SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, May XX, 2025 -- Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a global clinical-stage biotechnology company focused on the development of innovative targeted and immune-modulating cancer therapies, today announced topline results from its Phase III BURAN trial evaluating buparlisib (AN2025), a PI3K inhibitor, in combination with paclitaxel for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)..

新加坡和新泽西州北不伦瑞克和中国杭州，2025年5月XX日 -- Adlai Nortye Ltd.（纳斯达克股票代码：ANL）（“公司”或“Adlai Nortye”），一家专注于开发创新靶向和免疫调节癌症疗法的全球临床阶段生物技术公司，今天宣布了其III期BURAN试验的初步结果。该试验评估了PI3K抑制剂布帕利昔（AN2025）与紫杉醇联合用于治疗复发性或转移性头颈部鳞状细胞癌（HNSCC）患者的效果。

The study did not meet the primary endpoint of improving overall survival compared to paclitaxel alone. The safety profile of buparlisib was consistent with previous findings, with no new safety signals observed. Detailed results will be presented at an upcoming medical conference.

该研究未达到与单用紫杉醇相比改善总生存期的主要终点。Buparlisib 的安全性与之前的研究结果一致，未观察到新的安全信号。详细结果将在即将召开的医学会议上公布。

“We are disappointed with the outcome of the phase III BURAN study,” said Carsten Lu, CEO and Chairman of Adlai Nortye. “While the outcome is not what we hoped for, we are deeply grateful to the patients, investigators, and research teams whose commitment and contributions made this global trial possible.

“我们对III期BURAN研究的结果感到失望，”阿诺医药首席执行官兼董事长路杨表示：“尽管结果不如我们所希望的那样，我们深深感谢那些为这项全球试验做出承诺与贡献的患者、研究人员和研究团队。”

Based on these results, we have decided to discontinue further development of buparlisib. We will, however, continue to analyze the data to better understand the findings and to inform future drug development in HNSCC.”.

基于这些结果，我们决定停止 buparlisib 的进一步开发。然而，我们将继续分析数据，以更好地理解这些发现，并为未来 HNSCC 的药物开发提供参考。"

“The Company expects to make near-term changes to its business operations and to reduce its workforce in order to preserve cash, including but not limited to: optimizing workforce structure and compensation, pursuing strategic business development opportunities, and expanding our financing options,” Carsten Lu added.

“公司预计将对业务运营进行短期调整并减少员工数量，以保留现金。具体措施包括但不限于：优化员工结构和薪酬、寻求战略性业务发展机会以及拓宽融资渠道，”吕卡斯滕补充道。

“We will refocus our resources and efforts on advancing AN8025 and AN9025, together with our emerging candidates, which we believe have strong potential to address unmet needs across multiple tumor types, and deliver transformative therapies to patients worldwide.”.

“我们将重新聚焦资源和精力于推进AN8025和AN9025，以及我们新兴的候选药物，我们相信这些药物有很强的潜力满足多种肿瘤类型中未被满足的需求，并为全球患者提供变革性的治疗方案。”

About Phase III BURAN Trial

关于第三阶段BURAN试验

The BURAN study is a randomized (2:1), open-label Phase III study to assess the treatment effect of buparlisib in combination with paclitaxel compared to weekly paclitaxel alone in patients with recurrent and metastatic HNSCC that have progressed after anti-PD-(L)1-based treatment. A total of 487 patients were enrolled globally.

BURAN研究是一项随机（2:1）、开放标签的III期研究，旨在评估buparlisib联合紫杉醇与单用每周一次紫杉醇在复发性和转移性头颈部鳞状细胞癌（HNSCC）患者中的治疗效果，这些患者在接受抗PD-(L)1治疗后出现疾病进展。全球共入组了487名患者。

The primary endpoint of the trial was overall survival (OS), with secondary endpoints including progression-free survival (PFS), objective response rate (ORR), and duration of response (DoR). This Phase III trial builds on positive Phase II data, where the buparlisib-paclitaxel combination demonstrated improvements in ORR, PFS, and OS compared to paclitaxel alone.

该试验的主要终点是总生存期（OS），次要终点包括无进展生存期（PFS）、客观缓解率（ORR）和缓解持续时间（DoR）。这项 III 期试验基于积极的 II 期数据，其中布帕利西-紫杉醇组合相比于单独使用紫杉醇，在 ORR、PFS 和 OS 方面均显示出改善。

Notably, these Phase II findings preceded the establishment of anti-PD-(L)1 therapies as the cornerstone treatment for recurrent/metastatic HNSCC..

值得注意的是，这些二期研究结果是在抗PD-(L)1疗法成为复发/转移性头颈部鳞状细胞癌（HNSCC）的基石治疗之前得出的。

About AN8025

关于AN8025

AN8025 is a next-generation tri-specific antibody fusion protein in particular PD-1-based immunotherapy, derived from an approved αPD-L1 antibody and fused with functionally optimized CD86 and LAG3 variants. Designed to modulate T cell and antigen-presenting cell (APC) functions, preclinical studies have demonstrated that AN8025 enhances both the quantity and quality of APCs while also inducing robust PD-L1-dependent T cell activation and anti-tumor efficacy in vivo.

AN8025 是一种基于 PD-1 的下一代三特异性抗体融合蛋白，源自一种已获批的 αPD-L1 抗体，并与功能优化的 CD86 和 LAG3 变体融合。该药物旨在调节 T 细胞和抗原呈递细胞 (APC) 的功能，临床前研究已证明 AN8025 不仅能够提升 APC 的数量和质量，还能在体内诱导强劲的 PD-L1 依赖性 T 细胞活化及抗肿瘤效力。

The Company plans to submit the IND application in mid-2025..

公司计划在2025年年中提交IND申请。

About AN9025

关于AN9025

AN9025 is an in-house developed oral small molecule pan-RAS(ON) inhibitor with best-in-class potential, designed to target a broad spectrum of RAS mutations across various tumor types. Preclinical studies have demonstrated that AN9025 effectively inhibits RAS-mutant cancers with potent and durable efficacy, including pancreatic, lung, and colorectal adenocarcinomas, and shows comparable or superior results relative to a benchmark agent of the same class.

AN9025 是一种自主研发的口服小分子泛 RAS(ON) 抑制剂，具有同类最佳潜力，旨在靶向多种肿瘤类型中的广泛 RAS 突变。临床前研究表明，AN9025 能有效抑制携带 RAS 突变的癌症，展现出强效且持久的疗效，包括胰腺癌、肺癌和结直肠腺癌，并且相对于同类别标杆药物表现出相当或更优的效果。

The company plans to submit an IND application in the second half of 2025..

公司计划在2025年下半年提交IND申请。

About AN4005

关于 AN4005

AN4005 is an orally available, small-molecule PD-L1 inhibitor that demonstrates antitumor activity by the blockade of PD-1/PD-L1 interaction. Preliminary results from the Dose-Escalation Phase, presented at SITC 2024, demonstrated that AN4005 exhibits favorable safety and tolerability in patients with advanced tumors.

AN4005是一种可口服的小分子PD-L1抑制剂，通过阻断PD-1/PD-L1相互作用显示出抗肿瘤活性。在SITC 2024上公布的剂量递增阶段初步结果显示，AN4005在晚期肿瘤患者中表现出良好的安全性和耐受性。

Encouraging preliminary efficacy was observed in a tumor type known to respond to anti-PD-(L)1 therapy. The trial has now advanced to the Expansion Phase, evaluating two doses of AN4005 in checkpoint inhibitor-naïve patients. Proof-of-concept data from the Expansion Phase is expected by the end of 2025..

在已知对 anti-PD-(L)1 疗法有反应的肿瘤类型中观察到了令人鼓舞的初步疗效。该试验现已进入扩展阶段，正在评估两种剂量的 AN4005 在未使用过检查点抑制剂的患者中的效果。预计扩展阶段的概念验证数据将在 2025 年底前公布。

About Adlai Nortye

关于阿德拉伊·诺特耶

Adlai Nortye (NASDAQ: ANL) is a global clinical-stage company focused on the development of innovative cancer therapies, with global R&D centers in the U.S. and China, the Company is advancing a robust oncology pipeline. We are advancing multiple drug candidates including AN8025, a multifunctional fusion protein acting as a T cell and antigen-presenting cell (“APC”) modulator, AN9025, an oral small molecule pan-RAS(ON) inhibitor and AN4005, an oral small molecule PD-L1 inhibitor..

Adlai Nortye（纳斯达克股票代码：ANL）是一家全球临床阶段公司，专注于创新癌症疗法的开发，在美国和中国设有全球研发中心，公司正在推进一系列强大的肿瘤学研发管线。我们正在推进多种候选药物，包括AN8025，一种多功能融合蛋白，作为T细胞和抗原呈递细胞（“APC”）调节剂；AN9025，一种口服小分子泛RAS(ON)抑制剂；以及AN4005，一种口服小分子PD-L1抑制剂。

Forward-Looking Statement

前瞻性声明

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “potential,” “continue,” “ongoing,” “targets” and similar statements.

本公告包含前瞻性陈述。这些陈述是根据美国1995年私人证券诉讼改革法案的“安全港”条款作出的。这些前瞻性陈述可以通过诸如“将”、“预期”、“预计”、“未来”、“打算”、“计划”、“相信”、“估计”、“潜在”、“持续”、“正在进行”、“目标”以及类似的表述加以识别。

Among other things, statements that are not historical facts, including statements about the Company’s beliefs and expectations, the business outlook and quotations from management in this announcement, as well as the Company’s strategic and operational plans, are or contain forward-looking statements..

本公告中包含的非历史事实的陈述，包括关于公司信念和预期、业务前景、管理层言论以及公司的战略和运营计划的陈述，均为前瞻性陈述或包含前瞻性陈述。

The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Forward-looking statements involve inherent risks and uncertainties.

公司还可能在向美国证券交易委员会（“SEC”）提交的定期报告、新闻稿和其他书面材料以及其高级职员、董事或员工向第三方作出的口头陈述中，包含书面或口头的前瞻性陈述。前瞻性陈述涉及固有的风险和不确定性。

Factors that could cause the Company’s actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of the Company’s preclinical studies, clinical trials and other therapeutic candidate development efforts; the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results will be predictive of real-world results; the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of the Company’s therapeutic candidates; the Company’s ability to establish, manage, and maintain corporate collaborations, as well as the ability of its collaborators to execute on their development and commercialization plans; the implementation of the Company’s business model and strategic plans for its business and therapeutic candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of the Company’s expenses, future revenues, capital requirements and its needs for and abi.

可能导致公司实际结果与这些前瞻性陈述中明示或暗示的结果存在重大差异的因素包括但不限于：公司临床前研究、临床试验及其他治疗候选产品开发工作的启动、时间、进展和结果；公司将治疗候选产品推进临床试验或成功完成临床前研究或临床试验的能力；临床试验结果是否能预测真实世界的结果；公司获得其治疗候选产品的监管批准，以及其他监管文件和批准的时间；公司治疗候选产品的临床开发、商业化及市场接受度；公司建立、管理和维持企业合作的能力，及其合作伙伴执行开发和商业化计划的能力；公司业务模式的实施及其业务和治疗候选产品的战略计划；公司为其治疗候选产品建立和维护知识产权保护的范围，以及公司在不侵犯他人知识产权的情况下运营其业务的能力；对公司费用、未来收入、资本需求及其对资金需求和能力的估计。

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