中国生物制药(01177):TQF6422注射液“ActRII A/B单抗”临床试验申请获NMPA批准

智通财经
Aug 21

智通财经APP讯,中国生物制药(01177)发布公告,本集团附属公司正大天晴药业集团股份有限公司(正大天晴)自主研发的国家1类创新药TQF6422注射液(ActRII A/B单抗)已获得中国国家药品监督管理局药品审评中心(CDE)批准开展临床研究,拟用于成人肥胖患者,或超重且合并至少一种体重相关合并症患者的体重管理。

TQF6422是一款靶向ActRII A/B的IgG1亚型全人源单克隆抗体,通过特异性结合ActRII A/B受体,强效阻断激活素、肌肉生长抑制素等配体介导的信号转导,在促进骨骼肌生长的同时增强脂肪分解,从而实现“减脂增肌”的双重量效潜力。

ActRII主要包括ActRII A和ActRII B两种亚型,主要存在于脂肪和肌肉细胞中:在脂肪细胞中,激活素(Activins)配体与ActRII受体结合后,促进脂质储存与内脏脂肪蓄积,是介导内脏脂肪积累和肥胖形成的关键驱动因素;在肌肉细胞中,激活素、肌肉生长抑制素(Myostatin)等配体,通过作用于 ActRII受体直接抑制肌肉生长,并导致肌肉萎缩,而阻断该信号能抑制萎缩并促进肌肉质量增加。因此,靶向ActRII通路具有同步改善脂肪量与瘦体重的潜力。

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