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国药现代(600420.SH):全资子公司药品通过仿制药一致性评价
Ge Long Hui A P P· 2026-01-12 09:16
格隆汇1月12日丨国药现代(600420.SH)公布,近日,公司全资子公司国药集团威奇达药业有限公司收到 国家药品监督管理局核准签发的《药品补充申请批准通知书》,批准注射用哌拉西林钠新增1.0g规格及 本品0.5g、1.0g、2.0g 通过仿制药质量和疗效一致性评价。 注射用哌拉西林钠主要适用于敏感肠杆菌科细菌、铜绿假单胞菌、不动杆菌属所致的败血症、上尿路及 复杂性尿路感染、呼吸道感染、胆道感染、腹腔感染、盆腔感染以及皮肤、软组织感染等。哌拉西林与 氨基糖苷类联合应用亦可用于有粒细胞减少症免疫缺陷病人的感染。 米内网数据库显示,注射用哌拉西林钠2024年全国公立医疗机构销售额约为人民币19.06亿元。CDE网 站显示,目前注射用哌拉西林钠(0.5g,1.0g,2.0g)通过/视同通过一致性评价的企业还有山东鲁抗医药 股份有限公司、山东安信制药有限公司、华北制药(维权)集团先泰药业有限公司等。 截止目前,国药威奇达用于开展注射用哌拉西林钠一致性评价的累计研发投入约人民币612万元(未经审 计)。 ...
2025回顾·新科技新产品记|搭建中试平台,解决反式乌头酸工业化生产世界难题
Qi Lu Wan Bao· 2026-01-12 03:27
Group 1 - Shandong has positioned technological innovation at the core of its development strategy, achieving significant breakthroughs in 2025, including the establishment of a pilot verification platform to address the industrialization challenges of trans-aconitic acid production [1] - Trans-aconitic acid is recognized as a high-quality bio-based raw material with applications in modern agriculture and high-end chemical industries, but large-scale industrial production has been a global challenge due to high costs of plant extraction and severe pollution from chemical synthesis [1] - The Chinese Academy of Sciences' Qingdao Institute of Energy has developed a method to synthesize trans-aconitic acid using genetically engineered microorganisms, achieving continuous technological breakthroughs from low to high yields [1] Group 2 - The establishment of a 10-ton pilot platform has been supported by provincial scientific funding, which is essential for scaling up production and addressing technical uncertainties [1][2] - The updated "Manufacturing Industry Pilot Platform Construction Guidelines" in 2025 aims to encourage leading enterprises to build pilot platforms, facilitating product research, design, and testing [2] - A partnership between LuKang Pharmaceutical and the Qingdao Institute of Energy has been formed to inject funding into the promotion and application of this new technology [2] Group 3 - The pilot platform allows for significant scaling from laboratory to industrial production, with investments around 3.5 million yuan for fermentation tanks ranging from 15L to 10 cubic meters [2] - The production process for trans-aconitic acid has been optimized to achieve a hundred-ton level of mass production, completing the entire extraction process in approximately 24 hours [3] - Shandong has established 40 provincial pilot demonstration bases and 6 provincial concept verification centers, completing 284 pilot projects and promoting 259 achievements for industrialization in the first half of 2025 [3]
第十二批集采8个品种备战!千亿市场大跌,复方注射剂飙涨219%,这家南京药企起飞
Xin Lang Cai Jing· 2026-01-08 11:37
Core Viewpoint - The antibacterial drug market in China is under pressure, with sales expected to drop below 100 billion yuan in 2024 and continue declining by approximately 18% in the first three quarters of 2025, reaching over 60 billion yuan [1][14]. Market Performance - The total sales of systemic antibacterial drugs in public medical institutions in China have been declining, with a significant drop in sales from 2024 to 2025 [1][14]. - The market for systemic antibacterial drugs includes 12 major therapeutic categories, with cephalosporins leading but experiencing four consecutive years of sales decline from 2022 to the first three quarters of 2025 [3][16]. Company Rankings - In the ranking of major companies, Pfizer, China National Pharmaceutical Group, and North China Pharmaceutical Group hold the top three positions, with sales exceeding 6.2 billion yuan, 2.1 billion yuan, and 1.9 billion yuan respectively in the first three quarters of 2025 [5][18]. - Nanjing Youke Biological, ranked fifteenth, showed remarkable growth with a year-on-year increase of 137.17%, marking its first entry into the top 20 groups [5][18]. Product Performance - The top 20 systemic antibacterial drugs accounted for over 50% of the market share, with the leading product, injectable cefoperazone/sulbactam (2:1), achieving sales of over 4.5 billion yuan [21][22]. - Notably, the compound injection of cefoperazone/sulbactam saw a dramatic increase of 219.32%, marking a significant rise in its market presence [21][23]. National Procurement Impact - Among the top 20 products, 15 have been included in the national procurement program, with 13 experiencing double-digit declines in sales [21][23]. - The tenth batch of national procurement saw injectable piperacillin/tazobactam drop by 55.61%, while the eleventh batch saw injectable cefoperazone/sulbactam decline by 47.56% [21][23]. New Drug Development - Currently, there are no domestic class 1 new drugs among the top 20 systemic antibacterial products, although five class 1 new antibacterial drugs have been approved since 2021 [25][26]. - Eight products meet the criteria for national procurement inclusion, with seven being injectable forms and one oral formulation [25][26].
鲁抗医药荣获第七届济宁市市长质量奖
Qi Lu Wan Bao· 2026-01-07 15:11
Group 1 - The seventh Jining City Mayor Quality Award was awarded to Shandong Lukang Pharmaceutical Co., Ltd. for its outstanding quality management, technological innovation, and industry leadership [1] - The Jining High-tech Zone Market Supervision Administration emphasized the importance of cultivating quality enterprises and provided targeted support for the award application process, including one-on-one guidance and assistance in preparing application materials [1][2] - The award is a recognition of Lukang Pharmaceutical's quality management efforts and reflects the successful implementation of the "Quality Strong Zone" initiative by the local market supervision authority [2] Group 2 - Shandong Lukang Pharmaceutical, as a leading enterprise in the health industry of the high-tech zone, adheres to a "quality first" development philosophy and has developed a "three-quality linkage" management model covering the entire process from R&D to production and sales [2] - The company has received multiple honors, including being recognized as a national quality efficiency advanced enterprise and a demonstration enterprise for drug quality integrity [2] - The next steps for the Jining High-tech Zone Market Supervision Administration include deepening quality improvement actions, enhancing support for quality enterprises, and promoting advanced quality management models to help more companies achieve quality development [2]
鲁抗医药:新增股份约1.47亿股
Mei Ri Jing Ji Xin Wen· 2025-12-30 11:15
每经AI快讯,鲁抗医药12月30日晚间发布公告称,公司向特定对象发行人民币普通股(A股)股票对应 的约1.47亿股已于2025年12月29日在中国证券登记结算有限责任公司上海分公司办理完毕登记、托管及 限售手续。本次公司新增股份数约1.47亿股,发行价格8.19元/股,募集资金总额约12亿元。 (记者 曾健辉) 每经头条(nbdtoutiao)——2025十大财经新闻出炉!护航、酣战、变局、狂飙分别指向哪些大事件? ...
鲁抗医药(600789) - 山东鲁抗医药股份有限公司2024年度向特定对象发行A股股票上市公告书
2025-12-30 10:04
证券代码:600789 证券简称:鲁抗医药 山东鲁抗医药股份有限公司 2024 年度向特定对象发行 A 股股票 上市公告书 保荐人(联席主承销商):中国国际金融股份有限公司 联席主承销商:方正证券承销保荐有限责任公司 二〇二五年十二月 特别提示 一、发行数量及价格 1、发行数量:146,520,146 股 2、发行价格:8.19 元/股 3、募集资金总额:人民币 1,199,999,995.74 元 4、募集资金净额:人民币 1,186,829,138.68 元 二、新增股票上市安排 本次发行新增股份将于限售期届满后的次一交易日起在上海证券交易所主 板上市流通交易,如遇法定节假日或休息日,则顺延至其后的第一个交易日。 三、新增股份的限售安排 本次发行完成后,华鲁集团认购的本次发行的股份自发行结束之日起十八个 月内不得转让,其他发行对象认购的公司本次发行的股份自发行结束之日起六个 月内不得转让。本次发行完成后至限售期满之日止,发行对象所取得公司本次向 特定对象发行的股票因公司分配股票股利、资本公积转增等情形所取得的股份, 亦应遵守上述限售安排。 上述限售期届满后,该等股份的转让和交易将根据届时有效的法律法规及中 ...
鲁抗医药(600789) - 中国国际金融股份有限公司关于山东鲁抗医药股份有限公司2024年度向特定对象发行A股股票之上市保荐书
2025-12-30 10:04
关于山东鲁抗医药股份有限公司 2024 年度向特定对象发行 A 股股票 之 上市保荐书 保荐机构 (北京市朝阳区建国门外大街 1 号国贸大厦 2 座 27 层及 28 层) 二〇二五年十二月 山东鲁抗医药股份有限公司 上市保荐书 上海证券交易所: 中国国际金融股份有限公司(以下简称"保荐机构"、"保荐人"、"本机构"或 "中金公司")接受山东鲁抗医药股份有限公司(以下简称"鲁抗医药"、"发行人" 或"公司")的委托,就发行人 2024 年度向特定对象发行 A 股股票并在主板上市事项 (以下简称"本次发行")出具本上市保荐书。 保荐机构及其保荐代表人根据《中华人民共和国公司法》(以下简称"《公司法》")、 《中华人民共和国证券法》(以下简称"《证券法》")、《证券发行上市保荐业务管 理办法》(以下简称"《保荐办法》")、《上市公司证券发行注册管理办法》(以下 简称"《注册管理办法》"),以及《上海证券交易所股票上市规则》(以下简称"《上 市规则》")、《上海证券交易所发行上市审核规则适用指引第 2 号——上市保荐书内 容与格式》(以下简称"《指引第 2 号》")等法律法规和中国证券监督管理委员会(以 下简称"中 ...
鲁抗医药(600789) - 鲁抗医药关于向特定对象发行股票发行结果暨股本变动公告
2025-12-30 10:01
本公司董事会及全体董事保证本公告内容不存在任何虚假记载、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法律责任。 重要内容提示: 证券代码:600789 证券简称:鲁抗医药 公告编号:2025-061 山东鲁抗医药股份有限公司 关于向特定对象发行股票发行结果暨股本变动公告 预计上市时间:山东鲁抗医药股份有限公司(以下简称"公司""本公司""鲁 抗医药"或"发行人")向特定对象发行人民币普通股(A 股)股票(以下简称"本次 发行")对应的 146,520,146 股已于 2025 年 12 月 29 日在中国证券登记结算有限责任公 司上海分公司办理完毕登记、托管及限售手续。公司本次发行新增股份为有限售条件流 通股,将于限售期届满后的次一交易日起在上海证券交易所(以下简称"上交所")上 市流通交易,如遇法定节假日或休息日,则顺延至其后的第一个交易日。 资产过户情况:本次发行的股票全部以现金认购,不涉及资产过户情况。 一、本次发行概况 (一)本次发行履行的相关程序 1、本次发行履行的内部决策程序 2024 年 12 月 20 日,发行人召开 2024 年第十一届董事会第五次会议、第十一届监 事会第 ...
鲁抗医药(600789) - 鲁抗医药关于收到南厂区土地收储补偿款的进展公告
2025-12-30 10:01
证券代码:600789 证券简称:鲁抗医药 公告编号:2025-060 (公告编号:2022-066)、《鲁抗医药关于公司南厂区土地办理完成移交手续 暨进展公告》(公告编号:2024-034)。 山东鲁抗医药股份有限公司 关于收到南厂区土地收储补偿款的进展公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、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法律责任。 一、情况概述 山东鲁抗医药股份有限公司(以下简称"公司")分别于2022年8月10日召 开第十届董事会第十二次(临时)会议、2022年9月15日召开2022年第一次临时 股东大会,审议通过了《关于政府收储部分国有土地使用权的议案》,同意公 司与济宁市自然资源和规划局签订《济宁市国有建设用地使用权收回合同》, 将公司南厂区五宗国有建设用地237100平方米(折合约355.65亩,其中含原山 东鲁抗医药集团有限公司土地14675平方米,委托本公司统一办理)进行收储, 并支付公司土地收储包干补偿费36039.60万元(其中含原山东鲁抗医药集团有 限公司土地包干补偿费2282.256万元,系公司接受山东鲁抗医药集团有限公司 委托代 ...
鲁抗医药:南厂区土地收储补偿款累计收到1.32亿元
Ge Long Hui· 2025-12-30 09:45
Core Viewpoint - The company, LuKang Pharmaceutical, announced the acquisition of five state-owned construction land parcels in its southern plant area, with a total compensation fee of 360 million yuan [1] Group 1: Land Acquisition and Compensation - The company has completed the overall transfer of the land [1] - By December 30, 2025, the company will receive the fifth installment of the land compensation amounting to 10 million yuan [1] - As of now, the company has received a total of 132 million yuan in compensation, with a remaining balance of 228 million yuan yet to be received [1]