Core Viewpoint - The approval of the clinical trial for HDM2005 marks a significant advancement in the company's drug development process, enhancing its core competitiveness in the oncology treatment sector [1] Group 1: Clinical Trial Approval - The company's wholly-owned subsidiary, Hangzhou Sino-American East Pharmaceutical Co., Ltd., received the clinical trial approval notice from the National Medical Products Administration for HDM2005 [1] - HDM2005 is an antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), used in combination with rituximab, cyclophosphamide, doxorubicin (or epirubicin), and prednisone (R-CHP) for treating previously untreated diffuse large B-cell lymphoma (DLBCL) [1] Group 2: Clinical Trial Progress - The drug has received approval for clinical trials in both China and the United States, with indications for advanced malignancies [1] - Currently, the drug is in the I phase of clinical trials in China, having completed the first four dose escalations without any dose-limiting toxicities (DLT), and is now in the fifth dose escalation stage [1] Group 3: Regulatory Milestones - In February 2025, HDM2005 received orphan drug designation from the FDA for the indication of mantle cell lymphoma (MCL) [1] - The approval of this clinical trial is a crucial step in the product's development, which is expected to strengthen the company's position in the oncology market [1]