Ranibizumab (Genentech)

具体财务及年报以及业务演示文稿太多就不发 了需要可以私发 罗氏集团 2025 年业绩及战略进展详细总结（基于 2026 年 1 月 29 日公告） 罗氏集团（Roche）依据《上市规则》第 53 条发布的特别公告，核心披露 2025 年全年财务业绩、业务板块表现、研发管线突破、管理层变动及 2026 年展望，全面展现公司在制药与诊断领域的全球竞争力。一、核心财务业绩：营收与利润双增长，汇率影响显著 2025 年罗氏集团整体经营表现强劲，受药品与诊断解决方案需求驱动，关键财务指标均实现增长，但瑞士法郎升值对以本币计价的业绩产生一定稀释作用（以下数据除特别标注外，均包含 “固定汇率（CER）” 与 “瑞士法郎（CHF）” 双维度）。1. 整体营收集团总销售额 ：达 615.16 亿瑞士法郎，较 2024 年的 604.95 亿瑞士法郎增长 7%（CER）、2%（CHF）；其中第四季度销售额同比增长 8%（CER），延续全年积极增长势头。汇率影响 ：瑞士法郎对美元等主要货币升值，导致以本币计价的增速低于固定汇率增速，是财务数据的核心影响因素之一。2. 利润与每股收益核心营业利润 ：218.33 亿瑞士法郎，同比增长 13%（CER）、5%（CHF），增长动力来自销售额提升与运营效率优化。核心稀释每股收益（EPS） ：19.46 瑞士法郎，同比增长 11%（CER）、4%（CHF），反映股东回报能力稳步增强。IFRS 净利润 ：137.99 亿瑞士法郎，同比大幅增长 58%（CER）、50%（CHF），主要因 2025 年强劲运营表现，叠加 2024 年资产减值损失形成的 “基数效应”（2024 年净利润仅 91.87 亿瑞士法郎）。3. 股息提案 董事会提议将每股股息（含无投票权股权证券）提高至 9.80 瑞士法郎，若获股东批准，将成为罗氏连续第 39 年上调股息，彰显公司对股东回报的长期承诺。二、两大业务板块表现：制药驱动增长，诊断抵消政策压力 罗氏业务分为 “制药事业部” 与 “诊断事业部”，2025 年两者呈现差异化增长，制药板块为核心增长引擎，诊断板块则通过细分市场突破抵消外部政策影响。1. 制药事业部：9% 增长，5 大药物贡献核心增量营收规模 ：销售额 476.69 亿瑞士法郎，占集团总营收的 77.5%（2024 年为 461.71 亿瑞士法郎），同比增长 9%（CER）、3%（CHF），是集团增长的主要支柱。增长驱动力 ：5 款核心药物表现突出，合计销售额达 214 亿瑞士法郎，较 2024 年增加 32 亿瑞士法郎（CER），具体包括：Phesgo （乳腺癌）：销售额 24.41 亿瑞士法郎，同比激增 48%（CER），国际市场（如中国）因纳入医保报销，增速达 172%（CER）。Xolair （食物过敏、哮喘）：销售额 30.75 亿瑞士法郎，同比增长 32%（CER），美国市场为主要贡献地（占比 100%）。Ocrevus （多发性硬化症）：销售额 70.10 亿瑞士法郎，同比增长 9%（CER），欧洲与国际市场增速领先（分别为 13%、21%）。Hemlibra （A 型血友病）：销售额 47.54 亿瑞士法郎，同比增长 11%（CER），国际市场增速达 38%（CER）。Vabysmo （严重眼病，如糖尿病黄斑水肿）：销售额 41.02 亿瑞士法郎，同比增长 12%（CER），国际市场增速高达 116%（CER），成为眼科领域核心增长点。专利到期影响 ：Avastin（癌症）、Herceptin（乳腺癌 / 胃癌）、MabThera/Rituxan（血液癌 / 类风湿关节炎）等专利到期产品，合计销售额减少 7 亿瑞士法郎（CER），但被核心药物的增量完全覆盖。2. 诊断事业部：2% 增长，抵消中国定价改革冲击营收规模 ：销售额 138.47 亿瑞士法郎，占集团总营收的 22.5%（2024 年为 143.24 亿瑞士法郎），同比增长 2%（CER）、下降 3%（CHF）。增长逻辑 ：病理与分子诊断解决方案需求强劲，完全抵消中国医疗定价改革对营收的负面影响；分区域看，北美（+9% CER）、欧洲中东非洲（+6% CER）、拉丁美洲（+11% CER）均实现增长，仅亚太地区因中国政策下降 12%（CER）。产品突破 ：推出 2 个仪器平台、6 个数字解决方案及 53 项新检测项目，其中：Elecsys 登革热抗原检测 ：获欧盟 CE 认证，18 分钟出结果，覆盖 4 种登革热病毒血清型，提升疫情期间诊断效率。cobas BV/CV 检测 ：通过 PCR 技术精准诊断阴道炎，单样本可完成多指标检测，减少患者采样次数。抗生素治疗监测检测 ：获 CE 认证，使罗氏自动化质谱平台的体外诊断菜单扩展至 39 项，成为全球首个覆盖该领域的自动化方案。三、研发管线：10 款药物进入 III 期，多领域突破治疗瓶颈 2025 年罗氏研发投入聚焦肿瘤、自身免疫、代谢等领域，制药板块研发支出 104 亿瑞士法郎（集团研发总支出 122 亿瑞士法郎，同比均下降 3%），但效率显著提升，核心突破如下：1. 已获监管批准的关键药物Lunsumio（血液癌） ：获美国 FDA 与欧盟批准皮下注射剂型，将给药时间从 2-4 小时缩短至约 1 分钟，且在滤泡性淋巴瘤三线治疗中展现高完全缓解率，适配患者临床需求与生活偏好。Gazyva/Gazyvaro（狼疮肾炎） ：获欧盟批准用于成人活动性狼疮肾炎，基于 II 期 NOBILITY 与 III 期 REGENCY 研究，证实其优于标准疗法，是首个在随机 III 期研究中显示 “完全肾脏缓解” 获益的抗 CD20 抗体，有望惠及欧盟约 13.5 万患者。2. III 期 / 关键临床数据积极的药物CT-388（肥胖） ：II 期数据显示，每周皮下注射 24mg 剂量组，48 周时安慰剂校正后体重减轻 22.5%（p<0.001），且未达减重平台期；54% 患者 BMI 降至 30 以下（安慰剂组仅 13%），安全性与同类 GLP-1/GIP 双受体激动剂一致，为 III 期启动奠定基础。Giredestrant（乳腺癌） ：在 ER 阳性早期乳腺癌中，将侵袭性疾病复发或死亡风险降低 30%，是 20 年来首个在辅助治疗中显示 “侵袭性无病生存期” 优势的口服 SERD（选择性雌激素受体降解剂），覆盖 70% 的乳腺癌患者群体。Fenebrutinib（多发性硬化症） ：全球首个在 “复发型（RMS）” 与 “原发进展型（PPMS）” 均获阳性 III 期数据的 BTK 抑制剂：RMS 研究中较特立氟胺显著减少复发，PPMS 研究中延缓残疾进展效果不劣于现有标准药 Ocrevus。Gazyva/Gazyvaro（系统性红斑狼疮 / SLE） ：III 期 ALLEGORY 研究达所有终点，显著降低疾病活动度，若获批将成为首个直接靶向 B 细胞的抗 CD20 疗法，惠及全球 340 万 SLE 患者。3. 管线推进效率 2025 年共有10 款关键分子进入 III 期开发，同时 12 项后期临床研究获阳性结果，覆盖血液癌、肾病、自身免疫等领域，为未来 3-5 年产品上市储备充足动力。四、管理层变动：董事会新增数字化领导力，成员正常更替新增董事提名 ：董事会提议选举法国兴业银行执行副总裁 Lubomira Rochet（1977 年生）为新董事，其在 “数字化转型与技术驱动业务变革” 领域拥有深厚经验，将助力罗氏提升数字化竞争力。董事离任 ：Claudia Suessmuth Dyckerhoff 博士决定不再参与 2026 年股东大会的董事连任选举，属于正常人事更替。五、2026 年展望：营收与利润目标明确，股息持续上调 罗氏对 2026 年全球业务增长保持乐观，基于现有产品 momentum 与研发管线潜力，提出以下目标：集团销售额 ：预计增长 “中个位数”（CER）。核心每股收益 ：预计增长 “高个位数”（CER）。股息政策 ：计划继续以瑞士法郎上调股息，维持长期稳定的股东回报机制。六、补充信息：区域销售与公司定位1. 区域销售分布（制药事业部） 区域 2025 年销售额（亿 CHF） 占比 同比增速（CER） 增长动力 美国 253.55 53.2% +8% Xolair、Ocrevus、Phesgo 欧洲 91.64 19.2% +5% Ocrevus、Vabysmo、Polivy 日本 28.82 6.0% +5% Phesgo、Vabysmo、Hemlibra 国际（含中国） 102.68 21.6% +14% Phesgo（医保纳入）、Xofluza2. 公司定位 罗氏成立于 1896 年，总部位于瑞士巴塞尔，是全球最大的生物技术公司与体外诊断领导者，致力于通过 “制药 + 诊断” 双轮驱动个性化医疗；同时承诺 2045 年实现碳中和，将可持续发展融入业务核心。 综上，2025 年罗氏通过 “核心药物放量 + 诊断技术突破 + 研发管线高效推进” 实现稳健增长，2026 年将继续依托差异化产品与全球化布局，巩固在医疗健康领域的领先地位。 网页信息：Group sales grew by 7%1 at constant exchange rates (CER; 2% in CHF), driven by strong demand for medicines and diagnostic solutions. Sales in the fourth quarter increased by 8%, reflecting the positive momentum.Pharmaceuticals Division sales  increased by 9% (3% in CHF), with Phesgo (breast cancer), Xolair (food allergies), Ocrevus (multiple sclerosis), Hemlibra (haemophilia A) and Vabysmo (severe eye diseases) being the top growth drivers.Diagnostics Division sales  grew 2% (-3% in CHF) as demand for pathology and molecular solutions continued to more than offset the impact of healthcare pricing reforms in China.Core operating profit  increased by 13% (5% in CHF), driven by higher sales and efficiency gains.Core earnings per share  showed growth of 11% (4% in CHF); IFRS net income increased by 58% (50% in CHF), due to the strong operational performance in 2025 and the base effect of impairment charges in 2024.Highlights: US and EU approval for the subcutaneous form of Lunsumio for a type of blood cancer EU approval for Gazyva/Gazyvaro for lupus nephritis, a serious kidney disease Positive data on several therapies: (phase III) giredestrant for breast cancer, fenebrutinib for two forms of multiple sclerosis, Gazyva/Gazyvaro for two immune-related diseases, PiaSky for a rare, life-threatening kidney condition and Enspryng for a rare autoimmune disease that affects the brain, spinal cord and optic nerves; (phase II) CT-388 for obesity Advancement of 10 key molecules into phase III development in 2025 EU CE mark for novel Elecsys Dengue Ag test to diagnose dengue and for cobas BV/CV assay to improve diagnostic accuracy for women affected by vaginitis CE Mark for test to monitor antibiotic therapies, expanding the only automated mass spectrometry platform on the market to an in vitro diagnostic menu of 39 tests Board proposes a dividend increase to CHF 9.80 per share and non-voting equity security. If approved by shareholders, this would be the 39th consecutive dividend increase. Change in Board of Directors Outlook for 2026Roche (SIX: RO, ROG; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs.Key figuresCHF millions% changeJanuary–December20252024At CER1In CHF Group sales 61,516 60,495 7 2 Pharmaceuticals Division 47,669 46,171 9 3 Diagnostics Division 13,847 14,324 2 -3 Core operating profit 21,833 20,823 13 5 Core EPS – diluted (CHF) 19.46 18.80 11 4 IFRS net income 13,799 9,187 58 50 Roche CEO Thomas Schinecker: “2025 was a strong year for Roche, reflecting our continued focus on operational and R&D excellence. We have significant momentum across our pharmaceutical pipeline: ten potential new medicines advanced into final-stage development, and 12 late-stage clinical studies delivered positive results. We had important breakthroughs in lupus and oestrogen receptor-positive breast cancer, which accounts for approximately 70% of all breast cancer cases, as well as the first positive late-stage clinical results in a new therapy for multiple sclerosis. We are also setting new standards in diagnostics: our next-generation sequencing technology, which will be launched this year, decoded an entire human genome in less than four hours. With our strong financial performance and our continued progress in innovation, we are well positioned for growth.” Change in Board of DirectorsThe Board of Directors will propose Lubomira Rochet (1977), Executive Vice President and member of the Group Executive Committee of Societe Generale, for election as a new Board member at the upcoming Annual General Meeting. Severin Schwan, Chairman of the Board: “Lubomira Rochet brings a broad leadership track record and deep experience in business transformations through digital and technology. I am very pleased that we can propose her for election to the Board of Directors.” As previously announced, Dr Claudia Suessmuth Dyckerhoff has decided not to stand for re-election as a member of the Roche Board of Directors at the Annual General Meeting in 2026. Group resultsIn 2025, Roche achieved sales growth of 7% (2% in CHF) to CHF 61.5 billion due to strong demand for pharmaceutical products and diagnostic solutions. The appreciation of the Swiss franc against most currencies, notably the US dollar, had a significant impact on the results reported in Swiss francs compared to constant exchange rates. Core operating profit increased by 13% (5% in CHF) to CHF 21.8 billion, driven by higher sales and efficiency gains. Core earnings per share increased by 11% (4% in CHF). IFRS net income increased by 58% (50% in CHF) to CHF 13.8 billion due to the strong operating performance in 2025 and the base effect of impairment charges in 2024. Sales in the Pharmaceuticals Division increased by 9% (3% in CHF) to CHF 47.7 billion, with medicines for severe diseases continuing their strong growth. The top five growth drivers – Phesgo, Xolair, Ocrevus, Hemlibra and Vabysmo – achieved total sales of CHF 21.4 billion, an increase of CHF 3.2 billion (CER) compared to 2024. Sales of products with expired patents – Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Esbriet (lung disease), Lucentis (severe eye diseases) and Actemra/RoActemra (rheumatoid arthritis) – decreased by a combined CHF 0.7 billion (CER). In the United States, sales rose by 8% due to continued growth of Xolair and continuing uptake of Ocrevus, Phesgo, Hemlibra and Polivy (blood cancer). This growth more than compensated for the decline in sales of medicines with expired patents. Sales in Europe grew 5% as strong demand for Ocrevus and Vabysmo and the continuing uptake of Polivy, Hemlibra and Phesgo more than compensated for the lower sales of Perjeta (breast cancer) due to the ongoing conversion of patients to Phesgo, and the impact of biosimilar competition on Actemra/RoActemra sales. In Japan, sales increased by 5%, mainly due to the strong uptake of Phesgo, Vabysmo, Hemlibra,  Enspryng (acute inflammation of optic nerve and spinal cord) and PiaSky (paroxysmal nocturnal haemoglobinuria). Sales growth was partially offset by the decline in sales of Avastin because of biosimilar erosion and Perjeta due to the continued conversion of patients to Phesgo. Sales in the International region rose by 14%, led by Phesgo, Xofluza (influenza), Hemlibra, Vabysmo, Elevidys (Duchenne muscular dystrophy) and Polivy. In China, sales rose by 10%, driven by the uptake of Phesgo due to the inclusion in the government drug reimbursement list, strong sales of Xofluza and the continued roll-out of Vabysmo and Polivy. The Diagnostics Division’s sales increased by 2% (-3% in CHF) to CHF 13.8 billion as growth in demand for pathology and molecular solutions more than offset the impact of healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region increased by 6%, driven by higher sales of clinical chemistry and immunodiagnostic products. In North America, sales increased by 9%, with growth across all customer areas. Sales in Asia-Pacific decreased by 12% due to healthcare pricing reforms in China. In Latin America, sales grew by 11%. Pharmaceuticals Division: pipelineWith 66 new molecular entities (NMEs) and a total of 107 projects, Roche has a promising pipeline with a wide variety of therapeutic approaches. Pharmaceuticals research and development (R&D) expenditure decreased by 3% to CHF 10.4 billion (Group R&D: -3% to CHF 12.2 billion). Oncology remained the primary area for R&D, with substantial investments also in the areas of cardiovascular, renal and metabolism and immunology. 集团销售额按固定汇率（CER）计算增长 7%1（按瑞士法郎计算增长 2%），这得益于对药品和诊断解决方案的强劲需求。 第四季度销售额增长 8%，反映出积极的发展势头。 制药部门销售额增长 9%（按瑞士法郎计算增长 3%），其中 Phesgo（乳腺癌治疗药物）、Xolair（食物过敏治疗药物）、Ocrevus（多发性硬化症治疗药物）、Hemlibra（A 型血友病治疗药物）和 Vabysmo（严重眼病治疗药物）是主要的增长驱动力。 诊断部门销售额增长 2%（按瑞士法郎计算下降 3%），这是因为对病理学和分子解决方案的需求持续增长，足以抵消中国医疗定价改革带来的影响。 核心营业利润增长 13%（按瑞士法郎计算增长 5%），这得益于销售额的增长和效率的提升。 核心每股收益增长 11%（按瑞士法郎计算增长 4%）；国际财务报告准则（IFRS）净利润增长 58%（按瑞士法郎计算增长 50%），这归因于 2025 年强劲的运营表现以及 2024 年减值费用的基数效应。 亮点：美国和欧盟批准 Lunsumio 的皮下注射剂型用于治疗一种血癌欧盟批准 Gazyva/Gazyvaro 用于治疗狼疮性肾炎（一种严重的肾脏疾病）多项疗法取得积极数据：（III 期）giredestrant 用于乳腺癌治疗、fenebrutinib 用于两种多发性硬化症治疗、Gazyva/Gazyvaro 用于两种免疫相关疾病治疗、PiaSky 用于一种罕见的危及生命的肾脏疾病治疗以及 Enspryng 用于一种影响大脑、脊髓和视神经的罕见自身免疫性疾病治疗；（II 期）CT-388 用于肥胖症治疗2025 年有 10 个关键分子进入 III 期研发阶段新型 Elecsys 登革热抗原检测试剂获得欧盟 CE 认证，可用于诊断登革热；cobas BV/CV 检测试剂也获得认证，能提高对阴道炎女性患者的诊断准确性用于监测抗生素治疗的检测试剂获得 CE 认证，将市场上唯一的自动化质谱平台扩展至包含 39 项检测的体外诊断菜单董事会提议将每股股息及无投票权股权证券的股息提高至 9.80 瑞士法郎。若获得股东批准，这将是连续第 39 次提高股息。董事会变更 2026 年展望罗氏（瑞士证券交易所：RO、ROG；场外交易市场 QX：RHHBY）预计 2026 年集团销售额按固定汇率计算将实现中个位数增长。核心每股收益目标按固定汇率计算实现高个位数增长。罗氏预计将进一步提高以瑞士法郎计价的股息。 关键数据  单位：百万瑞士法郎  增长率（%）1-12 月  2025 年  2024 年  按固定汇率 1  按瑞士法郎集团销售额  61,516  60,495  7  2制药部门  47,669  46,171  9  3诊断部门  13,847  14,324  2  -3核心营业利润  21,833  20,823  13  5核心每股收益（稀释后，单位：瑞士法郎）  19.46  18.80  11  4国际财务报告准则净利润  13,799  9,187  58  50 罗氏首席执行官 Thomas Schinecker 表示：“2025 年对罗氏而言是强劲的一年，这体现了我们持续专注于卓越运营和研发。 我们的制药产品线势头强劲：10 种潜在新药进入最终研发阶段，12 项后期临床研究取得积极成果。我们在狼疮和雌激素受体阳性乳腺癌（约占所有乳腺癌病例的 70%）治疗方面取得了重要突破，在多发性硬化症新疗法方面也获得了首个积极的后期临床结果。 我们在诊断领域也树立了新的标准：我们将于今年推出的下一代测序技术，能在不到 4 小时内解码整个人类基因组。 凭借强劲的财务表现和在创新方面的持续进展，我们已为增长做好充分准备。” 董事会变更董事会将提议 Lubomira Rochet（1977 年生）在即将召开的年度股东大会上当选为新的董事会成员，她目前是法国兴业银行执行副总裁兼集团执行委员会成员。董事会主席 Severin Schwan 表示：“Lubomira Rochet 拥有丰富的领导经验，在通过数字技术实现业务转型方面具备深厚资历。我非常高兴我们能提议她当选为董事会成员。” 如先前宣布，Claudia Suessmuth Dyckerhoff 博士决定不在 2026 年的年度股东大会上寻求连任罗氏董事会成员。 集团业绩2025 年，得益于对药品和诊断解决方案的强劲需求，罗氏销售额增长 7%（按瑞士法郎计算增长 2%），达到 615 亿瑞士法郎。 与固定汇率相比，瑞士法郎对大多数货币（尤其是美元）的升值对以瑞士法郎计价的业绩产生了重大影响。 核心营业利润增长 13%（按瑞士法郎计算增长 5%），达到 218 亿瑞士法郎，这得益于销售额的增长和效率的提升。 核心每股收益增长 11%（按瑞士法郎计算增长 4%）。 国际财务报告准则净利润增长 58%（按瑞士法郎计算增长 50%），达到 138 亿瑞士法郎，这归因于 2025 年强劲的运营表现以及 2024 年减值费用的基数效应。 制药部门销售额增长 9%（按瑞士法郎计算增长 3%），达到 477 亿瑞士法郎，用于治疗严重疾病的药物继续保持强劲增长。 五大增长驱动力 ——Phesgo、Xolair、Ocrevus、Hemlibra 和 Vabysmo 的总销售额达到 214 亿瑞士法郎，按固定汇率计算较 2024 年增长 32 亿瑞士法郎。 专利到期产品的销售额 —— 安维汀（用于多种癌症）、赫赛汀（用于乳腺癌和胃癌）、美罗华（用于血癌、类风湿性关节炎）、吡非尼酮（用于肺部疾病）、雷珠单抗（用于严重眼病）和托珠单抗（用于类风湿性关节炎）—— 按固定汇率计算合计下降 7 亿瑞士法郎。 在美国，由于 Xolair 的持续增长以及 Ocrevus、Phesgo、Hemlibra 和 Polivy（血癌治疗药物）的持续推广，销售额增长 8%。这一增长足以抵消专利到期药物销售额的下降。 在欧洲，销售额增长 5%，这是因为对 Ocrevus 和 Vabysmo 的强劲需求以及 Polivy、Hemlibra 和 Phesgo 的持续推广，足以抵消因患者持续转向 Phesgo 导致的帕妥珠单抗（乳腺癌治疗药物）销售额下降以及生物类似药竞争对托珠单抗销售额造成的影响。 在日本，销售额增长 5%，主要得益于 Phesgo、Vabysmo、Hemlibra、Enspryng（用于视神经和脊髓急性炎症）和 PiaSky（用于阵发性睡眠性血红蛋白尿症）的强劲推广。但由于生物类似药的冲击导致安维汀销售额下降，以及患者持续转向 Phesgo 导致帕妥珠单抗销售额下降，部分抵消了销售增长。 国际地区销售额增长 14%，主要由 Phesgo、Xofluza（流感治疗药物）、Hemlibra、Vabysmo、Elevidys（杜氏肌营养不良症治疗药物）和 Polivy 引领。在中国，由于 Phesgo 被纳入政府药品报销目录后得到推广、Xofluza 的强劲销售以及 Vabysmo 和 Polivy 的持续推出，销售额增长 10%。 诊断部门销售额增长 2%（按瑞士法郎计算下降 3%），达到 138 亿瑞士法郎，这是因为对病理学和分子解决方案的需求增长足以抵消中国医疗定价改革带来的影响。 欧洲、中东和非洲（EMEA）地区销售额增长 6%，这得益于临床化学和免疫诊断产品销售额的增长。在北美，所有客户领域均实现增长，销售额增长 9%。由于中国的医疗定价改革，亚太地区销售额下降 12%。在拉丁美洲，销售额增长 11%。 制药部门：产品线罗氏拥有 66 个新分子实体（NMEs）和共计 107 个项目，其产品线前景广阔，涵盖多种治疗方法。 制药研发支出下降 3%，至 104 亿瑞士法郎（集团研发支出：下降 3%，至 122 亿瑞士法郎）。肿瘤学仍是研发的主要领域，同时在心血管、肾脏与代谢以及免疫学领域也有大量投资。 Pharmaceuticals: key developmentsCompoundMilestoneRegulatoryLunsumio Blood cancerFDA approves Lunsumio VELO for subcutaneous use in relapsed or refractory follicular lymphoma Lunsumio VELO reduces administration time from 2‒4 hours to approximately 1 minute. Availability of Lunsumio VELO allows treatment aligned to people’s clinical needs and personal preferences. The approval is supported by data demonstrating compelling complete response rate in third-line or later treatment of people with follicular lymphoma, a disease that typically becomes harder to treat after each relapse.More information: Media Release, 22 December 2025Gazyva/Gazyvaro Lupus nephritisEuropean Commission approves Gazyva/Gazyvaro for adults with active lupus nephritis Approval based on phase II NOBILITY and phase III REGENCY studies showing superiority of Gazyva/Gazyvaro over standard therapy alone. Gazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a benefit in a complete renal response in lupus nephritis in a randomised phase III study. Gazyva/Gazyvaro could become a new standard of care for up to an estimated 135,000 people affected by lupus nephritis in the European Union, potentially helping to delay or prevent end-stage kidney disease.More information: Media Release, 9 December 2025Lunsumio Blood cancerEuropean Commission approves Lunsumio subcutaneous for relapsed or refractory follicular lymphoma Lunsumio provides high rates of deep and long-lasting responses in third-line and later treatment of people with follicular lymphoma, a disease that typically becomes harder to treat each time a patient relapses. Lunsumio subcutaneous offers a new treatment option that can significantly reduce administration time to approximately 1 minute. Lunsumio SC allows patients to receive treatment aligned to clinical requirements and lifestyle preferences.More information: Media Release, 19 November 2025Phase III, pivotal and other key read-outsCT-388 ObesityRoche announces positive phase II results for its dual GLP-1/GIP receptor agonist CT-388 in people living with obesity A once-weekly subcutaneous injection of CT-388 achieved a statistically significant placebo-adjusted weight loss of 22.5% (p < 0.001) at 48 weeks at the highest dose tested (24 mg), without reaching a weight loss plateau.54% of participants on the 24 mg dose achieved resolution of obesity (BMI <30 kg/m2) vs 13% in the placebo group. CT-388 demonstrated a safety and tolerability profile generally consistent with that of its drug class with no new or unexpected safety signals.More information: Media Release, 27 January 2026Giredestrant Breast cancerGiredestrant reduces risk of invasive disease recurrence or death by 30% in ER-positive early-stage breast cancer Giredestrant is the only oral SERD to show superior invasive disease-free survival in the adjuvant setting, marking the first significant endocrine therapy advance in over 20 years1‒3. Transformational results support the potential of giredestrant to become a new standard-of-care for early-stage disease. ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and up to a third of patients experience recurrence on or after adjuvant endocrine therapy treatment.More information: Media Release, 10 December 2025Lunsumio Blood cancerRoche presents Lunsumio data showing potential across earlier treatment lines in indolent and aggressive lymphomas Lunsumio in combination with lenalidomide may offer an effective treatment in relapsed or refractory follicular lymphoma based on first data from single-arm US cohort of phase III CELESTIMO study. Data from subcutaneous Lunsumio plus Polivy reinforce its outpatient, chemotherapy-free potential in people with relapsed or refractory large B-cell lymphoma. Results highlight the potential of innovative Lunsumio combination regimens to offer improved outcomes for more people with lymphoma earlier in their disease.More information: Media Release, 8 December 2025Columvi Blood cancerColumvi combination shows sustained survival benefit at three-year follow-up of pivotal phase III STARGLO study Overall survival was twice as long for people treated with Columvi in combination with GemOx versus MabThera/Rituxan plus GemOx. This Columvi combination is available off-the-shelf and could offer a potentially curative treatment option for people with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who are not candidates for transplant. Columvi in combination with GemOx has now been approved in more than 50 countries worldwide and is recommended in international treatment guidelines.More information: Media Release, 8 December 2025Giredestrant Breast cancerGiredestrant becomes the first oral SERD to show superior invasive disease-free survival in early breast cancer At interim analysis, giredestrant demonstrated a statistically significant and clinically meaningful benefit versus standard-of-care endocrine monotherapy. These unprecedented results support its potential as a new standard-of-care endocrine therapy in the early-stage setting. lidERA is the second positive phase III read-out for giredestrant following evERA presented at ESMO 2025.More information: Media Release, 18 November 2025Fenebrutinib Multiple sclerosisFenebrutinib shows unprecedented positive phase III results as the potential first and only BTK inhibitor in both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) The first pivotal RMS study (FENhance 2) met its primary endpoint, with fenebrutinib significantly reducing relapses compared to teriflunomide. In the pivotal PPMS study (FENtrepid), fenebrutinib slowed disability progression at least as effectively as Ocrevus, the only approved therapy in PPMS. Full data from both studies will be shared at upcoming medical meetings; all data will be considered for regulatory submission after the second RMS study (FENhance 1) reads out, expected in the first half of 2026.More information: Media Release, 10 November 2025HaematologyRoche presents new data from its broad and innovative haematology portfolio at ASH 2025 Findings demonstrate the effectiveness of Roche’s approved medicines in advancing treatment standards for people with blood disorders. Data from innovative pipeline signals progress towards improved outcomes in haemophilia A, lymphoma and multiple myeloma.More information: Media Release, 3 November 2025Gazyva/Gazyvaro Systemic lupus erythematosusPositive phase III data for Gazyva/Gazyvaro show significant reduction in disease activity for systemic lupus erythematosus (SLE) Phase III ALLEGORY study met primary and all key secondary endpoints with Gazyva/Gazyvaro, demonstrating significant reduction in disease activity for SLE. Gazyva/Gazyvaro has the potential to become a transformative new standard of care for up to 3.4 million people affected by SLE worldwide, and would be the first anti-CD20 therapy for SLE to directly target B cells if approved. These positive results follow recent US FDA approval and positive EU CHMP opinion for Gazyva/Gazyvaro in lupus nephritis, as well as positive phase III data from the INShore study in idiopathic nephrotic syndrome.More information: Media Release, 3 November 2025Gazyva/Gazyvaro Idiopathic nephrotic syndromePositive phase III results for Gazyva/Gazyvaro in children and young adults with idiopathic nephrotic syndrome Gazyva/Gazyvaro versus mycophenolate mofetil shows significantly more children and young adults achieved sustained complete remission at week 52. If approved, Gazyva/Gazyvaro could help children and young adults sustain remission, potentially with a reduced need for steroids to manage their disease. INShore is the first global phase III study of a targeted therapy in this chronic kidney disease commonly diagnosed in early childhood.More information: Media Release, 28 October 2025Other89bio tender offerRoche completes tender offer for 89bio, Inc. shares and prepares to finalise acquisition Roche’s subsidiary Bluefin Merger Subsidiary, Inc. accepted for payment all shares validly tendered and not withdrawn in its tender offer for 89bio at USD 14.50 per share in cash plus a contingent value right for up to USD 6.00 per share. Approximately 94,113,710 shares, representing about 60.49% of 89bio’s outstanding common stock, were validly tendered and not withdrawn in the offer, and the tender offer expired on 29 October 2025. Roche intends to complete the acquisition of 89bio through a merger, after which 89bio will become a wholly owned subsidiary of Roche and its shares will be delisted from Nasdaq.More information: Media Release, 30 October 2025 Pharmaceuticals salesSalesCHF millionsAs % of sales% changeJanuary–December2025202420252024At CERIn CHF Pharmaceuticals Division 47,669 46,171 100.0 100.0 9 3 United States 25,355 24,774 53.2 53.7 8 2 Europe 9,164 8,832 19.2 19.1 5 4 Japan 2,882 2,874 6.0 6.2 5 0 International 10,268 9,691 21.6 21.0 14 6 International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, othersTop 20 best-selling pharmaceuticalsTotalUnited StatesEuropeJapanInternationalCHF m%CHF m%CHF m%CHF m%CHF m%Ocrevus Multiple sclerosis 7,010 9 4,874 7 1,451 13 - - 685 21Hemlibra Haemophilia A 4,754 11 2,665 6 1,002 10 377 8 710 38Vabysmo Eye diseases (nAMD, DME, RVO) 4,102 12 2,857 3 741 21 146 22 358 116Tecentriq Cancer immunotherapy 3,566 3 1,640 -2 878 3 349 -4 699 18Xolair2 Asthma, food allergies 3,075 32 3,075 32 - - - - - -Perjeta2 Breast cancer 2,968 -13 1,268 0 552 -13 69 -37 1,079 -21Actemra/RoActemra2 RA, COVID-19 2,470 -2 1,206 -4 588 -9 310 5 366 16Phesgo Breast cancer 2,441 48 708 31 812 12 188 44 733 172Kadcyla2 Breast cancer 2,025 7 768 6 532 -4 91 -3 634 22Evrysdi Spinal muscular atrophy 1,757 13 612 10 616 9 90 1 439 25Alecensa Lung cancer 1,562 6 565 14 262 -6 204 7 531 5Polivy Blood cancer 1,470 38 688 28 290 53 207 9 285 87MabThera/Rituxan2 Blood cancer, RA 1,251 -4 794 0 140 -5 14 -11 303 -12Activase/TNKase2 Cardiac diseases 1,107 -2 1,056 -2 - - - - 51 -11Herceptin2 Breast and gastric cancer 1,028 -22 225 -10 291 -2 7 -43 505 -32Gazyva/Gazyvaro2 Blood cancer 986 14 519 19 245 2 35 25 187 15Avastin2 Various cancer types 973 -17 299 -17 70 -16 145 -23 459 -14Pulmozyme2 Cystic fibrosis 479 12 343 20 65 -9 1 -12 70 1Xofluza Influenza 407 184 57 66 2 * - - 348 219CellCept2 Immunosuppressant 385 1 21 -5 131 8 44 17 189 -6 * Over 500%DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics Division: portfolioIn Diagnostics, Roche introduced two instrument platforms, six digital solutions and 53 new tests in 2025. The main areas of R&D activity included the development of high medical value assays, notably for the oncology disease area, as well as of digital solutions and sequencing. In addition, there were continuing investments in cardiometabolic diseases, particularly for continuous blood glucose monitoring. Diagnostics: key developmentsProductMilestonecobas Mass Spec solutionRoche expands automated mass spectrometry menu with antibiotics drug monitoring CE mark approval offering industry’s broadest in vitro diagnostic menu With this approval, Roche’s automated mass spectrometry platform now offers the industry’s broadest in vitro diagnostic menu with 39 tests, including tests for therapeutic drug monitoring for immunosuppressants and antibiotics, as well as steroid hormones and vitamin D metabolites. The comprehensive menu brings the sensitivity and specificity of gold-standard testing into routine labs for a wide range of the most frequently tested targets. The fully automated solution replaces labour-intensive manual workflows, reducing turnaround times and supporting faster, standardised, high-quality care.More information: Media Release, 11 December 2025cobas BV/CV test VaginitisRoche launches new PCR test to help improve diagnostic accuracy for women affected by vaginitis in countries following the CE mark The new PCR test aids in the diagnosis of infectious causes of vaginitis through the detection of bacteria associated with bacterial vaginosis and yeast associated with candida vaginitis. The test will help improve diagnostic accuracy for millions of women affected by vaginitis annually, delivering more accurate and specific results. This test offers faster diagnosis by using a single vaginal swab for broader sexual health testing, eliminating the need for an additional sample.More information: Media Release, 9 December 2025cobas liat Bordetella panel Infectious diseasesRoche receives FDA clearance with CLIA waiver and CE mark for its first point-of-care test for diagnosing Bordetella infections, including whooping cough (pertussis) The point-of-care test delivers PCR-accurate results in just 15 minutes, enabling healthcare providers to act quickly and prevent severe complications and onward transmission. The test detects and differentiates between three types of Bordetella infection that can cause similar cough symptoms, ensuring patients receive the right diagnosis at the earliest opportunity. Early diagnosis can reduce the risk of complications and severe disease in vulnerable groups such as infants and the elderly, by enabling faster, more precise care decisions.More information: Media Release, 2 December 2025Elecsys Dengue Ag test DengueRoche receives CE mark for novel automated high-throughput Elecsys Dengue Ag test to diagnose dengue New dengue antigen test delivers high clinical sensitivity and specificity, as well as inclusivity for all four dengue virus serotypes, helping clinicians confidently distinguish dengue from other acute fever-causing illnesses. Full automation facilitates medium to high throughput and enables improvement of lab efficiency and test traceability, while reducing the risk of human error. Test delivers results in just 18 minutes, enabling faster laboratory workflows and patient management during outbreaks.More information: Media Release, 29 October 2025 Diagnostics salesSalesCHF millionsAs % of sales% changeJanuary–December2025202420252024At CERIn CHF Diagnostics Division 13,847 14,324 100.0 100.0 2 -3Customer areas3 Core Lab 7,614 8,011 55.0 55.9 0 -5 Molecular Lab 2,527 2,554 18.3 17.8 4 -1 Near Patient Care 1,983 2,160 14.3 15.1 -3 -8 Pathology Lab 1,723 1,599 12.4 11.2 14 8 Regions Europe, Middle East, Africa 4,965 4,822 35.9 33.7 6 3 North America 4,444 4,335 32.1 30.3 9 3 Asia-Pacific 3,386 4,099 24.4 28.6 -12 -17 Latin America 1,052 1,068 7.6 7.4 11 -1