Dizal Pharmaceutical Co., Ltd (SHA: 688192) and Burning Rock Ltd (NASDAQ: BNR, FRA: 6BU0) have announced a significant regulatory milestone in China’s precision medicine space. Their jointly developed companion diagnostic (CDx) for epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), designed to pair with the targeted therapy sunvozertinib, has received the green light from China’s National Medical Products Administration (NMPA). This marks the first NGS-based CDx for lung cancer to gain NMPA approval since the release of the CDx guideline in China, underscoring a new chapter in non-small cell lung cancer (NSCLC) treatment.
The approval is a testament to the synergistic development of Dizal’s innovative EGFR exon20ins targeted therapy, sunvozertinib, and Burning Rock’s proprietary LungCure CDx, which detects a combination of 9 human gene mutations associated with NSCLC. This dual development approach provides a cutting-edge precision treatment solution for NSCLC patients harboring the EGFR exon20ins mutation.
Sunvozertinib, noted for its irreversible inhibition of EGFR with selectivity for wild-type EGFR, received its initial marketing approval in China in August 2023. The therapy targets a broad spectrum of EGFR mutations, offering new hope for patients with EGFR exon20ins mutations, a group that often exhibits reduced responsiveness to conventional tyrosine kinase inhibitors (TKIs).
This regulatory approval not only signifies a victory for Dizal and Burning Rock but also represents a stride forward in personalized medicine for NSCLC in China, highlighting the potential of targeted therapies in improving patient outcomes. – Flcube.com
