独家期权权利涵盖最多37种潜在首发生物类似药候选物，将使Fresenius的产品组合从目前的29种已上市和在研分子，在未来十年内扩大至最多66种，覆盖超过3700亿欧元的原研药销售额；这是迄今为止生物类似药行业宣布的最大开发协议。
Exclusive option rights for up to 37 potential first-to-market biosimilar candidates to significantly expand Fresenius’ portfolio from 29 marketed and pipeline molecules today to up to 66 in the next decade, addressing more than €370 billion in originator sales; the largest development agreement announced in the biosimilars industry to date.
该协议赋予Fresenius完全的战略灵活性，可根据其既定筛选标准，自主选择并推进生物类似药候选物进行开发，同时保留协议项下产品的全部商业化收益。
Agreement gives Fresenius full strategic flexibility to select and advance biosimilar candidates to develop, against its established selection criteria, while retaining full commercialization economics of products under the agreement.
Fresenius将为每个候选物制定长期制造策略，并可选择利用mAbxience网络，该网络自2026年10月起为其全资拥有。
Fresenius will determine the long-term manufacturing strategy for each candidate, with optionality to leverage the mAbxience network, wholly owned since October 2026.
Fresenius SE & Co. KGaA（XETR: FRE；OTCM: FSNUY）今日宣布，已与WuXi Biologics（2269.HK）签订独家开发协议。WuXi Biologics是一家领先的全球研发与制造合同组织，拥有经过验证的大规模生物制品研发和制造能力，在单克隆抗体、双特异性抗体和抗体偶联药物方面有着卓越业绩，其网络遍及欧洲、美国、中国和新加坡。
Fresenius SE & Co. KGaA (XETR: FRE; OTCM: FSNUY) today announced that it has entered an exclusive development agreement with WuXi Biologics (2269.HK), a leading global contract organization for research, development and manufacturing. WuXi Biologics brings proven large-scale biologics development and manufacturing capability, a track record across monoclonal and bispecific antibodies and antibody-drug conjugates, and a worldwide network spanning Europe, the United States, China and Singapore.
该协议显著扩大并加速了Fresenius的生物类似药研发管线，同时保持战略灵活性和审慎的资本配置。它提供了一条可扩展的路径，将产品组合从目前的29种已上市和在研分子增加到最多66种分子，覆盖超过3700亿欧元的原研药标价销售额，从长期来看，将使生物制药业务的增长延伸至其2030年目标之后。
The agreement significantly expands and accelerates Fresenius’ biosimilars pipeline while preserving strategic flexibility and disciplined capital allocation. It provides access to a scalable pathway to increase the portfolio from 29 marketed and pipeline molecules today to up to 66 molecules, addressing more than €370 billion in originator list-price-based-sales, extending Biopharma growth in the long term beyond its 2030 ambition.
该协议为弗雷塞纽斯提供未来十年内最多37个已确定生物类似药候选物的独家获取权，使其成为迄今为止生物类似药行业宣布的最大开发协议。开发项目将根据弗雷塞纽斯既定的选择标准进行筛选和推进，标准包括市场吸引力、开发风险和预期回报。根据该协议，弗雷塞纽斯将拥有独家全球商业化权利，包括营销授权，以及每个商业化产品的全部经济收益。
The agreement provides Fresenius with exclusive access to up to 37 identified biosimilar candidates over the next decade, making it the largest development agreement announced in the biosimilars industry to date. Development programs will be selected and advanced against Fresenius’ established selection criteria, based on market attractiveness, development risk, and expected returns. Fresenius will hold exclusive global commercialization rights, including marketing authorizations, and the full economics of each commercialized product under the agreement.
弗雷塞纽斯首席执行官迈克尔·森表示：“我们正在加大对生物制药业务的投入。通过这项协议，我们将在速度和规模至关重要的市场中获得开发能力。这提供了一种有纪律、可扩展的方式，可能使我们的产品组合翻三倍，同时保留经济所有权、战略控制权以及将资本投向最具吸引力机会的灵活性。结合对mAbxience的全资拥有，这将推动我们的生物制药增长远超2030年。”
Michael Sen, Chief Executive Officer of Fresenius, said: “We are doubling down on our Biopharma business. With this agreement we are gaining access to development capabilities in a market where speed and scale are of the essence. It provides a disciplined, scalable way to potentially triple our portfolio while retaining economic ownership, strategic control and the flexibility to allocate capital to the most compelling opportunities. Combined with the full ownership of mAbxience, this fuels our Biopharma growth well beyond 2030.”
下一代产品组合预计将涵盖13个治疗领域，包括扩展至神经学、肾病学和心肺领域，同时进一步巩固弗雷塞纽斯在肿瘤学、免疫学和胃肠病学领域的既有地位。它将涵盖多种生物制剂技术，包括单克隆抗体和双特异性抗体、抗体偶联药物以及融合蛋白。初步开发预计将聚焦于波拉妥珠单抗，一种用于治弥漫性大B细胞淋巴瘤的抗体偶联药物，以及特雷珠单抗，一种用于治疗甲状腺眼病的单克隆抗体。
The next-generation portfolio is expected to span 13 therapeutic areas, including expanding into neurology, nephrology and cardiopulmonary, while further strengthening Fresenius’ established positions in oncology, immunology, and gastroenterology. It will encompass multiple biologic technologies, including monoclonal and bispecific antibodies, antibody-drug conjugates and fusion proteins. Initial development is expected to focus on polatuzumab vedotin, an antibody-drug conjugate for the treatment of diffuse large B-cell lymphoma, and teprotumumab, a monoclonal antibody for the treatment of thyroid eye disease.
该协议是内部研发、针对性合作和选择性引进许可相结合的平衡管道扩张战略的一部分。该协议使弗雷塞尼乌斯能够优先接触全球快速发展的生物技术格局，并将其与弗雷塞尼乌斯的全球制造和商业化网络相结合。预计开发活动将使用药明生物的全球网络进行。在最近收购总部位于西班牙的mAbxience的基础上，该协议显著扩大了弗雷塞尼乌斯全资平台的潜在开发候选物管道，使其能够在开发、制造和商业化价值链中捕获更大价值。
The agreement forms part of a balanced pipeline expansion strategy through internal R&D, targeted collaboration, and selective in-licensing. It gives Fresenius privileged access to the rapidly advancing biotech landscape worldwide and combines this with Fresenius’ global manufacturing and commercialization network. Development activities are expected to be conducted using WuXi Biologics’ global network. Building on the recent acquisition of Spain-headquartered mAbxience, the agreement significantly expands the funnel of potential development candidates for Fresenius’ wholly owned platform, enabling greater value capture across the development, manufacturing and commercialization value chain.
财务考量 弗雷塞尼乌斯全年2026年指引保持不变，公司确认了2025年12月宣布的2030年生物制药雄心——即与2025年相比，生物制药收入大约翻一番，息税前利润率约为20%——该雄心涉及现有上市和后期管线产品。该协议是增量性的，将机会扩展到2030年之后，因此，弗雷塞尼乌斯预计将显著提高其长期生物制药雄心。
Financial Considerations Fresenius’ full-year 2026 guidance remains unchanged, and the company confirms the 2030 Biopharma ambition announced in December 2025 of – approximately doubling Biopharma revenue compared with 2025 at an EBIT margin of around 20% – which relates to the existing marketed and late-stage portfolio. The agreement is additive, expanding the opportunity beyond 2030, and, as a result, Fresenius expects to raise its long-term Biopharma ambitions significantly.
根据协议条款，弗雷塞尼乌斯将按服务收费的方式向药明生物支付费用，针对弗雷塞尼乌斯选择用于开发的每个生物类似药候选物。研发投资仅随着选定项目的推进而规模化，每个期权的行动均基于弗雷塞尼乌斯既定的选择标准（市场吸引力、开发风险和预期回报）。弗雷塞尼乌斯将确定每个生物类似药候选物的长期制造战略，包括将选定产品逐步转移至mAbxience的潜在可能性。
Under the terms of the agreement, Fresenius will compensate WuXi Biologics on a fee-for-service basis for each biosimilar candidate that Fresenius selects for development. Research and development investment scales only as selected programs progress, with each option exercised against Fresenius’ established selection criteria (market attractiveness, development risk, and expected returns). Fresenius will determine the long-term manufacturing strategy for each biosimilar candidate, including the potential progressive transfer of selected products to mAbxience.
弗雷塞尼乌斯将拥有每个商业化产品的独家全球商业化权利，包括营销授权，以及协议项下每个商业化产品的全部经济收益。
Fresenius will hold exclusive global commercialization rights, including marketing authorizations, and the full economics of each commercialized product under the agreement.
随着甄选候选药物的推进，生物制药研发支出和盈利能力将相应反映开发阶段投资水平的提升，领先于未来收入和盈利能力的增长。
As selected candidates advance, Biopharma research and development expenditure and profitability will correspondingly reflect the increased level of investment during the development phase, ahead of future revenue and profitability growth.
该协议符合弗雷塞尼乌斯不变的财务框架，继续将强大的资产负债表和进一步降杠杆作为优先事项；资金来源于经营现金流，无需新融资。标准普尔将弗雷塞尼乌斯评级为BBB，展望为正面；穆迪评级为Baa3，展望为稳定；惠誉评级为BBB-，展望为正面。
The agreement fits within Fresenius’ unchanged financial framework, with continued priority on a strong balance sheet and further deleveraging; it is funded from operating cash flow and requires no new financing.
弗雷塞尼乌斯于2026年10月1日宣布收购mAbxience剩余45%股权的公告可在此处查阅。弗雷塞尼乌斯卡比于2022年3月31日宣布收购mAbxience 55%多数股权的公告可在此处查阅，2022年8月1日的完成公告可在此处查阅。生物制药“管理层面对面”演示文稿于2025年12月15日发布，可在此处查阅。
Fresenius is rated BBB with a positive outlook by S&P, Baa3 with a stable outlook by Moody’s, and BBB- with a positive outlook by Fitch. The 1 October 2026 announcement of Fresenius' acquisition of the remaining 45% of mAbxience is available here.
关于波拉妥珠单抗 波拉妥珠单抗是一种抗体偶联药物（ADC），以商品名Polivy®上市，用于治疗弥漫性大B细胞淋巴瘤（DLBCL），这是非霍奇金淋巴瘤最常见的亚型。1 全球范围内，DLBCL约占非霍奇金淋巴瘤的三分之一。² 2024年，全球新诊断非霍奇金淋巴瘤病例超过562,000例，约235,000例死亡病例归因于该疾病。
The 31 March 2022 announcement of Fresenius Kabi's acquisition of a 55% majority stake in mAbxience is available here, and the 1 August 2022 completion announcement here. The Biopharma 'Meet the Management' presentation of 15 December 2025 is available here. About polatuzumab vedotin Polatuzumab vedotin is an antibody-drug conjugate (ADC) marketed under the brand name Polivy® for the treatment large B-cell lymphoma (DLBCL), the most common subtype of non-Hodgkin lymphoma.1 Globally, DLBCL accounts for approximately one-third of non-Hodgkin lymphomas.² In 2024, more than 562,000 new cases of non-Hodgkin lymphoma were diagnosed worldwide, with approximately 235,000 deaths attributed to the disease.3 The polatuzumab vedotin ADC comprises a monoclonal antibody directed against CD79b, a protein expressed on B cells including DLBCL cells, linked to the microtubule-disrupting agent monomethyl auristatin E (MMAE) through a cleavable linker.
3 波拉妥珠单抗ADC由一种针对CD79b的单克隆抗体组成，CD79b是一种在B细胞（包括DLBCL细胞）上表达的蛋白，通过可裂解连接子与微管破坏剂单甲基奥立他汀E（MMAE）相连。ADC与CD79b结合后被细胞内化，释放出MMAE，破坏微管并导致细胞死亡。1 Polivy®通过静脉输注给药，是Genentech, Inc.的注册商标。
Following binding to CD79b, the ADC is internalized and MMAE is released, disrupting microtubules and leading to cell death.1 Polivy® is administered by intravenous infusion and is a registered trademark of Genentech, Inc.
关于特珀妥尤单抗 特珀妥尤单抗是一种人源单克隆抗体，以特珀齐（Tepezza®）为品牌上市，用于治疗甲状腺眼病（TED），这是一种与格雷夫斯病相关的罕见自身免疫性疾病。4 甲状腺眼病估计每年每10万人中约有16名女性和3名男性受影响，约25%至50%的格雷夫斯病患者会出现甲状腺眼病的体征和症状。5 特珀妥尤单抗与胰岛素样生长因子-1受体（IGF-1R）结合并抑制其活性，该受体参与与甲状腺眼病的发展和进展相关的细胞信号传导通路。
About teprotumumab Teprotumumab is a human monoclonal antibody marketed under the brand name Tepezza® for the treatment of thyroid eye disease (TED), a rare autoimmune condition associated with Graves' disease.4 TED is estimated to affect approximately 16 women and 3 men per 100,000 people annually, with around 25-50% of patients with Graves' disease developing signs and symptoms of TED.5 Teprotumumab binds to and inhibits the insulin-like growth factor-1 receptor (IGF-1R), a receptor involved in cellular signaling pathways associated with the development and progression of TED.
通过抑制IGF-1R信号传导，特珀妥尤单抗有助于减轻与该疾病相关的炎症和组织重塑过程。特珀齐（Tepezza®）通过静脉输注给药，是安进公司（Amgen Inc.）的注册商标。
By inhibiting IGF-1R signaling, teprotumumab helps reduce the inflammatory and tissue-remodeling processes associated with the disease. Tepezza® is administered by intravenous infusion and is a registered trademark of Amgen Inc.
关于弗雷塞纽斯 弗雷塞纽斯（XETR: FRE，OTCM: FSNUY）是一家全球性的、以治疗为重点的医疗保健公司，致力于拯救和改善世界各地人们的生命。通过弗雷塞纽斯卡比（Fresenius Kabi）和弗雷塞纽斯赫利奥斯（Fresenius Helios），该公司在整个医疗护理连续体中提供系统关键性、创新且负担得起的医疗保健：弗雷塞纽斯卡比是危重和慢性病患者挽救生命的药物、医学营养和医疗技术的主要提供商，每年覆盖约4.5亿人。弗雷塞纽斯赫利奥斯是欧洲最大的私立医院运营商，每年治疗约2700万名患者。
About Fresenius Fresenius (XETR: FRE, OTCM: FSNUY) is a global, therapy-focused healthcare company dedicated to saving and improving human lives around the world. Through Fresenius Kabi and Fresenius Helios, the company delivers system-critical, innovative and affordable healthcare across the full continuum of care: Fresenius Kabi is a leading provider of lifesaving medicines, medical nutrition, and medical technologies for critically and chronically ill patients, reaching around 450million peopleeach year. Fresenius Helios is Europe’s largest private hospital operator, treating around 27million patientsannually.
弗雷塞纽斯拥有超过17.8万名员工，在60多个国家开展业务，2025年营收达226亿欧元。
With more than178,000employees and operating in more than 60 countries, Fresenius generated €22.6billion in revenue in 2025.
更多信息，请访问 www.fresenius.com 并关注弗雷塞纽斯媒体联系人：Steffi Kim 集团传播部 弗雷塞纽斯股份有限公司及合伙有限责任公司 Else-Kröner-Straße 1 61352 巴德洪堡 德国 M +49 175 3284 722 参考文献 [1] Polivy®（波拉妥珠单抗维达妥昔单抗）美国处方信息。可查阅：[最后访问时间：2026年10月]。
For more information, visit www.fresenius.com and follow Fresenius on Press Contact: Steffi Kim Group Communications Fresenius SE & Co. KGaA Else-Kröner-Straße 1 61352 Bad Homburg Germany M +49 175 3284 722 References [1] Polivy® (polatuzumab vedotin-piiq) U.S. Prescribing Information. Available at: [Last accessed October 2026].
[2] Wang, S. S. (2023) 弥漫性大B细胞淋巴瘤（DLBCL）的流行病学与病因学。Semin. Hematol. 60, 255–266. [3] 国际癌症研究署。全球癌症观察站：非霍奇金淋巴瘤事实资料，GLOBOCAN 2024。可查阅：[最后访问时间：2026年10月] [4] Tepezza®（特珠单抗-trbw）美国处方信息。可查阅：[最后访问时间：2026年10月]。
[2] Wang, S. S. (2023) Epidemiology and Etiology of Diffuse Large B-Cell Lymphoma (DLBCL). Semin. Hematol. 60, 255–266. [3] International Agency for Research on Cancer. Global Cancer Observatory: Non-Hodgkin Lymphoma Fact Sheet, GLOBOCAN 2024. Available at: [Last accessed October 2026] [4] Tepezza® (teprotumumab-trbw) U.S. Prescribing Information. Available at: [Last accessed October 2026].
[5] Moledina, M., Damato, E. M. & Lee, V. (2024) 甲状腺眼病的变化格局：当前临床进展与未来展望。Eye 38, 1425-37.关于前瞻性陈述的谨慎声明 本新闻稿包含前瞻性陈述，受各种风险和不确定性影响，包括关于与药明生物协议下开发的生物类似物候选物潜在数量、由此产生的管道规模（包括提及“多达66”个分子）、向mAbxience网络转移制造的时间和范围，以及弗雷塞纽斯2030年后的增长前景的陈述。
[5] Moledina, M., Damato, E. M. & Lee, V. (2024) The changing landscape of thyroid eye disease: current clinical advances and future outlook. Eye 38, 1425-37. Cautionary Statement on Forward-Looking Statements This release contains forward-looking statements that are subject to various risks and uncertainties including statements regarding the potential number of biosimilar candidates developed under the agreement with WuXi Biologics, the resulting pipeline size (including references to "up to 66" molecules), the timing and scope of any transfer of manufacturing to the mAbxience network, and Fresenius' growth prospects beyond 2030.
根据协议开发的候选物是否开发、何时开发以及开发多少，仍取决于弗雷塞纽斯未来对每个候选物行使期权，无法保证任何或所有已识别的候选物将被开发或上市。未来结果可能因某些因素而与这些前瞻性陈述中描述的结果存在重大差异，例如商业、经济和竞争状况的变化、监管改革、临床试验结果、外汇汇率波动、诉讼或调查程序中的不确定性、融资可用性以及国际冲突的不可预见影响。弗雷塞纽斯不承担任何责任更新本新闻稿中的前瞻性陈述。
Whether, when and how many candidates are developed under the agreement remains subject to Fresenius' future exercise of options on a candidate-by-candidate basis, and no assurance can be given that any, or all, of the identified candidates will be developed or will reach the market. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, the availability of financing and unforeseen impacts of international conflicts. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
注册办公室：德国巴特洪堡 / 商事注册：巴特洪堡地方法院，HRB 11852 监事会主席：沃尔夫冈·基尔施 普通合伙人：弗雷塞尼乌斯管理 SE 董事会：米夏埃尔·森（主席）、萨拉·亨尼肯、马克-亚历山大·马尔博士、米夏埃尔·莫泽博士、克里斯蒂安·鲍卢博士
Registered Office: Bad Homburg, Germany / Commercial: Amtsgericht Bad Homburg, HRB 11852 Chairman of the Supervisory Board: Wolfgang Kirsch General Partner: Fresenius Management SE Management Board: Michael Sen (Chairman), Sara Hennicken, Dr. Marc-Alexander Mahl, Dr. Michael Moser, Dr. Christian Pawlu