The Center for Drug Evaluation (CDE) website indicates that Beijing Pearl Biotechnology Co., Ltd’s APL-101/PLB1001 (breatinib), a small molecule kinase inhibitor targeting c-MET, is set for priority review for its use in treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition factor (MET) exon 14 skipping. This development highlights the potential of breathinib as a new treatment option for patients with this specific type of lung cancer.
Drug Background and Clinical Data
Breatinib, a highly selective c-Met inhibitor originated by Crown Bioscience, is now being co-developed by Crown Bioscience’s spin-off CBT Pharmaceuticals (now named Apollomics Inc.) and Pearl Bio. A Phase I clinical study has shown that the drug is well-tolerated and preliminarily able to penetrate the blood-brain barrier in patients, suggesting its potential efficacy in treating brain metastases.
Market Landscape and Competitors
HutchMed’s Orpathys (savolitinib) was China’s first MET inhibitor to be approved, receiving regulatory approval in June last year for treating NSCLC with MET exon 14 skipping alterations following chemotherapy. Multiple c-Met inhibitors are under development in China, including HaiHe Bio’s glumetinib, Betta Pharma’s MCLA-129, a licensed bispecific antibody targeting EGFR and c-MET, Hansoh Pharma’s HS-10241, Hengrui Medicine’s SHR-A1403, a c-MET antibody drug conjugate (ADC), and Henlius’s HLX55. Glumetinib was awarded priority review status in February this year in China, where Merck’s tepotinib is awaiting regulatory decisions after a market filing in March.-Fineline Info & Tech
