Hong Kong, August 21, 2026

Akeso, Inc. has announced that its investigational B7-H3-targeting antibody-drug conjugate (ADC), AK157D1, has received clinical trial clearance from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The regulatory clearance enables Akeso to initiate a Phase I clinical trial in patients with advanced malignant solid tumors, marking another step in the company’s expansion of its next-generation oncology pipeline. AK157D1 is the company’s third ADC candidate to enter clinical development, following AK146D1, a TROP2/Nectin-4 ADC, and AK138D1, a HER3 ADC.

AK157D1 Targets Broadly Expressed B7-H3

B7-H3 is highly expressed across multiple solid tumors, including non-small cell lung cancer, small cell lung cancer, prostate cancer, esophageal cancer, nasopharyngeal carcinoma, colorectal cancer, breast cancer and glioblastoma, while showing limited expression in normal tissues, according to Akeso. This expression profile has made B7-H3 an attractive target for developing targeted cancer therapies. AK157D1 was developed entirely in-house using Akeso’s proprietary ADC design. The investigational therapy consists of a recombinant humanized IgG1/κ monoclonal antibody that is site-specifically conjugated to Dxd, a camptothecin-derived topoisomerase I inhibitor. The drug payload is connected through an MC-AAA linker to interchain cysteine residues. In preclinical studies, AK157D1 demonstrated potent antitumor activity and a favorable safety profile. Akeso believes these characteristics could potentially help address safety and therapeutic-window limitations associated with some existing ADC approaches, although the candidate’s clinical safety and efficacy remain to be established in human studies.

Phase I Study Expands Akeso’s ADC Pipeline

The newly cleared Phase I program will evaluate AK157D1 in patients with advanced malignant solid tumors, providing the first clinical opportunity to assess the candidate’s safety, tolerability and potential therapeutic activity in humans. Akeso also plans to investigate AK157D1 in combination with its proprietary bispecific antibodies ivonescimab and cadonilimab, supporting the company’s broader IO2.0 + ADC2.0 strategy. The strategy combines next-generation immuno-oncology assets with differentiated ADC technologies to explore potential treatment approaches across major cancer indications. Akeso already has two approved bispecific antibodies for cancer treatment and is evaluating its immuno-oncology products alongside next-generation ADC candidates. The company’s ADC portfolio includes AK146D1 and AK138D1, which are in clinical development, while AK157D1 and AK158D1, a bispecific ADC, are anticipated to enter clinical development. Through these programs, Akeso is seeking to develop therapies designed to improve the therapeutic window and address safety challenges associated with earlier generations of ADCs.

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Akeso Strengthens Next-Generation Oncology Strategy

The clinical clearance of AK157D1 further broadens Akeso’s innovative oncology pipeline, which includes antibody-based therapies, ADCs and other emerging therapeutic platforms. Founded in 2012, Akeso has developed proprietary technology platforms spanning bispecific and multispecific antibodies, AI-powered drug research, ADCs, T-cell engagers, siRNA/mRNA therapies and cell therapy. The company reports a pipeline of more than 50 innovative assets across oncology, autoimmune diseases, inflammation, metabolic disorders and other therapeutic areas, with multiple candidates already in clinical development. By advancing AK157D1 into Phase I, Akeso is expanding its efforts to develop differentiated therapies against challenging cancer targets. The B7-H3 ADC candidate now enters clinical testing, where human data will determine whether its preclinical activity and proposed safety advantages can translate into meaningful benefits for patients with advanced solid tumors.

Source: Akeso press relese