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苯磺酸氨氯地平口服溶液用冻干粉
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诺和诺德下调全年财务指引;恩华药业上半年实现归母净利润约7亿元丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-07-29 23:20
NO.2 恩华药业:2025年上半年归母净利润约7亿元,同比增加11.38% 每经记者|许立波 每经编辑|魏官红 丨 2025年7月30日 星期三 丨 NO.1 诺和诺德下调全年财务指引 7月29日,诺和诺德美股盘前加速下跌,跌幅扩大至25%,此前公司下调2025年展望。公司预计2025年 在固定汇率下,全财年销售额增长8%~14%,此前预期增长13%~21%。这与Wegovy在美国肥胖市场的 增长预期较低,Ozempic在美国GLP-1糖尿病市场的增长预期较低,以及Wegovy在部分IO(国际运营) 市场的渗透率低于预期有关。 点评:诺和诺德下调全年业绩指引反映出GLP-1赛道从超预期增长向理性回归的趋势,也揭示出即便是 头部企业,在高基数和激烈市场竞争下亦难以持续高速扩张。Wegovy在肥胖适应证和Ozempic在糖尿病 领域的增长放缓,可能会影响整个GLP-1赛道的投资情绪,包括前期炒作激烈的国内相关原料药企业。 点评:此次产品获FDA批准,是长春高新在改良型创新药出海方面的一次积极尝试,显示出公司具备一 定的国际注册与改良药开发能力。 NO.4 智翔金泰:斯乐韦米单抗注射液获得药物临床试验批准通知书 ...
【早报】中美经贸会谈在瑞典斯德哥尔摩举行;IMF:大幅调高今年中国经济增速预期0.8个百分点
财联社· 2025-07-29 23:10
Macro News - The International Monetary Fund (IMF) has significantly raised China's economic growth forecast for this year by 0.8 percentage points to 4.8%, reflecting stronger-than-expected economic activity in the first half of the year and lower actual tariff rates compared to previous predictions [4] - In the first half of the year, state-owned enterprises in China reported total operating revenue of 4,074.96 billion yuan, a year-on-year decrease of 0.2%. Their total profit amounted to 218.25 billion yuan, down 3.1% year-on-year, and tax payments were 300.26 billion yuan, a decline of 0.8% [4] Industry News - Hong Kong's "Stablecoin Regulation" will come into effect on August 1, with the Hong Kong Monetary Authority releasing five regulatory documents for licensed stablecoin issuers [7] - The China Photovoltaic Industry Association issued a statement refuting claims made by some media regarding "anti-involution" in the photovoltaic industry, particularly concerning polysilicon, stating that the reports were severely inconsistent with actual conditions [7] Company News - WuXi AppTec announced an adjustment to its share repurchase price ceiling to no more than 114.15 yuan per share [11] - The PCB industry is experiencing a significant improvement in market conditions compared to the same period last year, especially for high-end products, with strong demand and rising prices [9] - Changchun High-tech announced that its innovative drug, Amlodipine Besylate Oral Solution, has received approval from the FDA for market launch in the United States [12]
长春高新控股子公司药品 在美国获批上市
Zheng Quan Shi Bao· 2025-07-29 18:28
长春高新(000661)7月29日晚公告,公司获悉,控股子公司Brillian Pharma INC.(简称"倍利年")申报的 苯磺酸氨氯地平口服溶液用冻干粉已获美国食品药品监督管理局(FDA)批准上市,获批适应症为适用于 6岁以上和成人高血压,以及成人慢性稳定性心绞痛,血管痉挛性心绞痛,经血管造影证实的冠心病。 据介绍,高血压是一种以动脉血压持续升高为特征的慢性疾病,若长期控制不佳,会对身体多个器官和 系统造成严重损害,甚至引发致命性并发症。根据美国疾病控制与预防中心2024年10月发布的数据, 2021年8月至2023年8月期间,美国18岁及以上成年人高血压患病率为47.7%,6—17岁的美国儿童高血 压患病率为3.8%。 美国高血压指南治疗指出,药物治疗儿童及青少年高血压治疗的总体目标是降低靶器官损伤的风险,最 终降低成人高血压及心血管疾病的风险,氨氯地平作为长效二氢吡啶钙通道阻滞剂,是儿童高血压治疗 初始阶段的首选药物。 苯磺酸氨氯地平口服溶液用冻干粉是倍利年研发的一款专门针对6岁以上儿童和存在吞咽困难的成人高 血压患者的505B2改良型创新药,能够降低6岁以上儿童和成人的血压,可以减少致命和非致命心 ...
长春高新控股子公司药品在美国获批上市
Group 1 - Changchun High-tech's subsidiary Brillian Pharma INC. received FDA approval for the oral solution of benzenesulfonic acid amlodipine, targeting hypertension in individuals aged 6 and above, as well as chronic stable angina and vasospastic angina in adults [1] - The prevalence of hypertension among adults in the U.S. was reported at 47.7% from August 2021 to August 2023, while the prevalence among children aged 6-17 was 3.8% [1] - Amlodipine is recommended as a first-line treatment for hypertension in children, aiming to reduce the risk of organ damage and cardiovascular diseases [1] Group 2 - The benzenesulfonic acid amlodipine oral solution is a 505B2 modified innovative drug developed for children over 6 and adults with swallowing difficulties, designed to lower blood pressure and reduce cardiovascular event risks [2] - The product is based on existing FDA-approved formulations, offering ease of use, accurate dosing, and palatability, which enhances medication adherence among pediatric patients [2] - The approval of this product is expected to strengthen Brillian Pharma's product portfolio in the U.S. market, enhancing the company's competitiveness in the pharmaceutical sector [2] Group 3 - Changchun High-tech's subsidiary, Changchun Jinsai Pharmaceutical, received approval for the injection of Fushen Qibai monoclonal antibody, a new biological product for treating acute gouty arthritis in adults [3] - The company has diversified its business into various pharmaceutical segments, including gene engineering, biological vaccines, antibody drugs, and modern traditional Chinese medicine [3] Group 4 - The company is advancing clinical trials for several new drugs, including GenSci098 for thyroid eye disease and GenSci122 for advanced solid tumors, both of which have received FDA clinical trial permissions [4] - The company plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy and international financing capabilities [4]