October 9, 2024 – Xadcera Biopharmaceutical (Suzhou) Co., Ltd., a subsidiary of Doma, announced that its self-developed Class 1 innovative drug, DM001 (EGFR/TROP2 bispecific antibody-drug conjugate [ADC] for injection), has received the Clinical Trial Approval Notice (2024LP02269) from Chinese regulatory authorities.

DM001 employs a dual-targeting strategy against tumor-associated antigens, specifically targeting the epidermal growth factor receptor (EGFR) and trophoblast cell surface antigen 2 (TROP2). Preclinical studies demonstrated DM001's potent antitumor activity and favorable safety profile. Earlier this year, on July 4, DM001 secured Investigational New Drug (IND) approval from the U.S. FDA. The drug is currently undergoing Phase I clinical trials in the United States and Australia, enrolling patients with solid tumors including breast cancer, EGFR wild-type and mutant non-small cell lung cancer (NSCLC), esophageal cancer, gastric cancer, and colorectal cancer.