众生药业(002317.SZ):创新药研发项目临床试验进度、审评和审批结果具有不确定性

智通财经
Nov 16

智通财经APP讯,众生药业(002317.SZ)公告称,目前,公司正在推进昂拉地韦颗粒治疗2~11岁儿童单纯性甲型流感患者和昂拉地韦片治疗12~17岁青少年单纯性甲型流感患者的两项III期临床试验、RAY1225注射液治疗肥胖/超重患者的III期临床试验、以及RAY1225注射液治疗2型糖尿病患者的两项III期临床试验。创新药研发项目的临床试验进度、审评和审批的结果以及未来产品市场竞争格局都具有一定的不确定性。药品能否获批上市以及获批上市的时间、上市后的生产和销售情况存在不确定性。

用于治疗成人单纯性甲型流感的小分子创新药昂拉地韦片已获得国家药品监督管理局批准上市,是全球首款流感RNA聚合酶PB2蛋白抑制剂。由于医药产品的行业特点,药品获批后的商业化将受到市场、政策、环境变化等不确定因素影响,并且受相关疾病的预防性疫苗的普及、治疗药物的陆续获批、后续产品市场推广等多种因素影响,未来昂拉地韦片的商业化和销售情况存在不确定性。

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