Burning Rock Biotech Breast Cancer NGS CDx Kit Enters CMDE Priority Review Channel

Reuters01-26

<a href="https://laohu8.com/S/BNR">Burning Rock Biotech</a> Breast Cancer NGS CDx Kit Enters CMDE Priority Review Channel

Burning Rock Biotech Ltd. announced that its self-developed "OncoScreen® BCMatch Tissue Kit," a breast cancer NGS companion diagnostic (CDx) kit, has entered the Priority Review Channel of the Center for Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA) in China. This development marks the first breast cancer NGS CDx kit in China to enter the priority review process, which is expected to accelerate its domestic approval. The company highlighted previous regulatory milestones, including the approval of the Capivasertib CDx module by Japan's Ministry of Health, Labour and Welfare (MHLW) and the approval of the Sunvozertinib CDx kit by the NMPA for lung cancer, achieved through partnerships with AstraZeneca and Dizal Pharma, respectively.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Burning Rock Biotech Ltd. published the original content used to generate this news brief on January 26, 2026, and is solely responsible for the information contained therein.

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This development marks the first breast cancer NGS CDx kit in China to enter the priority review process, which is expected to accelerate its domestic approval. The company highlighted previous regulatory milestones, including the approval of the Capivasertib CDx module by Japan's Ministry of Health, Labour and Welfare (MHLW) and the approval of the Sunvozertinib CDx kit by the NMPA for lung cancer, achieved through partnerships with AstraZeneca and Dizal Pharma, respectively.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. 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This development marks the first breast cancer NGS CDx kit in China to enter the priority review process, which is expected to accelerate its domestic approval. The company highlighted previous regulatory milestones, including the approval of the Capivasertib CDx module by Japan's Ministry of Health, Labour and Welfare (MHLW) and the approval of the Sunvozertinib CDx kit by the NMPA for lung cancer, achieved through partnerships with AstraZeneca and Dizal Pharma, respectively.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. 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