Faricimab

关注并星标CPHI制药在线 1月29日，罗氏发布2025年财报，全年营收615.16亿瑞士法郎（约744.28亿美元），同比增长7%，延续了稳健的增长态势。研发投入122.43亿瑞士法郎（约148.13亿美元），占总营收的20%，但较2024年研发投入规模略有下降。 罗氏收入来自制药和诊断业务两部分，其中制药业务收入476.69亿瑞士法郎（约576.27亿美元），同比增长9%。全球诊断业务收入138.47亿瑞士法郎（约167.53亿美元），同比增长2%。 从地区来看，制药业务中美国是最大收入来源，共收入253.55 亿瑞士法郎，同比增长8%。聚焦中国区，2025年罗氏制药业务同比增长10%，收入30.34亿瑞士法郎，但诊断业务收入严重下滑，同比下降24%至17.26亿瑞士法郎。 细看制药业务，2025年罗氏各治疗领域均保持增长趋势，其中肿瘤领域是最大收入来源，共收入239.38亿瑞士法郎，同比增长6%。神经科学、免疫、眼科领域增长明显，分别同比增长11%、12%和10%。 具体品种来看，Phesgo、Xolair、Ocrevus、Hemlibra、Vabysmo 五大重磅产品成为拉动罗氏制药业务的绝对核心，据统计这五款药物2025年合计销售额达214亿瑞士法郎，较2024年同比增加32亿瑞士法郎，这一增长不仅完全覆盖了Avastin、Herceptin等专利到期产品合计7亿瑞士法郎的销售额下滑，更成为制药业务增长的第一动力。同时Polivy等新晋品种表现亮眼，与2024年形成鲜明的增长格局，成为财报最亮眼的看点。 肿瘤领域中，Phesgo作为罗氏对冲HER2靶点老药专利悬崖的核心品种，2025年迎来爆发式增长，全年销售额同比增增长48%。Phesgo凭借皮下注射的剂型优势，将给药时间从数小时缩短至5分钟，叠加中国市场医保准入的红利，前三季度在华销售额就达18.27亿瑞士法郎，成为乳腺癌领域的新晋爆款。同时在欧美日市场，患者持续从Perjeta向Phesgo转换，进一步推高销量，成为罗氏肿瘤板块为数不多的高增长品种。 免疫领域， Xolair随着食物过敏新适应症的商业化落地，在欧美市场快速渗透，叠加传统过敏性哮喘、慢性自发性荨麻疹适应症的稳定需求，成为全球食物过敏治疗领域的标杆产品。其中美国市场是Xolair最大增量来源，销售额占比超七成，成为拉动罗氏美国市场增长的核心动力之一。 神经科学领域，多发性硬化症Ocrevus 2025年保持稳健增长，全年销售额同比增长9%，持续坐稳全球多发性硬化症治疗药物的头把交椅。该药在欧美市场的渗透率已接近天花板，但在亚太、拉美等新兴市场仍实现快速增长，同时凭借长期的临床数据优势，不断巩固在一线治疗中的地位，2025年销售额就达70.10亿瑞士法郎，其中美国市场贡献超48.74亿瑞士法郎，是罗氏神经板块的收入压舱石。 眼科领域，Vabysmo作为全球首个VEGF/Ang-2双抗，2025年延续高增态势，全年销售额同比增长12%至约41.02亿瑞士法郎，跻身罗氏“50亿美元俱乐部”，成为罗氏眼科板块的核心增长引擎。 此外，罗氏多款新晋重磅品种表现亮眼，成为业绩增长的重要补充，尤其在血液肿瘤、抗流感等领域，形成新的增长极。其中Polivy 2025年销售额同比增长38%至14.70亿瑞士法郎，成为血液肿瘤领域的爆款ADC，而且这主要得益于一线DLBCL适应症的获批。双抗药物中，Columvi和Lunsumio表现也相当亮眼，分别同比增长75%和68%，至2.88亿瑞士法郎和1.14亿瑞士法郎，这彰显了罗氏在双抗赛道的研发与商业化实力。 研发上，罗氏2025年虽小幅降低了研发投入规模，但研发效率显著提升，管线推进节奏持续加快。相较于2024年研发管线的调整与优化，2025年罗氏在核心赛道的临床进展频频落地：Susvimo获美国FDA批准用于糖尿病视网膜病变，Itovebi获欧盟批准用于晚期乳腺癌，多款药物进入3期临床阶段，同时在GLP-1、RNAi疗法等前沿赛道的布局也稳步推进。 而且，罗氏在公布2025年财报时，也透露了2025年第四季度管线变动情况,包括新增10个管线项目和剔除7个管线项目。其中新增管线涉及眼科药物RG6913、小核酸药物RG6496、炎症性肠病（IBD）药物RG6498等。 总结 2025年的财报成绩，印证了罗氏“聚焦核心重磅产品、打造多赛道增长极”战略调整的有效性。在专利到期、市场竞争加剧的行业背景下，通过核心品种的强势放量、新晋品种的快速补位，实现了营收与盈利的双提升。对比2024年，罗氏的产品增长更加多元，从“肿瘤单极驱动”转向“肿瘤、免疫、神经、罕见病、眼科多极发力”，而其在ADC、双抗等前沿技术领域的布局，也为后续业绩增长提供了坚实支撑。对于罗氏而言，2026年将面临Xolair等核心产品即将迎来生物类似药竞争的挑战，如何持续挖掘现有重磅产品的市场潜力，加速创新管线的商业化落地，将成为其维持增长态势的关键。 END 扫码领取CPHI China2026展会门票 智药研习社近期直播 来源：CPHI制药在线 声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。 投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

A potential FDA approval of giredestrant in breast cancer and a phase 3 readout for fenebrutinib in relapsing multiple sclerosis are key events in 2026 for Roche's pharma division, which is led by Teresa Graham. Roche is looking to a busy 2026 after 10 new molecules entered late-stage testing last year and as a potential launch of closely watched breast cancer candidate giredestrant draws near.But behind another strong report marked by a 9% annual sales growth at constant exchange rates in the pharmaceutical division, a miss from the star eye drug Vabysmo stood out.With 4.1 billion Swiss francs ($5.3 billion) in sales in 2025, Vabysmo was Roche’s No. 3 drug by sales, a remarkable feat considering the bispecific antibody was first approved by the FDA in 2022.Nevertheless, the drug’s 1 billion Swiss francs haul in the fourth quarter undershot analysts’ consensus by 8%, according to Jefferies. Its sales in the second half of 2025 were 32 million Swiss francs lower than in the first half. Ophthalmology market dynamicsThe slowdown was caused by the “contraction of the U.S. branded market” of anti-VEGF drugs for conditions such as wet age-related macular degeneration, Roche’s pharma chief Teresa Graham told investors on a conference call Thursday.“We saw a big reset in the branded market in the U.S.,” Graham said. “With the closure of the copay foundations, fewer patients were put on branded drugs, [and] more patients were put on Avastin and biosimilars.”The branded intravitreal injection market in the U.S. shrank by 15% throughout 2025, Graham noted. Despite the overall market slowdown, Vabysmo still gained market share, according to Roche. And these days, more than 60% of Vabysmo patient starts in the U.S. are from treatment-naïve individuals, which Graham said “further solidifies Vabysmo’s position as the standard of care.” The Swiss pharma expects a growth acceleration for Vabysmo in 2026 driven by ex-U.S. launches and recovery in the U.S.What gives Roche confidence in a recovery is what’s known as “the blizzard,” Graham explained. In the next few months, retinal specialists in the U.S. are expected to reverify their patients' insurance benefits. As new coverage plans take effect and deductibles and out-of-pocket costs reset, patients will determine whether to stay on existing medications or switch. That should allow Roche to “see the actual branded growth” without the effect of donations, as people go on to new therapies, she said.But as one analyst pointed out on the call, more competition could be coming in addition to Regeneron’s Eylea franchise. Ocular Therapeutix is nearing a pivotal wet AMD readout for its Axpaxli, which is administered less frequently at six months between doses. Vabysmo allows for treatment intervals of up to four months. Doctors already have a lot of good experience in extending doses with Vabysmo, Graham noted. As to the Ocular product, Graham argued that a well-defined safety profile will give Vabysmo an advantage.“This drug is going into phase 3 with a very small safety database and really no known data on long-term safety,” the Roche exec said of the competitor. “When you talk about something that’s [administered] interocularly over a long period of time, long-term safety is incredibly important.”Previously, a safety concern tripped up Novartis’ once-hyped anti-VEGF eye drug Beovu even after its FDA approval. Tecentriq trial miss Besides the Vabysmo slowdown, Roche snuck a piece of bad news from its oncology department into its full-year earnings report. After a long wait, Roche has called its quits on a phase 3 trial of Tecentriq as a perioperative treatment for resectable early-stage non-small cell lung cancer.The phase 3 IMpower030 trial did not meet its primary endpoint of event-free survival in the overall study population, a Roche spokesperson confirmed to Fierce Pharma. That’s a big disappointment for the brand, considering that Merck & Co.’s Keytruda, Bristol Myers Squibb’s Opdivo and AstraZeneca’s Imfinzi have all been approved as part of separate perioperative treatment regimens in resectable NSCLC.Despite the flop, Tecentriq demonstrated a clinically meaningful improvement of EFS in the subgroup of patients with wild-type tumors without EGFR or ALK genomic alterations, the spokesperson noted.Tecentriq returned to growth last year with sales of nearly 3.6 billion Swiss francs. Roche’s oncology business—excluding blood cancer drugs—grew sales by 2% year over year at constant exchange rates, driven by the company's HER2 franchise. But with continued biosimilar erosion and competitive pressure from AZ and Daiichi’s antibody-drug conjugate Enhertu, Roche expects sales from its HER2 franchise will peak this year at about 9 billion Swiss francs.Meanwhile, attention on Roche’s oncology portfolio is shifting from HER2 to the oral SERD drug giredestrant, which the company suggests could replace existing standard-of-care endocrine therapy in HR-positive breast cancer.The Swiss pharma has filed giredestrant in second-line HR-positive, HER2-negative breast cancer with the FDA and expects to do the same for its adjuvant use in early breast cancer in the first half of this year. A phase 3 readout from the persevERA trial in the first-line setting is also expected this year. BTK inhibitor updateAnother key phase 3 readout Roche expects this year is FENhance 1, the second for fenebrutinib in relapsing multiple sclerosis. Investors were getting anxious after the FDA turned down Sanofi’s rival BTK inhibitor tolebrutinib. But Graham argued that people should not apply tolebrutinib’s case to fenebrutinib.“We have to be very, very cautious here,” she said. “If you actually read that [complete response letter], it is incredibly specific to the risk-benefit that was seen with tolebrutinib. And unfortunately, they had a number of failed trials. They had a number of Hy’s law cases.” The FDA identified six cases in Sanofi’s phase 3 program that met Hy’s Law—a principle for assessing the risk of drug-induced liver injury—out of 2,700 total patients. Roche’s fenebrutinib program also experienced a liver toxicity signal. One of the two cases of elevated liver enzymes that caught the FDA’s attention met Hy’s Law, and the other one was confounded by alcohol use. The one confirmed case is from FENhance 1, which remains blinded, according to Graham. “It’s also really important to note that since we put liver monitoring in place in the clinical trials, we have not seen any more cases,” Graham said. “So I think we feel very good about the overall benefit-risk profile that we have with fenebrutinib, particularly when you consider the other half of that coin, which is the benefit.”All told, Roche’s group sales grew by 7% at constant exchange rates to 61.5 billion Swiss francs in 2025, including 47.7 billion from the pharma division.