Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct two clinical studies. One study will investigate the combination of its drug candidate BL-B01D1 with osimertinib (Tagrisso) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations. The other study is for BL-M11D1, an antibody-drug conjugate (ADC) targeting CD33, in the treatment of recurrent or refractory acute myeloid leukemia (AML).
BL-B01D1: An In-House Developed ADC Targeting EGFR and HER3
BL-B01D1, an in-house developed ADC by Sichuan Biokin, targets EGFR and HER3 and is currently subject to five Phase Ia/Ib clinical studies covering 16 solid tumors. This drug candidate shows potential for advancement to pivotal regulatory clinical trials in patients with NSCLC and end-line nasopharyngeal carcinoma. The company has filed for three single-arm Phase III regulatory studies and two single-arm pivotal studies. Additionally, the combination of BL-B01D1 and SI-B003 with or without chemotherapy has been approved for Phase II clinical trials.
BL-M11D1: An ADC Targeting CD33 for AML
The second clinical study approved by the NMPA involves BL-M11D1, an antibody-drug conjugate targeting CD33, which is being developed for the treatment of recurrent or refractory AML. This study marks a significant step forward in the development of novel therapies for patients with AML, a disease with limited treatment options.-Fineline Info & Tech
