沙库巴曲缬沙坦

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润都股份:通过巴西国家卫生监督局GMP认证
news flash· 2025-06-27 10:54
Core Viewpoint - The company has successfully obtained GMP certification from Brazil's National Health Surveillance Agency (ANVISA) for four chemical raw materials, indicating compliance with international quality standards [1] Group 1: Certification Details - The GMP certification was conducted from March 17 to March 21, 2025, covering the following products: Candesartan Cilexetil, Sacubitril/Valsartan, Telmisartan, and Valsartan [1] - The certification is valid until May 26, 2027, and June 9, 2027, respectively, for the two certificates issued by ANVISA [1] - The on-site inspection by ANVISA concluded that the company’s facilities met the required standards, resulting in a qualified status for the four raw material products [1]
平安证券(香港)港股晨报-20250627
Ping An Securities Hongkong· 2025-06-27 01:23
港股晨报 港股回顾 点,跌幅随即扩大至 247 点,低见 23730 点,其后跌幅 一度收窄至仅 20 点,午后大盘走势偏软,尾盘沽压再 度扩大。截至收盘,恒指收报 23831 点,下跌 145 点或 0.61%;国指收报 9656 点,下跌 47 点或 0.49%,大市 成交进一步减至 827.99 亿。港股通录得净流入资金 4.84 亿,其中港股通(沪)净流入 2.83 亿,港股通(深)净 流入 2.01 亿。板块方面,本地地产、软件、5G 概念板 块跌幅靠前;黄金股逆市走强。 周四港股股指小幅调整,恒生指数收跌 0.61%报 24325.40 点,结束四日连涨,恒生科技指数跌 0.26%,恒生中国企业指数跌 0.63%。全日市场成 交额 2617 亿港元。南向资金净买入额 52.86 亿港 元。医药股领跌,荣昌生物跌近 12%。券商股冲 高回落,国泰君安国际跌超 4%。旅游股表现活 跃,香港中旅涨超 85%,成交超 75 亿港元。三只 新股表现分化,周六福、圣贝拉分别涨超 25%、 33%,颖通控股跌超 16%。 美股市场 1. 市场评估联储局官员减息预期,白宫称特朗普或 会延长关税暂停期限,美股周四高 ...
珠海润都制药股份有限公司关于通过美国FDA现场检查的公告
Shang Hai Zheng Quan Bao· 2025-06-26 19:59
Core Viewpoint - The company successfully passed the FDA's cGMP inspection, which is a significant achievement that enhances its competitiveness and supports its expansion into the U.S. raw material drug market [1][2]. Group 1: FDA Inspection Details - The company underwent an FDA cGMP inspection from February 12 to February 17, 2025, focusing on the production of nine active pharmaceutical ingredients [1]. - The inspection covered various systems including quality, production, equipment, laboratory control, and material management [1]. - The company received the Establishment Inspection Report (EIR) confirming the successful completion of the inspection [1]. Group 2: Implications for the Company - Passing the FDA inspection establishes a solid foundation for the company's further expansion into the U.S. raw material drug market [2]. - This achievement is expected to inject momentum into the company's ongoing international market expansion efforts [2]. - The successful inspection is anticipated to enhance the company's overall competitiveness and promote future development [2].
德源药业(832735) - 投资者关系活动记录表
2025-06-16 13:15
证券代码:832735 证券简称:德源药业 公告编号:2025-042 江苏德源药业股份有限公司 投资者关系活动记录表 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假记载、 误导性陈述或者重大遗漏,并对其内容的真实性、准确性和完整性承担个别及连 带法律责任。 一、 投资者关系活动类别 二、 投资者关系活动情况 活动时间:2025 年 6 月 12 日至 2025 年 6 月 13 日 活动地点:北京金融街威斯汀大酒店 参会单位及人员:申万宏源、华诺投资、中信证券、红塔证券、兴业证券、 首创证券、中泰证券、中邮基金、相聚资本、泓德基金、景顺长城基金、华泰柏 瑞基金(排名不分先后) 上市公司接待人员:公司副总经理、董事会秘书、财务负责人:王齐兵先生 三、 投资者关系活动主要内容 公司副总经理、董事会秘书、财务负责人王齐兵先生介绍了公司总体情况、 1 / 3 回复:根据公司 2025 年财务预算,公司 2025 年研发投入预计 1.63 亿元,其 中创新药 8,500 万元,仿制药 7,800 万元。 公司研发产品布局将围绕以代谢紊乱为特征的慢性病治疗药物为方向开展, 目前已布局降血糖、降血压、降血 ...
新华制药:获得沙库巴曲缬沙坦钠化学原料药上市申请批准
news flash· 2025-06-11 08:38
Core Viewpoint - The company has received approval from the National Medical Products Administration for the marketing application of Sacubitril/Valsartan Sodium, which is indicated for adult patients with heart failure with reduced ejection fraction, aimed at reducing the risk of cardiovascular death and hospitalization due to heart failure [1] Company Summary - The approved drug, Sacubitril/Valsartan Sodium tablets, is specifically for adult patients suffering from chronic heart failure with reduced ejection fraction [1] - The anticipated sales revenue for Sacubitril/Valsartan Sodium tablets in Chinese public medical institutions is approximately RMB 4.9 billion in 2024 [1]
逾百个品种已满足第十一批药品集采条件
Xin Jing Bao· 2025-06-07 01:56
Core Insights - The National Healthcare Security Administration (NHSA) plans to conduct the 11th batch of centralized drug procurement in the first half of the year, with over 130 drug varieties meeting the initial conditions for procurement [1][2] - The injectable drug Cefoperazone Sodium has a domestic sales revenue exceeding 4 billion yuan in 2023, with 37 companies meeting the evaluation criteria, indicating strong market competition [2][3] - The government aims to optimize drug procurement policies, enhancing quality assessment and regulation to ensure safer medication for the public [4] Group 1 - The NHSA has identified over 130 drug varieties that meet the criteria for centralized procurement, with 7 varieties having more than 30 companies that have passed the evaluation [1][2] - Cefoperazone Sodium injection leads the market with a sales revenue of approximately 4.4 billion yuan in 2023, ranking second among cephalosporin products [2] - The 11th batch of procurement is the first since the government report emphasized optimizing procurement policies, raising questions about potential adjustments to procurement rules [4] Group 2 - The draft proposal for optimizing drug procurement policies includes measures to prevent abnormal low pricing and ensure fair competition among companies [4] - The proposal also mentions that drugs under negotiation in the National Drug Catalog will generally not be included in the procurement scope, indicating a shift in policy [4] - Since the initiation of the "4+7" pilot program in November 2018, the NHSA has successfully procured 435 types of drugs, saving approximately 440 billion yuan in healthcare funds [4]
集采之下,沙坦类降压药“量增额减”!华海、天宇...布局国内领先
Ge Long Hui· 2025-05-19 01:20
Core Insights - The rapid development of the domestic pharmaceutical industry has significantly advanced the raw material drug sector, particularly in the "sartan" antihypertensive drug market [1][2] Group 1: Market Overview - The global consumption of sartan raw materials from 2016 to 2022 reached 34,282.2 tons, with valsartan being the most consumed at 9,925.53 tons [2][3] - The highest growth rate in consumption was observed for aliskiren ester, with a compound annual growth rate (CAGR) of 227.76% [4][5] - The top three consumed sartan raw materials in China from 2016 to 2022 were irbesartan, valsartan, and aliskiren ester, with total consumption of 298.96 tons, 172.73 tons, and 37.19 tons respectively [10][21] Group 2: Sales Performance - The global sales of sartan formulations in 2022 reached $23.115 billion, with a CAGR of 12.19% from 2018 to 2022 [8][20] - The leading active ingredient in global sartan formulation sales in 2022 was sacubitril/valsartan, generating $6.941 billion, significantly surpassing other sartan drugs [6][7] - In China, the sales of sartan formulations from 2016 to 2022 totaled 240.37 billion yuan for valsartan, 134.41 billion yuan for irbesartan, and 79.20 billion yuan for losartan [21][22] Group 3: Competitive Landscape - Major companies in the sartan raw material export market include Huahai Pharmaceutical, Tianyu Pharmaceutical, and Shanghai Pharmaceuticals, with Huahai leading in export volume [14][15] - The domestic market for angiotensin II receptor antagonists (sartans) accounted for 26.17% of the total antihypertensive drug market in 2022, indicating a strong market presence [17][20] - The competitive landscape is influenced by the approval of domestic generic drugs and centralized procurement policies, which are expected to drive growth in the sartan raw material and formulation markets [8][20] Group 4: Future Outlook - The report predicts continued growth in the sartan raw material and formulation markets, driven by increasing demand and favorable policy environments [1][24] - Aliskiren ester, a domestically developed angiotensin receptor antagonist, is expected to see significant growth, especially as its compound patent expires in July 2026 [24]
复星医药(600196):创新持续发力,国际化渐入佳境
ZHESHANG SECURITIES· 2025-05-14 13:20
证券研究报告 | 公司点评 | 化学制药 复星医药(600196) 报告日期:2025 年 05 月 14 日 创新持续发力,国际化渐入佳境 ——复星医药更新点评 投资要点 ❑ 研发保持高投入,我们看好国际化&创新化持续兑现驱动公司持续增长。 ❑ 业绩:利润快速增长,现金流提升 公司披露 2024 年业绩:2024 年实现营业收入 410.67 亿元(YOY-0.80%)。其中, 创新产品收入稳步增长,核心品种创新型抗 PD-1 单抗斯鲁利单抗注射液(汉斯 状)、CAR-T 细胞治疗产品奕凯达(阿基仑赛注射液)、止吐药物奥康泽(奈妥 匹坦帕洛诺司琼胶囊)以及长效重组人粒细胞集落刺激因子产品珮金(拓培非格 司亭注射液)、心衰和高血压治疗药物一心坦(沙库巴曲缬沙坦钠片)均实现较 快增长。 现金流:有所提升,经营质量较佳。2024 年实现经营现金流 44.77 亿元,同比增 长 31.13%,高于当期经营性利润的增速, 同时通过资产结构优化和严格控制资本 性支出等多项措施,实现自由现金流的提升。 利润端快速增长,费用率下降。2024 年实现归母净利润 27.70 亿元,同比增加 16.08%。扣非净利润 23.14 ...
复星医药(600196):更新点评:创新持续发力,国际化渐入佳境
ZHESHANG SECURITIES· 2025-05-14 07:30
证券研究报告 | 公司点评 | 化学制药 复星医药(600196) 报告日期:2025 年 05 月 14 日 创新持续发力,国际化渐入佳境 ——复星医药更新点评 投资要点 ❑ 研发保持高投入,我们看好国际化&创新化持续兑现驱动公司持续增长。 ❑ 业绩:利润快速增长,现金流提升 公司披露 2024 年业绩:2024 年实现营业收入 410.67 亿元(YOY-0.80%)。其中, 创新产品收入稳步增长,核心品种创新型抗 PD-1 单抗斯鲁利单抗注射液(汉斯 状)、CAR-T 细胞治疗产品奕凯达(阿基仑赛注射液)、止吐药物奥康泽(奈妥 匹坦帕洛诺司琼胶囊)以及长效重组人粒细胞集落刺激因子产品珮金(拓培非格 司亭注射液)、心衰和高血压治疗药物一心坦(沙库巴曲缬沙坦钠片)均实现较 快增长。 现金流:有所提升,经营质量较佳。2024 年实现经营现金流 44.77 亿元,同比增 长 31.13%,高于当期经营性利润的增速, 同时通过资产结构优化和严格控制资本 性支出等多项措施,实现自由现金流的提升。 利润端快速增长,费用率下降。2024 年实现归母净利润 27.70 亿元,同比增加 16.08%。扣非净利润 23.14 ...
昂利康(002940) - 002940昂利康投资者关系管理信息20250506
2025-05-06 00:30
证券代码:002940 证券简称: 昂利康 浙江昂利康制药股份有限公司投资者关系活动记录表 编号:2025-001 | 投资者关系活 | 特定对象调研 □分析师会议 | | --- | --- | | 动类别 | □媒体采访 □业绩说明会 | | | □新闻发布会 □路演活动 | | | 现场参观 | | | □其他(请文字说明其他活动内容) | | 参与单位名称 | 浙江凛冬资产管理有限公司吴真军 | | 及人员姓名 | | | 时间 | 2025 年 4 月 30 日上午 8 点 30 分 | | 地点 | 公司二楼小会议室 | | 上市公司接待 | 董事会秘书、副总经理:孙黎明 | | 人员姓名 | 证券事务代表:王燕红 | | | 问答与交流 | | | 年一季度营收较 1、2024 年营收较上年度有所下降,2025 | | | 上年同期有所下降,主要原因 | | | 答:2024 年度营业收入较 年度同比下降 5.41%,主要 2023 | | 投资者关系活 | 原因是左益受集采影响退出医院市场及 2024 年第二季度开始 | | 动主要内容介 | 实施"四同"政策,导致该产品 年度在销量和销售 ...