China-based 4B Technologies Investments Ltd has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its potential first-in-class monoclonal antibody (mAb) FB1001 (ZG103). This marks a significant milestone in the development of the drug candidate, which was developed by the company’s founder, Dr. Lu Bai.
Mechanism of Action and Preclinical Results
FB1001 is a Category 1 drug candidate that plays a neuroprotective and reparative role by specifically activating the downstream signaling pathway of the TrkB receptor. Preclinical studies have demonstrated that intravitreal injection of FB1001 has a clear protective and repair effect on the optic nerve, along with reliable safety. This unique mechanism of action positions FB1001 as a promising candidate for treating conditions related to optic nerve damage.
Advancing Neuroprotective Therapies
The approval to proceed with clinical trials is a crucial step in bringing FB1001 closer to potential commercialization. This development underscores 4B Technologies’ commitment to advancing innovative neuroprotective therapies and addressing unmet medical needs in the field of ophthalmology.-Fineline Info & Tech
