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Burning Rock's OncoGuide™ OncoScreen™ Plus CDx System Now Approved in Japan as a Companion Diagnostic for Capivasertib in Breast Cancer
Globenewswire· 2025-09-24 06:42
Core Viewpoint - Riken Genesis Co., Ltd. and Burning Rock Biotech Limited announced the approval of the OncoGuide™ OncoScreen™ Plus CDx System in Japan, which will serve as a companion diagnostic for AstraZeneca's capivasertib, enhancing precision diagnostics for breast cancer patients [1][4][5]. Group 1: Product Details - The OncoGuide™ OncoScreen™ Plus CDx System is a combination medical device that includes the OncoGuide™ OncoScreen™ Plus CDx Kit and the OncoGuide™ OncoScreen™ Plus CDx Analysis Program, designed for use with next-generation sequencing [3][8]. - This diagnostic tool detects PIK3CA, AKT1, and PTEN alterations in a single test, aimed at guiding treatment decisions for adult patients with unresectable or recurrent hormone-receptor-positive, HER2-negative breast cancer [3][4]. Group 2: Market Impact - The approval of the CDx system is expected to improve access to precision diagnostics for breast cancer patients in Japan, ultimately expanding therapeutic opportunities [4]. - Riken Genesis plans to prepare for insurance coverage to ensure timely and equitable access for all eligible patients [4]. Group 3: Company Insights - Burning Rock's CEO highlighted that the approval is a significant milestone in the company's global strategy, emphasizing the system's role in optimizing treatment plans and enhancing patient outcomes [5]. - Riken Genesis expressed commitment to delivering the innovative diagnostic tool to patients as quickly as possible, marking their first approval for a combination medical device product [5][9].
Burning Rock Reports Second Quarter 2025 Financial Results
GlobeNewswire· 2025-09-08 05:39
Core Viewpoint - Burning Rock Biotech Limited reported a 9.6% increase in total revenues for Q2 2025 compared to the same period in 2024, driven by growth in in-hospital and pharma research and development services, while central laboratory revenues declined. Financial Performance - Total revenues for Q2 2025 were RMB 148.5 million (US$ 20.7 million), up from RMB 135.5 million in Q2 2024 [2] - Cost of revenues increased slightly to RMB 40.5 million (US$ 5.6 million), a 0.9% rise from RMB 40.1 million in Q2 2024 [3] - Gross profit reached RMB 108.1 million (US$ 15.1 million), marking a 13.3% increase from RMB 95.4 million in Q2 2024, with a gross margin of 72.8% compared to 70.4% in the prior year [4] - Non-GAAP gross profit was RMB 110.5 million (US$ 15.4 million), an 8.4% increase from RMB 101.9 million in Q2 2024, with a non-GAAP gross margin of 74.4% [5] Operating Expenses - Operating expenses significantly decreased by 42.1% to RMB 119.6 million (US$ 16.7 million) from RMB 206.7 million in Q2 2024, attributed to budget control and headcount reduction [6] - Research and development expenses fell by 23.4% to RMB 49.8 million (US$ 6.9 million) from RMB 65.0 million in Q2 2024 [8] - Selling and marketing expenses decreased by 21.5% to RMB 38.4 million (US$ 5.4 million) from RMB 48.9 million in Q2 2024 [8] - General and administrative expenses dropped by 66.1% to RMB 31.4 million (US$ 4.4 million) from RMB 92.8 million in Q2 2024 [9] Revenue Breakdown - Revenue from in-hospital business increased by 4.4% to RMB 62.5 million (US$ 8.7 million) from RMB 59.9 million in Q2 2024 [7] - Revenue from central laboratory business decreased by 16.2% to RMB 40.9 million (US$ 5.7 million) from RMB 48.8 million in Q2 2024 [7] - Revenue from pharma research and development services surged by 68.1% to RMB 45.2 million (US$ 6.3 million) from RMB 26.9 million in Q2 2024 [7] Net Loss and Cash Position - The net loss for Q2 2025 was RMB 9.7 million (US$ 1.4 million), a significant reduction from RMB 108.0 million in Q2 2024 [9] - As of June 30, 2025, cash, cash equivalents, and restricted cash totaled RMB 455.0 million (US$ 63.5 million) [9]
燃石医学上涨2.53%,报9.535美元/股,总市值1.03亿美元
Jin Rong Jie· 2025-08-21 17:33
Core Insights - The stock price of Burning Stone Medical (BNR) increased by 2.53% on August 22, reaching $9.535 per share, with a total market capitalization of $103 million [1] - As of March 31, 2025, the total revenue of Burning Stone Medical is projected to be 133 million RMB, reflecting a year-on-year growth of 5.94%, while the net profit attributable to the parent company is expected to be -13.5 million RMB, showing a significant year-on-year increase of 88.89% [1] Company Overview - Burning Stone Medical, established in 2014, focuses on providing clinically valuable next-generation sequencing (NGS) for precision oncology, with a mission to "guard the light of life with science" [2] - The company's business and research directions primarily cover: 1) detection of cancer patient populations, holding a leading market share in China; 2) collaboration with global anti-cancer pharmaceutical companies on biomarkers and companion diagnostics; 3) early detection of multiple cancer types [2] - In July 2018, the company received the first certification for NGS testing kits for cancer from the National Medical Products Administration (NMPA) in China, marking a milestone in the field of in vitro diagnostics [2] - The laboratory located in Guangzhou, China, has passed the technical review by the Guangdong Provincial Clinical Testing Center and has obtained quality system certifications from CLIA and CAP in the United States; the laboratory in California has also received CLIA and CAP certifications [2] - The company is committed to developing innovative and reliable NGS testing products to advance the field of precision oncology [2]
燃石医学上涨9.35%,报11.121美元/股,总市值1.20亿美元
Jin Rong Jie· 2025-08-19 13:49
Core Viewpoint - BNR (Burning Stone Medical) shows a significant increase in stock price and positive financial growth, indicating a strong position in the precision oncology market [1][2]. Financial Performance - As of March 31, 2025, BNR reported total revenue of 133 million RMB, representing a year-on-year growth of 5.94% [1]. - The company recorded a net profit attributable to shareholders of -13.5 million RMB, which is an improvement with a year-on-year growth of 88.89% [1]. Major Events - BNR is scheduled to disclose its mid-year report for the fiscal year 2025 on August 28, with the actual date subject to company announcement [1]. Company Background - Founded in 2014, BNR focuses on providing clinically valuable next-generation sequencing (NGS) for precision oncology, with a mission to "guard the light of life with science" [1]. - The company has a leading market share in tumor patient testing in China and collaborates with global anti-tumor pharmaceutical companies on biomarkers and companion diagnostics [1]. - BNR has achieved significant milestones, including receiving the first NGS testing kit certification from the National Medical Products Administration (NMPA) in China in July 2018 [2]. - The laboratories in Guangzhou and California have obtained quality system certifications from CLIA and CAP, ensuring high standards in their testing processes [2].
8月19日早餐 | 重磅会议要求激发消费潜力、稳定房地产
Xuan Gu Bao· 2025-08-19 00:14
Market Overview - US stock market showed slight fluctuations ahead of the global central bank meeting, with the S&P 500 index down 0.01%, Dow Jones down 0.08%, and Nasdaq up 0.03% [1] - The Nasdaq Golden Dragon China Index rose by 0.12%, with notable gains in Chinese concept stocks such as Xunlei up over 37%, Burning Stone Medical up about 36%, and Huami Technology up over 28% [3] Company Performance - Meta Platforms saw a decline of over 2%, while Tesla rebounded by over 1% and Intel dropped nearly 3.7% [2] - Novo Nordisk's stock increased by nearly 7%, and its partner GoodRx surged by 37% following the announcement of a cash payment discount for its weight loss drug [2][7] - China Shipbuilding reported zero objection shares, leading to stock resumption [22] Economic Indicators - US Treasury yields have risen for three consecutive days, with the ten-year yield reaching a two-week high [4] - The dollar index rebounded, moving away from a two-week low [4] Industry Developments - India and Vietnam have imposed anti-dumping duties on Chinese PVC and steel products, respectively [6] - The low-altitude economy is gaining traction, with the first low-altitude route connecting Kunshan and Shanghai officially launched, reducing travel time to 20 minutes [15] - Beijing is advancing hydrogen energy infrastructure and applications, with plans for a comprehensive network in the Beijing-Tianjin-Hebei region [16] Financial Results - Shan Jin International reported a net profit of 1.596 billion yuan for the first half of the year, a year-on-year increase of 48.43% [24] - Cambridge Technology's net profit for the first half of the year was 121 million yuan, up 51.12% year-on-year, driven by strong performance in high-speed optical modules and telecom broadband access [24] - Fei Rongda's net profit surged by 118.54% to 166 million yuan, attributed to increased market share and demand recovery in consumer electronics [24] New Initiatives - Guangdong has released guidelines for financial support for AI and robotics projects, with individual projects eligible for up to 50 million yuan in subsidies [11] - Chongqing is seeking public opinion on its hydrogen station industry development plan for 2025-2035, aiming for systematic infrastructure development [11][16]
燃石医学上涨30.88%,报9.79美元/股,总市值1.05亿美元
Jin Rong Jie· 2025-08-18 15:38
Core Viewpoint - BNR's stock price surged by 30.88% on August 18, reaching $9.79 per share, with a total market capitalization of $105 million [1] Financial Performance - As of March 31, 2025, BNR reported total revenue of 133 million RMB, representing a year-on-year growth of 5.94% [1] - The net profit attributable to the parent company was -13.5 million RMB, showing a significant year-on-year improvement of 88.89% [1] Company Overview - BNR was established in 2014 with a mission to "guard the light of life with science," focusing on providing clinically valuable next-generation sequencing (NGS) for precision oncology [1] - The company's business and R&D directions primarily cover: 1) tumor patient population testing, holding a leading market share in China; 2) collaborations with global anti-tumor pharmaceutical companies for biomarkers and companion diagnostics; 3) early detection of multiple cancer types [1] Regulatory Milestones - In July 2018, BNR received the first certificate for NGS testing kits for tumors from the National Medical Products Administration (NMPA) in China, marking a milestone in the in vitro diagnostic field [2] - The laboratory in Guangzhou has passed the technical review by the Guangdong Provincial Clinical Testing Center and obtained quality system certifications from CLIA and CAP; the laboratory in California has also received CLIA and CAP certifications [2] - The company is committed to developing innovative and reliable NGS testing products to advance the field of precision oncology [2]
燃石医学上涨5.35%,报7.88美元/股,总市值8484.08万美元
Jin Rong Jie· 2025-08-18 14:25
Core Insights - BNR's stock price increased by 5.35% to $7.88 per share, with a total market capitalization of $84.84 million as of August 18 [1] - For the fiscal year ending March 31, 2025, BNR reported total revenue of 133 million RMB, a year-on-year increase of 5.94%, and a net profit attributable to shareholders of -13.5 million RMB, reflecting a significant year-on-year improvement of 88.89% [1] Company Overview - BNR was established in 2014 with a mission to "guard the light of life with science," focusing on providing clinically valuable next-generation sequencing (NGS) for precision oncology [2] - The company's business and R&D directions include: 1) leading market share in tumor patient testing in China; 2) collaborations with global anti-tumor pharmaceutical companies for biomarkers and companion diagnostics; 3) early detection of multiple cancer types [2] - BNR received the first NGS testing kit certification for tumors from the National Medical Products Administration (NMPA) in July 2018, marking a milestone in the in vitro diagnostic field [2] - The laboratory in Guangzhou has passed the technical review by the Guangdong Provincial Clinical Testing Center and obtained quality system certifications from CLIA and CAP, while the laboratory in California has also received CLIA and CAP certifications [2] - The company is committed to developing innovative and reliable NGS testing products to advance the field of precision oncology [2]
燃石医学上涨2.27%,报7.65美元/股,总市值8236.45万美元
Jin Rong Jie· 2025-08-18 13:53
Core Insights - The stock price of Burning Stone Medical (BNR) increased by 2.27% on August 18, reaching $7.65 per share, with a total market capitalization of $82.36 million [1] - As of March 31, 2025, the total revenue of Burning Stone Medical was 133 million RMB, reflecting a year-on-year growth of 5.94%, while the net profit attributable to the parent company was -13.5 million RMB, showing a significant year-on-year increase of 88.89% [1] Company Overview - Burning Stone Medical was established in 2014, with a mission to "guard the light of life with science," focusing on providing clinically valuable next-generation sequencing (NGS) for precision oncology [2] - The company's business and research directions primarily cover: 1) tumor patient population testing, holding a leading market share in China; 2) collaborations with global anti-tumor pharmaceutical companies for biomarkers and companion diagnostics; 3) early detection of multiple cancer types [2] - In July 2018, the company received the first certificate for NGS testing kits for tumors from the National Medical Products Administration (NMPA) in China, marking a milestone in the in vitro diagnostic field [2] - The laboratory located in Guangzhou, China, has passed the technical review by the Guangdong Provincial Clinical Testing Center and obtained quality system certifications from CLIA and CAP; the laboratory in California, USA, has also received CLIA and CAP certifications [2] - The company is committed to developing innovative and reliable NGS testing products to advance the field of precision oncology [2]
燃石医学上涨2.16%,报7.1美元/股,总市值7644.28万美元
Jin Rong Jie· 2025-08-15 13:54
Group 1 - The core viewpoint of the article highlights the financial performance and market position of Burning Stone Medical (BNR), indicating a positive growth trajectory in revenue and net profit [1][2] - As of August 15, BNR's stock opened at $7.1 per share, with a total market capitalization of approximately $76.44 million [1] - The company reported total revenue of 133 million RMB for the fiscal year ending March 31, 2025, reflecting a year-on-year growth of 5.94%, while the net profit attributable to shareholders was -13.5 million RMB, showing a significant improvement with a year-on-year increase of 88.89% [1] Group 2 - Important upcoming event: BNR is scheduled to disclose its mid-year report for the fiscal year 2025 on August 28, with the actual date subject to company announcement [2] - Burning Stone Medical, established in 2014, focuses on providing clinically valuable next-generation sequencing (NGS) for precision oncology, holding a leading market share in tumor patient detection in China [2] - The company has achieved significant milestones, including receiving the first NGS testing kit approval from the National Medical Products Administration (NMPA) in China and obtaining quality system certifications (CLIA and CAP) for its laboratories in both China and the United States [2]
燃石医学上涨7.54%,报7.517美元/股,总市值8093.25万美元
Jin Rong Jie· 2025-08-14 14:17
Core Insights - The stock price of Burning Stone Medical (BNR) increased by 7.54% on August 14, reaching $7.517 per share, with a total market capitalization of $80.93 million [1] - As of March 31, 2025, the total revenue of Burning Stone Medical was 133 million RMB, reflecting a year-on-year growth of 5.94%, while the net profit attributable to the parent company was -13.5 million RMB, showing a significant year-on-year increase of 88.89% [1] Company Overview - Burning Stone Medical, established in 2014, focuses on providing clinically valuable next-generation sequencing (NGS) for precision oncology, with a mission to "guard the light of life with science" [2] - The company's business and R&D directions include: 1) detection of cancer patient populations, holding a leading market share in China; 2) collaboration with global anti-cancer pharmaceutical companies on biomarkers and companion diagnostics; 3) early detection of multiple cancer types [2] - The company received the first NGS testing kit certification for tumors from the National Medical Products Administration (NMPA) in July 2018, marking a milestone in the in vitro diagnostic field [2] - The laboratory in Guangzhou, China, has passed the technical review by the Guangdong Provincial Clinical Testing Center and obtained quality system certifications from CLIA and CAP, while the laboratory in California, USA, has also received CLIA and CAP certifications [2] - Burning Stone Medical is committed to developing innovative and reliable NGS testing products to advance the field of precision oncology [2]