2023年2月23日,中国成都--康诺亚生物医药科技有限公司(HK:02162)和乐普生物科技股份有限公司 (HK:02157)今日共同宣布与阿斯利康(AstraZeneca,LSE/STO/纳斯达克:AZN)就潜在世界首创Claudin 18.2抗体偶联药物CMG901达成全球独家授权协议。根据许可协议,阿斯利康将负责 CMG901 的全球研发、生产和商业化。

CMG901正在进行治疗Claudin18.2阳性表达的实体瘤患者的I期临床试验。I期临床试验的初步结果表明,CMG901具有良好的安全性和耐受性,并在目前临床试验的剂量水平上呈现出令人鼓舞的抗肿瘤疗效。

基于此协议及条款,由康诺亚和乐普生物合资设立的KYM Biosciences Inc.将获得6300万美元的预付款和超过11亿美元的潜在额外研发和销售相关的里程碑付款,以及高达低双位数的分层特许权使用费。阿斯利康将获得 CMG901 研究、开发、注册、生产和商业化的独家全球许可。该交易预计于 2023 年上半年完成,具体取决于惯例成交条件和监管许可。

康诺亚联合创始人、董事长兼首席执行官和KYM Biosciences Inc.董事长陈博博士表示:“我们非常高兴与阿斯利康合作。作为世界一流的生物制药企业,阿斯利康在抗肿瘤药物领域拥有丰富、成功的药物开发和商业化经验。此次合作不仅基于对CMG901作为潜在世界首创Claudin18.2 ADC的肯定,也是对康诺亚自主研发创新能力的认可。期待此次全球范围的项目合作惠及广大国内外患者。”

阿斯利康肿瘤研发部生物制品工程与肿瘤靶向递送高级副总裁Puja Sapra 表示:“我们很高兴有机会加速 CMG901 的开发,这是一种可用于Claudin18.2 阳性表达的癌患者的潜在新药。 CMG901不仅加强了我们不断增加的抗体药物偶联物产品线,也支持我们为胃肠道癌症患者拓展治疗选择和改善预后的雄心。“

关于CMG901

CMG901是首个在中国及美国均取得临床试验申请批准的靶向Claudin 18.2的全新重组人源化单克隆抗体偶联药物,由抗Claudin 18.2单克隆抗体、可裂解的链接体和细胞毒性小分子单甲基澳瑞他汀E(MMAE)组成。CMG901由 KYM Biosciences Inc.(KYM)所有,KYM 是 康诺亚(KYM 70%的所有权)和乐普生物(KYM 30%的所有权)成立的合资企业,旨在共同开发、生产和商业化 CMG901。

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