East China Medicine: Injection HDM2005 clinical trial approved

East China Pharmaceutical announced that its wholly-owned subsidiary Hangzhou Sino-American East China Pharmaceutical Co., Ltd. has received the "Notice of Approval for Drug Clinical Trial" issued by the National Medical Products Administration. The clinical trial application for injectable HDM2005, submitted by Sino-American East China, has been approved. Injectable HDM2005 is a monoclonal antibody drug conjugate targeting receptor tyrosine kinase-like orphan receptor 1, used in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone to treat diffuse large B-cell lymphoma that has not been previously treated systemically. The drug has been approved for clinical trials in China and the United States, with indications for late-stage malignant tumors. Currently in Phase I clinical trials in China, the first four dose escalations have been completed without DLT, entering the fifth dose escalation stage and the expansion stage of the fourth dose group. In February 2025, the indication of HDM2005 for T-cell lymphoma obtained orphan drug status recognition from the FDA. The approval of this clinical trial is an important advancement in the product's R&D process, enhancing the company's core competitiveness in the field of oncology treatment.