Investment Rating - The report maintains a BUY rating for Akeso with a target price of HK$185.80, representing a 47.0% upside from the current price of HK$126.40 [3][9]. Core Insights - Akeso delivered strong product sales of RMB3.0 billion in FY25, reflecting a 52% year-over-year growth, closely aligning with previous estimates of RMB3.1 billion. This growth was primarily driven by the inclusion of cadonilimab and ivonescimab in the NRDL in January 2025 [1][2]. - Revenue growth is expected to accelerate further in FY26, supported by additional NRDL inclusions for major front-line indications [1]. - The company demonstrated operational leverage, with selling and R&D expenses as a percentage of product sales decreasing to 47% and 51%, respectively, from 49% and 56% in FY24 [1]. - Despite a reported net loss of RMB1.14 billion in FY25, Akeso maintains a robust balance sheet with RMB9.2 billion in cash and equivalents, providing a strong foundation for its late-stage clinical programs [1][2]. Financial Summary - Revenue projections for FY26 are estimated at RMB5.01 billion, with a year-over-year growth of 63.9%, followed by RMB8.68 billion in FY27 and RMB11.46 billion in FY28 [2][13]. - The net profit is projected to improve to RMB725.3 million in FY27 and RMB1.63 billion in FY28, after a loss of RMB733.7 million in FY26 [2][13]. - The gross profit margin is expected to normalize to 79% in FY25, down from 86% in FY24, due to price cuts associated with NRDL inclusions [1][2]. Clinical Development and Strategic Initiatives - Akeso is anticipating pivotal data readouts for ivonescimab, which has already met its primary PFS endpoint in a Phase 3 trial, showing a median PFS of 11.1 months compared to 6.9 months for the comparator [1][9]. - The company is advancing the global footprint of cadonilimab through pivotal trials, including a global Phase 2 trial for IO-resistant 2L HCC and a Phase 3 trial for 1L GC [1][9]. - Akeso's strategy includes the development of proprietary ADCs, with ongoing Phase 2 trials for HER3 ADC and TROP2/Nectin-4 ADC, aiming to evaluate combinatorial regimens with existing therapies [1][9].

Core Viewpoint - Akeso has received clearance to initiate Phase II clinical trials for two novel antibody-drug conjugates (ADCs), AK146D1 and AK138D1, as part of its "IO 2.0 + ADC 2.0" strategy, which aims to enhance cancer treatment through innovative combination therapies [1][2][4]. Group 1: Clinical Trials and Development - The Phase II studies will evaluate AK146D1 and AK138D1 in combination with Akeso's bispecific antibodies, cadonilimab and ivonescimab, targeting advanced solid tumors [2][3]. - AK146D1 is designed to target Trop2 and Nectin4, while AK138D1 targets HER3, both addressing tumor heterogeneity and resistance mechanisms [5]. - The initiation of these trials marks a significant step in advancing Akeso's proprietary combination platform into mid-stage clinical development [2][4]. Group 2: Strategic Positioning and Competitive Advantage - Akeso is positioned as a leader in the convergence of immuno-oncology and ADC modalities, with a unique advantage of having two approved bispecific antibodies [4]. - The company aims to expand the therapeutic window and mitigate safety limitations associated with traditional ADCs through its next-generation candidates [4][5]. - Akeso is also advancing a comprehensive portfolio of combination strategies, including collaborations with other immune checkpoint inhibitors and novel therapeutic platforms [6]. Group 3: Company Overview and Innovation - Founded in 2012, Akeso is focused on developing innovative biological medicines and has established a robust R&D ecosystem [8][9]. - The company has over 50 innovative assets in its pipeline, with 27 candidates currently in clinical trials, including bispecific antibodies and ADCs [9]. - Akeso's commitment to integrating global resources aims to provide affordable therapeutic options and create significant commercial and social value [9].

Financial Data and Key Metrics Changes - The company reported a net income of $3.8 million for Q4 2025, translating to $0.06 per share, while the full-year net loss was $84.9 million or $1.81 per share [25][26] - Total operating expenses decreased from $112.6 million in 2024 to $86.9 million in 2025, marking a 23% reduction [25] - Cash equivalents and short-term investments decreased from $94.1 million at the end of 2024 to $58.5 million at the end of Q4 2025 [25] Business Line Data and Key Metrics Changes - The primary focus remains on advancing INO-3107 towards FDA approval, with significant resources allocated to this lead candidate [5][24] - The company has also advanced its DNA medicine platform, including promising phase 1 proof of concept data for dMAb technology [21] Market Data and Key Metrics Changes - The market for recurrent respiratory papillomatosis (RRP) treatment is characterized by a significant burden on patients, with many requiring numerous surgeries throughout their lives [15] - Market research indicates that INO-3107 could become the preferred treatment option based on its efficacy and tolerability [16] Company Strategy and Development Direction - The company is focused on optimizing resources to extend its cash runway towards the October 30, 2026 PDUFA date for INO-3107 [24][60] - Strategic partnerships are being leveraged to advance other promising candidates in the pipeline, including collaborations in glioblastoma research [8][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in INO-3107's ability to meet an unmet medical need and provide a meaningful therapeutic benefit over existing treatments [7][11] - The company is preparing for a meeting with the FDA to discuss the BLA for INO-3107 and is awaiting feedback on an updated protocol for a confirmatory trial [10][30] Other Important Information - The company has reduced headcount by approximately 15% to conserve financial resources [24] - The FDA has accepted the BLA for INO-3107 under the Accelerated Approval Program, with a standard review timeline of 10 months [5][9] Q&A Session Summary Question: Additional data needed for FDA conversations regarding accelerated approval - Management confirmed that no new clinical data is required, but they have submitted new documentation to the FDA [30] Question: Impact of a potential priority review on launch preparations - The focus is currently on ensuring alignment with the FDA for accelerated approval, with commercial preparations well advanced [34][35] Question: Feedback from KOLs and patients on recent publications - Research indicates a strong preference for INO-3107 based on its efficacy and tolerability, with significant reductions in surgeries reported by patients [37][38] Question: Incorporating learnings from competitor's rollout into distribution strategy - The company is learning from competitor experiences and ensuring that their distribution strategy is well-prepared for launch [42][44] Question: Biological rationale of the dual PD-1/CTLA-4 blockade in partnership with Akeso - The combination aims to enhance immune responses against tumor-associated antigens, building on previous encouraging data [48][49] Question: Plans for INO-3112 if INO-3107 is approved - The company plans to focus resources on INO-3107 first, with potential to advance INO-3112 following approval and available financial resources [55]

Core Viewpoint - The collaboration aims to evaluate Akeso's cadonilimab in combination with INOVIO's INO-5412 as a potential treatment for glioblastoma, the most common and aggressive form of brain cancer [1] Group 1: Study Details - The novel combination therapy will be studied as part of the Phase II adaptive platform trial known as the INdividualized Screening trial of Innovative Glioblastoma Therapy (INSIGhT), sponsored by the Dana-Farber Cancer Institute [1] - This study builds on previously reported positive Phase II results involving INO-5401 in glioblastoma [1] Group 2: Treatment Mechanism - The combination adds a novel, first-in-class PD-1/CTLA-4 bi-specific immunotherapy, which potentially provides additional checkpoint inhibition through CTLA-4 binding [1]

Core Insights - INOVIO and Akeso have announced a clinical collaboration to evaluate a novel combination therapy for glioblastoma (GBM), which includes INO-5412 and cadonilimab [1][2] - The combination therapy will be part of the INSIGhT Phase 2 adaptive platform trial, aiming to find new treatments for GBM [1][2] - Dosing for the trial is expected to begin in the second half of 2026 [1] Company Overview - INOVIO is focused on developing DNA medicines for cancer and infectious diseases, utilizing proprietary technology for the design and delivery of its therapies [2] - Akeso is a biopharmaceutical company committed to innovative biological medicines, with a robust pipeline of over 50 assets in various disease areas, including cancer [2] Treatment Details - INO-5412 combines INO-5401 and INO-9012, showing potential for enhanced immune responses and improved patient outcomes when used with checkpoint inhibitors [1][2] - Cadonilimab is a first-in-class PD-1/CTLA-4 bispecific antibody, already approved in China for multiple cancer indications, demonstrating effectiveness regardless of PD-L1 expression [1][2] Clinical Trial Insights - The INSIGhT trial is designed to test multiple investigational therapies simultaneously, with the collaboration between INOVIO and Akeso focusing on the safety and efficacy of the combination therapy in patients with confirmed GBM [1][2] - GBM has a poor prognosis, with a median overall survival of approximately 15 months for patients receiving standard care [2] Market Context - The estimated annual incidence of GBM in the U.S. is 11,362 cases, highlighting the significant unmet medical need in this area [2] - The collaboration aims to leverage the strengths of both companies to address the challenges of treating this aggressive form of brain cancer [1][2]

Core Insights - Akeso, Inc. has initiated a Phase I clinical trial for its personalized mRNA vaccine AK154, targeting pancreatic cancer as both a monotherapy and in combination with bispecific antibodies cadonilimab and ivonescimab [1][2][4] Company Overview - Akeso is a leading biopharmaceutical company founded in 2012, focusing on innovative biological medicines and has developed a comprehensive end-to-end drug development platform [8] - The company has over 50 innovative assets in its pipeline, with 24 candidates currently in clinical trials, including 15 bispecific/multispecific antibodies [8] Product Development - AK154 is Akeso's first mRNA-based therapeutic candidate, designed to address the "cold tumor" phenotype in pancreatic cancer by utilizing sequence-specific mRNA vaccines [2][3] - Preclinical data for AK154 indicates strong immunogenicity and anti-tumor activity, suggesting a favorable safety profile when combined with Akeso's bispecific antibodies [4]

Core Viewpoint - Akeso, Inc. has initiated a global Phase II registrational trial for cadonilimab, a bispecific antibody, to treat advanced hepatocellular carcinoma (HCC) in patients previously treated with atezolizumab and bevacizumab, marking a significant step in cancer immunotherapy development [1][2]. Group 1: Clinical Trials and Development - The COMPASSION-36 trial is the first global registrational Phase III trial for cadonilimab, currently being conducted in China, the U.S., and Europe, highlighting Akeso's commitment to advancing cancer treatment [2]. - Additional Phase III clinical trials for cadonilimab are in preparation, with a focus on both in-house development and open collaboration to enhance treatment accessibility [3]. - Patient enrollment for a Phase III trial of cadonilimab as adjuvant therapy for high-risk recurrence after curative surgery for HCC has been completed, and another trial combining cadonilimab with lenvatinib and TACE is ongoing [8]. Group 2: Market Need and Treatment Landscape - There is a critical need for effective second-line treatment options for patients with advanced malignancies who have progressed after immune checkpoint inhibitor (IO) combination therapies, as current options are limited [4]. - Hepatocellular carcinoma (HCC) is a prevalent malignancy, with approximately 865,000 new cases reported globally in 2022, and there are currently no FDA-approved second-line therapies available in the U.S. for patients who progress after first-line treatment [5]. - The combination of cadonilimab with other therapies has shown promising results in overcoming IO resistance and achieving high disease control rates in various studies [6][7]. Group 3: Company Overview - Akeso is a leading biopharmaceutical company focused on developing innovative biological medicines, with a robust pipeline of over 50 assets in various disease areas, including cancer [13]. - The company utilizes a comprehensive end-to-end drug development platform and has developed a unique integrated R&D innovation system, positioning itself as a globally competitive entity in the biopharmaceutical industry [13].

Core Insights - Akeso, Inc. reported record commercial sales in China and significant global advancements in its oncology and autoimmune pipelines for the first half of 2025, driven by its "IO 2.0 + ADC 2.0" strategy [2][11][34] - The company has established itself as a leader in immuno-oncology bispecific antibodies, particularly with cadonilimab and ivonescimab, which are being evaluated in numerous global clinical trials [5][6][9][22] - Akeso's non-oncology portfolio is also expanding, with recent product launches and ongoing developments in autoimmune diseases, contributing to overall growth [10][31][36] Financial Performance - Total commercial sales increased by 49.20%, from RMB 939.4 million in the first half of 2024 to RMB 1,401.6 million in the first half of 2025, reflecting robust market penetration [11] - Research and development expenses for the same period were RMB 731.2 million, with total cash and equivalents amounting to RMB 7,138.4 million as of June 30, 2025 [12] Oncology Pipeline - Ivonescimab and cadonilimab are being evaluated in 23 registrational/Phase III trials and over 20 Phase II studies globally, with ivonescimab demonstrating statistically significant overall survival benefits in its trials [6][8][18] - Cadonilimab has received approvals for multiple indications, including first-line treatments for cervical and gastric cancers, addressing significant unmet needs in immunotherapy [22][23][25] Non-Oncology Pipeline - The company has launched ebdarokimab and ebronucimab, with upcoming launches for gumokimab and manfidokimab, enhancing its competitive position in the autoimmune sector [10][31][35] - Akeso's innovative candidates targeting neurological diseases and other chronic conditions are also progressing through development [32][36] Strategic Initiatives - Akeso is advancing a next-generation pipeline of bispecific ADCs and dual-payload ADCs, aiming to redefine the oncology treatment landscape [27][29] - The company is open to strategic collaborations to enhance its global reach and maximize therapeutic value [26]

Core Viewpoint - Akeso, Inc. has received approval to initiate a global Phase II trial for cadonilimab, a bispecific antibody, to treat advanced hepatocellular carcinoma (HCC) in patients previously treated with other therapies, addressing a significant unmet need in cancer treatment [1][4][6] Group 1: Clinical Development - The COMPASSION-36/AK104-225 trial is a pivotal part of cadonilimab's global development strategy, aiming to improve treatment options for patients with HCC who have developed resistance to existing therapies [2][3] - Cadonilimab is the first bispecific antibody approved globally for cancer immunotherapy, demonstrating potential in combination therapies for HCC and other malignancies [5][6] Group 2: Market Need - HCC is a prevalent cancer, with approximately 865,000 new cases reported globally in 2022, and there are currently no FDA-approved second-line therapies for patients whose disease progresses after first-line treatment [4][6] - The lack of effective second-line treatment options for advanced malignancies highlights the critical need for new therapeutic strategies, which cadonilimab aims to address [3][4] Group 3: Research and Innovation - Akeso is advancing multiple clinical trials for cadonilimab, including studies for neoadjuvant therapy and combination therapies with other agents, showcasing its commitment to addressing cancer immunotherapy resistance [6][10] - The company has a robust pipeline of over 50 innovative assets, with 24 candidates in clinical trials, reflecting its focus on developing first-in-class and best-in-class therapies [10]

Group 1 - Akeso, Inc. has successfully enrolled the first patient in its Phase Ia clinical trial for AK146D1, a bispecific Antibody-Drug Conjugate (ADC) targeting Trop2 and Nectin4, marking its first bispecific ADC to enter clinical trials [1] - AK146D1 has received approvals from the U.S. FDA, Australia's TGA, and China's NMPA to begin clinical trials, indicating strong regulatory support for the product [1] - Akeso is the only company globally with two approved cancer immunotherapy bispecific antibodies, cadonilimab and ivonescimab, establishing a strong leadership advantage in the IO+ADC space [2] Group 2 - ADC therapeutics are a key component of Akeso's "IO+ADC" 2.0 strategy, which aims to reshape the global treatment landscape and set new standards for cancer care [3] - The company emphasizes the potential of innovative bispecific ADCs like AK146D1 to unlock global clinical opportunities and enhance cancer therapies [4] - Trop2 and Nectin4 are ideal targets for ADC therapy due to their high expression in various tumor types and low expression in normal tissues, which may improve treatment efficacy [4][5] Group 3 - AK146D1 is the first bispecific ADC targeting both Trop2 and Nectin4, with preclinical studies showing strong anti-tumor activity and favorable safety profiles [5] - The development of AK146D1 holds significant potential for improving treatment outcomes for cancer patients, highlighting Akeso's commitment to advancing cancer therapies [5]