Hong Kong, September 17, 2026

Akeso, Inc. has announced that its investigational AK158D1, a next-generation EGFR/TROP2 bispecific antibody-drug conjugate (ADC), has received Phase I clinical trial clearance from China’s National Medical Products Administration (NMPA) Center for Drug Evaluation. The authorization allows Akeso to initiate a Phase I clinical study evaluating AK158D1 in patients with advanced malignant solid tumors. The milestone adds another clinical-stage ADC to Akeso’s oncology pipeline and marks the company’s fourth ADC candidate to enter clinical development. AK158D1 is also the company’s second bispecific ADC to advance into clinical trials, supporting its broader strategy of developing next-generation immuno-oncology and ADC therapies.

AK158D1 Targets EGFR and TROP2 in Solid Tumors


AK158D1 is designed as a bispecific ADC targeting EGFR and TROP2, two molecular targets that are frequently expressed across multiple types of solid tumors. By combining dual-target recognition with an antibody-drug conjugate approach, the investigational therapy is being developed to deliver cytotoxic treatment more selectively to tumor cells. Akeso describes EGFR and TROP2 as potentially complementary targets because both are associated with a broad range of malignant solid tumors. The company is investigating whether the dual-targeting design can address some limitations associated with conventional single-target ADC approaches while supporting potent antitumor activity. However, AK158D1 remains investigational, and its clinical safety and efficacy will need to be established through human studies.The Phase I clearance represents an important transition from preclinical development to clinical evaluation. The upcoming study will assess AK158D1 in patients with advanced solid tumors and is expected to provide initial information regarding the candidate’s safety, tolerability, pharmacokinetics and preliminary antitumor activity. Early-stage clinical studies are essential for determining appropriate dosing and identifying potential treatment-related adverse events before larger studies can evaluate efficacy in specific cancer populations.

Akeso Expands Its Clinical ADC Pipeline

AK158D1 becomes the fourth ADC candidate from Akeso to enter clinical development. The company’s clinical-stage ADC portfolio also includes AK146D1, a TROP2/Nectin-4 bispecific ADC; AK138D1, a next-generation HER3 ADC; and AK157D1, a B7-H3 ADC. Akeso previously received NMPA clearance for AK157D1 to enter Phase I development in patients with advanced malignant solid tumors.

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The expansion of the ADC pipeline reflects Akeso’s broader IO2.0 + ADC2.0 strategy, which combines its immuno-oncology technologies with next-generation antibody-drug conjugates. The company has reported that AK146D1 and AK138D1 are already being evaluated in clinical studies, including combination approaches involving its proprietary bispecific antibody ivonescimab. Akeso’s 2026 interim update identified AK158D1 alongside its other ADC candidates as part of an expanding therapeutic matrix aimed at major solid tumors.

Phase I Study Opens New Clinical Development Path

The NMPA authorization enables Akeso to begin clinical investigation of AK158D1 in advanced solid tumors, creating an opportunity to evaluate the candidate directly in patients. The company has stated that preclinical studies demonstrated antitumor activity and that the program is intended to explore potential treatment options for patients with difficult-to-treat cancers. These findings remain preclinical, however, and further evidence from the Phase I study will be required to determine whether the observed activity translates into meaningful clinical benefit.

With AK158D1 now cleared for clinical development, Akeso continues to build a pipeline centered on bispecific antibodies, next-generation ADCs and immuno-oncology combinations. The company’s expanding ADC portfolio provides multiple approaches to investigate tumor-specific targeting and drug delivery across different cancer types. The progression of AK158D1 into Phase I represents another step in Akeso’s development of next-generation cancer therapeutics, while future clinical data will determine its potential role in treating patients with advanced solid tumors.

Source: Akeso press release