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SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced that it has entered into an exclusive licensing agreement with ASK Pharm for its proprietary pan-RAS (ON) inhibitor AN9025..
新加坡和新泽西州北不伦瑞克和中国杭州,2025年12月29日(环球新闻网)-- 临床阶段生物技术公司Adlai Nortye Ltd.(纳斯达克股票代码:ANL)(“公司”或“Adlai Nortye”),专注于开发创新癌症疗法,今日宣布已与ASK制药就其专有的泛RAS(ON)抑制剂AN9025达成独家许可协议。
Under the terms of the agreement, ASK Pharm will obtain exclusive rights to develop, manufacture, and commercialize AN9025 in mainland China, Hong Kong and Macao (the “Licensed Territory”). Adlai Nortye will retain worldwide rights to the compound excluding the Licensed Territory. Adlai Nortye is eligible to receive total consideration of up to RMB 1.6 billion (approximately USD 230 million), including an upfront payment and near-term milestone payments exceeding USD 20 million, plus tiered royalties ranging from a high single-digit to mid-teens percentage of net product sales in the Licensed Territory..
根据协议条款,ASK制药将获得在 mainland China、Hong Kong 和 Macao(“授权区域”)开发、生产和商业化AN9025的独家权利。Adlai Nortye将保留除授权区域外该化合物的全球权利。Adlai Nortye有资格获得总计高达16亿人民币(约合2.3亿美元)的款项,包括首付款和超过2000万美元的近期里程碑付款,以及在授权区域内基于产品净销售额的从个位数高位到十位数中位的分级特许权使用费。
Mr. Jingfei Ma, Director and General Manager of ASK Pharm, stated: “This partnership marks a pivotal milestone in our strategic innovation upgrade, signaling our decisive move into frontier innovation with high entry barriers. By leveraging our complementary strengths in R&D, clinical development, and commercialization, we aim to accelerate the development of AN9025 project while reinforcing our existing pipeline, ultimately delivering high-value therapeutic solutions to patients in China and around the world.”.
ASK Pharm公司董事总经理马敬飞先生表示:“此次合作标志着我们战略创新升级的一个重要里程碑,表明我们正果断进军具有高准入壁垒的前沿创新领域。通过结合双方在研发、临床开发和商业化方面的互补优势,我们旨在加速AN9025项目的开发,同时强化我们现有的产品管线,最终为中国乃至全球患者提供高价值的治疗解决方案。”
“We are delighted to partner with ASK Pharm on the development of AN9025, a differentiated pan-RAS (ON) inhibitor with the potential to be best-in-class,” said Yang Lu, Chairman and Chief Executive Officer of Adlai Nortye. “This collaboration represents a meaningful step forward in advancing the clinical and commercial potential of AN9025 and underscores the value of our RAS-targeted drug discovery platform.
“我们很高兴与ASK制药合作开发AN9025,这是一种具有同类最佳潜力的差异化泛RAS(ON)抑制剂,”Adlai Nortye董事长兼首席执行官陆阳表示。“此次合作标志着在推进AN9025的临床和商业潜力方面迈出了重要一步,并突显了我们针对RAS的药物发现平台的价值。”
By combining Adlai Nortye’s innovation capabilities with ASK Pharm’s strong development and commercialization expertise in Greater China, we aim to accelerate the delivery of novel treatment options for patients with RAS-mutated cancers who continue to face significant unmet medical needs.”.
通过结合Adlai Nortye的创新能力与ASK Pharm在大中华区强大的开发和商业化专长,我们旨在加速为持续面临显著未满足医疗需求的RAS突变癌症患者提供新型治疗方案。"
About AN9025
关于AN9025
AN9025 is an 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 是一种具有同类最佳潜力的口服小分子泛 RAS(ON) 抑制剂,旨在针对各种肿瘤类型中的广泛 RAS 突变。 临床前研究表明,AN9025 能够有效抑制携带 RAS 突变的癌症,展现出强大且持久的疗效,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结果。
The company expects to initiate the phase I clinical study in the first quarter of 2026..
公司预计将在2026年第一季度启动I期临床研究。
About Adlai Nortye
关于阿德莱·诺特
Adlai Nortye (NASDAQ: ANL) is a global clinical-stage company at the forefront of discovering and developing innovative cancer therapies. Leveraging our dual R&D presence in the U.S. and China, we are building a robust pipeline of drug candidates focused on two key areas where we believe we can make a significant difference.
Adlai Nortye(纳斯达克股票代码:ANL)是一家全球临床阶段公司,处于发现和开发创新癌症疗法的前沿。凭借我们在美国和中国的双重研发优势,我们正在构建一个强大的候选药物管道,专注于我们认为可以产生重大影响的两个关键领域。
(1) Next-generation cancer immunotherapies: our candidates, AN8025 (a tri-functional fusion protein of αPD-L1 x CD86 variant x LAG3 variant), a T-cell and antigen-presenting cell modulator, and AN4005 (a first-in-class oral small-molecule PD-L1 inhibitor), are designed to activate cancer immunity in novel ways.
下一代癌症免疫疗法:我们的候选药物AN8025(αPD-L1 x CD86变体 x LAG3变体的三功能融合蛋白)是一种T细胞和抗原呈递细胞调节剂,而AN4005(一种首创的口服小分子PD-L1抑制剂),旨在以新颖的方式激活癌症免疫。
(2) RAS-targeting therapies: we are tackling RAS-driven cancers with AN9025, an oral pan-RAS(ON) inhibitor, and AN4035, a CEACAM5-targeting ADC delivering a potent pan-RAS(ON) inhibitor directly to tumors..
(2) 针对RAS的疗法:我们正在使用AN9025(一种口服的泛RAS(ON)抑制剂)和AN4035(一种靶向CEACAM5的ADC,可将强效的泛RAS(ON)抑制剂直接递送至肿瘤)来应对RAS驱动的癌症。
About Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm)
关于江苏奥赛康药业有限公司(ASK Pharm)
Founded in January 2003, Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) is a research-based pharmaceutical enterprise that integrates and streamlines innovative research and development with manufacture, marketing promotion and sales of proprietary pharmaceuticals, fine chemicals and health-care products.
江苏奥赛康药业股份有限公司(ASK Pharm)成立于2003年1月,是一家以研发为基础的制药企业,集创新药物研发、生产、市场推广及销售于一体,专注于自有药品、精细化学品和保健产品的开发与运营。
ASK Pharm specializes in digestive disease, multidrug resistant infection, oncology and chronic disease areas..
ASK制药专注于消化系统疾病、多重耐药感染、肿瘤学和慢性疾病领域。
ASK Pharm focuses on the R&D of small-molecule targeted innovative drugs and immuno-oncology biologic drugs. Currently, there are 48 major research projects, including 10 disclosed key projects focused on innovative chemical and biologic drugs. Among these, Limertinib (the 3rd Gen EGFR TKI) is launched in 2025, while ASKC109 (maltol iron capsules), ASKB589 (Claudin18.2 monoclonal antibody), and ASKC202 (c-MET TKI) are in Phase III clinical trials.
ASK Pharm专注于小分子靶向创新药物和免疫肿瘤生物药物的研发。目前共有48个主要研究项目,其中包括10个已公开的关键项目,专注于创新化学药物和生物药物。其中,Limertinib(第三代EGFR TKI)将于2025年上市,而ASKC109(麦芽酚铁胶囊)、ASKB589(Claudin18.2单克隆抗体)和ASKC202(c-MET TKI)正在进行III期临床试验。
ASK Pharm has ranked among the top 20 best industrial enterprises in China’s pharmaceutical R&D pipeline for 14 consecutive years and it has also received numerous honors such as “Top Ten National R&D Innovators”, “Best National Enterprise for Investment”, and “National Torch Program High-Tech Enterprises”..
连续14年入选中国医药研发产品线最佳工业企业20强,并荣获“全国十大研发创新力企业”、“全国最佳投资企业”、“国家火炬计划高新技术企业”等多项荣誉。
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”、“预计”、“预期”、“未来”、“打算”、“计划”、“相信”、“估计”、“潜在”、“继续”、“持续”、“目标”以及类似的术语来识别。
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,除其他事项外,关于公司信念和期望、业务前景、管理层言论以及公司战略和运营计划的陈述,不是历史事实的陈述,这些陈述属于或包含前瞻性陈述。
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,以书面或口头形式作出前瞻性陈述。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药物开发工作的启动、时间、进展和结果;公司将治疗候选药物推进至临床试验的能力,或成功完成其临床前研究或临床试验的能力;临床试验结果是否能够预测真实世界的结果;公司治疗候选药物获得监管批准的情况以及其它监管文件和批准的时间;公司治疗候选药物的临床开发、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药物的战略计划;公司为其治疗候选药物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、资本需求及其对和能力的估计。
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