登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：300016 证券简称：北陆药业 公告编号：2025-094 一、重要提示 本半年度报告摘要来自半年度报告全文，为全面了解本公司的经营成果、财务状况及未来发展规划，投 资者应当到证监会指定媒体仔细阅读半年度报告全文。 所有董事均已出席了审议本报告的董事会会议。 非标准审计意见提示 □适用 √不适用 董事会审议的报告期利润分配预案或公积金转增股本预案 3、公司股东数量及持股情况 单位：股 ■ 持股5%以上股东、前10名股东及前10名无限售流通股股东参与转融通业务出借股份情况 □适用 √不适用 公司计划不派发现金红利，不送红股，不以公积金转增股本。 董事会决议通过的本报告期优先股利润分配预案 □适用 √不适用 公司是否需追溯调整或重述以前年度会计数据 □是 √否 ■ □适用 √不适用 前10名股东及前10名无限售流通股股东因转融通出借/归还原因导致较上期发生变化 □适用 √不适用 公司是否具有表决权差异安排 □是 √否 二、公司基本情况 1、公司简介 ■ 2、主要会计数据和财务指标 4、控股股东或实际控制人变更情况 控股股东报告期内变更 □适用 √不适用 ...

Business Overview - The company focuses on the dual strategy of "Traditional Chinese Medicine + Chemical Medicine" to drive growth through reforms in R&D, production, and sales [1] - The main business remains in drug R&D, production, and sales, with stable growth in the sales of contrast agents [1] - Sales revenue from iodine contrast agents is recovering after overcoming challenges from price drops due to centralized procurement [1] Product Development - The company has expanded its gadolinium contrast agent portfolio, now offering four MRI contrast agents [2] - Gadoxetic acid injection was approved in July 2024 and began procurement in April 2025, with further market share expected from gadobenate dimeglumine [2] - Sales revenue from antidiabetic products reached CNY 125.98 million in 2024, a year-on-year increase of 33.24% [3] Traditional Chinese Medicine Strategy - The company is enhancing its Traditional Chinese Medicine (TCM) segment through acquisitions, currently holding 59 TCM licenses [4] - The self-developed Jiuwei Zhenxin Granules is the first TCM approved for generalized anxiety disorder, aiming to establish a leading brand in this category [4][5] International Expansion - The company has successfully expanded its export markets, achieving overseas revenue of CNY 132.16 million in 2024, a 15.02% increase [6] - Products like iodine contrast agents have received registrations in EU countries, facilitating further international market penetration [6] R&D Progress - The company is restructuring its R&D resources and has made significant progress in various therapeutic areas, including CNS and endocrine drugs [7] - New product registrations include gadoxetic acid and paroxetine, with several products under review that have strong market potential [8] Integration of Acquired Companies - Following the acquisition of Tianyuan Pharmaceutical, the company is integrating operations across production, marketing, and finance to enhance management efficiency [9] Recent Developments in Associated Companies - The associated company, Shihe Gene, has made breakthroughs in multi-cancer early screening technology, achieving CE and FDA certifications for its products [10][11] - Shenzhen Yiwei Medical has developed a comprehensive AI-based service for brain diseases, focusing on early screening and rehabilitation [12]

北陆药业（300016）公告，公司收到匈牙利药监局核准签发的关于碘海醇注射液的《药品上市许可证 书》，持有人为北京北陆药业股份有限公司，注册号为OGYI-T-24580/1。药品名称为碘海醇350mg I/ml 注射液，获批日期为2025年6月11日，有效期为5年。该获批有利于公司进一步推进海外市场拓展，提升 公司对比剂产品的国际市场竞争力，为国际市场的可持续发展奠定坚实基础。 ...

Group 1: Contrast Agent Product Strategy - The company has successfully integrated multiple contrast agent products into the national drug centralized procurement system, leading to significant changes in the competitive landscape and sales model of the industry, creating both challenges and opportunities [1] - The company has overcome challenges posed by price reductions in iodine contrast agents and is experiencing a recovery trend, with a focus on expanding market share for iodinated contrast agents [1] - The company has diversified its gadolinium-based contrast agents, with the approval of Gadobutrol injection in July 2024, enhancing its product offerings to meet various clinical needs [1] - In 2024, the contrast agent products achieved sales revenue of CNY 58,804.95 million, representing a year-on-year growth of 9.87% [2] Group 2: Jinlianhua Granule Procurement Progress - Jinlianhua Granule, a core product of Tianyuan Pharmaceutical, is a natural single-component preparation with applications in treating upper respiratory infections and is covered by national insurance [3] - The product is a unique offering in the market and has been included in procurement lists across multiple provinces, enhancing its market presence [3] Group 3: Medical Technology Focus - The company's subsidiary, Shenzhen Yiwei Medical Technology Co., Ltd., specializes in brain disease early screening, precise diagnosis, and rehabilitation training, making it a leader in the field of brain science AI [4] - Yiwei Medical's core products target stroke, Alzheimer's disease, cognitive disorders, and developmental disorders in youth, providing a comprehensive solution for brain disease management [4] Group 4: Yiwei Medical's Business Model - Yiwei Medical offers a full-service model from screening to rehabilitation for brain diseases, creating a closed-loop medical service system [6] - The company collaborates with health check institutions to provide a comprehensive "brain routine" health check package and has developed a unique diagnostic platform for neurodegenerative diseases [6] - Yiwei Medical is exploring additional business models to expand market coverage and increase revenue streams [6] Group 5: Zhiyou Medical Progress - Zhiyou Medical has received NMPA approval for its BCR/ABL and AML1/ETO fusion gene testing kits, marking a significant milestone in the field of blood cancer molecular diagnostics [7] - The approval solidifies Zhiyou Medical's position in the precision diagnosis of blood cancers and complements its existing product offerings for solid tumors [7][8] - The company has obtained nearly 200 NMPA certifications, covering various disease areas and advancing the FISH technology from high-end testing to clinical application [8]

Financial Performance - In Q1 2025, Beilu Pharmaceutical achieved operating revenue of 28,268.07 million yuan, a year-on-year increase of 36.23% [2] - The net profit attributable to shareholders increased by 26.13%, amounting to 1,308.80 million yuan, while the net profit excluding non-recurring gains and losses rose by 14.34% [2] Business Growth Drivers - The growth in Q1 2025 was primarily driven by three core segments: chemical generic drugs, traditional Chinese medicine, and overseas markets [3] - The acquisition of Tianyuan Pharmaceutical has led to significant integration efforts, enhancing marketing strategies and operational efficiency [3] Market Expansion - The company plans to leverage EU and Brazil GMP certifications to accelerate market development in these regions, aiming to enhance international brand influence and market share [4][5] - In Q1 2025, the subsidiary Haichang Pharmaceutical's iodinated contrast agent received approval for sale in South Korea, and the iodinated injection was approved in the EU [4] Financial Structure - The debt ratio reached 42.49% in Q1 2025, an increase attributed to a new long-term loan of 160 million yuan for acquiring 80% of Tianyuan Pharmaceutical [4] - Future plans include optimizing the capital structure and reducing the debt ratio through diversified financing channels [4] Subsidiary Developments - The company has established several wholly-owned subsidiaries, including: - Beijing Aipai Kesi Pharmaceutical R&D Co., focusing on product development and technological upgrades [5] - Anhui Luying Pharmaceutical Co., assisting in operations at the Bozhou production base [5] - Hong Kong Yuan Zhi Pharmaceutical Co., serving as an overseas window for market expansion [5] Product and Market Strategy - The company is actively promoting the Jiuwei Zhenxin Granules to enhance market share, despite stable procurement prices for key ingredients [5] - The company has not yet entered the veterinary medicine sector, focusing instead on prescription drugs [7]