药品上市申请

Search documents
常山药业:公司艾本那肽注射液用于2型糖尿病的上市许可申请已获受理 能否上市及获批时间存在不确定性
news flash· 2025-06-09 10:38
智通财经6月9日电,常山药业(300255.SZ)公告称,公司股票连续两个交易日收盘价格涨幅偏离值累计 超过30%,自5月6日至6月9日期间股价累计涨幅达147.69%,已严重偏离同行业和创业板综合指数增长 幅度。公司艾本那肽注射液用于2型糖尿病的上市许可申请已获受理,但后续环节较多,获批上市及获 批时间存在不确定性。此外,艾本那肽注射液拟用于减重适应症的临床试验申请也已获受理,但能否获 得批准通知书存在不确定性。 常山药业:公司艾本那肽注射液用于2型糖尿病的上市许可申请已获受理 能否上市及获批时间存在不确 定性 ...
贝达药业:递交盐酸恩沙替尼上市申请
news flash· 2025-05-12 10:51
Core Viewpoint - The company has submitted a drug registration application for Ensartinib capsules to the Macau Drug Administration, aiming to treat patients with locally advanced or metastatic non-small cell lung cancer who are positive for anaplastic lymphoma kinase (ALK) [1] Group 1 - The drug, marketed as Baimena, is a new generation ALK inhibitor developed in collaboration with the company's subsidiary, Xcovery [1] - Ensartinib has already received marketing approval in China and the United States, and the company is advancing the application process in Europe [1] - The company will continue to monitor the review progress, and the short-term impact of this application on the company's operating performance is not expected to be significant [1]