2025 年 3 月，海曲泊帕乙醇胺片Ⅲ期临床试验(HR-TPO-ITP-Ⅲ-PED)达到了方案预设的主要研究终点。 该研究是一项在儿童和青少年原发免疫性血小板减少症患者中评价海曲泊帕乙醇胺片的有效性和安全性 的多中心、随机、双盲及开放性的Ⅲ期研究，由首都医科大学附属北京儿童医院王天有教授担任主要研 究者，共入组 100 例 6 岁及以上儿童和青少年原发免疫性血小板减少症患者。试验组在主要终点上显著 优于对照组，且长期治疗的安全性、有效性良好。 恒瑞医药(01276)公布，近日，公司收到国家药品监督管理局下发的《受理通知书》，公司海曲泊帕乙 醇胺片的药品上市许可申请获国家药监局受理，适应症为：适用于既往对糖皮质激素、免疫球蛋白等治 疗反应不佳的持续性及慢性原发免疫性血小板减少症(ITP)成人及≥6 岁的儿童患者。 ...

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]

人民财讯7月30日电，华东医药（000963）7月30日晚间公告，公司全资子公司中美华东收到国家药品监 督管理局签发的《受理通知书》，由中美华东申报的依达拉奉片(研发代码：TTYP01)用于治疗急性缺 血性脑卒中的上市许可申请获得受理。依达拉奉是神经系统药物中的重磅品种，相对于院内给药14天的 依达拉奉注射液，依达拉奉口服片剂可以降低医药资源占用，适合患者自主长期给药。 ...

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]

Core Viewpoint - Zhongguancun announced that its subsidiary Shandong Huasu Pharmaceutical Co., Ltd. has had its application for the listing permit of Bisoprolol Amlodipine Tablets accepted by the National Medical Products Administration, which is a combination therapy for hypertension treatment [1] Group 1 - The drug is a fixed-dose combination formulation of fumarate bisoprolol 5mg and amlodipine besylate (calculated as amlodipine) 5mg [1] - The project has accumulated research and development expenses of 6.0798 million yuan [1] - Shandong Huasu will actively promote the subsequent review work, and if the listing permit is successfully obtained, it will enhance its market competitiveness [1]