Jazz Pharmaceuticals Plc

美国《制药经理人》(Pharm Exec)杂志公布2025年度《全球制药企业50强》排行榜(2025 Pharm Exec 50)，强生、艾伯维和默沙东名列前三位。研发支出中，默沙东、强生、罗氏、阿斯利康、礼来和辉瑞的全年研发支出都超过100亿美元。共有六家中国制药企业进入了全球药企50强。其中，云南白药排名第33位，中国生物制药排名第39位，华东医药排名第41位，百济神州排名第44位，江苏恒瑞医药排名第46位，石药集团排名第48位。本次排名基于各大药厂2024财年的处方药销售数据。《制药经理人》每年的榜单数据来自全球医药市场研究机构Evaluate，这个榜单专注全球制药企业的处方药销售，所以一直被企业年度总结及医疗机构所重视。排名 公司 总部所在地 处方药年销售额/年研发投入1、强生(Johnson & Johnson) 美国  557.45亿美元/170.34亿美元2、艾伯维(AbbVie) 美国  544.84亿美元/80.56亿美元3、默沙东(Merck & Co.，在北美为默克公司) 美国   543.14亿美元/178.65亿美元4、罗氏(Roche) 瑞士  524.57亿美元/148.18亿美元5、辉瑞(Pfizer) 美国  519.53亿美元/108.22亿美元6、阿斯利康(AstraZeneca) 英国  509.46亿美元/122.11亿美元7、诺华(Novartis) 瑞士  501.91亿美元/93.02亿美元8、百时美施贵宝(Bristol-Myers Squibb) 美国  478.21亿美元/97.82亿美元9、赛诺菲(Sanofi) 法国  442.43亿美元/80.00亿美元10、诺和诺德(Novo Nordisk) 丹麦  421.22亿美元/69.71亿美元11、礼来(Eli Lilly) 美国  407.16亿美元/109.91亿美元12、葛兰素史克(GSK) 英国  397.18亿美元/76.98亿美元13、安进(Amgen) 美国  317.48亿美元/58.78亿美元14、武田(Takeda) 日本  297.82亿美元/54.06亿美元15、吉利德科学(Gilead Science) 美国   280.28亿美元/57.31亿美元16、勃林格殷格翰(Boehringer-Ingelheim) 德国  221.75亿美元/----17、拜耳(Bayer) 德国  177.10亿美元/67.18亿美元18、CSL 澳大利亚  150.09亿美元/14.99亿美元19、晖致(Viatris) 美国  145.34亿美元/7.88亿美元20、梯瓦(Teva Pharmaceutical Industries) 以色列  134.95亿美元/9.98亿美元21、安斯泰来(Astellas Pharma) 日本  118.16亿美元/21.52亿美元22、福泰制药(Vertex Pharmaceuticals) 美国  110.20亿美元/34.57亿美元23、第一三共(Daiichi Sankyo) 日本 109.12亿美元/28.61亿美元24、山德士集团(Sandoz Group) 瑞士   103.57亿美元/9.31亿美元25、默克集团(Merck KGaA) 德国  91.48亿美元/24.66亿美元26、大冢控股(Otsuka Holdings) 日本  89.75亿美元/20.77亿美元27、再生元(Regeneron  Pharmaceuticals) 美国  76.29亿美元/51.07亿美元28、渤健(Biogen) 美国  72.15亿美元/19.30亿美元29、基立福(Grifols)  西班牙  66.46亿美元/4.15亿美元 30、欧加隆(Organon) 美国  62.19亿美元/4.90亿美元31、太阳制药(Sun Pharmaceutical Industries) 印度  60.81亿美元/4.07亿美元32、优时比(UCB) 比利时  60.51亿美元/19.27亿美元33、云南白药(Yunnan Baiyao Group) 中国 55.56亿美元/4700万美元34、施维雅(LES LABORATOIRES SERVIER) 法国  52.62亿美元/--35、雅培(Abbott Laboratories) 美国  51.66亿美元/27.04亿美元36、博士康(Bausch Health Companies) 加拿大  49.77亿美元/6.15亿美元37、费森尤斯(Fresenius) 德国  48.10亿美元/6.94亿美元38、卫材(Eisai) 日本  45.36亿美元/10.78亿美元39、中国生物制药(Sino Biopharmaceutical) 中国香港   40.22亿美元/6.70亿美元40、美纳里尼(Menarini) 意大利  40.06亿美元/--41、华东医药(Huadong Medicine)  中国    39.56亿美元/----42、史达德(STADA Arzneimittel)  德国  39.30亿美元/---43、爵士制药(Jazz Pharmaceuticals)  爱尔兰  38.21亿美元/8.84亿美元44、百济神州(BeiGene) 中国  37.89亿美元/18.54亿美元45、益普生(Ipsen) 法国  37.08亿美元/7.43亿美元46、江苏恒瑞医药(Jiangsu Hengrui Pharmaceuticals)  中国  36.32亿美元/7.85亿美元47、因塞特(Incyte)  美国  36.19亿美元/26.07亿美元48、石药集团(CSPC Pharmaceutical Group)  中国    36.10亿美元/7.03亿美元49、瑞迪博士实验室(Dr.Reddy's Laboratories)  印度  33.04亿美元/3.21亿美元50、美德纳(Moderna) 美国  32.18亿美元/46.65亿美元联系美通社+86-10-5953 9500info@prnasia.com

BTCs include cholangiocarcinoma and gallbladder cancer. Credit: mi_viri/Shutterstock. Jazz Pharmaceuticals has received conditional marketing authorisation from the European Commission (EC) for its new bispecific antibody, Ziihera (zanidatamab), for biliary tract cancer (BTC). The dual human epidermal growth factor receptor 2 (HER2)-targeted antibody is authorised as a single agent in adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+) BTC. These individuals had previously received at least one line of systemic therapy. Zanidatamab is administered intravenously every two weeks, with a recommended dose of 20mg/kg until disease progression or unacceptable toxicity occurs. The approval of Ziihera extends across European Union (EU) member states along with Norway, Iceland and Liechtenstein. The EC’s decision marks Ziihera as the first conditionally authorised therapy targeting HER2-positive BTC within the EU. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Continuation of this approval depends on further clinical benefits demonstrated in Phase III HERIZON-BTC-302 trial comparing zanidatamab with standard-of-care treatments against standard care alone. The Phase IIb HERIZON-BTC-01 trial data supported the EC authorisation. This trial involved 87 participants and included patients with previously treated, unresectable, locally advanced or metastatic HER2-positive BTC. Ziihera showed a confirmed objective response rate (cORR) of 41.3%, including two complete responses after a median follow-up period of almost two years. Median duration of response reported was 14.9 months while median overall survival was 15 months. Jazz Pharmaceuticals executive vice-president, global head of research and development, and chief medical officer Robert Iannone stated: “This milestone reinforces our commitment to advancing biomarker-driven therapies that address serious unmet needs and improve patient outcomes. “We are actively recruiting for our global Phase III trial in first-line HER2-positive BTC and continue to explore zanidatamab’s potential in other HER2-expressing tumours.” BTCs, which include cholangiocarcinoma (CCA) and gallbladder cancer (GBC), are an aggressive group of cancers, often diagnosed at an advanced stage when curative surgery is not viable. In March 2025, Jazz Pharmaceuticals signed an agreement to acquire Chimerix for $935m. This deal will enable Jazz to gain control over dordaviprone. Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

– Conditional approval based on positive results from the HERIZON-BTC-01 Phase 2b trial – DUBLIN , July 1, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the European Commission (EC) has granted conditional marketing authorization1 for Ziihera® (zanidatamab), a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+)† biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy.2 BTCs, which include gallbladder cancer (GBC) and cholangiocarcinoma (CCA), are a rare and aggressive group of cancers,3 with most cases diagnosed at an advanced stage4 when curative surgery is no longer an option.5,6,7 Globally, approximately 26% of patients with BTC are HER2-positive,8 a biomarker associated with poorer outcomes compared to HER2-negative disease.9 Ziihera is the first HER2-targeted therapy given conditional authorization for HER2-positive BTC in the European Union (EU). Continued approval for this indication is contingent upon verification and description of clinical benefit in the ongoing Phase 3 HERIZON-BTC-302 trial, which is evaluating zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC.10 "People with HER2-positive biliary tract cancer who progress after first-line therapy face a challenging prognosis, with limited treatment options, poor tolerability, and median overall survival of only six to nine months," said Arndt Vogel , MD, managing senior consultant and professor in the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School , Germany . "Zanidatamab provides a much-needed targeted monotherapy for this population, and in the HERIZON-BTC-01 trial, it demonstrated clinically meaningful and durable responses with a manageable safety profile. These data represent a welcome advance for patients with historically poor outcomes and highlight the importance of HER2 testing in biliary tract cancer to ensure eligible patients are identified for biomarker-driven treatment." The EC decision is based on data from the Phase 2b HERIZON-BTC-01 trial, which evaluated Ziihera in patients with previously treated, unresectable, locally advanced or metastatic HER2-positive BTC. This is the largest Phase 2b trial conducted to date specifically in this population.11,12 The study enrolled 87 patients, including 80 in Cohort 1 with centrally confirmed HER2-positive tumors (IHC 2+/ISH+ [n=18] or IHC 3+/ISH+ [n=62]). The trial achieved its primary endpoint of confirmed objective response rate (cORR) in Cohort 1, as assessed by independent central review (ICR). At a median follow-up of 21.9 months, zanidatamab demonstrated a cORR of 41.3% (95% CI: 30.4, 52.8), including two complete responses.11 The median duration of response (DOR) was 14.9 months (95% CI: (7.4, not reached), and the median overall survival (OS) was 15.5 months (95% CI: 10.4, 18.5).11 Findings from a pre-specified subgroup analysis in patients with IHC 3+ tumors (n=62) showed that Ziihera demonstrated a cORR of 51.6% (95% CI: 38.6, 64.5), with a median DOR of 14.9 months (95% CI: 7.4, 24.0).2 The median OS in this subgroup was 18.1 months (95% CI: 12.2, 22.9).2 The recommended dose of Ziihera is 20 mg/kg, administered as an intravenous infusion every two weeks until disease progression or unacceptable toxicity.2 The safety profile for zanidatamab was evaluated in 87 patients with HER2-positive BTC (Cohorts 1 and 2) in HERIZON-BTC-01. The most common adverse reactions in this population were diarrhea (46%), infusion-related reaction (33.3%), abdominal pain (26.4%), anemia (25.3%) and fatigue (24.1%). Serious adverse reactions occurred in 16.1% of patients. The most frequent serious adverse reactions were diarrhea (2.3%), fatigue (2.3%), and increased alanine aminotransferase (2.3%).2 "This conditional approval represents significant progress for the patients we serve who have been diagnosed with advanced HER2-positive BTC," said Robert Iannone , MD., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals . "Ziihera is the first HER2-targeted therapy authorized in the European Union specifically for this population, and the European Commission's decision reflects both the strength of the HERIZON-BTC-01 data and the urgency for innovation in rare gastrointestinal cancers. This milestone reinforces our commitment to advancing biomarker-driven therapies that address serious unmet needs and improve patient outcomes. We are actively recruiting for our global Phase 3 trial in first-line HER2-positive BTC and continue to explore zanidatamab's potential in other HER2-expressing tumors." "Biliary tract cancers are becoming more common worldwide and are increasingly affecting people under the age of 60, resulting in a significant social and economic burden," said Zorana Maravic , chief executive officer at Digestive Cancers Europe (DiCE). "These cancers are typically diagnosed late, when patients have limited treatment options available and, unfortunately, their disease often progresses. Ziihera provides a much-needed alternative to chemotherapy for patients with HER2-positive BTC at this stage. It also brings hope to the digestive cancer patient community as another step in expanding the availability of targeted therapies." The European Commission authorization extends to all European Union Member States, as well as Iceland, Norway, and Liechtenstein. For a full list of side effects and information on dosage and administration, contraindications, and other precautions when using Ziihera, please refer to the Summary of Product Characteristics for further information. About Ziihera® (zanidatamab)Ziihera (zanidatamab) is a dual HER2-targeted bispecific antibody that simultaneously binds extracellular domains 2 and 4 on separate HER2 monomers (binding in trans). Binding of zanidatamab with HER2 results in internalization leading to a reduction of the receptor on the cell surface. Zanidatamab induces complement-dependent cytotoxicity ( CDC ), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and tumor cell death.2 On November 20, 2024 , in the United States, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Ziihera (zanidatamab-hrii) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.13 This accelerated approval was granted based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing Phase 3 HERIZON-BTC-302 confirmatory trial.13 It also received conditional approval from China's National Medical Products Administration (NMPA) in May 2025 for the treatment of patients with previously treated, unresectable or metastatic HER2+BTC. Continued approval of this indication will depend on the verification of clinical benefit in the patient population through an ongoing confirmatory trial. Zanidatamab is also being investigated in multiple other clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeOne Medicines Ltd. (formerly BeiGene, Ltd) under license agreements from Zymeworks, which first developed the molecule. Jazz has rights to commercialize zanidatamab in the U.S. , Europe , Japan and all other territories except for those Asia/Pacific territories that Zymeworks previously licensed to BeiGene, Ltd. [which are Asia (excluding Japan ), Australia and New Zealand ]. The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer. About Biliary Tract Cancer Biliary tract cancers (BTC), which include gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma, are rare and aggressive epithelial tumors often associated with poor prognosis.3,14 Although they account for less than 1% of all human cancers, cholangiocarcinoma is the second most common primary liver cancer after hepatocellular carcinoma and comprises approximately 10–15% of all primary liver cancers. Global mortality from BTC has risen in recent decades.5 Because early symptoms are often vague or nonspecific, most BTCs are diagnosed at an advanced stage,4 when curative surgery is not an option.5,6,7 While chemotherapy and, more recently, immunotherapy-based combinations are used in the first-line setting, disease progression is common. In the absence of molecular profiling, treatment options following first-line therapy are largely limited to chemotherapy.5,6,15 HER2 overexpression or amplification defines a distinct molecular subtype of BTC16 and is observed in approximately 26% of patients globally.8 HER2-positive BTC is associated with worse prognosis than HER2-negative disease.9 Across the U.S. , Europe , and Japan , an estimated 12,000 people are diagnosed with HER2-positive BTC each year.17 About Jazz Pharmaceuticals plc Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases – often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Media Contact: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc CorporateAffairsMediaInfo@jazzpharma.com Ireland +353 1 637 2141 U.S. +1 215 867 4948 Investors: Jack Spinks Senior Director, Investor Relations Jazz Pharmaceuticals plc investorinfo@jazzpharma.com Ireland +353 1 634 3211 U.S. +1 650 496 2717 References † IHC3+ stands for ImmunoHistoChemistry 3+ and refers to the highest level of HER2 protein overexpression in cancer cells1 European Medicines Agency. Conditional marketing authorisation. European Medicines Agency website. Accessed July 1, 2025 . Available at: https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/conditional-marketing-authorisation 2 Ziihera Summary of Product Characteristics (SmPC).3 Mirallas O, López-Valbuena D, García-Illescas D , et al. Advances in the systemic treatment of therapeutic approaches in biliary tract cancer. ESMO Open. 2022;7(3):100503. doi:10.1016/j.esmoop.2022.100503.4 Rimassa, L., Khan, S., Koerkamp, B. G., Roessler, S.,et al. Mapping the landscape of biliary tract cancer in Europe : challenges and controversies. The Lancet Regional Health–Europe. 2025; 50, 101171. doi.org/10.1016/j.lanepe.2024.101171.5 Vogel A, Bridgewater J, Edeline J, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment, and follow-up. Ann Oncol. 2023;34(2):127-40. doi:10.1016/j.annonc.2022.10.506.6 Chakrabarti, S., Kamgar, M., Mahipal, A. Targeted therapies in advanced biliary tract cancer: an evolving paradigm. Cancers. 2020;12(8), 2039. doi.org/10.3390/cancers12082039.7 Valle JW, Kelley RK, et al. Biliary tract cancer. Lancet . 2021;397(10272):428-44. doi:10.1016/S0140-6736(21)00153-7.8 Galdy S, Lamarca A, et al. HER2/HER3 pathway in biliary tract malignancies; systematic review and meta-analysis: a potential therapeutic target? Cancer Metastas Rev. 2017; doi: 10.1007/s10555-016-9645-x.9 Vivaldi, C. HER2 overexpression as a poor prognostic determinant in resected biliary tract cancer. Oncologist. 2020;25(10):886-893. doi:10.1634/theoncologist.2019-0922.10 ClinicalTrials.gov. Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer. Updated June 24, 2025 . Accessed July 1, 2025 . Available at: https://www.clinicaltrials.gov/study/NCT06282575 11 Pant, S et al. Zanidatamab in Previously Treated HER2-Positive Biliary Tract Cancer: Overall Survival and Longer Follow-Up From the Phase 2b HERIZON-BTC-01 Study. J Clin Oncol. 2024; 42(16_suppl). Abstract 4091.12 Harding J, Fan J, Oh D-Y, et al. Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study. Lancet Oncol. 2023;24(7):772-82. doi:10.1016/S1470-2045(23)00242-5.13 U.S. Food and Drug Administration. Ziihera® (zanidatamab-hrii) prescribing information. Accessdata.fda.gov. Updated November 2024 . Accessed July 1, 2025 . https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761416s000lbl.pdf 14 Kam A, et al. Current and emerging therapies for advanced biliary tract cancers. Lancet Gastroenterol Hepatol. 2021;6(11):956-69. doi:10.1016/S2468-1253(21)00171-0.15 Lamarca, A., Hubner, R. A., Ryder, W. D ., et al. Second-line chemotherapy in advanced biliary cancer: a systematic review. Annals of Oncology. 2025; 25(12), 2328-2338. doi.org/10.1093/annonc/mdu162.16 Hechtman, J. F., Liu, W., Sadowska, J.,et al. Sequencing of 279 cancer genes in ampullary carcinoma reveals trends relating to histologic subtypes and frequent amplification and overexpression of ERBB2 (HER2). Modern Pathology. 2015;28(8), 1123-1129. doi: 10.1038/modpathol.2015.57.17 Jazz Pharmaceuticals, Inc, Data on file. View original content to download multimedia:https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-receives-european-commission-marketing-authorization-for-ziihera-zanidatamab-for-the-treatment-of-advanced-her2-positive-biliary-tract-cancer-302495678.html SOURCE Jazz Pharmaceuticals plc