HDM2005 / Huadong Medicine - LARVOL DELTA

A phase I study of HDM2005, a ROR1 targeted antibody-drug conjugate (ADC), in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or classical Hodgkin lymphoma(cHL) (ASH 2025) - P1 | "HDM2005 was well tolerated and had promising albeit preliminary anti-tumor activity in patients withrelapsed/refractory B-NHL or cHL. MTD not reached at dose of 2.75 mg/kg."

Clinical • P1 data • Alopecia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Solid Tumor • CD20 • ROR1

A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - P1/2 | N=97 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1/2 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Huadong Medicine Announces Positive Preliminary Results from a Phase Ⅰ study of HDM2005, a ROR1-Targeting ADC (PRNewswire) - "As of July 4, 2025, a total of 29 patients were enrolled (n=1, 4, 10, 11 and 3 in the 0.3, 1.0, 1.8. 2.5 and 2.75 mg/kg dose cohorts), including 17 patients with mantle cell lymphoma (MCL), 8 patients with diffuse large B-cell lymphoma (DLBCL), and 4 patients with cHL....In the 1.8 mg/kg and 2.5 mg/kg cohorts, the objective response rate (ORR) was 50% (6/12) in MCL patients, including 1 complete response (CR) and 5 partial responses (PR). The ORR was 100% (2/2) in cHL patients with CRs."

P1 data • Diffuse Large B Cell Lymphoma • Hodgkin Lymphoma • Mantle Cell Lymphoma

A Study of HDM2005 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial • Oncology • Solid Tumor

A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=111 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Metastases • New P1 trial • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Huadong Medicine (000963.SZ): Clinical trial application for injection of HDM2005 drug approved by the U.S. FDA [Google translation] (Sina Corp) - "Huadong Medicine...issued an announcement that recently, its wholly-owned subsidiary Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd...received a notice from the U.S. Food and Drug Administration...that the clinical trial application for the injectable drug HDM2005 submitted by Sino-US Huadong has been approved by the U.S. FDA and can conduct Phase I clinical trials in the United States....The approval of the clinical trial of HDM2005 for injection is an important milestone in the development of this product and will further enhance the company's core competitiveness in the field of ADC tumor treatment."

IND • New P1 trial • Oncology • Solid Tumor

Huadong Medicine's Class 1 biological new drug HDM2005 for injection was approved by NMPA in China [Google translation] (Hithink RoyalFlush Information Network) - "Recently, Hangzhou Sino-US Huadong Medicine Co., Ltd...received the 'Notice of Approval for Drug Clinical Trial' approved and issued by the National Medical Products Administration (NMPA). The clinical trial application for HDM2005 for injection submitted by Sino-US Huadong was approved, and the indication is advanced malignant tumors."

New trial • Oncology • Solid Tumor