Huadong Medicine's HDM2005 Shows Promising Results in Phase I Clinical Trials for Lymphomas

Huadong Medicine's Advancements in Cancer Treatment

Huadong Medicine Co., Ltd., a leading player in the pharmaceutical industry, recently announced promising preliminary results from a Phase I clinical trial of HDM2005, their innovative antibody-drug conjugate (ADC) designed to target ROR1, a protein implicated in various cancers, including relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) and classical Hodgkin lymphoma (cHL). This announcement marks a significant milestone for Huadong Medicine, as HDM2005 shows potential to change the landscape of treatment options available to patients.

Background on HDM2005

HDM2005 is a Class 1 biologic drug developed entirely within China, specifically targeting the receptor tyrosine kinase-like orphan receptor 1 (ROR1). This transmembrane protein is crucial in cancer development, especially in certain lymphomas. HDM2005 consists of a humanized IgG1 monoclonal antibody, a linker that is cleaved by proteolytic enzymes, and monomethyl auristatin E (MMAE), a cytotoxic component designed to eliminate cancer cells effectively.

The clinical journey for this drug began when trials were approved by the National Medical Products Administration (NMPA) in June 2024, as well as by the U.S. Food and Drug Administration (FDA) shortly thereafter, advocating for its use in advanced malignancies.

Results from the Phase I Study

The Phase I study (NCT06615193), which began enrolling patients in July 2025, aimed at assessing the safety, tolerability, and initial efficacy of HDM2005. As of July 4, 2025, 29 patients suffering from relapsed or refractory B-NHL or cHL participated in the trial—many of whom had previously undergone three or more lines of anti-tumor therapies.

The results were encouraging: no patient permanently ceased treatment due to treatment-related adverse events (TRAEs). In fact, only 38.1% experienced Grade ≥3 TRAEs, with the most common being a decrease in neutrophil count. Notably, no severe gastrointestinal side effects or significant peripheral neuropathy were reported.

Patients in the cohorts receiving dosages of 1.8 mg/kg and 2.5 mg/kg experienced an objective response rate (ORR) of 50% among MCL patients. Furthermore, an impressive 100% ORR was observed in cHL patients, highlighting HDM2005's effectiveness in target demographics.

Future Directions and Commitment to Patients

Given these promising preliminary results, Huadong Medicine is steadfast in its commitment to advancing the clinical development of HDM2005. The company emphasizes its mission of a