Huadong Medicine’s CDH17-Targeting ADC HDM2017 gets FDA IND nod

On September 19, 2025, Huadong Medicine announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, has received notification from the U.S. FDA that the Investigational New Drug (IND) application for HDM2017 for Injection has been cleared to initiate a Phase I clinical trial in the United States for the treatment of advanced malignant solid tumors.

HDM2017 for Injection is a Class 1 innovative biologic drug, independently developed and globally owned by Zhongmei Huadong Pharmaceutical. It is a novel antibody-drug conjugate (ADC) targeting Cadherin 17 (CDH17, also known as LI-cadherin). The ADC is composed of an anti-CDH17 monoclonal antibody conjugated to a topoisomerase I inhibitor payload via a cleavable linker, with a drug-to-antibody ratio (DAR) of 4.

CDH17 is a non-classical member of the Cadherin superfamily of calcium-dependent proteins. It functions as a calcium-dependent cell adhesion transmembrane glycoprotein responsible for maintaining tissue integrity and morphogenesis. In normal tissues, CDH17 expression is confined to the basolateral membrane of intestinal epithelial cells. However, it demonstrates significant overexpression in gastrointestinal malignancies such as colorectal cancer, gastric cancer, and pancreatic cancer. This aberrant high expression is closely associated with tumor invasion, metastasis, and poor prognosis, making CDH17 an ideal target for targeted therapeutics.

HDM2017 specifically recognizes the CDH17-positive tumor surface antigen via the targeting action of its antibody. Following this binding, the ADC is internalized into the tumor cell through antigen-mediated endocytosis. Inside the cell, the cleavable linker is severed, releasing the potent cytotoxic payload to exert its anti-tumor effect. Additionally, HDM2017 demonstrates a bystander effect, which further enhances its tumor-killing efficacy. Preclinical studies have indicated that HDM2017 possesses favorable drug-like properties, along with a promising safety and efficacy profile. It has demonstrated potent anti-tumor activity in CDH17-positive pharmacodynamic models, including colorectal, pancreatic, and gastric cancers. The candidate was also well-tolerated in animal studies.

In August 2025, Zhongmei Huadong submitted the Investigational New Drug (IND) application for HDM2017 for Injection to the U.S. FDA, and recently received clearance from the agency. Additionally, the company had already submitted the IND application for this product to China's National Medical Products Administration (NMPA) in July 2025, which has been accepted for review. The proposed indication for both applications is advanced malignant solid tumors.

The U.S. FDA clearance of the IND application for HDM2017 for Injection represents a significant milestone in the product's development journey and will further enhance the company's competitive edge in the field of ADC-based oncology therapeutics. With a strategic focus on ADCs within its oncology pipeline, Huadong Medicine has established a unique global ADC R&D ecosystem, continuously strengthening its product portfolio. Moving forward, leveraging its world-class in-house R&D and industrial platform in the ADC domain, the company remains committed to developing differentiated innovative ADC drugs to provide better and more advanced treatment options for cancer patients.

Source: Huadong Medicine