COMPANY:

Burning Rock Biotech

"Burning Rock Biotech Limited...today reported financial results for the three months ended September 30, 2024...Total revenues were RMB128.6 million (US$18.3 million) for the three months ended September 30, 2024, representing a 0.8% increase from RMB127.6 million for the same period in 2023, the increased revenue of in-hospital business was offset by the decrease of central-lab business, as we transition from central-lab to more in-hospital based testing."

"Burning Rock Biotech Limited...today announced that it will hold its annual general meeting (“AGM”) on December 31, 2024 at 10:00 a.m. (local time) at the Company’s Shanghai office at 6/F, Building 10C, Pujiang Smart Plaza, No. 2168 Chenhang Highway, Minhang District, Shanghai. "

"Burning Rock Biotech Limited...and Dizal...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."

"Burning Rock Biotech Limited...has recently announced a collaboration with Bayer to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx), aiming to provide diagnostic methods, to enable treatment choice for patients with cancer in China, while driving innovation and development in cancer therapy. This collaboration will focus on the development of companion diagnostic products in China, jointly developing NGS-based CDx for Bayer's growing portfolio of precision cancer therapies."

"Burning Rock Biotech Limited...is pleased to announce that the Company and Boehringer Ingelheim officially have signed the Master Service Agreement (MSA) in the field of oncology companion diagnostics. This agreement aims to provide Chinese patients with safer, more efficient, and precise treatment options and diagnostic methods, thereby promoting innovation and development in cancer treatment. This partnership will primarily focus on advancing the clinical trials related to Boehringer Ingelheim's MDM2-p53 antagonist, brigimadlin (BI 907828), and the development of companion diagnostic products in China."

"Burning Rock Biotech Limited...is pleased to announce that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National Medical Products Administration(NMPA), which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA."

"Burning Rock Biotech Limited...is delighted to announce that our personalized Minimal Residual Disease (MRD) product, CanCatch® (PROPHETTM panel), was enrolled in a prospective observational study (MEDAL, MEthylation based Dynamic Analysis for Lung cancer, NCT03634826)...In MEDAL-PROPHET study, the CanCatch® demonstrated superior performance in head-to-head comparisons with tumor-agnostic fixed-panel and tumor-informed fixed-panel MRD assays."

"Burning Rock Biotech Limited...is pleased to announce that our flagship comprehensive genomic profiling (CGP) product, OncoScreen Plus, was featured in a phase 3 multi-regional clinical trial (MRCT), along with FoundationOneCDx, in support of advancement in breast cancer treatment...In the study, Burning Rock's flagship comprehensive genomic profiling (CGP) product, OncoScreen Plus, was used to determine activating mutations in PIK3CA and AKT1 and inactivating alterations in PTEN genes for patients enrolled in China."

"Burning Rock...announced that its OverC™ Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally...OverC™ MCDBT is intended for early detection of multiple cancer types (esophageal, liver, lung, ovarian, and pancreatic cancers) in adults of either sex, aged 50-75 years old, at average risk for cancer."

"Chinese precision oncology firm Burning Rock Biotech and sequencing technology company MGI Tech have partnered to develop precision oncology services and products, the firms said earlier this month..Under the collaboration agreement, Burning Rock will leverage MGI's DNBSeq high-throughput sequencers, including the MGISeq-2000 and DNBSeq-T7, to provide commercial services and develop in vitro diagnostic products, while MGI will offer technical support and services, the companies said."

"Burning Rock Biotech Limited...announced the launch of the PREVENT (a Prospective multi-canceR Early-detection and interVENTional) study, China’s first prospective interventional study to evaluate the performance of Burning Rock's early cancer detection test, OverC™, in the asymptomatic population. The study is expected to enroll 12,500 asymptomatic individuals, to evaluate the performance of the OverC™ test in detecting 6 cancers (lung, liver, colorectal, esophageal, pancreatic and ovarian cancers)."

"Burning Rock Biotech Limited...announced that it has received CE marking for its OverC™ Multi-Cancer Detection Blood Test manufactured in both the US and China facilities...The approval of CE mark for the OverC™ test is of much significance for the commercialization and compliance process of Burning Rock's multi-cancer early detection technology and marks a breakthrough in the company's global business strategy."