Sichuan Biokin Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange as (SHA: 688506), has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its antibody-drug conjugate (ADC), BL-M11D1. This therapy targets CD33 and is aimed at patients with recurrent or refractory acute myeloid leukemia (AML).
Biokin Pharma has previously been granted clinical trial approvals in the US for a suite of innovative therapies, including the EGFR/HER3 bispecific ADC, BL-B01D1, the HER2-targeted ADC, BL-M07D1, the EGFR/HER3 bispecific antibody, SI-B001, and another ADC, BL-M05D1. These approvals underscore the company’s commitment to advancing novel treatments in oncology and highlight its focus on addressing unmet medical needs.
The initiation of the Phase I study for BL-M11D1 represents a significant step forward in the development of this potential treatment for AML, a disease with limited therapeutic options. The FDA’s green light for this trial is a testament to Biokin Pharma’s robust pipeline and its potential to impact the global landscape of cancer treatments.- Flcube.com
