Sanofi

又一国产PD-1闯关FDA成功，并一连获批两项适应证！今日（4月25日），正大天晴、康方生物分别在官微宣布，安尼可（派安普利单抗注射液）已获得美国FDA批准上市，用于治疗复发或转移性鼻咽癌（NPC）的一线治疗和以铂类为基础的至少一线化疗治疗进展后治疗的2项适应证。派安普利单抗是正大天晴/康方生物第一个获美国FDA批准上市的创新生物药，也是第一个由中国公司全过程独立主导(研发，临床，生产供药和申报注册)且成功获得FDA批准上市的创新生物药。该产品由康方生物自主研发，并由康方生物与正大天晴合资的正大天晴康方负责后续开发和商业化。此次2项适应证获批，是基于国际多中心III期临床研究AK105-304研究和关键注册性研究AK105-202研究。其中，AK105-304研究是一项纳入了全球不同种族鼻咽癌患者的随机、双盲、国际多中心Ⅲ期注册性临床试验。该研究的数据将在2025年美国癌症研究协会年会（AACR）上以口头报告（Oral）的形式发布。2023年10月，君实生物特瑞普利单抗获得美国FDA批准上市，成为美国首个且唯一获批用于鼻咽癌治疗的药物，填补了美国鼻咽癌的治疗空白。不久后，君实合作伙伴Coherus公示了PD-1特瑞普利单抗在美定价，8892.03美元/瓶，折合人民币约为6.4万元，是国内定价的30倍，相当“诱人”。此次派安普利单抗同样闯入美国鼻咽癌市场后，如何定价、定什么样的价、能定多高的价，正大天晴康方PD-1在国际市场上市商业化的首次突破，将取得什么样的表现，值得期待。而截至到目前，中国PD-1在美获批数量达到三款，分别来自百济、君实、正大天晴/康方。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化 ｜ 猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖 ｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 |  荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药 ｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

制药巨头陆续公布2025Q1财报。面对专利到期、市场竞争和政策环境压力，MNC公司继续在创新产品和全球市场扩张上寻找增长机会。本文汇总默沙东、罗氏、赛诺菲、百时美施贵宝的第一季度表现，透视巨头开年业绩走向。默沙东默沙东公布2025年第一季度业绩，总营收155.29亿美元，同比下降2%，其中制药业务收入136.38亿美元，同比下降3%。中国区收入同比下滑62%至6.68亿美元，占据默沙东全球制药业务4.9%的份额。研发投入为36.21亿美元，同比下降9%。 2025年Q1，Keytruda（帕博利珠单抗）依然稳稳地撑起了默沙东的收入大盘，以4%的增长速度创收72.05亿美元，其销售额约占默沙东Q1总营收的46%。K药的增长主要得益于全球对早期适应症（包括三阴性乳腺癌、肾细胞癌和非小细胞肺癌），以及转移适应症（包括膀胱癌、子宫内膜癌和MSI-H癌症）的持续强劲需求。此外，默沙东成功研发出了K药的皮下注射制剂，大幅缩短了给药时间，平均仅需2分钟。目前，该制剂的上市申请正在接受美国和欧洲监管机构的审查，美国的PDUFA日期定于今年9月23日。默沙东其他的肿瘤产品也有不错表现。全球首创HIF-2α抑制剂Welireg取得1.37亿美元的销售额，同比增长62%。合作开发产品Lynparza（奥拉帕利）、Lenvima（仑伐替尼）、Reblozyl（罗特西普）则分别为默沙东带来了3.21、2.58、1.19亿美元的收入。HPV疫苗Gardasil/Gardasil 9在Q1的销售额为13.27亿美元，同比下降41%，这主要下是由于中国地区需求下降，库存仍居高不下。除中国外，其销售额增长14%。不久前，Gardasil 9在华获批新适应证，适用于16-26岁男性接种。心血管领域，肺动脉高压（PAH）新药Winrevair收入2.8亿美元，该药物是第一个被批准用于治疗PAH的激活素信号抑制剂疗法，仅需每3周皮下注射一次。在III期ZENITH研究中，与安慰剂相比，Winrevair将PAH的全因死亡、肺移植和住院综合风险降低了76%，由于中期分析的压倒性疗效，该研究提前停止。默沙东还引进了恒瑞的一款口服Lp(a)抑制剂HRS-5346，以扩展和补充其心血管代谢产品管线，交易首付款为2亿美元，里程碑付款最高可达17.7亿美元。默沙东预计2025年全年销售额将在641亿美元至656亿美元之间，这一展望包括美国政府迄今对其他国家进口商品实施的关税的影响，以及外国政府对美国征收的关税，其中最主要的关税与中国有关。默沙东估计关税将导致约2亿美元的增量成本，对毛利率产生负面影响。罗氏2025年第一季度，罗氏总营收154.40亿瑞士法郎（约172.40亿美元，按2025年平均汇率换算，1瑞士法郎=1.1166美元，下同），同比增长6%（按固定汇率计算），其中制药业务收入119.49亿瑞士法郎（约133.42亿美元，+8%），诊断业务收入34.91亿瑞士法郎（约38.98亿美元，与去年Q1持平）。此外，中国区制药业务实现了强劲增长（+14%）。今年第一季度，罗氏共有3款创新药的销售额超过十亿美元，其中Phesgo（帕妥珠单抗曲妥珠单抗皮下注射制剂）、Vabysmo（法瑞西单抗）、Xolair（玛巴洛沙韦）和Hemlibra（艾美赛珠单抗）表现突出，分别收入5.93亿瑞士法郎（约6.62亿美元，+52%）、10.18亿瑞士法郎（约11.37亿美元，+18%）、6.45亿瑞士法郎（约7.20亿美元，+26%）和11.65亿瑞士法郎（约13.01亿美元，+11%）。管线进展方面，罗氏透露了将在今年启动Aβ双抗Trontinemab治疗阿尔茨海默病的III期研究的计划，并披露了3个被剔除的项目，包括：①TGF-β3 单抗RG6315治疗纤维化的I期研究②Muc1 CAR T细胞疗法P-MUC1C-ALLO1治疗实体瘤的I期研究③TIGIT单抗tiragolumab联合阿替利珠单抗治疗局部晚期食管癌的III期研究。 赛诺菲2025年第一季度，赛诺菲总营收98.95亿欧元（约104.57亿美元，按2025年平均汇率换算，1欧元=1.0568美元，下同），同比增长9..7%（按固定汇率计算，下同）；研发投入18.08亿欧元（约19.11亿美元，+6.9%），占总营收的18.3%。从地域分布来看，美国市场收入46.57亿欧元（约49.22亿美元，+15.4%），欧洲市场收入20.43亿欧元（约21.59亿美元，+0.5%），中国市场收入7.01亿欧元（约7.41亿美元，-1.7%），从业务板块来看，赛诺菲免疫、罕见病、神经、肿瘤、疫苗以及其他类六大板块分别收入35.91亿欧元（约37.95亿美元）、15.66亿欧元（约16.55亿美元）、0.65亿欧元（约0.69亿美元）、2.55亿欧元（约2.69亿美元）、13.27亿欧元（约14.02亿美元）和30.92亿欧元（约32.68亿美元）。除了业绩，赛诺菲也在财报中透露了今年将达成的重要里程碑事件：度普利尤单抗治疗天疱疮（BP）的上市申请将在6月20日之前迎来FDA的审批决定第二季度将在美国递交艾沙妥昔单抗皮下制剂的上市申请2025年下半年将启动TL1A单抗Duvakitug的首个III期临床试验 2025年下半年将公布IL-33单抗Itepekimab治疗COPD的 III期研究数据，并在欧美递交其上市申请2025年下半年将公布TNFR1抑制剂balinatunfib治疗类风湿性关节的II期研究数据CD3单抗替利珠单抗用于延缓1型糖尿病发病的上市申请将在2025年下半年迎来中国国家药监局的审批决定2025年下半年将公布RSV mRNA疫苗SP0256的II期研究数据血友病RNAi疗法fitusiran的上市申请将在2025年下半年迎来中国国家药监局的审批决定BTK抑制剂Rilzabrutinib治疗免疫性血小板减少症的上市申请将在8月29日之前迎来FDA的审批决定BTK抑制剂Tolebrutinib治疗非复发性继发进展型多发性硬化症的上市申请将在9月28日之前迎来FDA的审批决定2025年下半年将公布BTK抑制剂Tolebrutinib治疗原发进展型多发性硬化症的III期研究数据2025年下半年将公布核药SAR447873治疗胃肠胰神经内分泌肿瘤的最终II期数据百时美施贵宝2025年第一季度，BMS总收入为112亿美元（-6%），其中美国收入为79亿美元（-7%），其他地区收入为33亿美元（-2%）。 BMS把产品划分为增长产品（Growth Products）和成熟产品（Legacy Products），一季度增长产品收入为56亿美元（+16%），主要由Opdivo、Breyanzi、Reblozyl 、Camzyos和Cobenfy等产品驱动。鉴于这一增长，BMS将2025年收入指引上调至458亿~468亿美元。从BMS肿瘤、血液、心血管、免疫和神经科学五大业务板块的重点产品来看，有以下显著变化：肿瘤产品Opdivo（纳武利尤单抗）和Opdualag（纳武利尤单抗+瑞拉利单抗）分别创收22.65亿美元和6.24亿美元（+9%，+7%），Abraxane（白蛋白紫杉醇）收入大幅下滑（-52%）至1.05亿美元，全球第2款KRAS G12C抑制剂Krazati（阿达格拉西）一季度收入4800万美元（+125%）；心血管领域，全球首创心肌肌球蛋白抑制剂Camzyos（玛伐凯泰）收入大幅增长（+89%），一季度全球收入1.59亿美元。目前，Camzyos已获批适应症为梗阻性肥厚型心肌病，治疗非梗阻性肥厚型心肌病III期研究未达到主要终点。该产品全球患者人数现达1.1万人，FDA近日更新该药物标签，减少维持期和禁忌症患者的超声心动图监测要求，有望继续扩大患者范围；血液学板块，Revlimid（来那度胺）和Pomalyst（泊马度胺）收入均下滑，CD19 CAR-T疗法Breyanzi销售继续大幅增长（+146%），单季度创收2.63亿美元；免疫板块产品Sotyktu收入5500万美元（+27%），该产品于2025年1月起受美国市场准入条件改善影响，拉动销售增长；神经科学领域，Cobenfy仍在市场拓展初期，一季度收入2700万美元。Copyright © 2025 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

Since its launch in 2015, it has been prescribed to more than 200,000 patients globally. The drug is currently approved for use in both men and women, expanding its market potential. Despite facing competition from other CDK4/6 inhibitors like Novartis' KISQALI and Eli Lilly's VERZENIO, IBRANCE maintains a strong position in the metastatic setting. LAS VEGAS, April 24, 2025 /PRNewswire/ -- DelveInsight's " IBRANCE Market Size, Forecast, and Market Insight Report" highlights the details around IBRANCE, a CDK4/6 inhibitor. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of IBRANCE. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Pfizer's IBRANCE (palbociclib) Overview IBRANCE is an oral medication that inhibits CDKs 4 and 6, which are crucial regulators of the cell cycle that drive cellular progression. In the U.S., IBRANCE is approved for treating adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. It is used in combination with an aromatase inhibitor as a first-line endocrine therapy for postmenopausal women or men or with fulvestrant for patients whose disease has progressed after endocrine treatment. IBRANCE is currently authorized in over 90 countries and has been prescribed to more than 200,000 patients worldwide. Learn more about IBRANCE projected market size for metastatic HR+/HER2− breast cancer @ IBRANCE Market Potential The HR+ HER2- subtype is the most commonly found type of breast cancer, characterized by cancer cells that have estrogen and progesterone receptors but do not overexpress HER2. A patient's journey typically begins with the onset of concerning symptoms, leading to a comprehensive clinical evaluation and various imaging tests. DelveInsight estimates that approximately 211K new cases of HR+/HER2– breast cancer occurred in the US in 2024. CDK4/6 inhibitors currently dominate the first-line treatment market and represent a significant advancement in the management of HR+/HER2-ve breast cancer. The data from large, randomized clinical trials are both strong and consistent. While single-agent endocrine therapies have shown limited benefits in the first and subsequent treatment lines for women with ER-positive metastatic breast cancer (mBC), combination therapies have emerged as a more effective option for many patients. In recent years, the treatment landscape for HR+/HER2−ve breast cancer has been transformed with the introduction of highly active targeted therapies, including CDK4/6 inhibitors, mTOR inhibitors, PARP inhibitors, new oral SERDs, and PI3K inhibitors. These advances have expanded the range of treatment options and improved survival outcomes for these patients. The market for metastatic HR+/HER2− breast cancer in the 7MM is projected to grow during the forecast period (2025–2034) due to the introduction of several novel therapies in the market. Discover more about the metastatic HR+/HER2− breast cancer market in detail @ Metastatic HR+/HER2− Breast Cancer Market Report Emerging Competitors of IBRANCE Some of the drugs in the pipeline include Gedatolisib (Celcuity), ARV-471 (Arvinas and Pfizer), OP-1250 (Olema Pharmaceuticals), KEYTRUDA (Merck), and Rupitasertib (Evexta Bio), among others. In December 2024, Arvinas and Pfizer presented preliminary data from the ongoing Phase 1b portion of the TACTIVE-U sub-study of vepdegestrant in combination with abemaciclib among patients with locally advanced or metastatic ER+/HER2- breast cancer at the San Antonio Breast Cancer Symposium (SABCS) 2024. In December 2024, Olema Pharmaceuticals presented clinical results from the ongoing Phase Ib/II study of palazestrant in combination with ribociclib in patients with ER+/HER2- advanced or metastatic breast cancer at SABCS 2024. To know more about the number of competing drugs in development, visit @ IBRANCE Market Positioning Compared to Other Drugs Key Milestones of IBRANCE In February 2021, Pfizer Inc. announced that the U.S. Patent and Trademark Office (USPTO) has granted a U.S. Patent Term Extension (PTE) certificate for IBRANCE. This extension prolongs the validity of U.S. Patent No. RE47,739 ('739) by over four years, now lasting until March 5, 2027. In April 2019, Pfizer announced that the FDA has approved a supplemental New Drug Application (sNDA) to broaden the uses of IBRANCE in combination with an aromatase inhibitor or fulvestrant, now including men with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced or metastatic breast cancer. In March 2017, Pfizer Inc. revealed that the FDA has approved a supplemental New Drug Application (sNDA) for IBRANCE, its pioneering cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor, following the positive outcomes from the confirmatory Phase 3 trial PALOMA-2. In September 2016, Pfizer Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive recommendation for the marketing authorization of IBRANCE® (palbociclib) in the European Union (EU). This recommendation is for its use in treating women with hormone receptor-positive, HER2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. In February 2016, Pfizer announced that the FDA has approved a new indication for IBRANCE 125mg capsules, expanding its use. The approval allows IBRANCE to be used in combination with fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in women whose disease has progressed after endocrine therapy. In February 2015, Pfizer announced that the FDA granted accelerated approval for IBRANCE in combination with letrozole to treat postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as the initial endocrine-based therapy for their metastatic disease. Discover how IBRANCE is shaping the metastatic HR+/HER2− breast cancer treatment landscape @ IBRANCE Drug IBRANCE Market Dynamics IBRANCE is a targeted therapy that has revolutionized the treatment of hormone receptor-positive, HER2-negative breast cancer, particularly in combination with aromatase inhibitors or letrozole. Developed by Pfizer, IBRANCE was one of the first CDK4/6 inhibitors approved by the FDA for metastatic breast cancer, and its approval has significantly changed the treatment landscape. The drug works by inhibiting cyclin-dependent kinases 4 and 6, which are key regulators of the cell cycle, thus preventing cancer cells from proliferating. Its market dynamics have been shaped by the growing demand for targeted therapies, as well as the increasing focus on precision medicine and improved patient outcomes. The global market for IBRANCE has been positively impacted by its proven efficacy in clinical trials and its ability to extend progression-free survival in breast cancer patients. The drug's market dominance is underpinned by its widespread acceptance and adoption by oncologists worldwide. However, competition is intensifying, with other CDK4/6 inhibitors such as VERZENIO (abemaciclib) and KISQALI (ribociclib) entering the market, offering similar benefits but with some distinct clinical profiles. This competitive landscape has led to strategic pricing and marketing strategies by Pfizer, aiming to maintain IBRANCE's market leadership while managing pressures from generic alternatives. Additionally, the evolving reimbursement landscape and regulatory policies around oncology drugs are crucial factors influencing the market dynamics. Health insurers and government healthcare programs often scrutinize the cost-effectiveness of cancer treatments, which can impact the pricing and accessibility of IBRANCE in different markets. Another factor is the rising focus on combination therapies, as IBRANCE is often used in conjunction with other drugs like letrozole, which boosts its efficacy and market potential. The shift toward personalized cancer treatment regimens is expected to continue fueling demand for CDK4/6 inhibitors like IBRANCE, especially in more advanced stages of breast cancer. In terms of geographical markets, IBRANCE has seen significant uptake in North America and Europe, where the healthcare infrastructure supports innovative cancer therapies. However, emerging markets, where the economic barriers to accessing expensive cancer treatments can be higher, present a challenge to the widespread use of IBRANCE. Pfizer's ongoing efforts to expand in these regions, through partnerships and pricing adjustments, will be key to ensuring continued growth in global market share. Overall, the IBRANCE market is poised for steady growth, driven by clinical advancements, increasing breast cancer diagnoses, and the continual push toward more targeted, effective therapies. Dive deeper to get more insight into IBRANCE's strengths & weaknesses relative to competitors @ IBRANCE Market Drug Report Table of Contents Related Reports Metastatic HR+/HER2− Breast Cancer Market Metastatic HR+/HER2− Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic HR+/HER2− breast cancer companies, including Merck, Arvinas, Olema Pharmaceuticals, Celcuity, Roche, AstraZeneca, Daiichi Sankyo, Eli Lilly, Sermonix Pharmaceuticals, Genentech, Veru Pharma, DualityBio, BioNtech, Evgen Pharma, Carrick Therapeutics, EQRx, G1 Therapeutics, Immutep, among others. HR+/HER2− Breast Cancer Pipeline HR+/HER2− Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HR+/HER2− breast cancer companies, including Regor Therapeuics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Seagen Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche, among others. 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Ltd., Immutep Limited, Arvinas Inc., G1 Therapeutics, Mirati Therapeutics Inc., Chia Tai Tianqing Pharmaceutical, Shanghai Pharmaceuticals Holding Co., Ltd, Pfizer, OncoTherapy Science, Inc., Eisai Inc., Dizal Pharmaceuticals, Jiangsu Hengrui Medicine Co., Tyme, Inc, Orion Pharma, HiberCell, Inc., Rhizen Pharmaceuticals SA, Hutchison Medipharma Limited, OncoPep Inc., Taizhou Hanzhong biomedical co. LTD, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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