智通财经APP获悉,翰森制药(03692)涨近6%,截至发稿,涨5.88%,报23.4港元,成交额1.34亿港元。
消息面上,根据中国国家药监局药品审评中心(CDE)官网以及公开资料梳理,4月14日~4月19日,有10款1类创新药首次在中国获得临床试验默示许可(IND)。这些产品涵盖了小分子、抗体偶联药物(ADC)、基因疗法、细胞疗法等类型,拟定适应症涵盖晚期实体瘤、1型糖尿病、脊髓损伤,以及杜氏肌营养不良(DMD)、阵发性睡眠性血红蛋白尿症等。
其中,翰森制药1类新药HS-10529片获批临床,拟开发治疗KRAS G12D突变的晚期实体瘤(胰腺癌、结直肠癌、非小细胞肺癌等)。根据翰森制药新闻稿介绍,这是该公司研发的一种靶向KRAS G12D的小分子抑制剂,具有高度选择性。临床前药效试验表明,HS-10529具有良好的临床前药效活性、药代动力学特征和安全性。
此外,翰森制药还有另外两款1类新药首次在中国获批IND,但尚未从公开渠道查询到该产品的具体作用机制。它们分别为:HS-20118片,拟开发治疗中重度斑块状银屑病;HS-10542胶囊,拟开发治疗阵发性睡眠性血红蛋白尿症。
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