Core Viewpoint - Huadong Medicine (000963.SZ) announced that its wholly-owned subsidiary, Sino-American Huadong, received the Acceptance Notice from the National Medical Products Administration for the marketing authorization application of Edaravone Tablets (R&D code: TTYP01) for the treatment of acute ischemic stroke [1] Group 1 - Sino-American Huadong has signed an exclusive licensing agreement with Ausgen Biotech, obtaining exclusive rights for all indications of TTYP01 in mainland China, Hong Kong, Macau, and Taiwan [1]

Core Viewpoint - Changshan Pharmaceutical's application for the marketing authorization of Abemaciclib injection for type 2 diabetes has been accepted, but there is uncertainty regarding its approval and timeline [1] Group 1: Stock Performance - The company's stock price has deviated significantly, with a cumulative increase of 147.69% from May 6 to June 9, which is over 30% deviation from the industry and ChiNext index growth [1] Group 2: Product Development - The application for clinical trials of Abemaciclib injection for weight loss indications has also been accepted, but there is uncertainty about receiving the approval notice [1]

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]

中关村公告，下属公司山东华素制药有限公司的比索洛尔氨氯地平片(规格：富马酸比索洛尔5mg与苯 磺酸氨氯地平(按氨氯地平计)5mg)上市许可申请获得国家药品监督管理局受理。该药品用于高血压治疗 的替代疗法，为固定剂量的富马酸比索洛尔和苯磺酸氨氯地平组成的复方制剂。项目已累计投入研发费 用607.98万元。山东华素将积极推进后续审评工作，如顺利通过上市许可将增加其市场竞争力。 ...