石药集团(01093.HK):创新药“SYHA1813口服液”获临床试验批件
格隆汇 11 月 3日丨石药集团(01093.HK)发布公告,集团1类新药“SYHA1813口服液”已获中国国家药品监督管理局批准,可在中国开展临床试验。该产品已在中国、美国等多个国家获得专利授权。
该产品为公司附属公司上海润石医药科技有限公司与中国科学院上海药物研究所共同开发的多靶点抑制剂。本次获批的临床适应症为复发或晚期实体瘤(包括高级别脑胶质瘤、脑转移瘤、肾癌、结直肠癌、甲状腺癌、肺癌、胃癌、腱鞘巨细胞瘤等)。
临床前研究显示,该产品通过高活性抑制多种激酶,对包括脑胶质瘤、肾癌、结直肠癌等多种肿瘤具有良好的效果,同时具有良好的安全性和药代动力学特点,极有希望在临床研究中展现出良好的抗肿瘤效果。集团将全力以赴推进该产品的临床研究工作,力争该产品尽快上市。
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