流感治疗

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一品红全资子公司获得磷酸奥司他韦胶囊药品补充申请批准通知书
Ge Long Hui· 2025-09-19 03:55
格隆汇9月19日丨一品红(300723.SZ)公布,公司全资子公司广州一品红制药有限公司(以下简称"一品红 制药")于近日收到国家药品监督管理局核准签发的关于磷酸奥司他韦胶囊的《药品补充申请批准通知 书》。 根据《中华人民共和国药品管理法》及有关规定,经审查,本品此次申请事项符合药品注册的有关要 求,同意本品增加45mg 规格,核发药品批准文号。同时批准如下关联补充申请事项:1、变更处方中 的辅料用量;2、变更包装材料和容器;3、注册标准变更。变更后的生产工艺及质量标准照所附执行, 有效期 12 个月,说明书及包装标签做相应修订,其他执行原批准信息。 根据核准的药品说明书,公司获批的磷酸奥司他韦胶囊适应症为:1.用于成人和1岁及1岁以上儿童的甲 型和乙型流感治疗(磷酸奥司他韦能够有效治疗甲型和乙型流感,但是乙型流感的临床应用数据尚不 多)。患者在首次出现症状48小时以内使用。2.用于成人和13岁及13岁以上青少年的甲型和乙型流感的 预防。目前,公司拥有该药品75mg和45mg双规格。 磷酸奥司他韦为神经氨酸酶(NA)抑制剂,其作用机理为选择性抑制神经氨酸酶的活性,阻止病毒由被 感染细胞释放和入侵邻近细胞,减少 ...
济川药业(600566):2022半年报点评:业绩阶段性承压,创新管线逐步进入收获期
Soochow Securities· 2025-08-26 10:05
Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company's performance is under pressure in the short term, but the innovation pipeline is gradually entering a harvest period [8] - The company achieved a revenue of 2.749 billion yuan in H1 2025, a year-on-year decline of 31.87%, and a net profit attributable to shareholders of 724 million yuan, down 45.87% [8] - The decline in performance is primarily due to changes in terminal demand and the impact of centralized procurement policies [8] - The company is actively responding to industry changes, maintaining healthy inventory levels and price controls [8] - The sales of respiratory products are expected to gradually recover as consumer purchasing behavior normalizes [8] - The company has completed the listing application for a new pediatric constipation drug, which is expected to be the first of its kind in the market [8] - The company has received approval for a new drug for influenza treatment, which has the potential to become a major product in the market [8] - The profit forecast for 2025-2026 has been adjusted downwards due to the overall market environment, with net profits expected to be 1.58 billion yuan and 1.78 billion yuan respectively [8] Financial Summary - Total revenue for 2023 is projected at 9.655 billion yuan, with a year-on-year growth of 7.32% [1] - The net profit attributable to shareholders for 2023 is projected at 2.823 billion yuan, with a year-on-year growth of 30.04% [1] - The earnings per share (EPS) for 2023 is estimated at 3.07 yuan [1] - The price-to-earnings (P/E) ratio for the current price and latest diluted EPS is 8.63 [1] - The company's total assets are projected to reach 18.459 billion yuan by 2024 [9] - The company's total liabilities are projected to be 3.733 billion yuan by 2024 [9]
金城医药:磷酸奥司他韦收到化学原料药CEP证书,可在欧洲市场销售
Cai Jing Wang· 2025-07-29 08:31
Core Viewpoint - Jincheng Pharmaceutical's subsidiary, Beijing Jincheng Tail Pharmaceutical Co., Ltd., has received the CEP certificate for Oseltamivir phosphate, indicating compliance with European Pharmacopoeia standards, which allows for sales in the European market [1] Company Summary - The CEP certificate enhances Jincheng Tail's product portfolio and supports its expansion into overseas markets, thereby increasing its competitiveness in the active pharmaceutical ingredient (API) market [1] - Oseltamivir phosphate is a selective neuraminidase inhibitor for influenza treatment, developed by Roche, and is available in various formulations including capsules, granules, and dry suspensions [1] Industry Summary - According to IMS data, the global sales of Oseltamivir formulations were $874 million in 2023, with an API consumption of 69.99 tons, projected to increase to $1.017 billion in 2024 with an API consumption of 92.31 tons [1]