Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), an innovative company in the field of precision oncology, and Dizal, a global biopharmaceutical company focused on malignant tumors and immunological diseases, jointly announced that the companion diagnostic (CDx) for EGFR exon 20 insertion mutation (exon20ins) for sunvozertinib, developed through their collaboration, has been approved by the National Medical Products Administration (NMPA) of China.

This marks the first co-developed NGS-based CDx for lung cancer approved by NMPA since the release of the CDx guideline in China.

The approval of this CDx test is the result of the simultaneous development of Burning Rock's independently developed LungCure CDx (a kit for the combined detection of 9 human gene mutations) and Dizal's innovative EGFR exon20ins targeted therapy - sunvozertinib, providing an innovative precision treatment solution for non-small cell lung cancer patients with EGFR exon20ins.

Mr. Yusheng Han, Founder and CEO of Burning Rock stated: "We are thrilled to have carried out a deep companion diagnostic collaboration with the global biopharmaceutical company Dizal. This collaboration sets a standardized and high-quality benchmark for the concurrent development of companion diagnostics for anti-tumor drugs. Burning Rock is strategically positioned to drive companion diagnostic development on a global scale for pharmaceutical companies. By integrating our resources and experience in the field of oncology diagnosis and treatment, we are confident that we can offer more precise treatment options for Chinese cancer patients."

Dr. Xiaolin Zhang, Founder, Chairman, and CEO of Dizal stated: “This achievement can be attributed to the collaborative innovation of the professional teams from both sides and reflects our unremitting pursuit of creating clinical value for the benefit of patients. Precision therapy is one of the core strategies of Dizal. Dizal will continue to adhere to the discovery and development of groundbreaking new medicines, and work with our partners to bring new hope of precision treatment to more patients.”