Burning Rock Biotech Limited
BNR US Equity MSCI China index constituent since May 2021
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Our value-building blocks
Extending leadership of NGS-based precision oncology from late-stage patients to earlier stages, driving the next phase of growth
New Business
Large market potential
At pipeline or early commercial stage
Common
Infrastructure
Accelerating growth of
new business
Base Business
Commercial stage
Early Detection | MRD | Biopharma |
Asymptomatic population | Early-stage oncology | Global CDx partner for |
patients | pivotal trials of targeted | |
drugs. Pharma R&D |
- Strong brand to support new product launches & attract talent
- Broad industry network and synergy across different business units
- Large volumes supporting lower cost & faster innovation
Therapy Selection
Late-stage oncology patients
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Summary of recent progress
Early detection
MRD
Therapy selection
Biopharma
Notes:
2022 commercialization on track
- Technology foundation manuscript published on Nature Biomedical Engineering1
- Early access program ongoing (over 2,000 volunteers tested) to prepare for operational readiness
- Good commercial traction, with 6 hospitals entering contracting stage
Product development on track for 2022 launch
- Lung-cancerdata read-out in 1H2022
- Colon, esophageal and other cancer-types / trials under planning
40% volume growth in 2Q21
- Continued execution of our strategic focus on in-hospital.In-hospital kit volumes grew by 70% YoY in 2Q21 to over 10,000 tests
Strong growth, international expansion
- Fast growing backlog. New contract value reached RMB98m during 1H21, 3x vs. 2020 full-year
- CDx development2 under the FDA pathway, using our CLIA-certified and CAP-accredited lab in California. Live pharma CDx project at our California lab started in 2Q21
4
- "Ultrasensitive detection of circulating tumour DNA via deep methylation sequencing aided by machine learning", Nature Biomedical Engineering, Apr 2021
2 Companion diagnostics development for a drug's pivotal clinical study
Pharma collaboration - our first step of global expansion
Newly contracted pharma projects
Coming off a small base, but building rapidly
RMBm 150
100 | 98 |
50
32
0
2020 full year | 1H 2021 |
New, strong demand
- New rules for CDx1 requirement from NMPA
- Innovative Chinese pharma going global
- MNCs seeking reliable global NGS CDx partners that can operate in China
Burning Rock advantages
- CLIA-certifiedand CAP-accredited labs in Guangzhou and California
- Global registration capability, with NMPA and FDA experience. Recent addition of Dr. Sharon Liang as VP of Regulatory Affairs (US and Europe) and Quality Assurance with extensive FDA experience2
- Comprehensive product line covering tissue and liquid modalities, with strong product performance
Notes | ||
1 | Companion diagnostics, associated with a targeted drug's pivotal study and regulatory approval | |
2 | Dr. Sharon Liang is a human genetics expert with nearly two decades of experience in molecular cancer diagnostic medical device product development and regulatory in academia, government and industry. | 5 |
She was the US FDA committee member for the US President's Precision Medicine Initiative (PMI) Project, leading Bioinformatics group. She led and contributed to the development of many molecular |
diagnostic devices approved by the FDA, including the first NGS sequencer, first NGS Oncopanel, first NGS tumor profiling assay, first Direct-to-Consumer test, first microarray genetic tests, and companion diagnostics. Before joining Burning Rock, Dr. Liang worked at GRAIL, a cancer early detection diagnostic company, primarily responsible for regulatory strategy and execution
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Burning Rock Biotech Ltd. published this content on 31 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 31 August 2021 07:51:02 UTC.