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北陆药业最新公告:获得碘美普尔注射液《药品注册证书》
Sou Hu Cai Jing· 2025-11-10 09:33
Core Viewpoint - Beilu Pharmaceutical (300016.SZ) has received approval from the National Medical Products Administration for the iodine-based contrast agent, Iodine Meperidine Injection, which is expected to enhance its product portfolio in the imaging diagnostics market [1] Group 1: Product Approval - The Iodine Meperidine Injection is a non-ionic monomer X-ray contrast agent used for various medical imaging diagnostics [1] - The product has been included in the National Medical Insurance Category B directory, indicating its significance in the healthcare system [1] Group 2: Market Performance - Sales of iodine-based contrast agents have been steadily increasing in the Chinese market in recent years, reflecting a growing demand for imaging diagnostics [1] - The approval of Iodine Meperidine Injection will further enrich the company's offerings in the iodine contrast agent segment [1] Group 3: Future Plans - The company plans to actively prepare for the launch of the new product following its approval [1]
北陆药业获得碘美普尔注射液药品注册证书
Zhi Tong Cai Jing· 2025-11-10 08:32
Core Viewpoint - Beilu Pharmaceutical (300016.SZ) has received approval from the National Medical Products Administration for the iodine-based contrast agent, Iodine Meper, which is expected to drive significant sales growth in the coming years [1] Group 1: Product Details - Iodine Meper is a non-ionic monomer X-ray contrast agent developed by Italy's Bracco, characterized by excellent physicochemical properties, including the lowest osmotic pressure and lower viscosity compared to similar agents at the same concentration [1] - The product is stable in its physicochemical properties and does not require the addition of chelating agents [1] - Indications for Iodine Meper include intravenous urography, CT scans, conventional angiography, and various forms of vascular imaging for both adults and children [1] Group 2: Market Potential - Iodine Meper has been included in the National Medical Insurance Class B directory, enhancing its market accessibility [1] - According to data from Minet, sales in China's three major terminal markets have been growing at double-digit rates, with projected sales exceeding 1.1 billion yuan in 2024, representing a year-on-year growth of approximately 32% [1] - In the first quarter of 2025, sales are expected to surpass 300 million yuan, with a year-on-year growth of about 39% [1]
北陆药业(300016.SZ):获得碘美普尔注射液《药品注册证书》
Ge Long Hui A P P· 2025-11-10 08:27
格隆汇11月10日丨北陆药业(300016.SZ)公布,收到国家药品监督管理局核准签发的碘美普尔注射液 《药品注册证书》。碘美普尔注射液由意大利Bracco研制,属于一种非离子型单体X射线造影剂。该产 品理化性质优异,与同类型的非离子型单体X射线造影剂相比,在同一浓度下,具有最低的渗透压及较 低的粘滞度;更因其理化性质稳定,无需添加螯合剂。适应症为:静脉尿路造影(成人,包括肾脏损害 或糖尿病患者)、CT(躯干)、常规血管造影、动脉DSA、心血管造影(成人和儿童),常规选择性 冠状动脉造影、介入性冠状动脉造影、瘘管造影、乳管造影、泪囊造影、涎管造影。 ...
北陆药业(300016.SZ)获得碘美普尔注射液药品注册证书
智通财经网· 2025-11-10 08:27
Core Viewpoint - Northland Pharmaceutical has received approval from the National Medical Products Administration for the iodine-based contrast agent, Iodine Meperidine Injection, which is expected to drive significant sales growth in the coming years [1] Company Summary - Northland Pharmaceutical has announced the approval of Iodine Meperidine Injection, developed by Italy's Bracco, which is a non-ionic monomer X-ray contrast agent [1] - The product exhibits superior physicochemical properties, having the lowest osmotic pressure and lower viscosity compared to similar agents at the same concentration, and does not require the addition of chelating agents [1] - The indications for Iodine Meperidine Injection include intravenous urography, CT scans, conventional angiography, and various other imaging procedures for both adults and children [1] Industry Summary - Iodine Meperidine Injection has been included in the National Medical Insurance Category B directory, indicating its significance in the healthcare market [1] - According to data from Minet, sales in China's three major terminal markets have been growing at a double-digit rate, with projected sales exceeding 1.1 billion yuan in 2024, representing a year-on-year growth of approximately 32% [1] - In the first quarter of 2025, sales are expected to surpass 300 million yuan, with a year-on-year growth of about 39% [1]
北陆药业:碘美普尔注射液获得药品注册证书
Xin Lang Cai Jing· 2025-11-10 08:21
Core Viewpoint - The company has received approval from the National Medical Products Administration for the iodine-based contrast agent, Iodixanol Injection, which enhances its product lineup in the contrast agent segment [1] Group 1: Product Approval - The Iodixanol Injection has been approved as a Class 4 chemical drug, indicating it has passed the consistency evaluation for generic drug quality and efficacy [1] - This approval allows the company to diversify its iodine contrast agent product offerings [1] Group 2: Business Development - The company's subsidiary, Zhejiang Haichang Pharmaceutical Co., Ltd., is expected to have the raw material for Iodixanol approved for market launch by August 2025 [1] - The business model of "raw material + formulation" for Iodixanol has been established, indicating a comprehensive approach to product development [1] Group 3: Market Strategy - The company plans to actively prepare for the launch of new products and aims to bring them to market as soon as possible [1] - However, the production and sales of these products may face some uncertainties [1]
北陆药业(300016) - 关于完成工商变更登记并换发营业执照的公告
2025-11-10 08:14
北京北陆药业股份有限公司 关于完成工商变更登记并换发营业执照的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有 虚假记载、误导性陈述或重大遗漏。 北京北陆药业股份有限公司(以下简称"公司") 于 2025 年 9 月 25 日 召开第九届董事会第四次会议,并于 2025 年 10 月 14 日召开 2025 年第三次临 时股东会,审议通过了《关于变更注册资本并修订<公司章程>的议案》。 股票代码:300016 股票简称:北陆药业 公告编号:2025-115 法定代表人:王旭 注册资本:56,287.3163 万元 成立日期:1992 年 09 月 05 日 "北陆转债"2021 年 6 月 11 日起开始转股。2025 年 7 月 14 日,北陆转 债触发有条件赎回条款。公司 2025 年 7 月 14 日召开第九届董事会第二次会议, 审议通过了《关于提前赎回"北陆转债"的议案》,决定按照债券面值加当期 应计利息的价格赎回在赎回登记日(2025 年 8 月 4 日)收市后登记在册的全 部"北陆转债"。"北陆转债"自 2025 年 7 月 31 日起停止交易,2025 年 8 月 5 日起停 ...
北陆药业(300016) - 关于获得碘美普尔注射液《药品注册证书》的公告
2025-11-10 08:14
股票代码:300016 股票简称:北陆药业 公告编号:2025-116 北京北陆药业股份有限公司 关于获得碘美普尔注射液《药品注册证书》的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有 虚假记载、误导性陈述或重大遗漏。 近日,北京北陆药业股份有限公司(以下简称"公司")收到国家药品监 督管理局核准签发的碘美普尔注射液《药品注册证书》。现将相关情况公告如 下: 一、药品的基本情况 主要成份:碘美普尔 药品通用名称:碘美普尔注射液 剂型:注射剂 规格:100ml:40g(I) 注册分类:化学药品 4 类 药品有效期:24 个月 包装规格:1 瓶/盒,10 瓶/盒 处方药/非处方药:处方药 证书编号:2025S03295 药品注册标准编号:YBH27532025 药品批准文号:国药准字 H20255838 药品批准文号有效期:至 2030 年 11 月 03 日 上市许可持有人名称:北京北陆药业股份有限公司 上市许可持有人地址:北京市密云区水源西路 3 号 生产企业名称:北京北陆药业股份有限公司 1 生产企业地址:北京市密云区水源西路 3 号 受理号:CYHS2401810 公司控股子公司浙江 ...
精准医疗板块11月4日跌1.77%,透景生命领跌,主力资金净流出9.79亿元
Sou Hu Cai Jing· 2025-11-04 08:57
Market Overview - The precision medicine sector experienced a decline of 1.77% on November 4, with TuoJing Life leading the drop [1][2] - The Shanghai Composite Index closed at 3960.19, down 0.41%, while the Shenzhen Component Index closed at 13175.22, down 1.71% [1] Stock Performance - Notable stock performances in the precision medicine sector included: - RenDu Bio (688193) closed at 52.90, up 1.05% with a trading volume of 7076.23 hands and a transaction value exceeding 36.99 million yuan [1] - TuoJing Life (300642) closed at 22.73, down 2.86% with a trading volume of 78,200 hands and a transaction value of 178 million yuan [2] - Other companies like DaAn Gene (002030) and Anke Bio (300009) showed minimal changes, with DaAn Gene remaining flat at 6.57 and Anke Bio down 0.55% to 10.84 [1][2] Capital Flow - The precision medicine sector saw a net outflow of 979 million yuan from institutional investors, while retail investors contributed a net inflow of 642 million yuan [2][3] - Specific stock capital flows indicated: - GuoMai Technology (002093) had a net inflow of 8.61 million yuan from institutional investors, while retail investors saw a net outflow of 15.98 million yuan [3] - TuoJing Life experienced minimal net inflow from institutional investors at 25,000 yuan, with retail investors also showing a slight outflow [3]
北陆药业:公司钆布醇注射剂拟中选第十一批全国药品集中采购
人民财讯10月29日电,北陆药业(300016)10月29日公告,公司参加了国家组织药品联合采购办公室组 织的第十一批全国药品集中采购投标工作,公司钆布醇注射剂拟中选。 ...
北陆药业:钆布醇注射剂拟中选第十一批全国药品集中采购
Xin Lang Cai Jing· 2025-10-29 09:37
Core Viewpoint - Beilu Pharmaceutical (300016.SZ) announced that its Gadobutrol injection has been selected for the 11th batch of national centralized drug procurement, which is expected to enhance the company's market share and brand influence in the contrast agent segment [1] Group 1: Product Approval and Sales Performance - The Gadobutrol injection received its drug registration certificate in April 2022 and the supplementary application approval in April 2024 [1] - The sales amount for the product in 2024 is 4.6859 million yuan, accounting for 0.48% of the company's total revenue for that year [1] - For the first three quarters of 2025, the sales amount reached 5.7854 million yuan, representing 0.67% of the company's revenue during that period [1] Group 2: Market Opportunities and Uncertainties - The execution of the procurement results is expected to rapidly open up the market for the Gadobutrol injection [1] - There are uncertainties regarding the signing of procurement contracts and the market sales execution following the centralized procurement [1] - The company will closely monitor the developments and disclose information in a timely manner [1]