苏州检查分局、审评核查苏州分中心助力百济神州1类新药“百悦达”加速上市

江苏药品监管01-06

12月30日，由百济神州自主研发的化学药品1类创新药索托克拉片（商品名：百悦达）正式获国家药监局批准上市。作为一款高效、高选择性的B细胞淋巴瘤2（BCL2）小分子抑制剂，该药物为既往接受过治疗的慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）及套细胞淋巴瘤（MCL）成人患者带来了新的治疗选择。创新药上市“加速度”的背后，离不开监管服务的“精准度”。作为服务企业创新发展的“护航者”，苏州检查...

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