The Center for Drug Evaluation (CDE) website indicates that China-based Hainan Yuekang Biological Medicine Co., Ltd’s YK-029A, a biosimilar of Tagrisso (osimertinib), is set to gain Breakthrough Therapy Designation (BTD) status for use in advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations (EGFR ex20ins).
YK-029A, an oral irreversible third-generation EGFR-TKI, is currently undergoing a clinical study in China for advanced NSCLC patients with acquired drug resistance and disease progression due to T790M mutation after previous EGFR-TKI therapy.
Competitive Landscape
Meanwhile, other drugs such as furmonertinib, CLN-081, DZD9008, JMT101, and TQ-B3395 are also in development in China for EGFR ex20ins advanced NSCLC. Notably, mobocertinib, amivantamab, furmonertinib, and DZD9008 have all obtained BTDs for this indication.-Fineline Info & Tech
