On September 17, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that AK158D1, its investigational next-generation bispecific antibody-drug conjugate (ADC) targeting EGFR and TROP2, has secured Phase I clinical trial clearance from the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA). The trial will assess the candidate in patients with advanced malignant solid tumors.
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AK158D1 is Akeso’s fourth ADC to enter clinical development and joins the Company’s growing clinical-stage ADC portfolio, which includes AK146D1 (TROP2/Nectin-4), AK138D1 (HER3), and AK157D1 (B7-H3). It is also Akeso’s second bispecific ADC to reach the clinic, further advancing the Company’s global strategy of combining next-generation immuno-oncology (IO2.0) approaches with next-generation ADC platforms (ADC2.0).
EGFR (epidermal growth factor receptor) and TROP2 (trophoblast cell surface antigen 2) constitute a highly promising target pair for bispecific ADC therapeutic development, with broad co-expression across a spectrum of solid tumor types. Each target has well-validated anti-tumor mechanisms of action, and their dual targeting holds significant synergistic anti-tumor potential.
To date, single-target ADCs directed against either EGFR or TROP2 have been constrained by three key clinical limitations: narrow tumor coverage, off-target toxicity, and multidrug resistance. As a next-generation dual-targeting ADC, AK158D1 integrates the precise tumor recognition enabled by bispecific antibodies, a highly potent cytotoxic payload, and an enhanced safety profile to create a potential breakthrough ADC to address the shortcomings of conventional single-target ADC modalities.
Preclinical data for AK158D1 have demonstrated potent anti-tumor activity with a favorable safety profile, supporting its potential as a novel therapeutic option for a wide range of patients, including those who are refractory to, intolerant, or ineligible for existing standard of care regimens.
Akeso is advancing its IO2.0 + ADC2.0 strategy, built on proprietary bispecific and multi-specific antibody technology and centered on cornerstone IO2.0 assets including ivonescimab and cadonilimab. Through this approach, the Company is elevating treatment standards for major diseases worldwide and building a broad oncology portfolio to create next-generation standard of care.
Leveraging its technological leadership in bispecific and multi-specific antibodies, Akeso is systematically building a comprehensive global IO2.0 + ADC2.0 therapeutic matrix for major diseases worldwide.
In the immuno-oncology field, Akeso has two approved bispecific antibodies for cancer treatment. The Company is actively evaluating ivonescimab and cadonilimab in combination with its proprietary next-generation ADC candidates. Increasingly, global partners recognize both ivonescimab and cadonilimab as preferred agents for combination regimens and breakthrough therapy explorations across a wide spectrum of tumor types. In the ADC space, Akeso has built a pipeline of highly differentiated next-generation candidates, including AK146D1, AK138D1, AK157D1 and AK158D1, which are already in clinical development. These agents are designed to address the narrow therapeutic window and safety limitations commonly associated with first-generation ADCs.
About AK158D1
AK158D1 is a bispecific ADC developed by Akeso, featuring a humanized antibody that dually targets EGFR and TROP2. Preclinical pharmacodynamic studies have shown strong antigen-binding affinity and robust in vitro and in vivo pharmacological activity.
(Press release, Akeso Biopharma, SEP 17, 2026, View Source [SID1234670931])