Akeso, Inc. announced that its investigational next-generation 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 clearance allows initiation of a Phase I study in patients with advanced malignant solid tumors. Development of AK157D1 in combination with Akeso's proprietary bispecific antibodies ivonescimab and cadonilimab is also planned.

AK157D1 is the third next-generation ADC candidate from Akeso to enter clinical development, following AK146D1 (TROP2/Nectin-4 ADC) and AK138D1 (HER3 ADC). The clearance further advances the Company's IO2.0 + ADC2.0 strategy and expands its broad innovative oncology pipeline.

B7-H3 is highly expressed in a broad range of solid tumors, including non-small cell lung cancer, small cell lung cancer, prostate cancer, esophageal cancer, nasopharyngeal carcinoma, colorectal cancer, breast cancer, and glioblastoma, with limited expression in normal tissues. This profile supports its potential as a broad-spectrum antitumor target.

AK157D1 was developed entirely in-house and incorporates a proprietary design. In preclinical studies, it has shown potent antitumor activity together with a favorable safety profile. These attributes may help address certain limitations associated with existing ADCs, including hematologic toxicity and interstitial lung disease, and support its continued development as a potential ADC of choice in both mono or combination therapies.

Akeso is advancing its IO2.0 + ADC2.0 strategy, built on proprietary bispecific and multispecific antibody technology and centered on cornerstone IO2.0 assets including ivonescimab and cadonilimab. Through this approach, the company is elevating treatment standards for major cancers worldwide and building a broad oncology portfolio to create next-generation standard of care.

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 differentiated pipeline of next-generation candidates, including AK146D1 and AK138D1, which are already in clinical development, and AK157D1 and AK158D1 (a bispecific ADC), which are anticipated to enter the clinic shortly. These agents are designed to address the narrow therapeutic window and safety limitations commonly associated with first-generation ADCs.