格隆汇 2 月 23日丨康方生物-B(09926.HK)发布公告，公司核心自主研发的、全球首创的新型肿瘤免疫治疗双特异性抗体新药Cadonilimab(PD-1/CTLA-4双特异性抗体，研发代号： AK104)获得美国食品药品监督管理局(“FDA”)授予的孤儿药资格认定，用于治疗宫颈癌(除极早期IA1期之外)。这是继2020年，Cadonilimab治疗经标准治疗后的复发或转移性宫颈癌获得FDA授予快速审批通道资格(FTD)和中国国家药品监督管理局(NMPA)授予“突破性治疗药物品种”后的又一重要进展。
根据披露，含铂药物化疗治疗失败的宫颈癌患者，目前尚无获批的标准治疗。后线化疗治疗的客观缓解率(ORR)不足10%，无进展生存时间短，长期化疗耐受性差，不良反应发生率较高，极需要有效的治疗药物来提高患者的疗效获益。目前， Cadonilimab在中国用于经标准治疗后复发或转移性宫颈癌的注册性II期临床试验已经完成患者入组。
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