China Capabilities

Experienced

Being a Pioneer means trial and error. Benefit from an experienced partner.

Relationship

we have a great working relationship with both the NMPA and HGR. This is critically important in China.

Scientific Soundness

The great scientific rationale is the basis of every successful trial.

Pioneers of the Chinese Market

Burning Rock is the NGS Market leader in China with a 27% overall market share. We received the first-ever NMPA approved CDx NGS oncology panel in 2018 and the project received the first ctDNA approval as well as the first TMB panel approval.

China’s commercial and regulatory environment has proven to be one of the most difficult regions in the world. We are seeing that the Chinese precision oncology market is growing exponentially and is projected to reach 40 B by 2030.

There is much confusion on the best strategy and best practices of how to commercialize a precision oncology therapeutic, how to run clinical trials, and assay reimbursement as well as legality.

It is also extremely difficult to get the required data, results, reports from patients in China, and Biosample export restrictions are extremely stringent.

Overall Coverage Network

600+

Cumulative Number of Referring Hospitals

350+

Sales Representatives

28%

Overall Market Share

In Hospital Channel

Integrate Genomic and Clinical Databases
Design Labs
#
Build-up NGS Platforms
#
Customize Lab SOPs and Reports
#
Train Hospital Staff

600+

Hospitals

80%

Market Share

We Can Help With

9
Overcoming challenges of running Clinical Trials in China and implications for global trials.
9
Data Sharing, HGRAC Approval, Changes to new CDx Indication.
9
Clinical Biomarker work, how to get your studies approved.
9
Regulatory approval (NMPA, HGRAC, NCCL).
9
Commercial launch, reimbursement, considerations for Day 1 assay availability.

Let Us Be Your Launchpad Into China

Burning Rock has a history of firsts in China and we are the NGS market leader

First IVD NGS

First NMPA (CFDA) approved IVD
NGS Panel (2018)

First Co-Development of CDx and Drug

Collaboration with Cstone Pharmaceuticals is the first case of Drug and CDx co-development in the history of NMPA

First Projected ctDNA & TMB Approval

First projected liquid biopsy panel
approval in China as well as the
first projected approval for TMB
(IO Biomarkers)

Study Proposal

Design Control

Pilot Manufacture

Product
Study

6-8 Months


  • R&D study proposal mainly includes raw material study, technological process, reaction setup, positive study, analytical pipeline, performance validation, stability, and data output
  • Establishment of R&D system and quality control system
  • Innovative device application
  • Technical Documentation

Registration Testing

Innovative Device Approval

Registration
Testing

Clinical Trial
Assay (CTA)

  • Material preparation and review
  • Classification (optional)
  • Confirmation of testing authority, sampling and testing;

Clinical Trial Assay

Clinical Trial
Assay (CTA)

8-12 Months


  • CTA study protocol preparation, Institute and investigator collaboration, IRB approval and CTA
  • CTA study protocol preparation, Institute and investigator collaboration, IRB approval and CTA
  • IVD testing in CTA: Accuracy; Sensitivity; Specificity Companion diagnostic validation
  • Registration document preparation and submission

QMS Inspection

Review and Supplement

Certificate Issue

Review &
Issue



  • Review report
  • Technical evaluation and supplements
  • Registration approval and certificate issue
  • Manufacture licence amendments
  • Change or renewal of registration (optional)