并加强其在颅内动脉粥样硬化性狭窄治疗领域的布局。集团将依托既有商业化能力,推进SeQuent® Please CIS在国内市场的导入与销售。

公司同时提示,神普畅™ SeQuent® Please CIS最终能否成功商业化仍存在不确定性,股东及潜在投资者在买卖公司股份时应审慎行事。

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