Fresenius SE & Co. KGaA

MADRID, Dec. 4, 2025 /PRNewswire/ -- mAbxience, a Fresenius entity, and HP Inc., a global leader in technology, announce a new project to develop an innovative artificial intelligence (AI) solution that optimizes the production process of monoclonal antibodies and biosimilars. Continue Reading Mabxience company facilities The project represents a pioneering step in the application of AI to industrial biotechnology through the creation of a digital twin of the biological process, designed to enhance predictability, consistency, and efficiency in large-scale production."This is a clear example of technology with purpose: we use artificial intelligence not only to optimize processes but to help critical treatments reach more people, faster and better," said Sergio Martínez, Technical Lead of the project at HP. Beyond its technological innovation, this solution holds transformational potential for all of mAbxience's partners, both biosimilar licensees and CDMO clients. By integrating AI into its manufacturing operations, mAbxience aims to significantly optimize its development approach towards biologics development, enhancing operational efficiencies, and optimizing resource utilization. This advancement will strengthen the company's position as a trusted, cost-competitive global biomanufacturing partner, while helping to optimize patient access to safe, high-quality biologic medicines. "Artificial intelligence may open a lot of yet untapped potential for biomanufacturing optimization," said Timo Liebig, Chief Innovation Officer at mAbxience. "Through this collaboration with HP, we have successfully developed our first prototype enabling more efficient, more robust and even more tightly controlled manufacturing campaigns. This project demonstrates how technological innovation can directly translate into better access for patients to essential biologic therapies," commented Iván Sánchez, R&D Director at mAbxience. The development was based on real production data processed through advanced neural network models and validated in an industrial setting. The resulting tool allows mAbxience teams to simulate, analyze, and optimize distinct stages of the cell culture manufacturing process, with the ultimate goal of increasing yields while reducing process variability. This initiative marks the first project under the strategic collaboration framework between HP and mAbxience, which aims to apply AI across multiple critical areas of the company to enhance productivity, quality, and sustainability throughout its global operations. The solution, designed and validated in León, also has potential to be replicated across other mAbxience sites and processes worldwide. Photo: SOURCE mAbxience 21% more press release views with Request a Demo

mAbxience, a Fresenius entity, has entered into a collaboration with HP Inc. to develop an artificial intelligence (AI) solution aimed at making biomanufacturing more efficient and reliable. The joint project uses AI and digital-twin technology to model and optimize key steps in the production of monoclonal antibodies and biosimilars. By simulating critical cell-culture parameters and predicting process outcomes, the system is designed to support more consistent yields, faster development cycles, and better control of large-scale manufacturing environments. This is a showcase of Fresenius’ pathway in leveraging AI and digital solutions, from production and supply-chain to care delivery, improving treatment quality, and expanding access to state-of-the-art therapies. Both partners view the technology as a significant step toward more data-driven and tightly managed bioproduction. The prototype, developed with real manufacturing data and validated in an industrial setting, enables teams to test scenarios virtually before applying them on the shop floor. This initiative is the first project under a broader strategic framework between HP and mAbxience at its manufacturing facility in Leon, Spain, and has the potential to be rolled out across additional sites. It represents another milestone in advancing Fresenius’ (Bio)Pharma platform and supports the goals of #FutureFresenius. Fresenius in Spain The global healthcare company Fresenius is deeply rooted in Spain. With Quirónsalud, the country’s leading hospital operator, and Fresenius Kabi, offering essential medicines and technologies for critically and chronically ill patients, the company makes a decisive difference in the life-quality of Spanish citizens. With the majority acquisition of mAbxience in 2022, Fresenius created a dedicated and vertically integrated biosimilars development and manufacturing platform. In line with its #FutureFresenius strategy, the company is further scaling in (Bio)Pharma to deliver simplification and drive efficiencies, underscoring its commitment to offering accessible, innovative, and high-quality healthcare solutions.

这里是《21 健讯 Daily》，欢迎与 21 世纪经济报道新健康团队共同关注医药健康行业最新事件！政策动向国家医保局公布 5 起骗取生育保险基金典型案例国家医保局网站 12 月 3 日公布 5 起骗取生育保险基金的典型案例，以此提醒广大参保单位和参保人，通过合法途径参加生育保险，提供真实、准确、完整的申报材料申领生育津贴和生育医疗费，共同维护生育保险基金安全。包括云南省昆明市云南通昇茶叶贸易有限公司涉嫌骗取生育津贴案、河北省张家口市两家公司虚构劳动关系骗取生育津贴案、福建省泉州市超亿财税咨询有限公司骗取生育津贴案等。药械审批东诚药业：控股子公司获放射性药品生产许可证东诚药业 ( 002675 ) 12 月 3 日公告，控股子公司蓝纳成收到山东省药监督管理局下发的《放射性药品生产许可证》。此次蓝纳成取得药品生产许可证，预期不会对公司当前业绩产生重大影响，氟 [ 18F ] 思睿肽注射液待获得药品上市批准文号后可进行商业化生产。健友股份：丙泊酚乳状注射液获得美国 FDA 批准12 月 3 日，健友股份 ( 603707.SH ) 公告称，公司收到美国 FDA 签发的丙泊酚乳状注射液 ANDA 批准通知，规格包括 200 mg/20 mL、500 mg/50 mL 和 1,000 mg/100 mL。该产品适应症为全身麻醉及镇静，参比制剂由 FRESENIUS KABI USA LLC 持有。公司已投入研发费用约人民币 7,366.37 万元。新批准产品近期将安排在美国上市销售，有望对公司经营业绩产生积极影响。但需注意销售不达预期等风险。资本市场乐心医疗：控股股东潘伟潮解除质押 1871.00 万股12 月 3 日，乐心医疗公告，公司近日接到控股股东、实际控制人潘伟潮先生通知，其持有的 1871.00 万股公司股份已解除质押，质权人为国泰海通证券股份有限公司，本次解除质押占其所持股份比例的 28.01%，占公司总股本的 8.56%。截至公告披露日，潘伟潮累计质押公司股份 1100.00 万股，占其所持股份的 16.47%，占公司总股本的 5.03%。贝瑞基因：高扬及其一致行动人持股比例已降至 6.90%12 月 3 日，贝瑞基因公告，公司近日接到控股股东高扬通知，因股票质押违约，质权人国信证券股份有限公司于 2025 年 9 月 2 日至 12 月 2 日通过集中竞价交易方式对其所持股份实施司法强制执行，合计减持 206.35 万股，占公司总股本的 0.58%。本次权益变动后，高扬及其一致行动人侯颖合计持有公司股份比例由 7.48% 下降至 6.90%。本次变动未导致公司控制权发生变更，对公司生产经营、财务状况及治理结构无重大不利影响。太龙药业：控股股东筹划重大事项 预计继续停牌时间不超过 3 个交易日12 月 3 日，太龙药业公告，公司控股股东郑州泰容产业投资有限公司正在筹划公司股份转让事宜，该事项可能导致公司控制权发生变更。目前公司控股股东正在积极推动本次重大事项的各项工作，与交易方商谈本次交易条款，且交易各方需履行相关内部审批程序，公司预计无法在 2025 年 12 月 4 日开市起复牌。根据有关规定，经向上海证券交易所申请，公司股票将于 2025 年 12 月 4 日开市起继续停牌，预计继续停牌时间不超过 3 个交易日。21 点评：国资入主未满四年，太龙药业的控制权或再次发生变更。资料显示，太龙药业设立于 1998 年，前身为河南竹林众生制药股份有限公司，于 1999 年 11 月登陆上交所。其主要业务为药品制造和药品研发服务，具体包含药品制剂、中药饮片、药品研发服务和药品药材流通四个业务板块。行业大事亚虹医药：在欧洲结直肠大会发布 APL-1401 Ⅰ b 期临床试验数据亚虹医药 ( 688176 ) 12 月 3 日公告，近日，公司开展的 APL-1401 用于治疗中重度活动性溃疡性结肠炎的Ⅰ b 期临床试验结果入选第 19 届欧洲结直肠大会，并以壁报形式发布该研究的临床数据。APL-1401 是公司通过自主研究并发现其全新作用机制用于治疗自身免疫疾病的口服创新药物。目前该在研产品尚处于临床试验早期阶段，未来临床试验结果能否支持药品递交上市申请、能否最终获得上市批准以及何时获批均具有不确定性。复星医药：控股子公司拟用于治疗晚期恶性实体瘤创新药物 FXS887 片获临床试验批准12 月 3 日，复星医药 ( 600196.SH ) 公告称，控股子公司上海复星医药产业发展有限公司（简称"复星医药产业"）收到国家药品监督管理局关于同意 FXS887 片（简称" FXS0887 "）用于晚期恶性实体瘤开展临床试验的批准。FXS0887 为本集团（即本公司及控股子公司 / 单位）自主研发的口服小分子创新药物，拟用于治疗晚期恶性实体瘤。截至本公告日期（即 2025 年 12 月 3 日），于全球范围内尚无同靶点的小分子抑制剂单药或联合治疗方案获批上市。信立泰：SAL0140 片获得临床试验批准通知书12 月 3 日，信立泰 ( 002294.SZ ) 公告称，公司近日收到国家药品监督管理局核准签发的《临床试验批准通知书》，同意公司自主研发的创新小分子药物 SAL0140 片开展治疗慢性肾脏病（CKD）的临床试验。SAL0140 是公司具有自主知识产权的醛固酮合酶抑制剂，若能研发成功并获批上市，将有望为更多细分领域的患者提供新的用药选择，满足未被满足的临床需求。恒瑞医药：董事会提名聘任朱国新为公司高级副总裁12 月 3 日，恒瑞医药 ( 600276.SH ) 公告称，公司第九届董事会第二十次会议于 2025 年 12 月 3 日召开，会议审议并通过了《关于提名聘任公司高级副总裁的议案》，提名聘任朱国新为公司高级副总裁，任期自本次董事会审议通过之日起至本届董事会任期届满为止。朱国新拥有 30 余年全球跨职能药物发现领导经验，涉及多个疾病领域。加入恒瑞医药前，他在礼来新药研发中心担任副总裁，领导了多个发现研究和早期开发项目。朱国新本科毕业于浙江大学，在上海有机化学研究所获得硕士和博士学位，并在宾夕法尼亚州立大学完成博士后研究。京东健康与勃林格殷格翰动物保健达成战略合作12 月 2 日，京东健康与勃林格殷格翰动物保健（上海）有限公司签署战略合作协议。双方将依托京东健康的"超级医药供应链"以及丰富的医疗服务资源，在全渠道供应链、品牌共建及用户服务等领域开展深度合作。双方将通过资源整合和优势互补，携手推动国内宠物健康事业的高质量发展。舆情预警贵州百灵：因涉嫌内幕交易等 实控人姜伟被证监会立案12 月 3 日，贵州百灵 ( 002424.SZ ) 公告称，公司实际控制人姜伟近日收到中国证监会立案告知书，因涉嫌内幕交易、信息披露违法、违反限制性规定转让股票，中国证监会决定对其进行立案。本次立案系对姜伟个人的调查，与公司日常经营无关，不会影响上市公司及子公司生产经营。姜伟将配合证监会的调查工作，公司将持续关注进展并及时履行信息披露义务。