百奥泰(688177.SH)公告称,公司收到国家药监局核准签发的关于在研药品重组抗VEGF人源化单克隆抗体注射液(BAT5906)新增视网膜中央静脉阻塞所致黄斑水肿(CRVO-ME)和病理性近视的脉络膜新生血管(pmCNV)的《药物临床试验批准通知书》。BAT5906已获批临床试验的适应症包括新生血管性年龄相关性黄斑变性(w-AMD)、糖尿病性黄斑水肿(DME)、CRVO-ME和pmCNV。目前,公司已完成BAT5906在w-AMD适应症的I、II、III期临床研究,DME适应症已完成II期临床,CRVO-ME和pmCNV适应症也在II/III期临床研究准备阶段。
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