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海南海药(000566) - 关于子公司注射用美罗培南通过仿制药质量和疗效一致性评价的公告
2025-11-14 10:31
证券代码:000566 证券简称:海南海药 公告编号:2025-069 海南海药股份有限公司关于子公司 注射用美罗培南通过仿制药质量和疗效一致性评价的公告 本公司董事会及全体董事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。 海南海药股份有限公司(以下简称"公司")全资子公司海口市制药厂有限 公司近日获得国家药品监督管理局核准签发的化学药品注射用美罗培南的《药品 补充申请批准通知书》。现将相关情况公告如下: 一、药品基本情况 (一)药品名称:注射用美罗培南 二、 对公司的影响 1 剂型:注射剂 规格:0.25g、0.5g、1.0g 注册分类:化学药品 受理号:CYHB2550082、CYHB2550081、CYHB2550080 药品上市许可持有人:海口市制药厂有限公司 审批结论:经审查,本品通过仿制药质量和疗效一致性评价。 (二)药品的其他相关情况 美罗培南为人工合成的广谱碳青霉烯类抗生素,通过抑制细菌细胞壁的合成 而产生抗菌作用,美罗培南容易穿透大多数革兰阳性和阴性细菌的细胞壁,而达 到其作用靶点青霉素结合蛋白(PBPs)。除金属β-内酰胺酶以外,其对大多数 β-内酰胺酶(包括由 ...
海南海药:子公司注射用美罗培南通过仿制药一致性评价
Xin Lang Cai Jing· 2025-11-14 10:28
海南海药公告,全资子公司海口市制药厂有限公司近日获得国家药品监督管理局核准签发的化学药品注 射用美罗培南的《药品补充申请批准通知书》。根据国家相关政策,通过一致性评价的药品品种,质量 和疗效等同原研产品,本次注射用美罗培南通过一致性评价,将有利于提升该药品的市场竞争力,对公 司业绩产生积极的影响。 ...
海南海药(000566.SZ):注射用美罗培南通过仿制药质量和疗效一致性评价
Ge Long Hui A P P· 2025-11-14 10:28
格隆汇11月14日丨海南海药(000566.SZ)公布,全资子公司海口市制药厂有限公司近日获得国家药品监 督管理局核准签发的化学药品注射用美罗培南的《药品补充申请批准通知书》。美罗培南为人工合成的 广谱碳青霉烯类抗生素,通过抑制细菌细胞壁的合成而产生抗菌作用,美罗培南容易穿透大多数革兰阳 性和阴性细菌的细胞壁,而达到其作用靶点青霉素结合蛋白(PBPs)。除金属β-内酰胺酶以外,其对 大多数β-内酰胺酶(包括由革兰阳性菌及革兰阴性菌所产生的青霉素酶和头孢菌素酶)的水解作用具有 较强的稳定性。注射用美罗培南主要适用于成人和儿童由单一或多种对美罗培南敏感的细菌引起的感 染:肺炎(包括院内获得性肺炎)、尿路感染、腹腔内感染、妇科感染(如子宫内膜炎和盆腔炎)、皮肤软 组织感染、脑膜炎、败血症。 ...
海南海药:注射用美罗培南通过仿制药质量和疗效一致性评价
Ge Long Hui· 2025-11-14 10:27
格隆汇11月14日丨海南海药(000566.SZ)公布,全资子公司海口市制药厂有限公司近日获得国家药品监 督管理局核准签发的化学药品注射用美罗培南的《药品补充申请批准通知书》。美罗培南为人工合成的 广谱碳青霉烯类抗生素,通过抑制细菌细胞壁的合成而产生抗菌作用,美罗培南容易穿透大多数革兰阳 性和阴性细菌的细胞壁,而达到其作用靶点青霉素结合蛋白(PBPs)。除金属β-内酰胺酶以外,其对 大多数β-内酰胺酶(包括由革兰阳性菌及革兰阴性菌所产生的青霉素酶和头孢菌素酶)的水解作用具有 较强的稳定性。注射用美罗培南主要适用于成人和儿童由单一或多种对美罗培南敏感的细菌引起的感 染:肺炎(包括院内获得性肺炎)、尿路感染、腹腔内感染、妇科感染(如子宫内膜炎和盆腔炎)、皮肤软 组织感染、脑膜炎、败血症。 ...
流感概念涨1.24%,主力资金净流入这些股
截至11月14日收盘,流感概念上涨1.24%,位居概念板块涨幅第8,板块内,117股上涨,康芝药业、金 迪克等20%涨停,海南海药、人民同泰、特一药业等涨停,丹娜生物、康为世纪、金石亚药等涨幅居 前,分别上涨11.79%、8.60%、8.10%。跌幅居前的有宏源药业、博晖创新、司太立等,分别下跌 7.05%、4.53%、3.96%。 今日涨跌幅居前的概念板块 | 概念 | 今日涨跌幅(%) | 概念 | 今日涨跌幅(%) | | --- | --- | --- | --- | | 海南自贸区 | 4.63 | 国家大基金持股 | -3.07 | | 赛马概念 | 1.65 | 存储芯片 | -2.94 | | 自由贸易港 | 1.59 | AI PC | -2.92 | | 特色小镇 | 1.55 | 同花顺果指数 | -2.76 | | 幽门螺杆菌概念 | 1.50 | AI手机 | -2.67 | | 民营医院 | 1.35 | 中国AI 50 | -2.51 | | 福建自贸区 | 1.30 | 拼多多概念 | -2.36 | | 流感 | 1.24 | 共封装光学(CPO) | -2.30 | | 医 ...
海南自贸区概念上涨4.63%,5股主力资金净流入超亿元
海南自贸区概念资金流入榜 | 代码 | 简称 | 今日涨跌幅 | 今日换手率 | 主力资金流量(万 | 主力资金净流入比率 | | --- | --- | --- | --- | --- | --- | | | | (%) | (%) | 元) | (%) | | 002163 | 海南发 展 | 8.91 | 22.06 | 46793.22 | 16.60 | | 300086 | 康芝药 业 | 20.00 | 28.34 | 25798.14 | 20.78 | | 000566 | 海南海 药 | 10.08 | 8.34 | 25561.26 | 39.26 | | 601969 | 海南矿 业 | 9.97 | 5.54 | 17739.71 | 12.90 | | 000955 | 欣龙控 股 | 9.99 | 6.26 | 11809.70 | 48.07 | | 002320 | 海峡股 份 | 6.50 | 5.12 | 9252.72 | 5.80 | | 000796 | 凯撒旅 | 3.49 | 17.29 | 6702.44 | 3.73 | 截至11月14日收盘,海南自贸区概念 ...
民营医院概念涨1.35%,主力资金净流入28股
截至11月14日收盘,民营医院概念上涨1.35%,位居概念板块涨幅第6,板块内,42股上涨,海南海 药、大东方、人民同泰等涨停,嘉事堂、方盛制药、永和智控等涨幅居前,分别上涨5.97%、4.92%、 4.63%。跌幅居前的有*ST万方、麦迪科技、三星医疗等,分别下跌5.06%、3.09%、2.76%。 今日涨跌幅居前的概念板块 | 002622 | 皓宸医 | -0.55 | 2.89 | -233.92 | -2.65 | | --- | --- | --- | --- | --- | --- | | | 疗 | | | | | | 002524 | 光正眼 | 1.67 | 2.52 | -248.45 | -3.98 | | | 科 | | | | | | 000990 | 诚志股 | -0.25 | 0.87 | -249.25 | -2.97 | | | 份 | | | | | | 301103 | 何氏眼 科 | -0.40 | 1.37 | -256.07 | -6.87 | | 301239 | 普瑞眼 | -1.28 | 0.98 | -368.53 | -6.92 | | | 科 | | ...
化学制药板块11月14日涨0.32%,康芝药业领涨,主力资金净流入6.8亿元
证券之星消息,11月14日化学制药板块较上一交易日上涨0.32%,康芝药业领涨。当日上证指数报收于 3990.49,下跌0.97%。深证成指报收于13216.03,下跌1.93%。化学制药板块个股涨跌见下表: 从资金流向上来看,当日化学制药板块主力资金净流入6.8亿元,游资资金净流出4.13亿元,散户资金净 流出2.67亿元。化学制药板块个股资金流向见下表: | 代码 | 名称 | 主力净流入(元) | 主力净占比 游资净流入 (元) | | 游资净占比 散户净流入 (元) | | 散户净占比 | | --- | --- | --- | --- | --- | --- | --- | --- | | 300584 海辰药业 | | 3.02亿 | 21.33% | -2.02 Z | -14.27% | -1.00 Z | -7.06% | | 300086 康芝药业 | | 2.55 Z | 20.57% | -1.52 Z | -12.26% | -1.03亿 | -8.31% | | 000566 海南海药 | | 2.43/Z | 37.31% | -1.15亿 | -17.60% | -1.28 乙 ...
封关预期奏响“最强音”!海南板块高歌猛进,康芝药业20CM涨停
Ge Long Hui· 2025-11-14 07:00
Core Viewpoint - The A-share market in Hainan and the Hainan Free Trade Zone has experienced a significant surge, driven by the upcoming launch of the free trade port operations on December 18, which is expected to inject strong momentum into the region's industrial development [1][4]. Market Performance - Several stocks, including Kangzhi Pharmaceutical, Hainan Haiyao, and Xilong Holdings, have seen substantial gains, with Kangzhi Pharmaceutical hitting a 20% increase to 10.62, while Hainan Haiyao and Xilong Holdings rose by 10.08% and 9.99% respectively [2][1]. - The overall market sentiment is buoyed by the anticipation of policy benefits as the free trade port's operational date approaches [3]. Policy Developments - The free trade port's operations will implement a system characterized by "one line open, two lines controlled, and free movement within the island," which is expected to reshape the industrial ecosystem in Hainan [4]. - Recent adjustments to the duty-free shopping policy have already shown positive effects, with a first-day shopping amount of 78.549 million yuan, a 6.1% increase from the previous day, and a total of 506 million yuan in the first week, marking a 34.86% year-on-year growth [4]. Industry Opportunities - The "zero tariff" policy has expanded to cover various transportation modes, including air, land, and sea, which is expected to create new opportunities for related industries [5]. - Securities firms are optimistic about the long-term value brought by the free trade port, predicting growth in the duty-free market and modern service industries such as finance and tourism [6]. Company Responses - Companies like Haixia Co. and Shengshi Technology are actively responding to the opportunities presented by the free trade port, with Haixia Co. expecting increased traffic and investment due to the new policies [7]. - Hainan's only complete vehicle manufacturer, Haima Automobile, is leveraging the hydrogen energy sector and has already established a hydrogen production and refueling station, aiming to capitalize on the free trade port's policies [7]. Future Investment Trends - The upcoming free trade port operations are seen as a turning point for investment logic in Hainan, shifting focus from B2C consumption to B2B industrial upgrades and high-value services [8]. - Key investment themes include modern logistics and trade services, high-tech and green energy sectors, and high-value "tourism+" services such as medical care and international education [8].
杠杆资金抢筹海南岛,免税利好点燃市场热情
Huan Qiu Wang· 2025-11-14 05:52
Core Insights - The Hainan sector experienced a strong rally on November 14, driven by favorable policies and expectations of the full closure operation of the Hainan Free Trade Port, with stocks like Kangzhi Pharmaceutical and Hainan Haiyao hitting the daily limit [1][3] - The direct catalyst for this rally was the significant impact of the new duty-free shopping policy, which saw a nearly 35% year-on-year increase in shopping amounts and a corresponding rise in the number of shoppers during the first week of implementation [3] - The Hainan Free Trade Port is set to officially launch its full closure operation on December 18, which is expected to enhance foreign openness and benefit industries such as tourism and retail [4] Market Performance - The Hainan sector has shown strong performance throughout the year, with an overall increase of over 40%, and Haima Automobile leading with a remarkable 164% rise [3] - The net profit of listed companies in the Hainan sector grew nearly 25% year-on-year in the first three quarters, with several companies achieving double-digit growth or successfully turning losses into profits [3] Investment Trends - Leveraged funds have already begun to position themselves in the Hainan sector, with net purchases exceeding 4 billion yuan this year, indicating strong market confidence in the future prospects of the sector [4] - Institutions believe that the duty-free policy will continue to support the consumption market in Hainan, while the full closure operation will open new avenues for economic development [4]