공시 • Dec 02
Burning Rock Biotech Limited, Annual General Meeting, Dec 23, 2025 Burning Rock Biotech Limited, Annual General Meeting, Dec 23, 2025, at 10:30 China Standard Time. Location: 6/f, building 10c, pujiang smart plaza, no. 2168 chenhang highway, minhang district, shanghai China 공시 • Sep 24
Riken Genesis Co., Ltd. Announces OncoGuide OncoScreen Plus CDx System Now Approved in Japan as A Companion Diagnostic for Capivasertib in Breast Cancer Riken Genesis Co., Ltd. and Riken Genesis Co., Ltd. announced that the OncoGuide OncoScreen Plus CDx System based on OncoScreen™? Plus to be used as a companion diagnostic for AstraZeneca's capivasertib has received Manufacturing and Marketing Approval from Japan's Ministry of Health, Labour and Welfare (MHLW). The CDx System is a combination medical device consisting of the OncoGuide™? OncoScreen™? Plus CDx Kit and the OncoGuide™? oncoScreen™? Plus CD x Analysis Program, designed to be used with a next-generation sequencer. It enables the detection of PIK3CA, AKT1, and PTEN alterations in a single test. This diagnostic tool is intended to guide treatment decisions for adult patients with unresectable or recurrent hormone-receptor (HR)-positive, HER2-negative breast cancer who have progressed following endocrine therapy and whose tumors carry one or more PIK3CA, AK T1, or PTEN gene alterations. The approval of this CDx system supports the use for patient selection for capivasertib in combination with fulfilrant. With the introduction of this CDx System into clinical practice, access to precision diagnostics for breast cancer patients in Japan is expected to improve, ultimately expanding therapeutic opportunities. Riken Genesis will begin preparations for insurance coverage, aiming to ensure timely and equitable access for all eligible patients. 공시 • Dec 04
Burning Rock Biotech Limited, Annual General Meeting, Dec 31, 2024 Burning Rock Biotech Limited, Annual General Meeting, Dec 31, 2024, at 10:00 China Standard Time. Location: 6/f, building 10c, pujiang smart plaza, no. 2168 chenhang highway, minhang district, shanghai China 공시 • Oct 11
NMPA Approves Burning Rock and Dizal's First Co-Developed NGS-Based Companion Diagnostic for Lung Cancer in China Burning Rock Biotech Limited 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. Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval was based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The primary endpoint of the study was the confirmed objective response rate (cORR) as assessed by the Independent Review Committee (IRC) reached 61%. Anti-tumor efficacy was observed across a broad range of EGFR exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins. Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable. Two global pivotal studies are ongoing in = second-line (WU-KONG1 Part B) and first-line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins. Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery (IF:39.397) and The Lancet Respiratory Medicine (IF: 76.2). On March 11, 2022, the National Medical Products Administration (NMPA) officially approved the registration of the company's Human Nine-Gene Mutation Joint Detection Kit (reversible termination sequencing) (commercially known as "LungCure CDx") as a Class III medical device product. This test kit is Burning Rock’s second NMPA-approved companion diagnostic multi-gene tumor mutation co-detection test kit based on high-throughput sequencing technology and meeting companion diagnostic standards. It can be used for in vitro detection of multiple mutation statuses of EGFR, MET, ERBB2, KRAS, BRAF, PIK3CA, ALK, ROS1, and RET genes in non-small cell lung cancer patients, including point mutations, insertions/deletions, fusions (rearrangements), amplifications, etc., to comprehensively guide targeted therapy for non-small cell lung cancer. "LungCure CDx" has undergone rigorous clinical validation, enhancing the detection capability of rare mutation types. At the same time, "LungCure CDx" has entered into companion diagnostics development strategic partnerships with several well-known domestic and international pharmaceutical companies to jointly promote the development of standardized and precise diagnosis and treatment in oncology. 공시 • Aug 19
Burning Rock Biotech Announces Expected Delisting of American Depositary Shares Burning Rock Biotech Limited announces that, on August 19, 2024, it intends to submit requests (a) to the London Stock Exchange (the "LSE"), to cancel the admission to trading on the Main Market of its American Depositary Shares representing the class A ordinary shares of the Company (the "ADSs"), and (b) to the UK Financial Conduct Authority, to cancel the listing of the ADSs on the Official List. As a result of sustained low volume of trading and liquidity in the ADSs on the LSE, and taking into account the costs associated with maintaining such listing in place, the Company is seeking the delisting and cancellation of admission to trading of the ADSs from the LSE. It is anticipated that the Delisting will take effect on or about September 18, 2024. Following the Delisting, the ADSs will continue to trade on the Nasdaq Global Market. 