近日,国内首个全链条自主研发的Ⅰ类创新抗肿瘤药呋喹替尼,在上海张江创新药生产基地完成GMP符合性现场核查,即将取得商业化生产资格。这标志着该药正式由委托生产转入自主生产阶段,实现了从“张江研发”到“上海制造”的关键跨越。呋喹替尼用于治疗晚期结直肠癌,是张江药谷历经12年研发的重大成果,于2018年获批上市。得益于“药品上市许可持有人(MAH)制度”,企业在研发阶段通过委托生产,使新药提前3年惠及...
Source Link近日,国内首个全链条自主研发的Ⅰ类创新抗肿瘤药呋喹替尼,在上海张江创新药生产基地完成GMP符合性现场核查,即将取得商业化生产资格。这标志着该药正式由委托生产转入自主生产阶段,实现了从“张江研发”到“上海制造”的关键跨越。呋喹替尼用于治疗晚期结直肠癌,是张江药谷历经12年研发的重大成果,于2018年获批上市。得益于“药品上市许可持有人(MAH)制度”,企业在研发阶段通过委托生产,使新药提前3年惠及...
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