China's Baili Tianheng BL-M12D1 Clinical Trial for Hematologic Malignancies Approved
en.Wedoany.com Reported - On September 27, Sichuan Baili Tianheng Pharmaceutical Co., Ltd. announced that the company recently received the official "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration, approving the clinical trial of its independently developed innovative biologic drug BL-M12D1 for injection, intended for relapsed or refractory hematologic malignancies. This product had previously entered the drug review and approval process in July of this year, with acceptance number CXSL2600763.
BL-M12D1 belongs to Baili Tianheng's independently developed antibody-drug conjugate (ADC) pipeline. The company's early research and development materials had already listed this product under the hematologic tumor direction. After preclinical studies, the IND application was completed and clinical trial authorization was obtained this year, marking the project's official advancement from the preclinical stage to clinical development.
Baili Tianheng has currently established multiple ADC clinical development pipelines, covering solid tumors and hematologic malignancies. Among them, BL-M11D1 is positioned for acute myeloid leukemia, and BL-M08D1 has entered clinical studies related to relapsed or refractory hematologic malignancies; with the approval of BL-M12D1, the company's clinical pipeline of ADC for hematologic tumors has further expanded.
The company has not yet publicly disclosed the specific target, linker and toxin structure, clinical trial phase, or time of first patient dosing for BL-M12D1. Subsequent projects will be conducted in accordance with the clinical trial protocol to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy, and further development will be advanced based on clinical data.
