中国NMPA:批准Pellino-1抑制剂BBT-401治疗溃疡性结肠炎的IND

2019-12-28 Allan MedSci原创

韩国制药公司Bridge近日宣布,中国国家药品监督管理局(NMPA)药品评审中心(CDE)批准了于2019年9月25日提交的IND,旨在寻求Pellino-1抑制剂BBT-401治疗溃疡性结肠炎(UC)的临床研究。

韩国制药公司Bridge近日宣布,中国国家药品监督管理局(NMPA)药品评审中心(CDE)批准了于2019925日提交的IND,旨在寻求Pellino-1抑制剂BBT-401治疗溃疡性结肠炎UC)的临床研究。Bridge计划于20205月开始在中国受试者中进行BBT-401I期研究。该研究将以单次或多次递增口服剂量评估候选药物的安全性、耐受性和药代动力学特征。

根据201812月签署的许可和共同开发协议,该公司与日本大雄制药达成合作伙伴关系,共同开发BBT-401。大雄制药获得了包括中国在内的22个亚洲国家的BBT-401开发和商业化的独家权利。


原始出处:

https://www.firstwordpharma.com/node/1690169

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    2020-09-23 nymo
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    2020-10-08 jklm09
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    2020-10-31 feather89
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    2019-12-30 xiaogang319
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    2019-12-30 tidiq