Huadong Medicine Co., Ltd. has announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received a Drug Clinical Trial Approval Notice issued by the National Medical Products Administration on June 24, 2026. The clinical trial application for the injection HDM2017 submitted by the subsidiary has been approved.
The announcement indicates that HDM2017 specifically targets and binds to the CDH17-positive antigen expressed on the surface of tumor cells through its antibody component. This antigen-mediated internalization allows the antibody-drug conjugate (ADC) to enter the tumor cell, where the linker is cleaved, releasing the cytotoxic payload intracellularly to exert its anti-tumor effect. Additionally, the bystander effect of HDM2017 further enhances its tumor-killing efficacy.
Preclinical study results demonstrate that HDM2017 possesses favorable drug-like properties, safety, and effectiveness. The compound has shown potent anti-tumor activity in efficacy models for CDH17-positive cancers, including colorectal cancer, pancreatic cancer, and gastric cancer. It was also well-tolerated in animal studies.
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