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贝瑞基因子公司三代基因测序仪SequelII CNDx获得医疗器械注册证
Zhi Tong Cai Jing· 2025-10-31 11:04
Core Insights - Berry Genomics (000710.SZ) announced that its subsidiary, Hangzhou Berry Health and Technology Co., Ltd., has received the medical device registration certificate from the National Medical Products Administration (NMPA) for its third-generation sequencing instrument, Sequel II CNDx, marking it as the first clinically approved third-generation sequencing platform globally [1][2] Group 1: Product Approval and Features - The Sequel II CNDx is the first third-generation sequencing platform approved for clinical use, enabling rapid implementation of third-generation sequencing solutions in local laboratories [1] - The approval allows for "one machine, multiple uses" and "mixed loading," which reduces sample waiting times, accelerates report cycles, and enhances service quality within hospitals [1] Group 2: Clinical Applications and Impact - The clinical approval of Sequel II CNDx will enhance the birth defect prevention system and significantly improve the detection capabilities for complex single-gene diseases [2] - Berry Genomics aims to deepen the clinical application of third-generation sequencing technology by optimizing AI algorithms and local deployment plans, making testing services more precise, efficient, and economical for families [2] - The large-scale application of third-generation sequencing technology is expected to accelerate major public health initiatives, such as the prevention of birth defects, both in China and globally [2]
贝瑞基因(000710.SZ)子公司三代基因测序仪Sequel®II CNDx获得医疗器械注册证
智通财经网· 2025-10-31 10:45
Core Insights - Berry Genomics' subsidiary, Hangzhou Berry Genomics, has received NMPA approval for its Sequel® II CNDx third-generation gene sequencer, marking it as the first clinically approved third-generation sequencing platform globally [1][2] - The approval allows for rapid implementation of third-generation sequencing solutions in local clinical laboratories, enhancing service quality and reducing sample wait times [1] - Berry Genomics has achieved full local production of third-generation sequencing reagents and the deployment of an intelligent report interpretation system, providing comprehensive localized services from sample collection to report management [1] Industry Impact - The clinical approval of Sequel® II CNDx will enhance the birth defect prevention system and significantly improve the detection capabilities for complex single-gene diseases [2] - The advancement of domestic technology is expected to accelerate its global reach, with Berry Genomics aiming to optimize AI algorithms and local deployment plans to lower technical barriers [2] - The large-scale application of third-generation sequencing technology is anticipated to promote significant public health initiatives, particularly in the prevention of birth defects both in China and globally [2]
贝瑞基因:三代基因测序仪Sequel II CNDx获得医疗器械注册证
Zheng Quan Shi Bao Wang· 2025-10-31 10:08
Core Viewpoint - Berry Genomics (000710) announced that its wholly-owned subsidiary, Hangzhou Berry Genomics and Health Technology Co., Ltd., has recently received the medical device registration certificate from the National Medical Products Administration (NMPA) for its third-generation gene sequencer, Sequel II CNDx [1] Group 1 - The Sequel II CNDx is a third-generation gene sequencer [1] - The medical device registration certificate was issued by the National Medical Products Administration (NMPA) [1]
贝瑞基因:全球首款获准应用于临床的三代基因测序平台Sequel IICNDx获得医疗器械注册证
Mei Ri Jing Ji Xin Wen· 2025-10-31 09:45
Core Viewpoint - Berry Genomics has announced that its subsidiary, Hangzhou Berry Genomics and Health Technology Co., Ltd., has received a medical device registration certificate from the National Medical Products Administration for its third-generation gene sequencer, Sequel II CNDx, marking it as the world's first third-generation gene sequencing platform approved for clinical use [1] Company Summary - The Sequel II CNDx is the first third-generation gene sequencing platform to be approved for clinical application globally [1] - Berry Genomics has achieved full self-production of third-generation sequencing detection reagents and has deployed an intelligent report interpretation system locally [1]
华大智造(688114):业绩持续复苏 关注国内替代+产品技术全面出海
Xin Lang Cai Jing· 2025-10-30 12:37
Core Insights - The company reported a revenue of 1.869 billion yuan for the first three quarters of 2025, showing a slight year-on-year decrease of 0.01%, while the net loss attributable to shareholders was 120 million yuan, a reduction in loss of 74.2% year-on-year [1] - In Q3 2025, the company achieved a revenue of 755 million yuan, representing a year-on-year increase of 14.45%, with a net loss attributable to shareholders of 16 million yuan, a significant reduction in loss of 90.31% year-on-year [1] Revenue Structure and Cost Management - The company is optimizing its revenue structure and continuously promoting cost reduction and efficiency improvement, leading to gradual recovery in profits [2] - In the first three quarters of 2025, the revenue from the full-length sequencing business included 460 million yuan from instrument sales and 940 million yuan from reagent consumables, with the proportion of recurring revenue from reagents and services rising to nearly 70% [2] - The sales, management, and R&D expense ratios for Q3 2025 were 23.2%, 11.2%, and 14.8%, respectively, showing year-on-year decreases of 10.8, 12.2, and 12.7 percentage points, which contributed to the narrowing of losses [2] Market Share and Global Expansion - The company has significantly increased its market share domestically while continuing to expand in overseas markets, with a notable focus on technology export to support global layout [3] - In the first three quarters of 2025, the revenue from the sequencing business in China was 1 billion yuan, a year-on-year decrease of 5%, but the company secured over 70% of the bids for high-throughput sequencers, indicating a strong domestic market position [3] - The company reported revenues of 260 million yuan in the Europe and Africa region and 140 million yuan in the Americas, both showing a year-on-year increase of 14%, while the Asia-Pacific region saw a revenue of 110 million yuan, down 32% due to regional disruptions [3] - A recent licensing agreement with Swiss Rockets for sequencing technology is expected to generate an initial payment of 20 million USD and potential total revenues of at least 120 million USD, marking a new model for technology export [3] Profit Forecast - The company forecasts revenues of 3.585 billion, 4.184 billion, and 4.936 billion yuan for 2025-2027, with year-on-year growth rates of 19.01%, 16.69%, and 17.98% respectively [4] - The projected net profits attributable to shareholders for the same period are 29 million, 104 million, and 219 million yuan, with year-on-year growth rates of 104.79%, 262.33%, and 110.26% respectively [4]
华大智造在手订单7.7亿元 测序仪装机量持续增长
Zheng Quan Ri Bao Zhi Sheng· 2025-10-29 11:12
Core Insights - Shenzhen BGI Genomics Co., Ltd. (referred to as "the company") has demonstrated strong performance in key areas such as order reserves, platform replacement, and core product installation volume, laying a solid foundation for future growth before the third quarter of 2025 [1][2] Group 1: Product Performance - The company's core product installation volume has shown remarkable growth, driven by high demand for advanced equipment. The T1+ sequencer launched in March 2023 has gained significant industry recognition, leading to rapid installation growth [1] - In the Europe and Africa regions, the installation volume of the DNBSEQ-T series products has doubled year-on-year in a single quarter. In the U.S. market, the DNBSEQ-T7 series products lead in sales, with combined revenue from T7 instruments and sequencing reagents accounting for 72% of regional main business income [1] Group 2: Order Reserves - As of October 20, 2025, the company's order backlog reached 770 million yuan, with domestic orders accounting for 520 million yuan (68%) and overseas orders 250 million yuan (32%). The long-read sequencing business, as a core pillar, holds approximately 580 million yuan in orders, representing 75% of the total [1] Group 3: Platform Replacement - The company has accelerated its platform replacement process this year, having delivered nearly 400 sequencers to date. Public bidding data indicates that the company has a high-throughput sequencer winning rate exceeding 70% before October 1, 2025, significantly higher than the 15% rate of overseas competitors [2] - The fastest replacement pace is observed in the research service provider sector, with actual shipments increasing by approximately 20% year-on-year in the first three quarters. Clinical fields are expected to see procurement progress after budget approvals at the end of the year, despite longer qualification cycles [2] - The company is not only focusing on equipment replacement but is also integrating "long-read + short-read" solutions and multi-omics capabilities to provide comprehensive solutions for clients, enhancing market competitiveness [2]
华大智造(688114):2025Q3增长趋势延续,费用持续优化
Huaan Securities· 2025-10-28 03:44
Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company reported a revenue of 1.869 billion yuan for the first three quarters of 2025, showing a year-over-year decrease of 0.01%, while the net profit attributable to the parent company was -120 million yuan, an increase of 74.20% year-over-year [4][5] - In Q3 2025, the company achieved a revenue of 755 million yuan, representing a year-over-year growth of 14.45%, and a net profit of -16 million yuan, up 90.31% year-over-year [5] - The revenue growth in Q3 2025 is attributed to the shift of domestic customers' data platforms and increased installation and usage of related reagents due to Illumina being listed as an unreliable entity by the Ministry of Commerce [5][6] Financial Performance - The company’s revenue for Q1, Q2, and Q3 of 2025 was 455 million yuan (down 14.26% year-over-year), 659 million yuan (down 2.93% year-over-year), and 755 million yuan (up 14.45% year-over-year) respectively [5] - The company’s expense ratios for sales, management, and R&D in Q3 2025 were 23.19%, 11.19%, and 14.80%, respectively, showing significant reductions both year-over-year and quarter-over-quarter [5] - The company has entered a new phase of globalization by licensing its sequencing technology to Swiss Rockets, with an initial payment of 20 million USD and milestone payments totaling at least 120 million USD [6] Revenue and Profit Forecast - The company is expected to achieve revenues of 2.824 billion yuan, 3.341 billion yuan, and 3.943 billion yuan for the years 2025, 2026, and 2027, with year-over-year growth rates of -6.3%, 18.3%, and 18.0% respectively [7] - The net profit attributable to the parent company is projected to be -98 million yuan, 160 million yuan, and 382 million yuan for the years 2025, 2026, and 2027, with year-over-year growth rates of 83.6%, 262.9%, and 138.6% respectively [7][10]
国产基因测序仪公司入选“最具投资潜力的10大科学家创业公司”
仪器信息网· 2025-10-27 09:07
Core Insights - The formal domestication of the Orbitrap Exploris GC high-resolution mass spectrometer marks a new phase in the localization of high-resolution products [1] Group 1: Investment Potential - On October 17, the list of the top 10 most investment-worthy scientific entrepreneurial companies for 2025 was officially released, with Zhenmai recognized for its technological strength and scale potential in the field of gene sequencing [2] - The selection process involved over a hundred candidate companies across sectors such as AI, clean energy, and high-end medical technology, aiming to anchor high-value investment targets for capital [2] Group 2: Company Achievements - Since 2025, Zhenmai Bio has shown impressive results, completing a C+ round financing of 280 million yuan, which injects momentum for commercialization, globalization, and capacity expansion [5] - On the product technology front, Zhenmai launched the FASTASeq S high-throughput gene sequencer, and the SURFSeq 5000 platform has supported research teams in publishing results in Nature Aging, contributing to over 100 research papers [5] - In terms of market and industry recognition, Zhenmai was listed among the "Top 20 Innovative Companies in the Biomanufacturing Field for 2025," with its equipment entering over 50 countries globally [5]
国产基因测序仪龙头,前三季再亏1.2亿元
Shen Zhen Shang Bao· 2025-10-25 12:16
Core Insights - BGI Genomics reported a revenue of 1.869 billion yuan for the first nine months of the year, a slight decrease of 0.01% compared to the same period last year [1] - The company incurred a net loss of 120 million yuan for the first nine months, with a non-recurring net loss of 228 million yuan [1] - As of the end of Q3, the net cash flow from operating activities was -289 million yuan [1] Financial Performance - In Q3, BGI Genomics achieved a revenue of 755 million yuan, representing a year-on-year growth of 14.45% [1] - The net loss for Q3 was 16 million yuan, with a non-recurring net loss of 25.39 million yuan [1] - The latest gross margin was 53.32%, down 5.81 percentage points from the same period last year [1] - The latest debt-to-asset ratio was 23.69%, an increase of 4.06 percentage points compared to the same period last year [1] Research and Development - The company reduced its R&D expenditure to 447 million yuan in the first three quarters, a decrease of 24.25% year-on-year [1] - R&D spending accounted for 23.94% of total revenue, down 7.66 percentage points year-on-year [1] - BGI Genomics stated that it is focusing on cost reduction and efficiency improvement, leading to a decrease in R&D investment [1] Ownership Structure - As of September 30, 2025, major shareholders include Shenzhen BGI Technology Holdings Group Co., Ltd. with 36.73% ownership, and other investors with smaller stakes [2] - CPE Investment reduced its stake by 0.59 percentage points in Q3 2025 compared to the previous half-year report [2]
华大智造方面澄清:并非“造车”而是“用车”作为移动平台|快讯
Hua Xia Shi Bao· 2025-10-24 03:57
Core Viewpoint - Recent rumors suggested that BGI Genomics is venturing into car manufacturing, which the company clarified is not the case. Instead, it focuses on using vehicles as mobile platforms for various healthcare and scientific applications [2]. Group 1: Company Clarification - BGI Genomics emphasized that it is not "manufacturing cars" but rather utilizing vehicles for mobile platforms, including automated ultrasound vehicles and mobile testing units [2]. - The company has made significant contributions in areas such as public health and medical resource distribution through its mobile platforms [2]. - BGI Genomics maintains a clear focus on its core business, prioritizing the development and manufacturing of life science tools while adhering to principles of technological synergy and scenario extension for new business ventures [2]. Group 2: Business Overview - Established in 2016, BGI Genomics is dedicated to advancing research and clinical applications through core technologies in gene sequencing and multi-omics [3]. - The company has a global presence, with operations in over 110 countries and regions, nine R&D centers, seven production bases, and 13 customer experience centers as of June 30, 2025 [2]. - BGI Genomics serves over 3,560 users worldwide, highlighting its extensive reach and impact in the life sciences sector [2].