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奥赛康:子公司与阿诺医药达成1类创新药AN9025项目许可引进协议
Cai Jing Wang· 2025-12-30 06:03
在协议生效后的 10 个工作日内,奥赛康药业将向阿诺医药支付 3500 万元人民币的一次性、不可退还、 不可抵扣的首付款。并在产品研发、注册及上市的各阶段支付不超过4.7亿元人民币的里程碑付款,销 售里程碑事件达成相关付款总计不超过11.28亿元人民币。此外,产品在许可区域内实现商业销售后, 奥赛康药业将支付年度净销售额的梯度特许权使用费。 (奥赛康公告) AN9025 项目是阿诺医药开发的新型口服泛 RAS 抑制剂,能够同时结合活化的 RAS-GTP 和分子伴侣 (亲环素 A)形成三元复合物,高效抑制多种类型的KRAS、NRAS 及 HRAS 突变。AN9025 项目拟用 于治疗 RAS 突变型实体瘤,已在中国和美国完成新药临床试验申请(IND),并已获得了美国食品药 品监督管理局(FDA)的临床试验批准。 近日,奥赛康(002755)发布公告称,公司子公司江苏奥赛康药业有限公司与杭州阿诺生物医药科技有 限公司达成许可引进协议,根据协议,奥赛康药业将获得阿诺医药在研的1类创新药AN9025项目在许可 区域内的开发、生产及商业化的独占权益。 ...
奥赛康(002755.SZ):子公司与阿诺医药达成许可引进协议
Ge Long Hui A P P· 2025-12-29 11:44
格隆汇12月29日丨奥赛康(002755.SZ)公布,子公司江苏奥赛康药业有限公司(简称"奥赛康药业")与杭 州阿诺生物医药科技有限公司(简称"阿诺医药")达成许可引进协议。根据协议,奥赛康药业将获得阿 诺医药在研的1类创新药AN9025项目在许可区域内的开发、生产及商业化的独占权益。在协议生效后的 10个工作日内,奥赛康药业将向阿诺医药支付3500万元人民币的一次性、不可退还、不可抵扣的首付 款。奥赛康药业将向阿诺医药支付与产品研发、注册及上市相关的各阶段开发里程碑付款,总计不超过 4.7亿元人民币。奥赛康药业将向阿诺医药支付与若干销售里程碑事件达成相关的付款,总计不超过 11.28亿元人民币。 奥赛康药业围绕肿瘤治疗领域,通过自主研发与战略合作,搭建起丰富且具有潜力的研发管线。本次引 进的创新药AN9025项目是一款泛RAS抑制剂,可用于肺癌及结直肠癌、胰腺癌等肿瘤的治疗,有望进 一步强化公司在肺癌、消化道肿瘤等优势治疗领域的布局,与公司现有临床资源和商业化资源形成协同 效应。AN9025的引进将进一步丰富公司创新药产品管线,提升公司在抗肿瘤治疗领域的竞争力,对公 司的战略布局起到积极作用。 AN9025 ...
奥赛康:子公司与阿诺医药达成许可引进协议
Ge Long Hui· 2025-12-29 11:24
Core Viewpoint - Aosaikang Pharmaceutical has entered into a licensing agreement with Hangzhou Anuo Biopharmaceutical Technology, acquiring exclusive rights for the development, production, and commercialization of the innovative drug AN9025, a pan-RAS inhibitor targeting RAS mutation-related solid tumors [1][2] Group 1: Financial Terms of the Agreement - Aosaikang Pharmaceutical will pay a non-refundable upfront fee of 35 million RMB within 10 working days after the agreement takes effect [1] - Total milestone payments related to product development, registration, and market launch will not exceed 470 million RMB [1] - Additional payments related to sales milestones will not exceed 1.128 billion RMB [1] Group 2: Product Details and Clinical Development - AN9025 is a novel oral pan-RAS inhibitor that effectively targets KRAS, NRAS, and HRAS mutations by forming a ternary complex with activated RAS-GTP and molecular chaperone [1] - The drug is intended for the treatment of RAS mutation-related solid tumors and has received clinical trial approval from the FDA in the United States [1] Group 3: Strategic Implications for Aosaikang - The introduction of AN9025 enhances Aosaikang's pipeline in oncology, particularly in lung cancer, colorectal cancer, and pancreatic cancer, reinforcing its competitive position in these therapeutic areas [2] - The collaboration is expected to create synergies with the company's existing clinical and commercialization resources, positively impacting its strategic layout in the oncology sector [2]
奥赛康:子公司与阿诺医药达成AN9025项目许可引进协议
人民财讯12月29日电,奥赛康(002755)12月29日公告,公司子公司江苏奥赛康药业有限公司(简称"奥 赛康药业")与杭州阿诺生物医药科技有限公司(简称"阿诺医药")达成许可引进协议。根据协议,奥赛康 药业将获得阿诺医药在研的1类创新药AN9025项目在许可区域内的开发、生产及商业化的独占权益。在 协议生效后的10个工作日内,奥赛康药业将向阿诺医药支付3500万元的一次性、不可退还、不可抵扣的 首付款。奥赛康药业将向阿诺医药支付与产品研发、注册及上市相关的各阶段开发里程碑付款,总计不 超过4.7亿元;支付与若干销售里程碑事件达成相关的付款,总计不超过11.28亿元。 ...
Adlai Nortye Enters Exclusive License Agreement with ASK Pharm for Pan-RAS (ON) Inhibitor AN9025 in Greater China
Globenewswire· 2025-12-29 11:00
Core Viewpoint - Adlai Nortye Ltd. has entered into an exclusive licensing agreement with ASK Pharm for its pan-RAS (ON) inhibitor AN9025, which is aimed at advancing cancer therapies in Greater China [1][2][3] Company Overview - Adlai Nortye is a clinical-stage biotechnology company focused on developing innovative cancer therapies, with a dual R&D presence in the U.S. and China [5] - The company is building a robust pipeline targeting next-generation cancer immunotherapies and RAS-driven cancers [5] Licensing Agreement Details - ASK Pharm will have exclusive rights to develop, manufacture, and commercialize AN9025 in mainland China, Hong Kong, and Macao, while Adlai Nortye retains worldwide rights outside this territory [2] - The total consideration for the agreement could reach up to RMB 1.6 billion (approximately USD 230 million), including an upfront payment and milestone payments exceeding USD 20 million, along with tiered royalties on net product sales [2] Product Information - AN9025 is an oral small molecule pan-RAS(ON) inhibitor designed to target a wide range of RAS mutations across various tumor types, showing potent efficacy in preclinical studies [4] - The company plans to initiate a phase I clinical study for AN9025 in the first quarter of 2026 [4] ASK Pharm Overview - ASK Pharm is a research-based pharmaceutical enterprise founded in 2003, focusing on innovative drug development in areas such as oncology and chronic diseases [6][7] - The company has a strong R&D pipeline with 48 major research projects, including several in advanced clinical trials [8]
Adlai Nortye to Participate in Upcoming Investor Conferences
Globenewswire· 2025-11-21 13:00
Core Insights - Adlai Nortye Ltd. is a clinical-stage biotechnology company focused on developing innovative cancer therapies [2] - The company will participate in two upcoming investor conferences, including the Evercore Healthcare Conference and the Oppenheimer Annual Healthcare Life Sciences Conference [1][2] Company Overview - Adlai Nortye operates with a dual R&D presence in the U.S. and China, aiming to build a robust pipeline of drug candidates [2] - The company focuses on two key areas: next-generation cancer immunotherapies and RAS-targeting therapies [2] - Key drug candidates include AN8025, a tri-functional fusion protein, AN4005, a first-in-class oral small-molecule PD-L1 inhibitor, AN9025, an oral pan-RAS(ON) inhibitor, and AN4035, a CEACAM5-targeting ADC [2]
Adlai Nortye to Present Short Talk at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
Globenewswire· 2025-10-14 03:07
Core Insights - Adlai Nortye Ltd. is a clinical-stage biotechnology company focused on developing innovative cancer therapies and will present at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston from October 22-26, 2025 [1][2] Company Overview - Adlai Nortye operates globally with R&D centers in the U.S. and China, advancing a portfolio of innovative drug candidates in two key therapeutic areas: next-generation PD-1/L1 modulation and RAS-targeted therapies [3] - Key drug candidates include AN8025, a multifunctional fusion protein for T cell and antigen-presenting cell modulation; AN4005, a first-in-class oral small-molecule PD-L1 inhibitor; AN9025, an oral pan-RAS(ON) inhibitor; and AN4035, a novel CEACAM5-targeting antibody-drug conjugate [3]
Adlai Nortye (ANL) Earnings Call Presentation
2025-07-03 12:31
AN9025 Key Features - AN9025 is a novel pan-RAS(ON) inhibitor developed by Adlai Nortye with improved potency and a favorable PK/PD profile[8, 16] - AN9025 strongly binds to cyclophilin A (CypA) with a dissociation constant (KD1) of 3.2 nM, exhibiting a 4-fold stronger binding affinity compared to RMC-6236[3, 4, 8] - AN9025 exhibits a 3- to 8-fold higher binding affinity for tri-complex formation compared to RMC-6236[5] - AN9025 demonstrates approximately 100-fold greater potency in inhibiting cell viability across RAS-mutant cell lines compared to RMC-6236[8] - AN9025 shows potent anti-proliferative activity in RAS-addicted cancer cell lines with picomolar IC50 values[7, 8] In Vivo Efficacy and PK/PD - In vivo studies show that AN9025 induces deep tumor regression, with efficacy comparable to or exceeding RMC-6236 in mouse CDX models[8, 9] - AN9025 demonstrates a favorable pharmacokinetic (PK) and pharmacodynamic (PD) profile in vivo[8] - AN9025 exhibits more sustained DUSP6 inhibition compared to RMC-6236 across all tested doses[8] Clinical Development - The prolonged tumor DUSP6 suppression following AN9025 administration suggests the potential for an intermittent dosing regimen to optimize tolerability and efficacy[8] - AN9025 is advancing through the IND-enabling stage[8] - Adlai Nortye is actively seeking strategic partnerships to advance the development of AN9025[18]
Adlai Nortye Ltd. Announces Topline Results of Phase III Buran Trial Evaluating Buparlisib in Combination with Paclitaxel for Recurrent or Metastatic HNSCC
MarketScreener· 2025-05-30 14:38
Group 1 - Adlai Nortye Ltd. 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) [1] - The study did not meet the primary endpoint of improving overall survival compared to paclitaxel alone [1] - The safety profile of buparlisib was consistent with previous findings, with no new safety signals observed [1] Group 2 - Detailed results from the Phase III trial will be presented at an upcoming medical conference [2] - AN8025 is a next-generation tri-specific antibody fusion protein derived from an approved PD-L1 antibody, optimized for PD-1-based immunotherapy [2] - Preclinical studies have demonstrated that AN8025 enhances both the quantity and quality of antigen-presenting cells (APCs) while inducing robust PD-L1-dependent T cell activation and anti-tumor efficacy in vivo [3] Group 3 - The company plans to submit the IND application for AN8025 in mid-2025 [3] - AN9025 is an in-house developed oral small molecule pan-RAS(ON) inhibitor designed to target a broad spectrum of RAS mutations across various tumor types [3] - Preclinical studies have shown that AN9025 effectively inhibits RAS-mutant cancers, including pancreatic, lung, and colorectal adenocarcinomas, with potent and durable efficacy [4] Group 4 - The company plans to submit an IND application for AN9025 in the second half of 2025 [4] - AN4005 is an orally available small-molecule PD-L1 inhibitor that demonstrates antitumor activity by blocking PD-1/PD-L1 interaction [4] - Preliminary results from the Dose-Escalation Phase presented at SITC 2024 demonstrated that AN4005 exhibits favorable safety and tolerability in patients with advanced tumors [5]
Adlai Nortye(ANL) - Prospectus(update)
2023-09-27 16:28
TABLE OF CONTENTS As filed with the Securities and Exchange Commission on September 27, 2023 Registration No. 333-273465 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 4 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Adlai Nortye Ltd. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Adlai Nortye Ltd. c/o PO Box 309, Ugland H ...