Seven presentations deliver new insights into zanidatamab's differentiated HER2 biology, emerging pre-clinical data on dordaviprone and related imipridones, and advancing research on JZP898, a conditionally activated IFN

七份报告提供了对zanidatamab独特的HER2生物学的新见解，dordaviprone及相关imipridones的新兴临床前数据，以及关于JZP898（一种条件性激活的IFN）的进展研究。

⍺2b

⍺2b

cytokine

细胞因子

For U.S. media and investors only

仅限美国媒体和投资者

DUBLIN

都柏林

,

，

March 18, 2026

2026年3月18日

/PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq:

/PRNewswire/ -- Jazz Pharmaceuticals plc（纳斯达克：

JAZZ

爵士乐

) today announced that the company and its partners will present one oral and six poster presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting, taking place April 17-22, 2026, in San Diego.

）今天宣布，该公司及其合作伙伴将在2026年美国癌症研究协会（AACR）年会上进行一次口头报告和六次海报展示，会议将于2026年4月17日至22日在圣地亚哥举行。

The research highlights meaningful progress across Jazz's oncology portfolio, including new findings from company-sponsored research evaluating Ziihera

该研究强调了Jazz肿瘤学产品组合的有意义进展，包括评估Ziihera的公司赞助研究的新发现。

®

®

(zanidatamab-hrii), a HER2-targeted bispecific antibody; JZP898, an investigational, differentiated, conditionally activated interferon alpha-2b (IFN⍺2b) cytokine pro-drug designed for activation within the tumor microenvironment; and imipridone compounds including Modeyso™ (dordaviprone), a protease activator of the mitochondrial caseinolytic protease P (ClpP) and a dopamine D2 receptor (DRD2) inhibitor..

（zanidatamab-hrii），一种HER2靶向的双特异性抗体；JZP898，一种研究中的、差异化的、条件性激活的干扰素α-2b（IFN⍺2b）细胞因子前药，设计用于在肿瘤微环境中激活；以及包括Modeyso™（dordaviprone）在内的imipridone化合物，它是一种线粒体酪蛋白溶解蛋白酶P（ClpP）的蛋白酶激活剂和多巴胺D2受体（DRD2）抑制剂。

'Jazz is presenting research at AACR that highlights how we are advancing our oncology portfolio with pace and rigor to deliver differentiated science and new insights across multiple development programs,' said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals.

“Jazz 正在 AACR 上展示我们的研究成果，凸显了我们如何以快速且严谨的方式推进肿瘤学产品组合，在多个开发项目中提供独具特色的科学成果和全新见解，”Jazz Pharmaceuticals 执行副总裁、全球研发主管兼首席医学官 Rob Iannone 医学博士表示。

'Zanidatamab is already delivering meaningful benefits for adult patients with previously treated, unresectable or metastatic HER2+ (IHC 3+) biliary tract cancer. We are advancing our program in first-line HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma, and generating a robust body of evidence that characterizes its distinct HER2 biology and its potential across additional HER2-expressing tumors, including HER2+ breast cancer.

‘Zanidatamab 已在既往接受过治疗的不可切除或转移性 HER2+（IHC 3+）胆道癌成人患者中显示出显著益处。我们正在推进针对一线 HER2+ 局部晚期或转移性胃食管腺癌的项目，并生成大量证据以阐明其独特的 HER2 生物学特性及其在其他表达 HER2 的肿瘤（包括 HER2+ 乳腺癌）中的潜力。’

The NeoZanHER trial data being presented at AACR provide supporting evidence for our ongoing research in early-stage breast cancer.'.

“在AACR上展示的NeoZanHER试验数据为我们在早期乳腺癌方面的持续研究提供了支持证据。”

Highlights at the AACR Annual Meeting include:

美国癌症研究协会年会的亮点包括：

An oral presentation with results from the Phase 2 single-arm, open-label NeoZanHER trial (

一项来自二期单臂、开放标签的NeoZanHER试验的口头报告（

NCT05035836

NCT05035836

) evaluating zanidatamab for the investigational use as neoadjuvant monotherapy in patients with early-stage HER2+ breast cancer. At six weeks, zanidatamab treatment resulted in a statistically significant decrease in tumor size and volume from baseline, and 30% of patients (n=6) achieved pathologic complete response (pCR).

）评估zanidatamab作为新辅助单药治疗在早期HER2+乳腺癌患者中的研究性使用。在六周时，zanidatamab治疗使得肿瘤大小和体积较基线显著减少，并且30%的患者（n=6）达到了病理完全缓解（pCR）。

Treatment with zanidatamab was manageable with no new safety signals..

用扎尼达单抗治疗是可控的，没有新的安全信号。

A poster presentation detailing mechanistic and multi-omics analyses characterizing zanidatamab's differentiated HER2 biology, including dual, domain-specific binding and downstream effects on key cellular signaling pathways, with insights into activity in models following trastuzumab deruxtecan (T-DXd) exposure..

一张海报展示，详细介绍了关于zanidatamab的机制和多组学分析，阐明其与众不同的HER2生物学特性，包括双重、结构域特异性结合及其对关键细胞信号通路的下游影响，并在trastuzumab deruxtecan（T-DXd）暴露后的模型中提供了活性见解。

A poster presentation featuring preclinical data supporting the activity of JZP898 – currently in Phase 1 development – including evidence of tumor-localized interferon signaling and immune engagement in preclinical models.

一份海报展示，呈现了支持JZP898活性的临床前数据——该药物目前处于1期开发阶段——其中包括在临床前模型中肿瘤局部干扰素信号传导和免疫激活的证据。

A presentation featuring preclinical research evaluating imiprodones, inclusive of dordaviprone (formerly ONC201) and JZP3507 (formerly ONC206), across renal cell carcinoma and small-cell lung cancer models, including combination approaches and comparative analyses to further characterize activity and mechanism..

一份展示临床前研究的报告，评估了包括dordaviprone（原ONC201）和JZP3507（原ONC206）在内的imiprodones在肾细胞癌和小细胞肺癌模型中的表现，包括联合疗法和对比分析，以进一步明确其活性和作用机制。

Additional presentations will further explore zanidatamab's utility across HER2-expressing solid tumors and within innovative biomarker-driven clinical trial designs, including adaptive organ-preservation strategies in gastroesophageal adenocarcinoma (GEA).

更多的报告将进一步探讨扎尼达单抗在HER2表达的实体瘤中的应用，以及在创新的生物标志物驱动的临床试验设计中的应用，包括胃食管腺癌（GEA）中的适应性器官保留策略。

The AACR abstracts are available at:

AACR摘要可在此处获取：

https://www.aacr.org/meeting/aacr-annual-meeting-2026/

https://www.aacr.org/meeting/aacr-annual-meeting-2026/

The full list of Jazz- and partner-supported presentations at the 2026 AACR Annual Meeting are:

2026年AACR年会上由Jazz及其合作伙伴支持的报告完整列表如下：

Zanidatamab Presentations:

Zanidatamab 演示文稿：

Presentation Title

演示标题

Authors

作者

Presentation Details

演示详情

A phase 2 single-arm open-label trial evaluating zanidatamab in patients with early stage HER2 positive breast cancer: The NeoZanHER Study

一项评估扎尼达单抗在早期HER2阳性乳腺癌患者中的二期单臂开放标签试验：NeoZanHER研究

Valero V, Pohlmann PR, Mouabbi J, Huang X, Qiao W, Alonzo H, Murthy RK, Rauch GM, Adesoye T, Checka C, Symmans FW, Grachev D, Alajajyan F, Nwosu-Iheme A, Hassan A, Patel MM, Giordano SH, Hunt K, Tripathy D, Meric-Bernstam F

瓦莱罗·V，波尔曼·P·R，穆阿比·J，黄·X，乔·W，阿隆索·H，穆尔蒂·R·K，劳赫·G·M，阿德索耶·T，切卡·C，辛曼斯·F·W，格拉切夫·D，阿拉贾扬·F，恩沃苏-伊赫梅·A，哈桑·A，帕特尔·M·M，乔达诺·S·H，亨特·K，特里帕蒂·D，梅里克-伯恩斯坦·F

Type:

类型：

Oral Presentation

口头报告

Session:

会话：

Clinical Trials Minisymposium: Aiming for Cure: Perioperative Clinical Trials

临床试验小型研讨会：追求治愈：围手术期临床试验

Date/Time:

日期/时间：

April 18, 2026, 12:30-2:30 p.m. PST

2026年4月18日，下午12点30分至2点30分（太平洋标准时间）

Presentation number:

报告编号：

CT012

CT012

Zanidatamab modulates multiple pathways involved in tumor growth and survival and is efficacious post  T-DXd

Zanidatamab 调节参与肿瘤生长和存活的多条通路，并在 T-DXd 后有效。

Karmokar A, Loro E, Kyakulaga AH, Lau D, Weisser N, Desjardins G, Raghunatha P, Clark E, Humphreys R, and Vaidya K

卡尔莫卡 A，洛罗 E，基亚库拉加 AH，刘 D，魏瑟 N，德斯贾丁斯 G，拉古纳塔 P，克拉克 E，汉弗莱斯 R，和瓦伊迪亚 K

Type:

类型：

Poster

海报

Session:

会话：

Experimental and Molecular Therapeutics: Next-Generation Targeted Therapies Directed Against Tumor Surface Antigens

实验性和分子治疗学：针对肿瘤表面抗原的下一代靶向疗法

Date/Time:

日期/时间：

April 21, 2026, 9:00 a.m.-12:00 p.m. PST

2026年4月21日，上午9:00至中午12:00（太平洋标准时间）

Abstract number:

抽象编号：

4542

4542

DiscovHER PAN-206: Phase 2 tumor-agnostic study of zanidatamab in patients with previously treated human epidermal growth factor receptor 2-overexpressing solid tumors

DiscovHER PAN-206：zanidatamab 在既往接受过治疗的人类表皮生长因子受体2过表达实体瘤患者中的二期泛肿瘤研究

Subbiah V, Makker V, Oh DY, Gardener E, Gartner E, Meric-Bernstam F

苏比亚 V，马凯尔 V，欧 DY，加德纳 E，加特纳 E，梅里克-伯恩斯塔姆 F

Type:

类型：

Poster

海报

Session:

会话：

Phase II and Phase III Clinical Trials in Progress

第II期和第III期临床试验正在进行中

Date/Time:

日期/时间：

April 21, 2026, 9:00 a.m.-12:00 p.m. PST

2026年4月21日，上午9:00至中午12:00（太平洋标准时间）

Abstract number:

抽象编号：

CT209

CT209

AACR adaptive biomarker-driven organ preservation trial in GE adenocarcinomas (AACR-ADOPT-GEA)

AACR适应性生物标志物驱动的GE腺癌器官保留试验（AACR-ADOPT-GEA）

Elimova E, Ajani JA, Klempner SJ, Schalper K, Wainberg ZA, Yuan Y, Baranski JD, Boerner S, Durbin S, Gallagher D, Huh W, McLaughlin R, Strickland M, Rubin EH, Siu LL, Yap TA, LoRusso P

Elimova E, Ajani JA, Klempner SJ, Schalper K, Wainberg ZA, 袁Y, Baranski JD, Boerner S, Durbin S, Gallagher D, Huh W, McLaughlin R, Strickland M, Rubin EH, Siu LL, Yap TA, LoRusso P

Type:

类型：

Poster

海报

Session:

会话：

Phase II and Phase III Clinical Trials in Progress

第II期和第III期临床试验正在进行中

Date/Time:

日期/时间：

April 21, 2026, 9:00 a.m.-12:00 p.m. PST

2026年4月21日，上午9:00至中午12:00（太平洋标准时间）

Abstract number:

抽象编号：

CT223

CT223

Dordaviprone (formerly ONC201) Presentations:

Dordaviprone（原名ONC201）展示：

Presentation Title

演示标题

Authors

作者

Presentation Details

演示详情

Nuvisertib (TP-3654) and Dordaviprone (ONC201) synergize to reduce renal cell carcinoma cell viability

努维塞替布（TP-3654）和多尔达维普隆（ONC201）协同作用降低肾细胞癌细胞活力

Meza KS, Holder SL, El-Deiry W

梅扎 KS，霍尔德 SL，埃尔-德里 W

Type:

类型：

Poster

海报

Session:

会话：

Experimental and Molecular Therapeutics: Targeting Cell Surface Vulnerabilities to Overcome Therapeutic Resistance

实验与分子治疗学：靶向细胞表面脆弱性以克服治疗耐药性

Date/Time:

日期/时间：

April 20, 2026, 2:00-5:00 p.m. PST

2026年4月20日，下午2:00-5:00（太平洋标准时间）

Abstract number:

抽象编号：

3174

3174

Imipridones ONC201, ONC206, and ONC212 show potent killing and colony arrest of small-cell lung cancer cell lines

Imipridones ONC201、ONC206 和 ONC212 显示出对小细胞肺癌细胞系的有效杀伤和集落抑制作用。

Su AY, Purcell C, Zhang S, Zhou L, Uruchurtu AS, El-Deiry WS

苏AY，珀塞尔C，张S，周L，乌鲁丘图AS，埃尔-德里WS

Type:

类型：

Poster

海报

Session:

会话：

Experimental and Molecular Therapeutics: Cellular Responses to Anticancer Drugs

实验与分子治疗学：细胞对抗癌药物的反应

Date/Time:

日期/时间：

April 20, 2026, 2:00-5:00 p.m. PST

2026年4月20日，下午2:00-5:00（太平洋标准时间）

Abstract number:

抽象编号：

2937

2937

JZP898 Presentation:

JZP898 展示：

Presentation Title

演示标题

Authors

作者

Presentation Details

演示详情

JZP898, a conditionally activated interferon alpha, generates efficacy and robust TME engagement in syngeneic mouse models

JZP898，一种条件性激活的干扰素α，在同基因小鼠模型中产生疗效并引发强烈的肿瘤微环境参与。

Karmokar A, Loro E, Zhang Z, Mukavilli R, Gupta A, Trouba K, Amber V, Humphreys RC

卡尔莫卡 A，洛罗 E，张 Z，穆卡维利 R，古普塔 A，特鲁巴 K，安伯 V，汉弗莱斯 RC

Type:

类型：

Poster

海报

Session:

会话：

Experimental and Molecular Therapeutics: RNA, Gene and Cell Therapies, and Enabling Assay Technologies

实验与分子治疗学：RNA、基因和细胞疗法，以及辅助检测技术

Date/Time:

日期/时间：

April 19, 2026, 2:00-5:00 p.m. PST

2026年4月19日，下午2:00-5:00（太平洋标准时间）

Abstract number:

抽象编号：

470

470

About Ziihera

关于Ziihera

®

®

(zanidatamab-hrii)

(扎尼达单抗-hrii)

Ziihera

梓赫拉

(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。

[1]

[1]

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批准的检测方法确定的先前接受过治疗、不可切除或转移性的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了加速批准。该适应症的持续批准可能取决于在确证性试验中对临床益处的验证和描述。

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 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和BeOne根据与最初开发该分子的Zymeworks的许可协议进行开发。

A supplemental biologics license application for zanidatamab was submitted to the FDA under Real Time Oncology Review 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 standard-of-care chemotherapy for first-line HER2+ locally advanced or metastatic GEA.

针对zanidatamab的补充生物制品许可申请已根据实时肿瘤审评（Real Time Oncology Review）提交给FDA，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，另一项是与标准护理化疗联合用于一线治疗HER2阳性局部晚期或转移性GEA。

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 gastroesophageal junction) cancer, and esophageal cancer, as well as Orphan Drug designations from the European Medicines Agency for the treatment of BTC, gastric/gastroesophageal junction 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治疗GEA。此外，zanidatamab已获得FDA授予的孤儿药资格，用于治疗BTC、胃癌（包括胃食管交界处癌）和食管癌，同时也获得了欧洲药品管理局（EMA）授予的孤儿药资格，用于治疗BTC、胃/胃食管交界处癌和食管癌。

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可能会导致胚胎和胎儿伤害。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 会给孕妇腹中的胎儿造成伤害。在文献报道中，妊娠期间使用 HER2 导向抗体可导致羊水过少和表现为肺发育不全、骨骼异常以及新生儿死亡的羊水过少序列征。

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态。告知怀孕的妇女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首次出现的中位时间为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可能引起输液相关反应（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%）。导致永久停用ZIIHERA的IRRs在0.4%的患者中报告。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便立即使用。

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.

如果发生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BTC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

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%）患者的年龄在65至74岁之间，2名（3%）患者的年龄在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

完整版

U.S.

美国

Prescribing Information for

处方信息

ZIIHERA, including BOXED Warning, is available at:

ZIIHERA，包括盒装警告，可在以下位置获取：

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

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

About

关于

Modeyso

模式化

™

™

(dordaviprone)

(多尔达维普隆)

Modeyso

模式化

(dordaviprone) is approved by FDA for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.

（多达维普龙）获FDA批准用于治疗1岁及以上患有H3 K27M突变的弥漫性中线胶质瘤并在先前治疗后病情进展的成人和儿童患者。

[2]

[2]

Modeyso

模式化

is an orally administered small molecule given once weekly.

是一种每周一次口服的小分子药物。

Modeyso

模式化

is a protease activator of the mitochondrial ClpP and also inhibits DRD2. In vitro, dordaviprone activates the integrated stress response, induces apoptosis, and alters mitochondrial metabolism, leading to restored histone H3 K27 trimethylation in H3 K27M-mutant diffuse glioma.

是线粒体ClpP的蛋白酶激活剂，同时抑制DRD2。在体外，多达匹隆激活综合应激反应，诱导细胞凋亡，并改变线粒体代谢，从而恢复H3 K27M突变型弥漫性胶质瘤中组蛋白H3 K27的三甲基化。

2

2

Modeyso

模式化

received accelerated approval based on a pre-specified integrated efficacy analysis of 50 adult and pediatric patients with recurrent H3 K27M-mutant diffuse midline glioma enrolled across five open-label clinical studies (ONC006, ONC013, ONC014, ONC016, and ONC018). Continued approval may be contingent upon verification and description of clinical benefit in the ongoing Phase 3 ACTION trial (.

基于对五项开放标签临床研究（ONC006、ONC013、ONC014、ONC016 和 ONC018）中入组的 50 名复发性 H3 K27M 突变型弥漫性中线胶质瘤成人和儿童患者的预先设定的综合疗效分析，获得了加速批准。持续批准可能取决于正在进行的第 3 阶段 ACTION 试验中临床益处的验证和描述。

NCT05580562

NCT05580562

), which is evaluating the safety and clinical benefit of

），正在评估其安全性和临床益处

Modeyso

模式化

in newly diagnosed patients with H3 K27M-mutant diffuse glioma following radiotherapy. The FDA granted dordaviprone Rare Pediatric Disease designation and Fast-Track designation, and dordaviprone received Orphan Drug Designation in the United States, Europe and Australia.

在新诊断的H3 K27M突变型弥漫性胶质瘤患者放疗后使用。美国食品药品监督管理局（FDA）授予多拉维普朗罕见儿科疾病认定和快速通道认定，且多拉维普朗已在美国、欧洲和澳大利亚获得孤儿药资格。

Modeyso

模式化

was developed by Chimerix prior to its acquisition by Jazz Pharmaceuticals in April 2025.

是在2025年4月Jazz Pharmaceuticals收购之前，由Chimerix开发的。

Modeyso

模式化

(dordaviprone) is not approved anywhere else in the world.

(dordaviprone) 在世界其他地方均未获批准。

IMPORTANT SAFETY INFORMATION

重要安全信息

WARNINGS AND PRECAUTIONS

警告和注意事项

Hypersensitivity

超敏反应

MODEYSO can cause severe hypersensitivity reactions.

MODEYSO可能引起严重的过敏反应。

In the pooled safety population

在汇总的安全性群体中

,

，

Grade 3 hypersensitivity reactions occurred in 0.3% of patients receiving MODEYSO. Signs and symptoms of hypersensitivity may include rash, hives, fever, low blood pressure, wheezing, or swelling of the face or throat.

接受MODEYSO治疗的患者中有0.3%发生了3级超敏反应。超敏反应的体征和症状可能包括皮疹、荨麻疹、发热、低血压、喘息或面部或喉咙肿胀。

Inform patients about the signs and symptoms of hypersensitivity reactions and instruct them to seek immediate medical attention if symptoms occur.

告知患者关于超敏反应的体征和症状，并指导他们在出现症状时立即寻求医疗帮助。

If clinically significant hypersensitivity or anaphylaxis occur, immediately interrupt MODEYSO and initiate appropriate medical treatment and supportive care. Based on the severity of the adverse reaction, temporarily interrupt or permanently discontinue MODEYSO.

如果出现临床上显著的超敏反应或过敏反应，立即中断 MODEYSO 并启动适当的医疗处理和支持性护理。根据不良反应的严重程度，暂时中断或永久停用 MODEYSO。

QTc Interval Prolongation

QTc间期延长

MODEYSO causes concentration-dependent QTc interval prolongation, which can increase the risk for ventricular tachyarrhythmias (e.g. torsades de pointes) or sudden death.

MODEYSO会引起浓度依赖性的QTc间期延长，这可能会增加室性心动过速（如尖端扭转型室速）或猝死的风险。

In patients who received MODEYSO and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 6% and 1.2% of patients, respectively.

在服用MODEYSO并进行了至少一次基线后心电图检查的患者中，分别有6%和1.2%的患者QTcF比基线增加了超过60毫秒，并且QTcF超过500毫秒。

Monitor ECGs and electrolytes prior to initiation and periodically during treatment, as clinically indicated. Increase the frequency of monitoring in patients with congenital long QT syndrome, existing QTc prolongation, a history of ventricular arrhythmias, electrolyte abnormalities, heart failure, or who are taking strong or moderate CYP3A4 inhibitors..

在开始治疗前和治疗期间，根据临床需要定期监测心电图和电解质。对于患有先天性长QT综合征、现有QTc延长、室性心律失常病史、电解质异常、心力衰竭或正在服用强效或中效CYP3A4抑制剂的患者，应增加监测频率。

Avoid concomitant use with other agents known to prolong the QT interval. If concomitant use cannot be avoided, increase the frequency of monitoring and separate administration of MODEYSO and QT-prolonging product.

避免与已知会延长QT间期的其他药物同时使用。如果无法避免同时使用，增加监测频率，并分开使用MODEYSO和延长QT间期的产品。

Interrupt or reduce the dose of MODEYSO in patients who develop QT prolongation; permanently discontinue in patients with signs of life-threatening arrhythmias.

对于出现QT间期延长的患者，应中断或减少MODEYSO的剂量；对于有危及生命的心律失常迹象的患者，应永久停用。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

MODEYSO can cause fetal harm when administered to a pregnant woman.

MODEYSO 在给孕妇使用时可能会对胎儿造成伤害。

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with MODEYSO and for 1 month after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with MODEYSO and for 1 month after the last dose..

告知孕妇和有生殖潜力的女性对胎儿的潜在风险。建议有生殖潜力的女性在使用MODEYSO治疗期间以及最后一剂后1个月内使用有效避孕措施。建议有生殖潜力女性伴侣的男性患者在使用MODEYSO治疗期间以及最后一剂后1个月内使用有效避孕措施。

ADVERSE REACTIONS

不良反应

Serious adverse reactions occurred in 33% of the 376 patients who received MODEYSO. Serious adverse reactions in >2% of patients included hydrocephalus (5%), vomiting (4.3%), headache (3.2%), seizure (2.4%), and muscular weakness (2.1%). Fatal adverse reactions occurred in 1% of patients who received MODEYSO, including cardiac arrest (0.5%), intracranial hemorrhage (0.3%), and encephalopathy (0.3%)..

在376名接受MODEYSO治疗的患者中，33%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脑积水（5%）、呕吐（4.3%）、头痛（3.2%）、癫痫发作（2.4%）和肌肉无力（2.1%）。在接受MODEYSO治疗的患者中，1%发生了致命不良反应，其中包括心脏骤停（0.5%）、颅内出血（0.3%）和脑病（0.3%）。

The most common adverse reactions (≥20%) reported in clinical trials with MODEYSO were fatigue (34%), headache (32%), vomiting (24%), nausea (24%), and musculoskeletal pain (20%). The most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (7%), decreased calcium (2.7%), and increased alanine aminotransferase (2.4%)..

在MODEYSO的临床试验中，最常见的不良反应（≥20%）为疲劳（34%）、头痛（32%）、呕吐（24%）、恶心（24%）和肌肉骨骼疼痛（20%）。最常见的（≥2%）3级或4级实验室异常为淋巴细胞减少（7%）、钙减少（2.7%）和丙氨酸氨基转移酶升高（2.4%）。

DRUG INTERACTIONS

药物相互作用

Strong and Moderate CYP3A4 Inhibitors

强效和中效CYP3A4抑制剂

Avoid concomitant use of MODEYSO with strong and moderate CYP3A4 inhibitors. If concomitant use cannot be avoided, reduce the MODEYSO dose as recommended and monitor for toxicity.

避免将MODEYSO与强效和中效CYP3A4抑制剂同时使用。如果无法避免同时使用，请按照建议减少MODEYSO的剂量，并监测毒性。

Strong and Moderate CYP3A4 Inducers

强效和中效CYP3A4诱导剂

Avoid concomitant use of strong and moderate CYP3A4 inducers with MODEYSO.

避免同时使用强效和中效CYP3A4诱导剂与MODEYSO。

USE IN SPECIFIC POPULATIONS

在特定人群中使用

Lactation

泌乳

There are no data on the presence of MODEYSO in human milk because of the potential for serious adverse reactions from MODEYSO in breastfed children, advise women not to breastfeed during treatment with MODEYSO and for 1 week after the last dose.

由于MODEYSO可能对哺乳婴儿造成严重不良反应，尚无关于MODEYSO是否存在于人乳中的数据，建议女性在使用MODEYSO治疗期间及最后一剂后的一周内不要哺乳。

Pediatric Use

儿科使用

The safety and effectiveness of MODEYSO have not been established in patients less than 1 year of age. Dosing has not been established for patients weighing less than 22 pounds (10 kg).

MODEYSO 在未满 1 岁的患者中的安全性和有效性尚未确定。对于体重低于 22 磅（10 公斤）的患者，尚未确定剂量。

Please refer to the full Prescribing Information, including both Patient Information and Instructions for Use, for complete safety and administration information.

请参阅完整的处方信息，包括患者信息和使用说明，以获取完整的安全性和管理信息。

The full

完整

U.S.

美国

Prescribing Information for

处方信息

MODEYSO is available at:

MODEYSO 可在以下位置获取：

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

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

About JZP898

关于JZP898

JZP898 is an investigational differentiated, conditionally-activated IFNα INDUKINE™ molecule, and is currently in Phase 1 development for the investigational use in solid tumors as monotherapy and in combination with a PD-1 inhibitor. JZP898 is an engineered IFN⍺2b cytokine pro-drug that is activated specifically within the tumor microenvironment where it can stimulate IFNα receptors on cancer-fighting immune effector cells..

JZP898 是一种研究性差异化、条件性激活的 IFNα INDUKINE™ 分子，目前正处于 1 期临床开发阶段，用于实体瘤的单药治疗及与 PD-1 抑制剂联合使用的探索性研究。JZP898 是一种经过工程改造的 IFN⍺2b 细胞因子前药，能够在肿瘤微环境中特异性激活，从而刺激抗癌免疫效应细胞上的 IFNα 受体。

About Jazz Pharmaceuticals

关于Jazz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 life-changing medicines for people with rare disease — often with limited or no therapeutic options. We have a diverse portfolio of medicines, including leading therapies addressing epilepsies, cancers and sleep disorders.

是一家全球生物制药公司，其宗旨是通过创新来改变患者及其家人的生活。我们致力于为罕见病患者开发改变生活的药物，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，推动了我们在创新治疗药物的强大研发管线中取得突破性的研究和开发进展。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.

更多信息，请访问。

Cautionary Note Concerning Forward-Looking Statements

关于前瞻性声明的注意事项

This press release contains forward-looking statements, including, but not limited to, statements related to the potential therapeutic benefits of zanidatamab in HER2+ first-line GEA and other HER2-expressing cancers, JZP898 and dordaviprone, and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties.

本新闻稿包含前瞻性声明，包括但不限于与zanidatamab在HER2阳性一线GEA及其他表达HER2的癌症、JZP898和dordaviprone中的潜在治疗益处相关的声明，以及其他非历史事实的声明。这些前瞻性声明基于Jazz Pharmaceuticals当前的计划、目标、估算、预期和意图，且本质上涉及重大风险和不确定性。

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.

实际结果和事件发生的时间可能与这些前瞻性陈述中预期的情况存在重大差异，这是由于各种风险和不确定性所致，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，包括那些不时在Jazz Pharmaceuticals向美国证券交易委员会提交的文件和报告中“风险因素”标题下及其他部分描述的风险和不确定性，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。

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 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 Jazz Pharmaceu.

Jazz Pharmaceuticals目前尚未知晓的其他风险和不确定性也可能影响其前瞻性声明，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。本文件中的前瞻性声明仅截至本文件发布之日或前瞻性声明中注明的日期作出，即使这些声明在之后由Jazz Pharmaceuticals提供。

Contacts:

联系人：

Media Contact:

媒体联系人：

[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 Contact:

投资者联系方式：

[email protected]

电子邮件地址

Ireland +353 1 634 3211

爱尔兰 +353 1 634 3211

U.S. +1 650 496 2717

美国 +1 650 496 2717

1

1

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。

2

2

MODEYSO (dordaviprone) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.

MODEYSO（dordaviprone）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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