InnoCare Pharma (HKG: 9969; SHA: 688428), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its B-cell lymphoma-2 (BCL2) inhibitor, ICP-248. The drug is set to enter a Phase I trial to assess safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with various hematologic malignancies.
ICP-248, developed in-house by InnoCare, is a novel, orally bioavailable, and selective BCL-2 inhibitor. It marks the fifth drug from the company’s pipeline to advance into clinical trials in the United States. BCL2 is a key regulatory protein in the apoptosis pathway, and its abnormal expression is associated with a range of hematological malignancies. The first-in-class BCL2 inhibitor to enter the market was AbbVie/Roche’s Venclexta (venetoclax), which was introduced to the China market in 2021. Other Chinese companies also developing BCL2 inhibitors include Ascentage Pharma with lisaftoclax, BeiGene with sonrotoclax, and Fochon Pharmaceuticals Ltd.- Flcube.com
