Akeso gains NMPA clearance for a first-in-human trial of its EGFR/TROP2 bispecific ADC, expanding its oncology pipeline
Executive summary: Akeso announced that its investigational bispecific ADC AK158D1, targeting EGFR and TROP2, obtained NMPA Phase I clinical trial clearance for advanced solid tumors. The clearance adds a new candidate to Akeso's ADC pipeline, potentially diversifying its oncology offerings and attracting partner interest in a competitive bispecific ADC landscape.
Who is involved: Akeso, Inc. (9926.HK), the National Medical Products Administration (NMPA) of China, and the drug AK158D1.
Likely next: Akeso will initiate patient enrollment for the Phase I study, with initial safety data expected within the next 6-12 months.
Akeso has received clearance from China’s National Medical Products Administration to initiate a first‑in‑human Phase I trial of its EGFR/TROP2 bispecific antibody‑drug conjugate, designated AK158D1. This authorization makes AK158D1 the company’s fourth clinical‑stage ADC candidate and adds a new bispecific construct that simultaneously targets epidermal growth factor receptor and trophoblast cell‑surface antigen 2, two proteins that are frequently co‑expressed in solid tumours such as non‑small cell lung cancer, colorectal carcinoma and head‑and‑neck malignancies. The clearance allows Akeso to begin dosing patients with advanced solid tumours to assess the safety, tolerability and pharmacokinetics of AK158D1. While the move expands Akeso’s growing oncology pipeline and reinforces its focus on bispecific ADCs, the asset remains at an early experimental stage. Demonstrating an acceptable safety profile and preliminary signs of antitumor activity will be prerequisite before any later‑stage development, partnership discussions or commercial considerations can be pursued. The outcome of this Phase I study will therefore be a key near‑term milestone for evaluating the therapeutic potential of dual EGFR/TROP2 targeting in the ADC space.
What's next — scenarios
Base: Phase I proceeds as planned (60%)
Akeso advances AK158D1 through early clinical testing, laying groundwork for potential later-stage development.
- First patient dosed by Q4 2026
- No safety holds reported in initial 3-month period
- NMPA does not request additional preclinical data
Upside: Positive early efficacy leads to fast-track designation (25%)
Encouraging antitumor activity prompts NMPA to grant expedited pathways, accelerating timelines and increasing partnership prospects.
- Objective response rate ≥20% in Phase I cohort
- NMPA issues fast-track or breakthrough therapy notice by mid‑2027
- At least one global pharma expresses licensing interest
Downside: Safety concerns halt development (15%)
Adverse safety findings trigger a clinical hold, delaying or terminating the AK158D1 program and affecting pipeline valuation.
- Grade ≥3 treatment‑related adverse events in >20% of participants
- NMPA issues clinical hold notice within 6 months of start
- Akeso announces discontinuation of AK158D1 development
What to watch
- NMPA trial registry posting for AK158D1 (expected October 2026)
- First patient dosing announcement (expected November‑December 2026)
- Interim safety readout from Phase I (expected mid‑2027)
- Any FDA pre‑IND meeting request (expected Q1 2027)
- Potential licensing or co‑development deal announcement (expected H2 2027)
Timeline
- — Akeso's EGFR/TROP2 Bispecific ADC AK158D1 Granted NMPA Phase I Clearance for Advanced Solid Tumors, Marking Its Fourth Clinical-Stage ADC Candidate (PR Newswire)
- — Accro Bioscience Announces Inclusion of AC-101 tablets in the NMPA CDE's "Caring Plan-Extension" Pilot Program for Rare Disease Drug Development (PR Newswire)
- — InnoCare Announces Approval of Clinical Trial of Novel Bispecific ADC ICP-B381 Targeting PSMA/STEAP1 in China (GlobeNewswire)
Analysis — what this means
Likely next events
- Phase I patient enrollment to begin Q4 2026
- Initial safety data anticipated by mid‑2027
- Potential IND submission to FDA for global expansion in 2027
- Exploratory partnership talks with major oncology players in 2027
Sectors affected
- Biopharmaceutical oncology antibody-drug conjugate development
- Clinical trial site networks in China
- ADC manufacturing and conjugation services
Regulatory implications
- NMPA Phase I clearance permits first‑in‑human studies in China for bispecific ADCs
- Future NMPA IND submissions will need to address bispecific‑specific safety per CDE guidance
- Success may support eligibility for accelerated pathways under NMPA’s innovative drug policies
Historical parallels
- InnoCare’s bispecific ADC ICP‑B381 received NMPA clinical‑trial approval in September 2026
- Accro Bioscience’s AC‑101 was included in the NMPA CDE ‘Caring Plan‑Extension’ pilot program in September 2026
- Whitehawk Therapeutics presented PTK7 as a durable ADC target in EGFR‑wild‑type NSCLC at WCLC 2026 (September 2026)
Key entities
Sources
- Akeso's EGFR/TROP2 Bispecific ADC AK158D1 Granted NMPA Phase I Clearance for Advanced Solid Tumors, Marking Its Fourth Clinical-Stage ADC Candidate — PR Newswire
- Accro Bioscience Announces Inclusion of AC-101 tablets in the NMPA CDE's "Caring Plan-Extension" Pilot Program for Rare Disease Drug Development — PR Newswire
- InnoCare Announces Approval of Clinical Trial of Novel Bispecific ADC ICP-B381 Targeting PSMA/STEAP1 in China — GlobeNewswire
Related cases
- Accro Bioscience’s AC-101 tablets gain entry into NMPA’s Caring Plan‑Extension pilot, securing regulatory support for rare‑disease drug development in China
- PTK7 emerges as stable ADC target in EGFR wild-type NSCLC, boosting Whitehawk's HWK-007 prospects
- InnoCare secures Chinese IND clearance for its first bispecific ADC, ICP‑B381, targeting PSMA and STEAP1, marking a new clinical‑stage asset in the fast‑growing Chinese oncology pipeline
- Akeso’s 2026 interim results show record‑high drug sales and progress on its IO 2.0 strategy, advancing bispecific ADCs in oncology, immunology and Alzheimer’s
- Akeso's B7‑H3 ADC AK157D1 gains Phase I clearance, adding a third differentiated candidate to its oncology pipeline
- Henlius and Sandoz partner to co‑develop up to ten biosimilar mAb and ADC assets, aiming to accelerate global market access and revenue generation