注射剂
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博腾股份全资子公司通过欧盟QP审计
Zheng Quan Ri Bao Wang· 2025-12-29 12:42
本报讯(记者冯雨瑶)12月29日晚间,重庆博腾制药科技股份有限公司(以下简称"博腾股份(300363)") 发布公告称,公司全资子公司重庆博腾药业有限公司(以下简称"博腾药业")于近日获得欧盟质量受权人 (QualifiedPerson,QP)签发的符合性声明,顺利通过欧盟QP审计。 公告显示,本次审计依据EU GMP Guidelines EudraLex Volume4、EUClinicalTrial Regulation(536/2014)及 GMPfor IMP指导原则,审计范围涵盖公司重庆制剂生产基地注射剂、口服固体制剂及非无菌半固体制 剂业务的质量管理、生产管理、厂房设备设施、物料系统、包装与标签系统等方面。 本次顺利通过QP审计,标志着博腾药业的质量管理体系已达到欧盟GMP标准,能够为全球客户提供符 合国际标准的制剂定制研发生产服务。另据公告披露,本次通过欧盟QP审计不会对博腾股份当前业绩 产生重大影响。 ...
广西前三季度药品出口额创新高
Jing Ji Ri Bao· 2025-12-01 22:17
前三季度,广西共有22家药品生产企业88个品种取得《药品出口销售证明》,同比分别增长37.5%和 66.04%。其中,8家企业21个原料药品种获批《出口欧盟原料药证明》,同比分别增长300%和600%。 广西壮族自治区药品监督管理局局长李勇强表示,广西药品出口持续增长,源自国际市场对"广西制 造"药品质量体系的认同感持续提升。通过持续优化监管服务、推动产品结构升级、深化国际合作,广 西药品国际竞争力全面提升,为构建面向东盟的国际医药合作新格局奠定坚实基础。 近年来,广西围绕药品出口关键环节持续优化监管服务,积极推动药品生产企业提升国际竞争力。药品 出口在去年增长12.29%的基础上,延续良好增势,今年前三季度出口额达8.69亿元,同比增长27.23%, 创下年内出口新高。 在巩固抗疟药、原料药等传统优势产品出口的同时,广西中成药、中药配方颗粒、注射剂等高附加值产 品出口加速布局,出口药品价值链呈高端化趋势。前三季度,中成药出口品种数同比增长35%,其中正 骨水、桂龙药膏等产品首次进入秘鲁、新加坡、马来西亚等市场;中药配方颗粒远销美国、澳大利亚、 加拿大等国家。 此外,依托中国—东盟药品合作交流平台,广西全方位 ...
尔康制药:前三季度业绩增长 海外项目与技术研发多点推进
Zhong Zheng Wang· 2025-10-31 08:32
Core Viewpoint - The company has shown positive operational performance in the first three quarters of 2025, with significant growth in both revenue and profit, setting a solid foundation for achieving annual business goals [1] Financial Performance - The company achieved operating revenue of 1.006 billion yuan, representing a year-on-year increase of 17.81% [1] - The net profit reached 39.5759 million yuan, marking a turnaround from loss to profit [1] Overseas Expansion - In July 2025, the company approved a $10 million investment through its subsidiary, Erkang Tanzania Co., Ltd., for a comprehensive formulation production project [1] - The project is progressing as planned, with purification engineering and equipment installation underway, expected to complete equipment debugging by Q4 2025, and aims to meet GMP certification conditions [1] - The company is also preparing registration materials for drug approval in compliance with Tanzanian regulatory requirements [1] Technological Development - The company's subsidiary, Hangzhou Longde Intelligent Technology Co., Ltd., is focusing on AI technology applications, particularly in rehabilitation robots and security [1] - The subsidiary has obtained operating qualifications for second-class medical devices, supporting the marketization of related businesses [1] Intellectual Property - The subsidiary has completed the writing of documents for 3 new software copyrights and 2 invention patents, with one patent application receiving initial approval [2] - This enhances the company's intellectual property protection system and accumulates core resources to improve business technical barriers and market competitiveness [2] New Project Initiatives - The company announced plans to invest $8 million in a new injection production project in Nigeria, with an estimated construction period of 18 months [2] - This investment aligns with the company's overall development strategy and aims to expand its business reach and better meet overseas customer demands, potentially becoming a new profit growth point [2]
尔康制药前三季营收超10亿元 海外项目与技术研发多点推进
Zheng Quan Ri Bao Wang· 2025-10-29 12:49
Core Insights - The company reported a positive performance in Q3 2025, with a revenue of 1.006 billion yuan, representing a year-on-year growth of 17.81%, and a net profit of 39.5759 million yuan, showing a significant increase of 255.40% [1][3] - The company is expanding its overseas operations, with a $10 million investment in a comprehensive formulation production project in Tanzania, which is progressing as planned and is expected to meet GMP certification conditions by Q4 2025 [1][2] - The company is also investing $8 million in a new injection production project in Nigeria, which is part of its overall development strategy to enhance economic benefits and competitiveness [2] Financial Performance - For the first three quarters of 2025, the company achieved a revenue of 1.006 billion yuan, a 17.81% increase year-on-year [1] - The net profit for the same period was 39.5759 million yuan, reflecting a substantial growth of 255.40% compared to the previous year [1] Overseas Expansion - The company’s subsidiary in Tanzania is investing $10 million in a production project, with construction and equipment installation progressing on schedule [1] - The project aims to complete equipment debugging by Q4 2025 and is preparing for drug registration to facilitate market entry [1][2] - An additional investment of $8 million is planned for a new injection production project in Nigeria, expected to take 18 months to complete [2] Technological Development - The company’s subsidiary, Hangzhou Longde Intelligent Technology Co., Ltd., is focusing on AI applications in rehabilitation robots and security, and has obtained various medical device operating qualifications [2] - The subsidiary has also expanded its intellectual property portfolio, completing new software copyrights and patent applications to enhance its competitive edge [2] Market Outlook - Market analysts view the company’s stable growth in Q3 2025 as a result of solid progress in industrial breakthroughs and technology development, which supports its future stability [3] - The collaborative advancement across multiple business lines is seen as a strong foundation for the company’s ongoing development [3]
尔康制药:前三季度业绩稳步增长 海外项目与技术研发多点推进
Quan Jing Wang· 2025-10-29 12:34
Core Insights - The company reported a positive operational performance for the third quarter of 2025, achieving a revenue of 1.006 billion yuan, a year-on-year increase of 17.81%, and a net profit of 39.5759 million yuan, with a significant growth of 255.40% compared to the previous year [1][3] Group 1: Financial Performance - The company achieved a revenue of 1.006 billion yuan in the first three quarters of 2025, marking a 17.81% year-on-year growth [1] - The net profit for the same period reached 39.5759 million yuan, reflecting a substantial increase of 255.40% year-on-year [1] Group 2: Overseas Expansion - The company invested 10 million USD in a comprehensive formulation production project in Tanzania, which is progressing as planned with purification engineering and equipment installation [1] - The project is expected to complete equipment debugging by the fourth quarter of 2025 and is preparing for drug registration to meet regulatory requirements [1] Group 3: Technological Development - The company's subsidiary, Hangzhou Longde Intelligent Technology Co., Ltd., made advancements in AI technology applications, focusing on rehabilitation robots and security fields [2] - The subsidiary obtained operating qualifications for various medical devices, enhancing compliance for market expansion [2] - The company completed additional intellectual property filings, including 3 software copyrights and 2 invention patents, strengthening its technology barrier and market competitiveness [2] Group 4: New Projects - The company announced an investment of 8 million USD to establish an injection production project in Nigeria, with a construction period of 18 months [2] - This investment aligns with the company's overall development strategy and aims to expand its business reach and enhance economic benefits [2]
尔康制药前三季度净利润同比大增255% 海外项目与技术研发稳步推进
Zheng Quan Shi Bao Wang· 2025-10-29 12:25
Core Insights - The company reported a significant increase in revenue and net profit for the first three quarters of 2025, with revenue reaching 1.006 billion and a net profit of 39.5759 million, marking year-on-year growth of 17.81% and 255.40% respectively [1][2] Group 1: Financial Performance - The company achieved a revenue of 1.006 billion, reflecting a year-on-year growth of 17.81% [1] - The net profit for the same period was 39.5759 million, with a substantial increase of 255.40% compared to the previous year [1] Group 2: Overseas Expansion - The company is investing 10 million in a comprehensive formulation production project in Tanzania, which is progressing as planned and is expected to complete equipment debugging by the fourth quarter of 2025 [1] - An additional investment of 8 million is planned for a new injection production project in Nigeria, with an expected construction period of 18 months [2] Group 3: Research and Development - The company's subsidiary, Hangzhou Longde Intelligent Technology Co., Ltd., is conducting market research and business development in AI technology applications, achieving qualifications for various medical devices [1] - The company has completed the documentation for 3 new software copyrights and 2 invention patents, with one patent application receiving preliminary approval [1]
新建成注射剂智能工厂 科源制药加快形成多剂型共存产业生态
Xin Hua Cai Jing· 2025-09-28 11:48
Core Viewpoint - On September 28, Linuo Group celebrated its 31st anniversary, coinciding with the completion and commissioning of its subsidiary Koyuan Pharmaceutical's intelligent factory for injectable products [1] Group 1: Project Overview - The intelligent factory, characterized by "AI + computing power," was fully invested and constructed by Linuo Pharmaceutical, covering a total area of approximately 46,000 square meters [1] - The facility includes quality inspection and R&D buildings, high-end injectable production workshops, and a comprehensive intelligent storage warehouse [1] - The production and quality management systems are established according to national GMP, US FDA, and EU GMP standards, making it a high-end intelligent manufacturing plant for injectables [1] Group 2: Strategic Importance - The project is recognized as a key project for green, low-carbon, and high-quality development in Shandong Province, as well as a significant initiative for enterprise technological transformation and major industrial breakthroughs in the province [1] Group 3: Company Positioning - Koyuan Pharmaceutical is a leading player in the domestic chemical raw material drug sector, with its subsidiary Linuo Pharmaceutical focusing on formulations [1] - The company has built strong capabilities and competitive advantages in areas such as hypoglycemic agents, cardiovascular drugs, and central nervous system medications [1] - The completion of this project marks a significant transition for Koyuan Pharmaceutical and Linuo Pharmaceutical from oral solid formulations to the high-barrier injectable sector, accelerating the formation of a new industrial ecosystem with multiple dosage forms coexisting and thriving together [1]
力诺大健康的AI转型
Jing Ji Guan Cha Wang· 2025-09-28 11:30
Core Insights - The establishment of two AI-driven smart factories by Linuo Group marks a significant advancement in the AI transformation of its health industry, enhancing its competitive edge in the pharmaceutical sector [2][4][6] Group 1: Company Overview - Linuo Group, founded in 1994 and headquartered in Jinan, Shandong, is a leading enterprise in China's manufacturing sector, recognized as one of the top 500 manufacturing companies and one of the top 100 private enterprises in Shandong [2] - The company operates in various sectors, including health, new energy, and new materials, with a focus on integrating advanced technologies into its production processes [2] Group 2: Project Details - The "AI + Computing Power" smart factory for Linuo Pharmaceutical's injection project has been completed with a total investment of 900 million yuan and a construction area of approximately 46,000 square meters [3] - This smart factory adheres to national and international quality standards, including GMP, FDA, and EU GMP, and integrates advanced production and quality management systems [3][5] Group 3: Technological Integration - The smart factory incorporates cutting-edge pharmaceutical equipment and digital innovation technologies, establishing a comprehensive intelligent manufacturing system that enhances production efficiency and quality [4][5] - The factory's design follows the CMMM Level 4 intelligent manufacturing maturity standard, integrating AI technologies for prescription analysis and automated production processes [6][7] Group 4: Environmental and Operational Efficiency - The factory has implemented a digital traceability system covering the entire lifecycle of traditional Chinese medicine, achieving 100% automatic collection of 35 key traceability indicators [7] - Innovative energy recycling systems and drone delivery services have been introduced, significantly reducing carbon emissions and improving delivery efficiency for urgent medical needs [7][8] Group 5: Future Prospects - The smart factory is expected to begin trial production by October 2025, with an anticipated annual output value of 20 million yuan, contributing to the modernization and internationalization of traditional Chinese medicine [8]
奥克股份:在医药领域如丹参滴丸、速效救心丸、注射剂等方面都有聚乙二醇的应用
Zheng Quan Ri Bao Zhi Sheng· 2025-09-12 09:49
Core Viewpoint - Aok shares highlighted the non-toxic and non-irritating properties of polyethylene glycol (PEG) products, emphasizing their wide applications in various industries, including pharmaceuticals and daily chemicals [1] Group 1: Product Characteristics - PEG products are characterized by good water solubility and compatibility with many organic components [1] - The products exhibit excellent lubricating, moisturizing, dispersing, adhesive, antistatic, and softening properties [1] Group 2: Industry Applications - Aok's PEG products have achieved large-scale applications in pharmaceutical excipients, raw materials for drugs, lithium battery new energy, and daily chemicals [1] - In the pharmaceutical sector, PEG is utilized in products such as Danshen dripping pills, rapid heart rescue pills, and injectables [1]
汇宇制药: 关于超募资金投资项目结项的公告
Zheng Quan Zhi Xing· 2025-07-15 09:33
Core Points - Sichuan Huiyu Pharmaceutical Co., Ltd. has completed the investment project "High-end Green Pharmaceutical Industry Extension Project" using the raised funds and is now proposing to conclude this project [1][4] - The total amount raised from the public offering was 2,472.132 million RMB, with a net amount after deducting issuance costs [1] - The company has utilized 1,907.315 million RMB for projects related to its main business, with an additional 453.3598 million RMB from over-raised funds [2][4] Fundraising and Investment Project Details - The company issued 63,600,000 shares at a price of 38.87 RMB per share, leading to a total fundraising amount of 2,472.132 million RMB [1] - The total investment amount for the main business-related projects was 1,907.315 million RMB, while the total amount of over-raised funds was 453.3598 million RMB [2] - As of the announcement date, the remaining unused amount of over-raised funds was 44.46 RMB [2] Project Completion and Financial Summary - The "High-end Green Pharmaceutical Industry Extension Project" has completed construction, with some production lines already in trial production, meeting the conditions for project conclusion [4] - The total investment for the project was 315.61 million RMB, with 288.61 million RMB already invested and a remaining balance of 17.60753 million RMB after accounting for interest income [4] - The supervisory board has approved the conclusion of the project, confirming that it aligns with the interests of the company and its shareholders [4]