HONG KONG, March 25, 2026 /PRNewswire/ — Akeso, Inc. (9926.HK) (“Akeso” or the “Company”) announced today that it has received clearance from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to initiate Phase II clinical trials for AK146D1, a first-in-class Trop2 /Nectin4 bispecific antibody-drug conjugate (ADC), and AK138D1, an innovative HER3-targeting ADC.
The studies will evaluate these two novel ADC candidates in combination with the Company’s pioneering immuno-oncology (IO) 2.0 bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), as well as other proprietary high-potential anti-tumor assets, including AK117 (anti-CD47 monoclonal antibody) and AK109 (anti-VEGF monoclonal antibody), across a spectrum of advanced solid tumors. This milestone marks a strategic acceleration of Akeso’s proprietary “IO 2.0 + ADC 2.0” combination platform into mid-stage clinical development.
These Phase II studies will leverage the cadonilimab and ivonescimab as foundational backbone therapies, capitalizing on their validated clinical profiles in checkpoint blockades and dual VEGF/PD-1 inhibition. The regimens center on Akeso’s internally discovered next-generation ADCs while exploring synergies with the company’s broader internal portfolio.
The convergence of immuno-oncology and ADC modalities has emerged as a high-conviction frontier in oncology therapy, offering the potential to overcome the limitations of monotherapy approaches – such as antigen escape, heterogeneous expression, and narrow therapeutic indices. Akeso holds a distinct global competitive advantage as the only company with two approved cancer immunotherapy checkpoint bispecific antibodies. By pairing these IO backbones with next-generation ADC candidates like AK146D1 and AK138D1, the Company is driving the next generation of combination therapy. AK146D1 and AK138D1 have been specifically designed to expand the therapeutic window and mitigate safety-related limitations of traditional ADCs. The progression of these “IO 2.0 + ADC 2.0” combinations into Phase II development is a significant step in establishing Akeso’s next-generation leadership in the global oncology landscape.
AK146D1 is a first-in-class bispecific ADC engineered to simultaneously target Trop2 and Nectin4, antigens that are frequently co-expressed in epithelial-derived malignancies such as lung, breast, and bladder cancers. This dual-targeting approach is designed to enhance selectivity, address tumor heterogeneity, and overcome the resistance mechanisms common in single-target ADC therapies. AK138D1 is a next-generation ADC targeting HER3, a receptor associated with tumor progression and resistance to established EGFR and HER2 treatments in various malignancies, including ovarian, colorectal, melanoma, and prostate cancers. Early-stage data for both AK146D1 and AK138D1 have demonstrated potent anti-tumor activity and a highly manageable safety profile.
Akeso continues to extend its global IO 2.0 leadership into broader, high-impact combination strategies. Beyond the “IO 2.0 + ADC 2.0” portfolio, the Company is advancing a comprehensive portfolio of novel combination approaches aimed at addressing major unmet clinical needs. These include IO 2.0 combinations with other immune checkpoint inhibitors (ICIs), mRNA-based personalized cancer vaccines (such as AK154), DNA-based therapeutics, and additional novel therapeutic platforms.
This milestone underscores Akeso’s disciplined execution in translating proprietary platform synergies into clinical progress, positioning the Company at the forefront of next-generation global oncology innovation.
About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world’s first or best-in-class innovative biological medicines. Founded in 2012, the company has established a robust R&D innovation ecosystem centered on its proprietary Tetrabody multi-specific antibody platform, Dual-Shield Antibody-Drug Conjugates (ADCs), Dual-Lock T-cell engager (TCE), Tissue-Smart siRNA, Cell Therapies, and Flex-Nano mRNA platforms. Supported by a global-standard GMP manufacturing infrastructure and a highly efficient, integrated commercialization model, the company has evolved into a globally competitive biopharmaceutical focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 27 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.
Forward-Looking Statements
This announcement by Akeso, Inc. (9926.HK, “Akeso”) contains “forward-looking statements”. These statements reflect the current beliefs and expectations of Akeso’s management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso’s other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.
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