China Securities has issued a research report initiating coverage on AKESO (09926) with a "Buy" rating, citing the excellent efficacy and broad market potential of the company's innovative drug portfolio. The report highlights the imminent approval and launch of several pipeline products and new indications, alongside a continuously expanding and enriched early-stage pipeline, which underpins long-term sustainable growth. On the commercial front, the approval of Ivonescimab has contributed incremental sales, while Cadonilimab maintains stable growth, leading to a consistent year-on-year increase in the company's product revenue. The core views from China Securities are outlined below.
Investment Thesis
AKESO has evolved into a domestic leader in the bispecific antibody field, aspiring to become a global leader in innovative drugs, leveraging its world-leading Tetrabody bispecific technology platform and comprehensive, integrated R&D capabilities. The company has established a dual strategic focus on "IO 2.0 + ADC," forming a tiered portfolio centered on a "bispecific foundation + next-generation ADC + novel immunomodulators," with balanced emphasis on oncology and non-oncology areas. In the near to medium term, the focus is on global clinical advancement and value realization, while the long-term outlook hinges on the value delivery from its early-stage pipeline, positioning it as a globally competitive, comprehensive innovative drug leader.
Report Focus and Highlights
This report builds upon the firm's previous deep-dive coverage, which focused on the clinical potential and market opportunity of AK104 and AK112, by now highlighting the differentiated advantages of the company's seven cutting-edge early-stage pipelines. Beyond the market's general focus on the two core bispecifics, the analysis delves deeper into AKESO's potential for global first-in-class/best-in-class candidates in areas such as autoimmune diseases (AK139), central nervous system (AK152), chemotherapy-induced peripheral neuropathy (AK135), and in oncology: CD47 (AK117), ADC (AK146D1, AK138D1), and trispecific antibodies (AK150).
Bispecific Foundation Leading Globally, Commercialization Enters High-Quality Phase
Utilizing its leading Tetrabody platform, AKESO has successfully brought two global first-in-class bispecific antibodies to market: Ivonescimab (PD-1/VEGF) and Cadonilimab (PD-1/CTLA-4). In 2025, the company's product sales revenue grew 51.5% year-on-year to RMB 3.033 billion, with all 12 indications for its five self-developed novel drugs included in the National Reimbursement Drug List, marking both quantitative and qualitative improvement in commercialization. Concurrently, the company has built a differentiated innovation pipeline covering autoimmune, neurological, metabolic diseases, next-generation ADCs, and trispecific antibodies through its six core technology platforms.
Oncology Early-Stage Pipeline: Differentiated Next-Generation IO+ADC Strategy
1) AK117 (CD47): The first CD47 monoclonal antibody globally to enter a registrational Phase III trial in solid tumors, featuring a unique binding conformation that eliminates red blood cell agglutination for high efficacy and low toxicity.
2) AK146D1 (Trop2/Nectin-4 ADC): Demonstrates superior preclinical anti-tumor activity compared to combination therapies; Phase Ia dose has been escalated to 12mg/kg without dose-limiting toxicities.
3) AK138D1 (HER3 ADC): Dose escalation reached 9.6mg/kg without DLTs; complete responses observed in later-line pancreatic/bile duct cancer, showing best-in-class potential.
4) AK150 (ILT2/ILT4/CSF1R Trispecific): The world's first trispecific antibody with this target combination, designed to three-dimensionally reverse the immunosuppressive tumor microenvironment.
Dual Drivers in Non-Oncology: Autoimmune and CNS Blockbusters Emerging
1) AK139 (IL-4Rα/ST2): The world's first dual-target anti-inflammatory bispecific antibody; seven Phase II trials have been approved, showing efficacy superior to Dupilumab monotherapy and combination therapy.
2) AK152 (Aβ/BBB Receptor): Exhibits a 10-fold increase in brain penetration efficiency, potentially becoming a next-generation disease-modifying therapy for Alzheimer's; Phase I enrollment is ongoing.
3) AK135 (IL-1RAP): Targets chemotherapy-induced peripheral neuropathy (CIPN, an area with no globally approved drugs); shows significant relief of neuropathic pain in preclinical studies; Phase I dose escalation is progressing smoothly.
Upcoming Catalysts and Milestones
Focus areas include domestic autoimmune progress and Ivonescimab's overseas registration and commercialization.
(1) Ivonescimab: Overseas BLA (FDA) and domestic sq-NSCLC sNDA (NMPA) submissions are advancing.
(2) Cadonilimab: Indications included in the NRDL are scaling up; monitor the uptake pace of potential new indications.
(3) Autoimmune: Guselkumab (AS) sNDA and Risankizumab (AD) NDA are under regulatory review.
Monitor key clinical progress.
(1) Approximately 30 registrational/Phase III trials for Ivonescimab/Cadonilimab are ongoing, with focus on core indications like lung, gastric, and liver cancer.
(2) Platform Pipeline: ADCs (AK138D1, AK146D1) are in Phase I with combination Phase II trials advancing; multi-specifics (AK139, AK137, etc.) are in Phase I/II.
Watch for data readouts and academic presentations.
Potential updates in 2026 include domestic HARMONi-2 lung cancer OS data and domestic biliary tract cancer OS data. The second half of 2026 may see final mPFS analysis and potential interim OS trend analysis from the overseas HARMONi-3 squamous cell carcinoma trial.
Key Risks to Consider
Risks include changes in industry policy, clinical development setbacks, regulatory approval delays, and commercial sales underperformance.
Comments