Drugs received approval notice for Phase II/III clinical trials
February 20, 2025
Source: drugdu
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Baili Tianheng (688506) announced on the evening of February 18 that the company recently received the "Drug Clinical Trial Approval Notice" officially approved and issued by the National Medical Products Administration (NMPA), and the Phase II/III clinical trial of the company's independently developed innovative biological drug BL-M07D1 (HER2-ADC) for injection was approved. As of the disclosure date of this announcement, in addition to the newly approved clinical trial, BL-M07D1 is being evaluated as a single drug or in combination in 10 Phase I/II/III clinical trials in China and the United States. The various clinical studies include patients with various HER2-expressing/mutated solid tumors (including non-small cell lung cancer, breast cancer, urothelial carcinoma, gynecological tumors and digestive tract tumors).
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