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Prescription Drug User Fee Act (PDUFA) date set for August 25, 2026
《处方药使用者费用法案》(PDUFA)日期定于2026年8月25日
For U.S. media and investors only
仅限美国媒体和投资者
DUBLIN
都柏林
,
,
April 27, 2026
2026年4月27日
/PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq:
/PRNewswire/ -- Jazz Pharmaceuticals plc(纳斯达克:
JAZZ
爵士乐
) today announced that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the supplemental Biologics License Application (sBLA) for Ziihera
)今天宣布,美国食品药品监督管理局(FDA)已接受并优先审查Ziihera的补充生物制品许可申请(sBLA)。
®
®
(zanidatamab-hrii) containing combinations for the first-line treatment of adult patients with HER2-positive (HER2+) unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or gastroesophageal adenocarcinoma (GEA). The FDA has set a PDUFA target action date of August 25, 2026..
包含zanidatamab-hrii的组合用于一线治疗HER2阳性(HER2+)不可切除的局部晚期或转移性胃癌、胃食管交界部(GEJ)或胃食管腺癌(GEA)成年患者。FDA设定的PDUFA目标行动日期为2026年8月25日。
The sBLA is supported by data from the pivotal HERIZON-GEA-01 trial to investigate the efficacy and safety of zanidatamab in combination with standard-of-care chemotherapy with or without the PD-1 inhibitor Tevimbra
该sBLA得到了关键性HERIZON-GEA-01试验的数据支持,该试验研究了zanidatamab联合标准护理化疗(伴或不伴PD-1抑制剂Tevimbra)的疗效和安全性。
®
®
(tislelizumab) in patients with advanced or metastatic GEA, including gastric, GEJ and esophageal adenocarcinomas. The submission is under review via the Real-Time Oncology Review (RTOR) program, an initiative of FDA's Oncology Center of Excellence designed to provide a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible..
在患有晚期或转移性GEA(包括胃癌、胃食管结合部癌和食管腺癌)的患者中使用替雷利珠单抗(tislelizumab)。该提交正在通过实时肿瘤审查(RTOR)计划进行审查,这是FDA肿瘤卓越中心的一项举措,旨在提供更高效的审查流程,以确保患者能够尽早获得安全有效的治疗。
'The HERIZON-GEA-01 trial results are practice changing, supporting the potential of zanidatamab as the HER2-targeted agent-of-choice in HER2+ first-line locally advanced or metastatic GEA. Importantly, the results demonstrated adding tislelizumab to zanidatamab plus chemotherapy further enhanced clinical benefit and marked the first immuno-oncology combination to show efficacy across both PD-L1–positive and PD-L1–negative tumors in this clinical setting,' said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of R&D, and chief medical officer of Jazz Pharmaceuticals.
“HERIZON-GEA-01试验结果具有实践变革意义,支持了zanidatamab作为HER2阳性一线局部晚期或转移性GEA中首选HER2靶向药物的潜力。重要的是,研究结果表明,在zanidatamab联合化疗的基础上加入tislelizumab进一步增强了临床效益,并标志着这是首个在该临床环境中显示对PD-L1阳性及PD-L1阴性肿瘤均有效的免疫肿瘤学组合。” Jazz Pharmaceuticals执行副总裁、全球研发主管兼首席医学官Rob Iannone博士表示。
'We look forward to continuing to work closely with FDA to obtain approval and quickly bring zanidatamab to market for GEA patients in need of new options.'.
“我们期待继续与FDA密切合作,以获得批准,并尽快将zanidatamab推向市场,为需要新选择的GEA患者提供帮助。”
The FDA granted Breakthrough Therapy designation to zanidatamab in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab, for the first-line treatment of patients with HER2+ unresectable locally advanced or metastatic gastric, GEJ, or esophageal adenocarcinoma.
FDA授予zanidatamab联合含氟嘧啶和铂类化疗(无论是否使用tislelizumab)突破性疗法称号,用于一线治疗HER2阳性不可切除的局部晚期或转移性胃癌、胃食管交界处癌或食管腺癌患者。
Breakthrough Therapy designation is intended to expedite the development and review of therapies that, based on preliminary clinical evidence, may offer substantial improvement over available therapies on one or more clinically significant endpoints, reflecting both the seriousness of the disease and the unmet medical need in this setting..
突破性疗法指定旨在加快那些基于初步临床证据可能在一个或多个具有临床意义的终点上比现有疗法有显著改善的疗法的开发和审查,这反映了该疾病严重性及在此情况下的未满足医疗需求。
About the Phase 3 HERIZON-GEA-01 Trial
关于第三阶段HERIZON-GEA-01试验
HERIZON-GEA-01 (
赫里松-GEA-01 (
NCT05152147
NCT05152147
) is a global, randomized, open-label Phase 3 trial, conducted jointly with BeOne Medicines, to evaluate and compare the efficacy and safety of zanidatamab plus chemotherapy, with or without tislelizumab, to trastuzumab plus chemotherapy as first-line treatment for adult patients with advanced/metastatic HER2+ GEA.
)是一项全球性、随机、开放标签的3期试验,与BeOne Medicines联合开展,旨在评估和比较扎尼达单抗联合化疗(无论是否使用替雷利珠单抗)与曲妥珠单抗联合化疗作为晚期/转移性HER2+胃食管腺癌(GEA)成年患者一线治疗的疗效和安全性。
The trial randomized 914 patients from approximately 300 trial sites in more than 30 countries. Appropriate patients for this trial had unresectable locally advanced, recurrent or metastatic HER2+ GEA (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment.
该试验从30多个国家的大约300个试验地点随机抽取了914名患者。适合参加试验的患者为不可切除的局部晚期、复发性或转移性HER2+GEA(胃或食管腺癌,包括胃食管交界处),定义为IHC检测3+ HER2表达,或IHC检测2+ HER2表达且经中心评估ISH阳性。
Patients were randomized to the three trial arms: zanidatamab in combination with chemotherapy and tislelizumab; zanidatamab in combination with chemotherapy; and trastuzumab plus chemotherapy. The trial is evaluating dual primary endpoints, PFS per blinded independent central review (BICR) and OS. Results from the trial were .
患者被随机分配到三个试验组:zanidatamab联合化疗和tislelizumab;zanidatamab联合化疗;以及曲妥珠单抗加化疗。该试验正在评估两个主要终点,即由盲态独立中心审查(BICR)评估的无进展生存期(PFS)和总生存期(OS)。试验结果为。
presented
呈现
in January 2026 at the 2026 ASCO Gastrointestinal Cancers Symposium.
2026年1月在2026年ASCO胃肠道癌症研讨会上。
About Gastroesophageal Adenocarcinoma
关于胃食管腺癌
GEA, including cancers of the stomach, gastroesophageal junction, and esophagus, is the fifth most common cancer worldwide, and approximately 20% of patients have HER2+ disease.
胃食管腺癌(GEA),包括胃癌、胃食管交界处癌和食管癌,是全球第五大常见癌症,约20%的患者为HER2阳性。
1,2,3
1,2,3
HER2+ GEA has high morbidity and mortality, and patients are urgently in need of new treatment options. The overall prognosis for patients with GEA remains poor, with a global five-year survival rate of less than 30% for gastric cancer and about 19% for GEA.
HER2+ GEA的发病率和死亡率很高,患者迫切需要新的治疗选择。GEA患者的总体预后仍然不佳,胃癌的全球五年生存率不到30%,而GEA约为19%。
4
4
About Ziihera
关于Ziihera
®
®
(zanidatamab-hrii)
(扎尼达单抗-hrii)
Ziihera
紫赫拉
(zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP).
(zanidatamab-hrii) 是一种双特异性 HER2 导向抗体,能够结合 HER2 的两个胞外位点。Zanidatamab-hrii 与 HER2 的结合会导致内化,从而减少肿瘤细胞表面受体的 HER2 表达。Zanidatamab-hrii 能够诱导补体依赖性细胞毒性 (CDC)、抗体依赖性细胞毒性 (ADCC) 和抗体依赖性细胞吞噬作用 (ADCP)。
These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo..
这些机制导致肿瘤生长抑制以及体外和体内细胞死亡。
5
5
In the United States,
在美国,
Ziihera
紫赫拉
is indicated 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.
适用于治疗经FDA批准的检测方法确认的先前已接受过治疗、无法切除或转移性的HER2阳性(IHC 3+)胆道癌(BTC)成年患者。
1
1
The FDA granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
FDA基于总体缓解率和缓解持续时间给予该适应症加速批准。此适应症的持续批准可能取决于在确证性试验中对临床获益的验证和描述。
1
1
Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz Pharmaceuticals and BeOne under license agreements from Zymeworks, which first developed the molecule.
Zanidatamab正在多个临床试验中开发,作为针对表达HER2的实体瘤患者的靶向治疗选择。Zanidatamab由Jazz Pharmaceuticals和BeOne根据与最初开发该分子的Zymeworks的许可协议进行开发。
An sBLA for zanidatamab is being reviewed by the FDA under RTOR in first-line HER2+ locally advanced or metastatic GEA. The FDA granted two Breakthrough Therapy designations for zanidatamab's development: one as a single agent for previously treated HER2 gene-amplified BTC, and one in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab for first-line HER2+ unresectable locally advanced or metastatic gastric, GEJ or esophageal adenocarcinoma.
Zanidatamab的sBLA正在FDA的RTOR项目下接受审查,用于一线治疗HER2阳性局部晚期或转移性GEA。FDA授予了zanidatamab两项突破性疗法认定:一项是作为单药治疗既往接受过治疗的HER2基因扩增型BTC,另一项是与含氟嘧啶和铂类化疗联合使用、无论是否联合tislelizumab,用于一线治疗HER2阳性不可切除的局部晚期或转移性胃癌、胃食管交界处癌或食管腺癌。
The FDA also granted two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for first-line GEA. Additionally, zanidatamab has received Orphan Drug designations from the FDA for the treatment of BTC, gastric (including GEJ) cancer, and esophageal cancer, as well as Orphan Drug designations from the European Medicines Agency for the treatment of BTC, gastric/GEJ cancer and oesophageal cancer. .
FDA还授予zanidatamab两个快速通道资格:一个作为单药治疗难治性BTC,另一个与标准护理化疗联合用于一线GEA。此外,zanidatamab已获得FDA授予的孤儿药资格,用于治疗BTC、胃癌(包括胃食管结合部癌)和食管癌,同时也获得了欧洲药品管理局授予的孤儿药资格,用于治疗BTC、胃/胃食管结合部癌和食管癌。
Important Safety Information for ZIIHERA
ZIIHERA的重要安全信息
WARNING: EMBRYO-FETAL
警告:胚胎-胎儿
TOXICITY
毒性
Exposure to
暴露于
ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients
ZIIHERA在怀孕期间可能会导致胚胎-胎儿伤害。请告知患者。
of the risk and need for effective contraception.
关于风险和对有效避孕的需求。
WARNINGS AND PRECAUTIONS
警告与注意事项
Embryo-Fetal Toxicity
胚胎-胎儿毒性
ZIIHERA can cause fetal harm when administered to a pregnant woman. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
ZIIHERA 用于孕妇时可导致胎儿伤害。文献报道中,在妊娠期间使用 HER2 靶向抗体出现了羊水过少和表现为肺发育不全、骨骼异常及新生儿死亡的羊水过少序列征病例。
Verify the pregnancy status of females of reproductive potential prior to the initiation of ZIIHERA. Advise pregnant women and females of reproductive potential that exposure to ZIIHERA during pregnancy or within 4 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment with ZIIHERA and for 4 months following the last dose of ZIIHERA. .
在开始使用ZIIHERA之前,验证有生殖潜力的女性的怀孕状态。告知孕妇和有生殖潜力的女性,在怀孕期间或受孕前4个月内接触ZIIHERA可能会对胎儿造成伤害。建议有生殖潜力的女性在使用ZIIHERA治疗期间以及在最后一次使用ZIIHERA后的4个月内使用有效的避孕措施。
Left Ventricular Dysfunction
左心室功能障碍
ZIIHERA can cause decreases in left ventricular ejection fraction (LVEF). LVEF declined by >10% and decreased to <50% in 4.3% of 233 patients. Left ventricular dysfunction (LVD) leading to permanent discontinuation of ZIIHERA was reported in 0.9% of patients. The median time to first occurrence of LVD was 5.6 months (range: 1.6 to 18.7).
ZIIHERA 可能导致左心室射血分数 (LVEF) 降低。在233名患者中,有4.3%的患者LVEF下降超过10%且降至50%以下。有0.9%的患者因左心室功能障碍 (LVD) 而永久停用ZIIHERA。LVD首次发生的中位时间为5.6个月(范围:1.6至18.7)。
LVD resolved in 70% of patients. .
左心室功能障碍在70%的患者中得到解决。
Assess LVEF prior to initiation of ZIIHERA and at regular intervals during treatment. Withhold dose or permanently discontinue ZIIHERA based on severity of adverse reactions.
在开始使用ZIIHERA之前和治疗期间定期评估LVEF。根据不良反应的严重程度,暂停剂量或永久停用ZIIHERA。
The safety of ZIIHERA has not been established in patients with a baseline ejection fraction that is below 50%.
ZIIHERA 在基线射血分数低于 50% 的患者中的安全性尚未确定。
Infusion-Related Reactions
输液相关反应
ZIIHERA can cause infusion-related reactions (IRRs). An IRR was reported in 31% of 233 patients treated with ZIIHERA as a single agent in clinical studies, including Grade 3 (0.4%), and Grade 2 (25%). IRRs leading to permanent discontinuation of ZIIHERA were reported in 0.4% of patients. IRRs occurred on the first day of dosing in 28% of patients; 97% of IRRs resolved within one day. .
ZIIHERA可能引起与输注相关的反应(IRRs)。在临床研究中,233名接受ZIIHERA单药治疗的患者中,有31%报告了IRRs,其中包括0.4%的3级反应和25%的2级反应。导致永久停用ZIIHERA的IRRs在0.4%的患者中被报告。28%的患者在首次给药当天发生IRRs;97%的IRRs在一天内得到解决。
Prior to each dose of ZIIHERA, administer premedications to prevent potential IRRs. Monitor patients for signs and symptoms of IRR during ZIIHERA administration and as clinically indicated after completion of infusion. Have medications and emergency equipment to treat IRRs available for immediate use. .
在每次使用ZIIHERA之前,给予预防性药物以防止潜在的输液相关反应(IRRs)。在ZIIHERA给药期间及输注完成后根据临床需要监测患者是否出现IRRs的体征和症状。准备好治疗IRRs的药物和急救设备以供立即使用。
If an IRR occurs, slow, or stop the infusion, and administer appropriate medical management. Monitor patients until complete resolution of signs and symptoms before resuming. Permanently discontinue ZIIHERA in patients with recurrent severe or life-threatening IRRs.
如果出现IRR,减慢或停止输注,并进行适当的医疗管理。在症状和体征完全消除前持续监测患者,然后方可恢复用药。对于反复出现严重或危及生命的IRR患者,应永久停用ZIIHERA。
Diarrhea
腹泻
ZIIHERA can cause severe diarrhea.
ZIIHERA 可能导致严重腹泻。
Diarrhea was reported in 48% of 233 patients treated in clinical studies, including Grade 3 (6%) and Grade 2 (17%). If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Withhold or permanently discontinue ZIIHERA based on severity. .
在临床研究中,接受治疗的233名患者中有48%报告出现腹泻,其中包括3级(6%)和2级(17%)。如果发生腹泻,根据临床指征给予止泻治疗。根据临床指征进行诊断测试,以排除其他腹泻原因。根据严重程度暂停或永久停止使用ZIIHERA。
ADVERSE REACTIONS
不良反应
Serious adverse reactions occurred in 53% of 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA. Serious adverse reactions in >2% of patients included biliary obstruction (15%), biliary tract infection (8%), sepsis (8%), pneumonia (5%), diarrhea (3.8%), gastric obstruction (3.8%), and fatigue (2.5%).
在80名接受ZIIHERA治疗的不可切除或转移性HER2阳性胆道癌患者中,53%的患者发生了严重不良反应。超过2%的患者出现的严重不良反应包括胆道梗阻(15%)、胆道感染(8%)、败血症(8%)、肺炎(5%)、腹泻(3.8%)、胃梗阻(3.8%)和疲劳(2.5%)。
A fatal adverse reaction of hepatic failure occurred in one patient who received ZIIHERA. .
一名接受ZIIHERA治疗的患者发生了致命的肝衰竭不良反应。
The most common adverse reactions in 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA (≥20%) were diarrhea (50%), infusion-related reaction (35%), abdominal pain (29%), and fatigue (24%).
在80名接受ZIIHERA治疗的不可切除或转移性HER2阳性BTC患者中,最常见的不良反应(≥20%)是腹泻(50%)、输液相关反应(35%)、腹痛(29%)和疲劳(24%)。
USE IN SPECIFIC POPULATIONS
在特定人群中使用
Pediatric Use
儿科使用
Safety and efficacy of ZIIHERA have not been established in pediatric patients.
齐赫拉在儿科患者中的安全性和有效性尚未确定。
Geriatric Use
老年使用
Of the 80 patients who received ZIIHERA for unresectable or metastatic HER2-positive BTC, there were 39 (49%) patients 65 years of age and older. Thirty-seven (46%) were aged 65-74 years old and 2 (3%) were aged 75 years or older.
在80名接受ZIIHERA治疗的不可切除或转移性HER2阳性胆管癌患者中,有39名(49%)患者年龄在65岁及以上。其中37名(46%)年龄在65至74岁之间,2名(3%)年龄在75岁及以上。
No overall differences in safety or efficacy were observed between these patients and younger adult patients.
这些患者与较年轻的成年患者在安全性和有效性方面未观察到总体差异。
The full
完整
U.S.
美国
Prescribing Information for
处方信息
ZIIHERA, including BOXED Warning, is available at:
ZIIHERA,包括加框警告,可在此处获取:
https://pp.jazzpharma.com/pi/ziihera.en.USPI.pdf
https://pp.jazzpharma.com/pi/ziihera.en.USPI.pdf
® TEVIMBRA (tislelizumab) is a registered trademark of BeOne Medicines.
® TEVIMBRA(替雷利珠单抗)是贝一医药公司的注册商标。
About
关于
Jazz Pharmaceuticals
爵士制药公司
Jazz Pharmaceuticals plc (Nasdaq:
Jazz Pharmaceuticals plc(纳斯达克:
JAZZ
爵士乐
) 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 rare disease — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies addressing epilepsies, cancers and sleep disorders.
)是一家全球生物制药公司,致力于通过创新来改变患者及其家人的生活。我们专注于为罕见病患者开发可能改变生命的药物——这些患者通常面临有限或无治疗选择的困境。我们拥有多样化的上市药物组合,包括针对癫痫、癌症和睡眠障碍的领先疗法。
Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide.
我们以患者为中心、以科学为驱动的方法推动了我们在强大创新治疗管道中的开创性研发进展。Jazz 总部位于爱尔兰都柏林,在多个国家设有研究和开发实验室、制造设施及员工,致力于为全球患者服务。
Please visit .
请访问 。
www.jazzpharmaceuticals.com
www.jazzpharmaceuticals.com
for more information.
更多信息,请访问。
Cautionary Note Concerning Forward-Looking Statements
关于前瞻性声明的谨慎说明
This press release contains forward-looking statements, including, but not limited to, statements related to the potential therapeutic benefits of Ziihera (zanidatamab-hrii) and of combination therapies with zanidatamab, zanidatamab's potential as a new standard of care in HER2+ first-line GEA and other HER2-expressing cancers, expected timing of and ability to obtain FDA approval under the RTOR program for zanidatamab in HER2+ first-line GEA and other statements that are not historical facts.
本新闻稿包含前瞻性陈述,包括但不限于与 Ziihera(zanidatamab-hrii)和含 zanidatamab 的联合疗法潜在治疗益处相关的陈述,zanidatamab 作为 HER2 阳性一线 GEA 和其他 HER2 表达癌症新护理标准的潜力,预计在 RTOR 计划下获得 FDA 对 zanidatamab 用于 HER2 阳性一线 GEA 批准的时间和能力,以及其他非历史事实的陈述。
These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the successful completion of regulatory activities and uncertain regulatory approval, risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients and other risks and uncertainties affecting Jazz Pharmaceuticals and its development programs, including those described from time to time under the caption 'Risk Factors' and elsewhere in Jazz Pharmaceuticals' Securities and Exchange Commission filings and reports, including Jazz Pharmaceuticals' Annual Report on Form 10-K for the year ended December 31, 2025, and future filings and reports by Jazz Pharmaceuticals.
这些前瞻性陈述基于Jazz Pharmaceuticals当前的计划、目标、估计、预期和意图,本质上涉及重大风险和不确定性。由于这些风险和不确定性,实际结果和事件的时间安排可能与这些前瞻性陈述中预期的情况存在重大差异。这些风险和不确定性包括但不限于:与监管活动成功完成及不确定的监管批准相关的风险,与未能或延迟成功启动或完成临床试验及评估患者相关的风险,以及其他影响Jazz Pharmaceuticals及其开发项目的风险和不确定性,包括那些在Jazz Pharmaceuticals不时提交的“风险因素”标题下及其他部分中描述的内容,例如Jazz Pharmaceuticals截至2025年12月31日的年度报告Form 10-K,以及Jazz Pharmaceuticals未来的其他文件和报告中所述内容。
Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipat.
Jazz Pharmaceuticals目前尚未意识到的其他风险和不确定性也可能影响Jazz Pharmaceuticals的前瞻性声明,并可能导致实际结果和事件发生的时间与预期有重大差异。
Contacts:
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[email protected]
电子邮件地址
Ireland +353 1 637 2141
爱尔兰 +353 1 637 2141
U.S. +1 215 867 4948
美国 +1 215 867 4948
Investor:
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Ireland +353 1 634 3211
爱尔兰 +353 1 634 3211
U.S. +1 650 496 2717
美国 +1 650 496 2717
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Abrahao-Machado I.F., et al. HER2 testing in gastric cancer: An update WorldJGastroenterol. 2016;22(19):4619-4625.
阿布拉哈奥-马查多 I.F. 等。胃癌中HER2检测:更新。《世界胃肠病学杂志》。2016;22(19):4619-4625。
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Van Custem E., et al. HER2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer. Gastric Cancer. 2015;18(3):476-484.
范·库斯特姆 E. 等。来自ToGA的HER2筛查数据:针对胃癌和胃食管交界处癌的HER2治疗。《胃癌》。2015;18(3):476-484。
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Stroes, C.I., et al. A systematic review of HER2 blockade for the curative treatment of gastroesophageal adenocarcinoma: Successes achieved and opportunities ahead. CancerTreatRev. 2021;99:102249.
Stroes, C.I., 等。HER2阻断治疗胃食管腺癌的系统评价:已取得的成果与未来的机会。《癌症治疗评论》。2021年;99:102249。
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Battaglin F, et al. Molecular biomarkers in gastro-esophageal cancer: recent developments, current trends and future directions. Cancer Cell International. 2018;18(99).
巴塔格林 F 等。胃肠癌中的分子生物标志物:最新进展、当前趋势和未来方向。《癌症细胞国际》。2018;18(99)。
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ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
ZIIHERA(扎尼达单抗-hrii)处方信息。加利福尼亚州帕洛阿尔托:Jazz Pharmaceuticals公司。
SOURCE Jazz Pharmaceuticals plc
来源:Jazz Pharmaceuticals plc
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