SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today presented data from the ongoing global Phase 1a/1b study of ZL-1310, a potential best-in-class next-generation antibody-drug conjugate (ADC), at the EORTC-NCI-AACR (ENA) Symposium 2024 in Barcelona, Spain, as an oral presentation during the plenary session.

上海和剑桥，马萨诸塞州。-（商业新闻短讯）--Zai实验室有限公司（纳斯达克：ZLAB；香港交易所：9688）今天在西班牙巴塞罗那举行的EORTC-NCI-AACR（ENA）2024年研讨会上，作为全体会议期间的口头报告，提交了正在进行的ZL-1310全球1a/1b期研究的数据，ZL-1310是一种潜在的一流的下一代抗体药物偶联物（ADC）。

ZL-1310 is being tested in patients with previously treated extensive-stage Small Cell Lung Cancer (ES-SCLC) after at least one prior platinum-based chemotherapy regimen..

ZL-1310正在接受至少一种先前铂类化疗方案治疗的广泛期小细胞肺癌（ES-SCLC）患者中进行测试。。

Data shared in the ENA presentation from the ongoing Part 1a monotherapy dose-escalation portion of the study included results from 25 patients across four dose cohorts (0.8 mg/kg, 1.6mg/kg, 2.0 mg/kg, and 2.4 mg/kg). Nineteen patients had evaluable tumor assessments.

ENA报告中共享的数据来自正在进行的第1a部分单药治疗剂量递增部分的研究，包括来自四个剂量组（0.8 mg/kg，1.6mg/kg，2.0 mg/kg和2.4 mg/kg）的25名患者的结果。19名患者进行了可评估的肿瘤评估。

Key efficacy results include (n=19):

主要疗效结果包括（n=19）：

The ORR in patients with at least one post-treatment evaluation was 74% (95%CI, 48.8, 90.9). ZL-1310 anti-tumor activity was demonstrated across all dose levels.

至少有一次治疗后评估的患者的ORR为74%（95%CI，48.8,90.9）。在所有剂量水平上证明了ZL-1310抗肿瘤活性。

Responses were seen in patients with DLL3 H-scores from 5 (range: 5 to 260). No response was observed in a patient whose tumor did not express DLL3.

DLL3 H评分为5（范围：5至260）的患者出现反应。在肿瘤不表达DLL3的患者中未观察到反应。

Across all cohorts, median length of follow up is 2.4 months making duration of response not estimable. Of the 14 responders, 13 remain on treatment with the longest patient ongoing at 6.5+ months.

在所有队列中，中位随访时间为2.4个月，因此反应持续时间不可估计。在14名应答者中，有13名仍在接受治疗，持续时间最长的患者为6.5个月以上。

Of the six response-evaluable patients with baseline brain metastases, all achieved a partial response (PR).

在基线脑转移的六名可评估反应的患者中，所有患者均获得部分反应（PR）。

One patient who progressed after prior DLL3 bi-specific therapy achieved PR at the first tumor assessment.

一名在先前的DLL3 bi特异性治疗后进展的患者在第一次肿瘤评估时达到PR。

Key safety findings include (n=25):

主要安全调查结果包括（n=25）：

ZL-1310 was well tolerated across all dose levels with the majority of treatment emergent adverse events (TEAE) being Grade 1 or 2. One dose-limiting toxicity (DLT) was observed at 2.4mg/kg (Grade 4 transient neutropenia/thrombocytopenia). Grade ≥3 treatment-related adverse events occurred in five of the 25 patients (20%); neutropenia was the most common grade ≥3 event, occurring in three of the 25 patients (12%).

ZL-1310在所有剂量水平上都具有良好的耐受性，大多数治疗紧急不良事件（TEAE）为1级或2级。在2.4mg/kg（4级瞬时中性粒细胞减少症/血小板减少症）下观察到一种剂量限制性毒性（DLT）。25例患者中有5例（20%）发生≥3级治疗相关不良事件；中性粒细胞减少症是最常见的≥3级事件，发生在25例患者中的3例（12%）。

Serious treatment-related adverse events occurred in two patients (8%); three patients (12%) required dose reductions, and no patients discontinued treatment due to TEAE..

两名患者（8%）发生了严重的治疗相关不良事件；三名患者（12%）需要减少剂量，没有患者因TEAE停止治疗。。

All patients had progressed following standard platinum-based chemotherapy, and 92% of patients progressed after immune checkpoint inhibitors. Fifty-six percent had failed at least two prior lines of therapy. Twenty-eight percent of patients had brain metastases at baseline. At the time of the data cutoff, Oct.

所有患者均在标准铂类化疗后进展，92%的患者在免疫检查点抑制剂后进展。56%的患者至少两次治疗失败。28%的患者在基线时有脑转移。在数据截止时，10月。

10, 2024, 19 patients had at least one post-baseline tumor assessment per RECIST v1.1. DLL3 expression H-scores were assessed in 16 out of 19 patients..

102024,19名患者根据RECIST v1.1至少进行了一次基线后肿瘤评估。在19名患者中，有16名评估了DLL3表达H评分。。

“The preliminary results from the ongoing Phase 1 trial of ZL-1310 suggest that this next-generation ADC therapy has the potential to deliver anti-tumor responses in the majority of patients with ES-SCLC, with good tolerability,” said Dr. Alex Spira, a medical oncologist at Virginia Cancer Specialists and NEXT Oncology.

弗吉尼亚癌症专家和下一代肿瘤学的医学肿瘤学家Alex Spira博士说：“正在进行的ZL-1310第一阶段试验的初步结果表明，这种下一代ADC疗法有可能在大多数ES-SCLC患者中产生抗肿瘤反应，具有良好的耐受性。”。

“This is particularly encouraging given the urgent need for improved treatment options for these patients. These promising data support continued evaluation of ZL-1310 as a monotherapy in the dose-expansion phase of the ongoing Phase 1 clinical trial and in combination.”.

“鉴于迫切需要改善这些患者的治疗选择，这尤其令人鼓舞。这些有希望的数据支持继续评估ZL-1310作为正在进行的1期临床试验剂量扩展阶段的单一疗法和联合疗法。”。

“The ZL-1310 clinical program demonstrates Zai Lab’s commitment and ability to pursue novel modalities and validated cancer targets, and to advance innovative global oncology programs,” said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. “Based on the encouraging preliminary findings from our Phase 1 trial, we look forward to continuing development of ZL-1310 and advancing this promising asset across lines of therapy as part of our global oncology pipeline.”.

“ZL-1310临床项目展示了Zai实验室追求新模式和验证癌症靶点的承诺和能力，以及推进创新的全球肿瘤学项目，”Zai实验室全球研究与发展负责人Rafael G.Amado医学博士说，“基于我们第一阶段试验令人鼓舞的初步结果，我们期待着ZL-1310的继续发展，并将这一有前途的资产作为我们全球肿瘤学管道的一部分。”。

Webcast and Conference Call

网络广播和电话会议

To access the webcast and conference call on October 24, 2024, at 8:30 a.m. ET, please register at https://register.vevent.com/register/BI6f8ba8dc42d04cd3afd7095cf7c83d40.

要访问2024年10月24日美国东部时间上午8:30的网络广播和电话会议，请登录https://register.vevent.com/register/BI6f8ba8dc42d04cd3afd7095cf7c83d40.

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.

所有参与者必须在电话会议之前使用上述链接完成在线注册过程。拨入详细信息将在参与者注册后收到的确认电子邮件中。

A replay will be available shortly after the call and can be accessed by visiting the Company's website.

通话后不久将提供重播，您可以访问该公司的网站。

About Zai Lab

关于Zai实验室

Zai Lab (NASDAQ: ZLAB; HKEX: 9688; “Zai Lab”) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease.

Zai Lab（纳斯达克股票代码：ZLAB；香港交易所代码：9688；“Zai Lab”）是一家位于中国和美国的创新型、研究型、商业化生物制药公司。我们专注于发现、开发和商业化创新产品，以解决肿瘤学、免疫学、神经科学和传染病领域严重未满足需求的医疗条件。

Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide..

我们的目标是利用我们的能力和资源，对中国和全球的人类健康产生积极影响。。

For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.

有关Zai实验室的更多信息，请访问www.zailaboratory.com或通过www.twitter.com/ZaiLab\u Global关注我们。

About ZL-1310

关于ZL-1310

ZL-1310 is a novel ADC in Zai Lab’s growing, global oncology pipeline that targets Delta-like ligand 3 (DLL3), an antigen that is overexpressed in many neuroendocrine tumors, is typically associated with poor clinical outcomes, and is a validated therapeutic target for SCLC. ZL-1310 comprises a humanized anti-DLL3 monoclonal antibody linked to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload.

ZL-1310是Zai实验室不断发展的全球肿瘤学管道中的一种新型ADC，其靶向δ样配体3（DLL3），一种在许多神经内分泌肿瘤中过表达的抗原，通常与不良的临床结果相关，并且是SCLC的有效治疗靶点。ZL-1310包含与新型喜树碱衍生物（拓扑异构酶1抑制剂）连接的人源化抗DLL3单克隆抗体作为其有效载荷。

The compound was designed with a novel ADC technology platform called TMALIN®, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies, including off-target payload toxicity..

该化合物是用一种称为TMALIN®的新型ADC技术平台设计的，该平台利用肿瘤微环境来克服与第一代ADC疗法相关的挑战，包括脱靶有效载荷毒性。。

The ongoing Phase 1a/1b clinical trial is evaluating ZL-1310 as monotherapy and in combination with atezolizumab, an immune checkpoint inhibitor, for the treatment of extensive-stage SCLC.

正在进行的1a/1b期临床试验正在评估ZL-1310作为单一疗法，并与免疫检查点抑制剂atezolizumab联合用于治疗广泛期SCLC。

Zai Lab Forward-Looking Statements

Zai实验室前瞻性声明

This press release contains forward-looking statements relating to our future expectations, plans, and prospects, for Zai Lab, including, without limitation, statements relating to our prospects and plans for developing and commercializing next generation ADCs, including ZL-1310, the potential benefits of ZL-1310, and the potential treatment of SCLC and neuroendocrine tumors.

本新闻稿包含与我们对Zai实验室的未来期望，计划和前景有关的前瞻性声明，包括但不限于与我们开发和商业化下一代ADC（包括ZL-1310）的前景和计划有关的声明，ZL-1310的潜在益处，以及SCLC和神经内分泌肿瘤的潜在治疗。

These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

这些前瞻性陈述可能包含诸如“目标”、“预期”、“相信”、“可能”、“估计”、“预期”、“预测”、“目标”、“打算”、“可能”、“计划”、“可能”、“潜在”、“将”、“将”和其他类似表达。此类声明构成1995年《私人证券诉讼改革法案》所指的前瞻性声明。

Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements.

前瞻性陈述不是对历史事实的陈述，也不是对未来业绩的保证或保证。。

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most r.

由于各种重要因素，实际结果可能与此类前瞻性声明所显示的结果存在重大差异，包括但不限于（1）我们成功商业化并从我们批准的产品中产生收入的能力，（2）我们获得运营和业务计划资金的能力，（3）我们候选产品的临床和临床前开发结果，（4）相关监管机构就候选产品的监管批准做出决定的内容和时间，（5）与在中国开展业务有关的风险，以及（6）我们most r中确定的其他因素。

Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.sec.gov.

我们的SEC文件可以在我们的网站www.zailaboratory.com和SEC的网站www.SEC.gov上找到。