Phase 2 trial results continue to show clinically meaningful efficacy and durable responses, including 36.5-month median overall survival after four years of follow-up, with a manageable safety profile

二期试验结果继续显示出具有临床意义的疗效和持久的响应，包括在四年随访后，中位总生存期达到36.5个月，且安全性可控。

Findings presented today at ASCO 2025 and concurrently published in

今天在ASCO 2025上发表并同时发布在

The Lancet Oncology

《柳叶刀·肿瘤学》

For

为了

U.S.

美国

media and investors only

仅限媒体和投资者

DUBLIN

都柏林

,

，

June 2, 2025

2025年6月2日

/PRNewswire/ --

/PRNewswire/ --

Jazz Pharmaceuticals

爵士制药公司

plc (Nasdaq: JAZZ) today announced long-term data, including the first report of median overall survival (OS) from the Phase 2 trial evaluating Ziihera

Jazz制药公司（纳斯达克股票代码：JAZZ）今天宣布了长期数据，包括评估Ziihera的2期试验中位总生存期（OS）的首次报告。

®

®

(zanidatamab-hrii), a dual HER2-targeted bispecific antibody, in combination with chemotherapy for the investigational use in first-line HER2-positive (IHC 3+ or IHC 2+/FISH+) locally advanced nonresectable gastroesophageal adenocarcinoma (mGEA). The data were featured as a rapid oral presentation at the .

（zanidatamab-hrii），一种双重HER2靶向的双特异性抗体，与化疗联合用于一线治疗HER2阳性（IHC 3+ 或 IHC 2+/FISH+）局部晚期不可切除的胃食管腺癌（mGEA）。这些数据在会议上被作为快速口头报告展示。

American Society of Clinical Oncology

美国临床肿瘤学会

(ASCO) Annual Meeting, and the results were concurrently published in

（ASCO）年会，并且结果同时发表在

The Lancet Oncology

《柳叶刀·肿瘤学》

.

。

Among 41 patients with centrally confirmed HER2-positive tumors, treatment with

在41名经中心确认为HER2阳性肿瘤的患者中，接受治疗的

Ziihera

齐赫拉

in combination with physician's choice of chemotherapy resulted in a median progression-free survival (PFS) of 15.2 months [95% CI: 9.5, 33.4], and a median overall survival (OS) of 36.5 months [95% CI: 23.6, not estimable (NE)]. Median PFS remained stable with the additional four-year follow-up, consistent with previously reported results..

与医生选择的化疗方案联合使用时，中位无进展生存期（PFS）为15.2个月[95% CI：9.5，33.4]，中位总生存期（OS）为36.5个月[95% CI：23.6，不可估计（NE）]。经过额外四年的随访，中位PFS保持稳定，与之前报告的结果一致。

Among all 46 patients in the study with HER2-expressing mGEA, median PFS was 12.5 months [95% CI: 8.2, 21.8], and median OS also reached 36.5 months [95% CI: 23.6, NE], with the longest observed survival at 57.9 months (censored at data cutoff). Long-term follow-up also demonstrated low discontinuation rates, with no new safety signals observed..

在研究中所有46名表达HER2的mGEA患者中，中位PFS为12.5个月[95% CI：8.2，21.8]，中位OS也达到36.5个月[95% CI：23.6，未达到]，观察到的最长生存期为57.9个月（数据截止时删失）。长期随访还显示停药率较低，且未观察到新的安全性信号。

'Gastroesophageal adenocarcinoma remains a highly aggressive cancer with a poor prognosis, even with currently available treatment options,' said Dr. Elena Elimova, lead trial investigator and a medical oncologist at

“即使有目前可用的治疗方案，胃食管腺癌仍然是一种高度侵袭性的癌症，预后较差，”首席试验研究员、医学肿瘤学家埃琳娜·埃利莫娃博士表示。

Princess Margaret Cancer Centre

玛格丽特公主癌症中心

,

，

Toronto, Canada

加拿大多伦多

. 'The long-term survival outcomes presented today at ASCO demonstrate the sustained antitumor activity achieved with zanidatamab plus chemotherapy over four years of follow-up. These results are especially encouraging given the high unmet need for better first-line treatment options for this patient population.'.

“今天在ASCO上展示的长期生存结果表明，在四年的随访中，扎尼达单抗联合化疗持续展现出抗肿瘤活性。鉴于这一患者群体对更好的第一线治疗方案存在高度未满足的需求，这些结果尤其令人鼓舞。”

'These long-term survival data from our Phase 2 trial build on previously reported results and further strengthen our belief in

“我们二期试验的这些长期生存数据建立在先前报告的结果之上，并进一步坚定了我们的信念。

Ziihera

齐赫拉

as a transformative treatment option for patients with HER2-positive disease,' said

作为一种针对HER2阳性疾病的变革性治疗选择，

Rob Iannone

罗伯·伊安诺内

, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of

医学博士，硕士，执行副总裁，全球研发主管，首席医务官

Jazz Pharmaceuticals

爵士制药公司

. 'An estimated median overall survival of 36.5 months in this patient cohort is very encouraging given recent observations with standard of care regimens in similar populations, where median survival has typically ranged from 15 to 20 months. The sustained 15.2-month progression-free survival in the centrally confirmed HER2-positive subgroup after four years is a meaningful indicator of durable clinical benefit.

“考虑到近期在类似人群中的标准治疗方案的观察结果，这一患者队列的预估中位总生存期为36.5个月，非常令人鼓舞，其中中位生存期通常在15到20个月之间。在经过四年时间后，中心确认的HER2阳性亚组中持续的15.2个月无进展生存期是持久临床获益的一个有意义的指标。”

We look forward to the top line results of the pivotal Phase 3 HERIZON-GEA-01 trial later this year and remain committed to advancing .

我们期待着今年晚些时候关键的3期HERIZON-GEA-01试验的顶线结果，并继续致力于推进。

Ziihera

梓赫拉

across multiple tumor types.'

跨多种肿瘤类型。

Phase 2 mGEA Trial Results

第二阶段mGEA试验结果

The data include four-year follow-up and the first report of median OS from an ongoing, open-label Phase 2 trial (

数据包括四年的随访和来自一个正在进行的、开放标签的二期试验的首次中位OS报告 (

NCT03929666

NCT03929666

) evaluating

) 评估

Ziihera

齐赫拉

in combination with chemotherapy as a first-line treatment for patients with HER2-expressing mGEA, which includes gastric, esophageal and gastroesophageal junction (GEJ) adenocarcinomas. Patients had not received prior HER2-targeted agents nor systemic treatment for mGEA. A total of 46 patients with HER2-expressing mGEA (41 patients with centrally confirmed HER2-positive mGEA) were enrolled from 14 sites across the United States, Canada and South Korea.

与化疗联合作为HER2表达的mGEA患者的一线治疗方案，包括胃癌、食管癌和胃食管交界处（GEJ）腺癌。患者之前未接受过HER2靶向药物或针对mGEA的系统性治疗。研究共纳入了46名HER2表达的mGEA患者（其中41名患者的HER2阳性mGEA经中心确认），来自美国、加拿大和韩国的14个研究中心。

Patients received .

患者接受了。

Ziihera

齐赫拉

with physician's choice of chemotherapy, including fluoropyrimidine maintenance regimens. Chemotherapy-based regimens remain the current standard first-line treatment for mGEA.

使用医生选择的化疗方案，包括氟嘧啶维持治疗方案。基于化疗的方案仍然是目前mGEA的一线标准治疗。

The longer-term data (median duration of follow-up of 48 months [range, 29-59]) demonstrate the promising antitumor activity of

长期数据（中位随访时间为48个月[范围，29-59]）显示了其具有前景的抗肿瘤活性，

Ziihera

齐赫拉

combined with chemotherapy as a first-line treatment for HER2-positive mGEA. In a post-hoc subgroup analysis of the 41 treated patients with centrally confirmed HER2-positive tumors, median PFS was 15.2 months [95% CI: 9.5, 33.4], and median OS was 36.5 months [95% CI: 23.6, NE]. These survival outcomes were consistent with prior analyses, with PFS durability maintained at the four-year follow-up.

与化疗联合使用作为HER2阳性mGEA的一线治疗。在对41名经中心确认为HER2阳性肿瘤患者的事后亚组分析中，中位无进展生存期（PFS）为15.2个月[95%置信区间：9.5, 33.4]，中位总生存期（OS）为36.5个月[95%置信区间：23.6, 未达到]。这些生存结果与之前的分析一致，在四年的随访中，PFS的持久性得以维持。

The confirmed objective response rate (cORR), the study's primary endpoint, was 83.8% [95% CI: 68.0, 93.8], and median duration of response (DOR) was 20.4 months [95% CI: 8.3, 44.1]. These results further support the observed clinical benefit in this centrally confirmed population..

研究的主要终点，即确认的客观缓解率（cORR）为83.8% [95% CI: 68.0, 93.8]，中位缓解持续时间（DOR）为20.4个月 [95% CI: 8.3, 44.1]。这些结果进一步支持了在这一中心确认人群中观察到的临床益处。

Among all 46 patients in the study, median PFS was 12.5 months [95% CI: 8.2, 21.8], and the estimated 24-month PFS rate was 31% [95% CI: 17%, 46%]. Median OS was also 36.5 months [95% CI: 23.6, NE], with an estimated 24-month OS rate of 65% [95% CI: 49%, 77%]. The cORR was 76.2% [95% CI: 60.5, 87.9], and median DOR was 18.7 months [95% CI: 10.4, 44.1]..

在研究的所有46名患者中，中位无进展生存期（PFS）为12.5个月 [95% CI: 8.2, 21.8]，估计的24个月PFS率为31% [95% CI: 17%, 46%]。中位总生存期（OS）为36.5个月 [95% CI: 23.6, 未达到]，估计的24个月OS率为65% [95% CI: 49%, 77%]。总体缓解率（cORR）为76.2% [95% CI: 60.5, 87.9]，中位缓解持续时间（DOR）为18.7个月 [95% CI: 10.4, 44.1]。

With additional follow-up, the safety and tolerability profile of

随着进一步的随访，安全性和耐受性特征

Ziihera

齐赫拉

plus chemotherapy showed low discontinuation rates, with no new safety signals identified. Diarrhea (39%) and hypokalemia (22%) were the most common Grade 3-4 treatment-related adverse events (TRAEs); the incidence of Grade 3 diarrhea was reduced from 52% to 24% for patients enrolled after the implementation of mandated antidiarrheal prophylaxis.

加化疗的中断率较低，且未发现新的安全信号。腹泻 (39%) 和低钾血症 (22%) 是最常见的 3-4 级治疗相关不良事件 (TRAE)；在实施强制性止泻预防措施后，3 级腹泻的发生率从 52% 降至 24%。

There were no treatment-related deaths. Five patients discontinued .

没有与治疗相关的死亡。五名患者停止了治疗。

Ziihera

梓赫拉

due to TRAEs.

由于TRAEs。

Ongoing Phase 3 Trial

正在进行的第三阶段试验

The Phase 3 randomized clinical trial, HERIZON-GEA-01 (

第三阶段随机临床试验，HERIZON-GEA-01 (

NCT05152147

NCT05152147

), evaluating

)，评估

Ziihera

梓赫拉

in combination with standard of care chemotherapy with and without the addition of a PD-1 agent as a first-line treatment for HER2-expressing mGEA is currently underway. This is an events-based trial, and top-line results are expected to read out in the second half of 2025.

与标准护理化疗联合使用，无论是否添加PD-1抑制剂，作为HER2表达的mGEA的一线治疗方案的研究正在进行中。这是一项基于事件的试验，预计主要结果将在2025年下半年公布。

About Gastroesophageal Adenocarcinoma

关于胃食管腺癌

Gastroesophageal adenocarcinoma (GEA) is the fifth most common cancer worldwide, and approximately 20% of patients have HER2-positive disease.

胃食管腺癌（GEA）是全球第五大常见癌症，大约20%的患者为HER2阳性。

i

我

,ii,iii

，ii，iii

HER2-positive 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 percent for gastric cancer and about 19 percent for GEA.

HER2阳性GEA的发病率和死亡率较高，患者迫切需要新的治疗选择。GEA患者的总体预后仍然较差，胃癌的全球五年生存率不到30%，而GEA约为19%。

iv

四

About Ziihera

关于Ziihera

®

®

(zanidatamab-hrii)

（扎尼达单抗-hrii）

Ziihera

齐赫拉

(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 (.

(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 还诱导补体依赖性细胞毒性 (CDC)。

CDC

疾控中心

), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.

），抗体依赖的细胞毒性（ADCC）和抗体依赖的细胞吞噬作用（ADCP）。这些机制在体外和体内导致肿瘤生长抑制和细胞死亡。

v

v

In

在

the United States

美国

,

，

Ziihera

齐赫拉

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、既往接受过治疗的、不可切除或转移性的HER2阳性（IHC 3+）胆道癌（BTC）成人患者。

v

v

The U.S. Food and Drug Administration (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).

美国食品药品监督管理局 (FDA) 基于总体缓解率和缓解持续时间加速批准了该适应症。此适应症的继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。

v

v

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 and BeiGene, Ltd. (BeiGene) 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和百济神州（BeiGene）根据与Zymeworks的许可协议开发，Zymeworks是最初开发该分子的公司。

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).

FDA授予zanidatamab在既往治疗过的HER2基因扩增型BTC患者中的突破性疗法认定，并给予zanidatamab两项快速通道认定：一项是作为单药治疗难治性BTC，另一项是与标准护理化疗联合用于一线胃食管腺癌（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.  .

此外，zanidatamab 已获得 FDA 授予的用于治疗 BTC 和 GEA 的孤儿药资格，以及欧洲药品管理局授予的用于治疗 BTC 和胃癌的孤儿药资格。

Important Safety Information for ZIIHERA

ZIIHERA的重要安全信息

WARNING: EMBRYO-FETAL TOXICITY

警告：胚胎-胎儿毒性

Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients

怀孕期间接触ZIIHERA可能会对胚胎和胎儿造成伤害。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在给孕妇使用时会对胎儿造成伤害。文献报道中，在妊娠期间使用HER2导向抗体可导致羊水过少和羊水过少序列征，表现为肺发育不全、骨骼异常和新生儿死亡。

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，验证具有生育潜力的女性的怀孕状况。告知孕妇和具有生育潜力的女性，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。建议具有生育潜力的女性在使用ZIIHERA治疗期间以及在最后一次服用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%，并降至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..

LVD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可能引起输注相关反应（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3级（0.4%）和2级（25%）。有0.4%的患者因IRRs而永久停止使用ZIIHERA。28%的患者在首次给药当天出现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，应预先给予药物以防止潜在的输注相关反应（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的迹象和症状。确保有治疗IRRs的药物和急救设备可供立即使用。

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退前持续监测患者，然后再恢复用药。对于出现反复严重或危及生命的IRR的患者，永久停用ZIIHERA。

Diarrhea

腹泻

ZIIHERA can cause severe diarrhea.

齐拉菌素可能引起严重腹泻。

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（BTC）患者中，53%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

特定人群中的使用

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BTC患者中，有39名（49%）患者年龄在65岁及以上。其中，37名（46%）患者的年龄为65至74岁，2名（3%）患者的年龄为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 U.S. Prescribing Information for ZIIHERA, including BOXED Warning, is available at:

ZIIHERA的完整美国处方信息，包括黑框警告，可在此处获取：

https://pp.jazzpharma.com/pi/ziihera.en.USPI.pdf

https://pp.jazzpharma.com/pi/ziihera.en.USPI.pdf

About Jazz Pharmaceuticals

关于Jazz制药公司

Jazz Pharmaceuticals

爵士制药公司

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.

plc（纳斯达克股票代码：JAZZ）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。我们专注于为患有严重疾病的人群开发可能改变生命的药物，这些疾病通常缺乏或没有任何治疗选择。我们拥有多样化的上市药物组合，包括针对睡眠障碍和癫痫的领先疗法，并且我们的癌症治疗药物组合也在不断增长。

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.

我们以患者为中心、以科学为驱动的方法，推动了我们在肿瘤学和神经科学领域强大的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，在多个国家设有研发实验室、制造设施和员工，致力于为全球患者服务。

Please visit .

请访问 。

www.jazzpharmaceuticals.com

www.jazzpharmaceuticals.com

for more information.

欲了解更多信息。

Jazz Pharmaceuticals plc

Jazz制药公司

Caution Concerning Forward-Looking Statements

关于前瞻性陈述的注意事项

This press release contains forward-looking statements, including, but not limited to, statements related to zanidatamab's potential as a transformative treatment option for patients with HER2-positive disease, expected timing of top-line results of the pivotal Phase 3 HERIZON-GEA-01 and other statements that are not historical facts.

本新闻稿包含前瞻性声明，包括但不限于有关扎尼达单抗作为 HER2 阳性疾病患者的变革性治疗选择的潜力、关键性 3 期 HERIZON-GEA-01 试验主要结果的预期时间以及其他非历史事实的声明。

These forward-looking statements are based on .

这些前瞻性陈述基于 。

Jazz Pharmaceuticals'

Jazz制药公司

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 .

当前的计划、目标、估计、预期和意图均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的预期存在重大差异，这些风险和不确定性包括但不限于：顺利完成监管活动及不确定的监管批准相关的风险、未能成功启动或完成临床试验及评估患者的风险、以及其他影响的风险和不确定性。

Jazz Pharmaceuticals

爵士制药公司

and its development programs, including those described from time to time under the caption 'Risk Factors' and elsewhere in

及其发展计划，包括不时在“风险因素”标题下及其他地方描述的那些计划，

Jazz Pharmaceuticals plc's

爵士制药公司

Securities and Exchange Commission

证券交易委员会

filings and reports (Commission File No. 001-33500), including

文件和报告（委员会文件编号：001-33500），包括

Jazz Pharmaceuticals'

Jazz制药公司

Annual Report on Form 10-K for the year ended

截至年度的10-K表年报

December 31, 2024

2024年12月31日

, as supplement by

，补充由

Jazz Pharmaceuticals'

Jazz制药公司

Quarterly Report on Form 10-Q for the quarter ended

截至季度末的10-Q表季度报告

March 31, 2025

2025年3月31日

, and future filings and reports by

，以及未来的文件和报告由

Jazz Pharmaceuticals

爵士制药公司

. Other risks and uncertainties of which

. 其他风险和不确定性

Jazz Pharmaceuticals

Jazz制药公司

is not currently aware may also affect

当前未意识到的也可能影响

Jazz Pharmaceuticals'

爵士制药公司

forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by .

前瞻性声明，可能导致实际结果和事件发生的时间与预期有重大差异。本前瞻性声明仅于本日期或前瞻性声明中指明的日期作出，即使其后可能由其他信息提供者发布。

Jazz Pharmaceuticals

爵士制药公司

on its website or otherwise.

在其网站上或以其他方式。

Jazz Pharmaceuticals

爵士制药公司

undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

不承担更新或补充任何前瞻性陈述的义务，以反映实际结果、新信息、未来事件、其预期的变化或其他在作出前瞻性陈述的日期之后存在的情况。

Contacts:

联系人：

Media Contact:

媒体联系人:

Kristin Bhavnani

克莉丝汀·巴瓦尼

Head of

头部

Global Corporate Communications

全球企业传播

Jazz Pharmaceuticals plc

爵士制药公司

CorporateAffairsMediaInfo@jazzpharma.com

公司事务媒体信息@jazzpharma.com

Ireland

爱尔兰

+353 1 637 2141

+353 1 637 2141

U.S.

美国

+1 215 867 4948

+1 215 867 4948

Investors:

投资者：

Jeff Macdonald

杰夫·麦克唐纳

Executive Director, Investor Relations

投资者关系执行董事

Jazz Pharmaceuticals plc

Jazz制药公司

investorinfo@jazzpharma.com

投资者信息@爵士制药.com

Ireland

爱尔兰

+353 1 634 3211

+353 1 634 3211

U.S.

美国

+1 650 496 2717

+1 650 496 2717

i

我

Abrahao-Machado I.F

阿布拉哈奥-马查多 I.F

., et al. HER2 testing in gastric cancer: An update WorldJGastroenterol. 2016;22(19):4619-4625.

., 等。胃癌中HER2检测：更新 世界胃肠病学杂志。2016；22（19）：4619-4625。

ii

ii

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。《胃癌》。2015年；18(3)：476-484。

iii

iii

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：已取得的成就与未来的机遇。《癌症治疗评论》2021年；99:102249。

iv

四

Battaglin F, et al. Molecular biomarkers in gastro-esophageal cancer: recent developments, current trends and future directions.

巴塔格林 F 等。胃食管癌的分子生物标志物：最新进展、当前趋势和未来方向。

Cancer Cell International

癌症细胞国际

. 2018;18(99).

. 2018;18(99).

v

v

ZIIHERA (zanidatamab-hrii) Prescribing Information.

ZIIHERA（扎尼达单抗-hrii）处方信息。

Palo Alto, CA

加利福尼亚州帕洛阿尔托

:

：

Jazz Pharmaceuticals, Inc.

爵士制药公司

).

）。

View original content to download multimedia:

查看原始内容以下载多媒体：

https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-reports-clinically-meaningful-long-term-median-overall-survival-data-for-ziihera-zanidatamab-hrii-in-first-line-her2-positive-metastatic-gastroesophageal-adenocarcinoma-at-asco-2025-302470879.html

https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-reports-clinically-meaningful-long-term-median-overall-survival-data-for-ziihera-zanidatamab-hrii-in-first-line-her2-positive-metastatic-gastroesophageal-adenocarcinoma-at-asco-2025-302470879.html

SOURCE

源代码

Jazz Pharmaceuticals plc

Jazz制药公司