Burning Rock and CStone Pharmaceuticals reached a strategic collaboration on the co-development of companion diagnostics for pralsetinib in China

On June 29, 2020, Burning Rock Biotech Limited (NASDAQ: BNR) announced a strategic partnership with CStone Pharmaceuticals (HKEX: 2616) to co-develop and commercialize companion diagnostics (CDx) for pralsetinib, an investigational treatment developed by CStone’s partner Blueprint Medicines, in China for the detection of RET alterations in cancer patients.

“In an era of rapid development of precision medicines, CDx is of great significance to accurately identify the patient populations who could benefit from specific therapies. Burning Rock will continue to develop CDx-related products based on advanced next generation sequencing (NGS) technology, and work with partners to promote the clinical application of precision diagnostics and treatment, potentially bringing clinical benefits to more patients,” said Dr. Hao Liu, Chief Medical Officer at Burning Rock. “CStone is an excellent company focusing on innovative immuno-oncology and precision medicine programs. CStone’s partner Blueprint Medicines released promising global data for pralsetinib this June at ASCO 2020. Burning Rock’s close cooperation with CStone is expected to promote the standardization of RET gene testing in China.”

“Precision medicine is one of the core strategies at CStone, and the importance of CDx is self-evident.Burning Rock is the first NASDAQ-listed, oncology-focused, leading NGS company in China. We are very happy to collaborate with this leading company to leverage our respective advantages in CDx development. I believe that CStone and Burning Rock will accelerate the development and commercialization of a CDx for pralsetinib under joint cooperation in China,” said Archie Tse MD, PhD, Chief Translational Medicine Officer at CStone.

Clinical data from the ongoing global ARROW trial of pralsetinib in RET fusion-positive non-small cell lung cancer (NSCLC) were announced at the American Society of Clinical Oncology (ASCO) Virtual Scientific Forum on May 30, 2020. The data included response-evaluable patient populations who received a starting dose of 400 mg once daily. Results showed that as of a data cutoff date of November 18, 2019, the overall response rate was 73 percent (95% CI: 52-88%) in 26 patients with no prior systemic therapy and 61 percent (95% CI: 50-72%) in 80 patientswho previously received platinum-based chemotherapy. Among 354 patients who received a starting dose of 400 mg once daily, pralsetinib was well-tolerated and most treatment-related adverse events were Grade 1 or 2. The results of this study support the broad potential of pralsetinib in RET fusion-positive NSCLC.

About Pralsetinib

Pralsetinib is an investigational, once-daily oral precision therapy specifically designed for highly potent and selective targeting of oncogenic RET alterations. Blueprint Medicines is developing pralsetinib for the treatment of patients with RET -altered NSCLC, thyroid cancer and other solid tumors.

In June 2018, Blueprint Medicines and CStone Pharmaceuticals announced an exclusive collaboration and license agreement for the development and commercialization of pralsetinib and certain other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for pralsetinib in the rest of the world.

About CStone

CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 15 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, 5 late-stage candidates are at pivotal trials. With an experienced team, a rich pipeline, a robust clinical development-driven business model and substantial funding, CStone’s vision is to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide.

For more information about CStone Pharmaceuticals, please visit:www.cstonepharma.com.

About Burning Rock
Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of 1) NGS-based therapy selection testing for late-stage cancer patients, 2) Global pharmaceutical services on biomarker detection and companion diagnostics developing, and 3) NGS-based cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.

For more information, please visit www.brbiotech.com

Safe Harbor Statement

This press release contains forward-looking statements. These statements constitute “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “target,” “confident” and similar statements. Burning Rock may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about Burning Rock’s beliefs and expectations, are forward-looking statements. Such statements are based upon management’s current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond Burning Rock’s control. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. All information provided in this press release is as of the date of this press release, and Burning Rock does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.