By Fineline Cube 
China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its TQB2101 antibody-drug conjugate (ADC). The trial will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of TQB2101 in patients with advanced malignant tumors.
Mechanism of Action
TQB2101 is an innovative ADC targeting ROR1, a transmembrane protein in the type I receptor tyrosine kinase family. ROR1 is highly expressed in various malignancies, including hematological cancers, lung cancer, pancreatic cancer, breast cancer, colon cancer, and ovarian cancer, while showing low expression in normal adult tissues. This selective expression makes ROR1 an attractive target for cancer therapy.
Preclinical Results
Preclinical studies demonstrated that TQB2101 exhibits robust anti-tumor activity across multiple ROR1-positive tumor models. The drug has shown promising efficacy and a favorable safety profile, supporting its potential as a novel treatment option for patients with advanced malignancies.
Clinical Trial Objectives
The Phase I study will focus on assessing the safety and tolerability of TQB2101, as well as its pharmacokinetic profile and preliminary efficacy in treating advanced solid tumors and hematological malignancies. This marks a significant step forward in the development of targeted therapies for cancers with high unmet medical needs.-Fineline Info & Tech