Akeso's B7‑H3 ADC AK157D1 gains Phase I clearance, adding a third differentiated candidate to its oncology pipeline
Executive summary: Akeso's B7‑H3‑targeting antibody‑drug conjugate AK157D1 received clinical trial clearance from China's Center for Drug Evaluation to start a Phase I trial in solid tumors. The clearance adds a third differentiated ADC to Akeso’s pipeline, broadening its oncology assets and potentially addressing unmet needs in solid‑tumor indications.
Who is involved: Akeso, Inc. (9926.HK) and the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration.
Likely next: Initiation of patient dosing in the Phase I study, early safety read‑out expected in the first half of 2027, and potential advancement to Phase II or partnership discussions pending favorable data.
Akeso announced that its investigational antibody‑drug conjugate targeting B7‑H3, AK157D1, has received clinical trial clearance from China’s Center for Drug Evaluation to begin a Phase I study in solid tumors. This marks the company’s third distinct ADC entering clinical development, following the HER3‑targeting AK138D1 and the TROP2/Nectin‑4 bispecific AK146D1. The clearance expands Akeso’s ability to address solid‑tumor indications with a novel payload and reinforces its strategy of building a diversified ADC portfolio.
Timeline
- — Akeso's AK157D1 (B7-H3 ADC) Cleared for Phase I Trial in Solid Tumors, Adding a Third Differentiated ADC to Its Pipeline (PR Newswire)
- — Akeso IO2.0 + ADC2.0 Strategy Makes Another Advancement: First Patient Dosed in Phase Ib/II Study of HER3 ADC (AK138D1) Combined with Ivonescimab in Lung Cancer (PR Newswire)
- — Akeso Doses First Patient in Phase II Study of Novel TROP2/Nectin-4 Bispecific ADC (AK146D1) in Combination with Ivonescimab for Advanced NSCLC (PR Newswire)
Analysis — what this means
Likely next events
- Phase I dosing of AK157D1 expected to commence Q4 2026
- Initial safety and tolerability data anticipated H1 2027
- If Phase I is positive, Akeso may seek IND clearance from the FDA/EMA for broader trials
Sectors affected
- Biotechnology
- Antibody‑drug conjugates (ADCs)
- Oncology therapeutics
Regulatory implications
- CDE clearance permits a China‑based Phase I trial; future IND submissions to the FDA or EMA will be required for global development
- ADC programs remain subject to specific guidance on payload toxicity and manufacturing controls
- Should AK157D1 show activity in a narrow solid‑tumor subset, Akeso could pursue orphan‑drug designation
Historical parallels
- Akeso dosed the first patient in a Phase II study of its TROP2/Nectin‑4 bispecific ADC AK146D1 on July 20, 2026
- Akeso initiated a Phase Ib/II study of its HER3‑targeted ADC AK138D1 combined with Ivonescimab on July 28, 2026
Key entities
Sources
- Akeso's AK157D1 (B7-H3 ADC) Cleared for Phase I Trial in Solid Tumors, Adding a Third Differentiated ADC to Its Pipeline — PR Newswire
- Akeso Doses First Patient in Phase II Study of Novel TROP2/Nectin-4 Bispecific ADC (AK146D1) in Combination with Ivonescimab for Advanced NSCLC — PR Newswire
- Akeso IO2.0 + ADC2.0 Strategy Makes Another Advancement: First Patient Dosed in Phase Ib/II Study of HER3 ADC (AK138D1) Combined with Ivonescimab in Lung Cancer — PR Newswire
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- Akeso initiates first‑in‑human trial of its HER3‑targeted ADC combined with Ivonescimab in lung cancer, advancing its IO2.0+ADC2.0 pipeline
- Mabwell's ESMO 2026 oral presentation of clinical data for its Nectin-4-targeting ADC 9MW2821 highlights potential progress in triple-negative breast cancer therapy and could affect oncology investment sentiment