NMPA Approves First NGS-Based EGFR Exon20ins CDx for Lung Cancer

Burning Rock Biotech Limited (NASDAQ: BNR), a leading precision oncology company, and Dizal, a global biopharmaceutical firm focused on cancer and immunological diseases, have announced that their co-developed companion diagnostic (CDx) for EGFR exon 20 insertion mutations (exon20ins) has been approved by China's National Medical Products Administration (NMPA). This is the first NGS-based CDx for lung cancer to receive NMPA approval since the introduction of CDx guidelines in China. The approval combines Burning Rock's LungCure CDx test, which detects nine gene mutations, with Dizal's EGFR exon20ins-targeted therapy, sunvozertinib, offering a new precision treatment solution for non-small cell lung cancer patients with exon20ins mutations.

Burning Rock's CEO, Yusheng Han, expressed excitement over the successful collaboration with Dizal, emphasizing its significance in setting a high-quality benchmark for the development of companion diagnostics for cancer drugs. He highlighted Burning Rock's strategic focus on advancing companion diagnostics globally, enhancing cancer treatment options for Chinese patients.

Dizal’s CEO, Dr. Xiaolin Zhang, credited the achievement to the innovative teamwork between both companies, reiterating Dizal’s commitment to discovering groundbreaking therapies and advancing precision medicine to benefit more patients.