Core Viewpoint - Adlai Nortye Ltd. has initiated dosing of the first patient in the U.S. for its Phase 1 clinical trial of AN9025, a pan-RAS (ON) inhibitor, marking a significant milestone in its clinical development strategy [1][3]. Group 1: Clinical Trial Details - The Phase 1 study is a first-in-human, multicenter, open-label trial aimed at assessing the safety, tolerability, pharmacokinetics, and anti-tumor activity of AN9025 in patients with advanced or metastatic solid tumors that have RAS mutations [2]. - This trial is being conducted in collaboration with Jiangsu Aosaikang Pharmaceutical Co. Ltd. as a multi-regional clinical trial, with Adlai Nortye retaining ex-China rights to AN9025 [2]. Group 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 and durable efficacy in preclinical studies against pancreatic, lung, and colorectal adenocarcinomas [4]. - The drug demonstrates comparable or superior results relative to benchmark agents in the same class, indicating its potential as a best-in-class therapy [4]. Group 3: Company Overview - Adlai Nortye is a global clinical-stage biotechnology company focused on discovering and developing innovative cancer therapies, with a dual R&D presence in the U.S. and China [5]. - The company is building a robust pipeline that includes next-generation cancer immunotherapies and RAS-targeting therapies, with candidates such as AN8025 and AN4035 alongside AN9025 [5].

Core Viewpoint - Adlai Nortye Ltd. has announced a private investment in public equity financing expected to generate approximately $140 million in gross proceeds, aimed at supporting its innovative cancer therapies [1][3]. Group 1: Financing Details - The company is selling 64,615,386 Class A ordinary shares at a price of $2.1667 per share, equivalent to $6.50 per American Depositary Share (ADS) [2]. - The private placement is co-led by Cormorant Asset Management and Columbia Threadneedle Investments, with participation from both new and existing investors, including Balyasny Asset Management L.P. and Point72 [3]. - Approximately $55 million of Class A ordinary shares will be sold to entities controlled by Yang Lu, the Chairman and CEO of the company [3]. Group 2: Company Overview - Adlai Nortye is a clinical-stage biotechnology company focused on developing innovative cancer therapies, leveraging its R&D presence in the U.S. and China [7]. - The company is building a pipeline of drug candidates in two key areas: next-generation cancer immunotherapies and RAS-targeting therapies [7]. - Key drug candidates include AN8025, a tri-functional fusion protein, and AN4005, a first-in-class oral small-molecule PD-L1 inhibitor, aimed at activating cancer immunity [7].

Core Viewpoint - Aosaikang (002755) has entered into a licensing agreement with Hangzhou Anuo Biopharmaceutical Technology Co., Ltd. for the exclusive rights to develop, manufacture, and commercialize the innovative drug AN9025 in the designated region [1] Group 1: Licensing Agreement Details - Aosaikang's subsidiary, Jiangsu Aosaikang Pharmaceutical Co., Ltd., will pay a one-time, non-refundable, and non-offsettable upfront payment of 35 million RMB to Anuo Biopharma within 10 working days after the agreement takes effect [1] - The total milestone payments for product development, registration, and market launch will not exceed 470 million RMB, with additional payments of up to 1.128 billion RMB tied to sales milestone events [1] Group 2: Product Information - AN9025 is a novel oral pan-RAS inhibitor that can simultaneously bind to activated RAS-GTP and molecular chaperone (Cyclophilin A), effectively inhibiting various types of KRAS, NRAS, and HRAS mutations [1] - The drug is intended for the treatment of RAS-mutant solid tumors and has completed Investigational New Drug (IND) applications in both China and the United States, receiving FDA approval for clinical trials [1] Group 3: Financial Implications - Aosaikang will pay a tiered royalty fee based on annual net sales once the product achieves commercial sales in the licensed region [1]

Group 1 - The core viewpoint of the news is that Aosaikang (002755.SZ) has entered into a licensing agreement with Hangzhou Anuo Biopharmaceutical Technology Co., Ltd. for the innovative drug project AN9025, which provides Aosaikang exclusive rights for development, production, and commercialization in the licensed area [1] - Aosaikang will pay a non-refundable upfront fee of 35 million RMB within 10 working days after the agreement takes effect, along with milestone payments related to product development, registration, and market launch, totaling up to 470 million RMB [1] - The AN9025 project is a novel oral pan-RAS inhibitor designed to treat RAS mutation-driven solid tumors, having received clinical trial approval from the FDA in the United States [1] Group 2 - Aosaikang is building a robust and promising R&D pipeline in the oncology treatment field through independent research and strategic partnerships [2] - The introduction of the AN9025 project, a pan-RAS inhibitor, is expected to enhance the company's positioning in the treatment of lung cancer, colorectal cancer, and pancreatic cancer, creating synergistic effects with existing clinical and commercialization resources [2] - The addition of AN9025 will enrich the company's innovative drug pipeline and strengthen its competitiveness in the anti-tumor treatment sector, positively impacting the company's strategic layout [2]

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]

Core Viewpoint - Aosaikang (002755) has entered into a licensing agreement with Hangzhou Anuo Biopharmaceutical Technology Co., Ltd. for the exclusive rights to develop, produce, and commercialize the innovative drug AN9025 within the licensed area [1] Group 1: Agreement Details - Aosaikang's subsidiary, Jiangsu Aosaikang Pharmaceutical Co., Ltd., will pay a non-refundable upfront fee of 35 million yuan to Anuo Biopharmaceutical within 10 working days after the agreement takes effect [1] - The total milestone payments related to product development, registration, and market launch will not exceed 470 million yuan [1] - Additional payments related to achieving certain sales milestones will not exceed 1.128 billion yuan [1]

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]

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]

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]

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]