The Center for Drug Evaluation (CDE) website indicates that China-based Jacobio Pharmaceuticals Group Co., Ltd’s (HKG: 1167) KRAS G12C inhibitor JAB-21822 has received breakthrough therapy designation (BTD) status for its potential as a treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS p.G12C mutation. The drug is being developed for patients who have received at least one systemic treatment.
JAB-21822: Development and Clinical Trials
Discovered by Jacobio in-house, JAB-21822 is an innovative small-molecule anti-cancer drug viewed as a potential best-in-class KRAS G12C inhibitor. The molecule is already undergoing Phase I/II clinical studies in advanced solid tumors in China, the US, and Europe, including as a monotherapy in first-line NSCLC, or in combination with SHP2 inhibitor or cetuximab. The drug obtained the go-ahead for a pivotal Phase II clinical study in advanced or metastatic NSCLC with KRAS G12C mutation in September this year. The company will file a new drug application (NDA) if the study is successful.-Fineline Info & Tech