行业评级：看好（维持） 证券研究报告|行业专题报告 医药生物 2025年11月20日 --结直肠癌早筛龙头，更多大单品即将兑现 证券分析师 姓名：刘闯 资格编号：S1350524030002 邮箱：liuchuang@huayuanstock.com 联系人 姓名：梁裕 邮箱：liangyu@huayuanstock.com 请务必仔细阅读正文之后的评级说明和重要声明 报告要点 ◼ 结直肠癌早筛龙头，向肿瘤筛查平台转型。精密科学为美国结直肠癌早筛龙头，公司成立初期便致力于开发结直肠癌早筛产品，旗下拥有首个在美国实现商业化的 mt-sDNA结直肠癌筛查产品Cologuard。目前收入主要由筛查业务（以Cologuard为核心）、精准肿瘤检测（以Oncotype Dx系列为核心）两部分构成，2025Q1-3实现 收入20.5亿美元，同比增长16%。目前暂未实现净利润层面盈利，但FCF已处于持续转正态势，2025Q1-3调整后EBITDA利润率为14%，并有望在2027年超过20%，利润 有望加速兑现。 ◼ 结直肠癌早筛：公司基本盘，保持稳健增长，血检有望贡献弹性 1 • 结直肠早筛行业：结直肠疾病进展期长，早期发 ...

Group 1: Market Performance - The Hong Kong Innovative Drug Selected ETF (520690) increased by 0.22%, with the latest price at 0.89 yuan as of October 29, 2025 [3] - The ETF recorded a turnover of 4.25% during the trading session, with a total transaction value of 21.78 million yuan [3] - Over the past year, the average daily transaction volume of the ETF was 120 million yuan [3] Group 2: Clinical Data and Industry Insights - Grail presented initial data from its multi-cancer early detection product Galleri at the 2025 ESMO annual meeting, showing a positive predictive value of 61.6% and a specificity of 99.6% [3] - Among the detected new cancers, 69.3% were in stages I-III, with a tissue origin accuracy of 91.7% [3] - Guosen Securities views this data as a significant milestone in the multi-cancer early detection field, suggesting Galleri could enhance existing screening systems [3] Group 3: Company Earnings and Trends - Over 280 pharmaceutical and biotech companies, including Heng Rui Pharmaceutical and WuXi AppTec, reported strong Q3 results, driven by advancements in R&D pipelines and new drug launches [3] - The overall industry is exhibiting a positive trend characterized by "innovation as a foundation and overseas expansion" [3] Group 4: CDMO Sector Performance - Lonza, a leading overseas CDMO, reported strong Q3 results, maintaining a revenue growth forecast of 20-21% for the year, with core EBITDA margins between 30-31% [4] - Medpace has seen consecutive growth in new orders for two quarters, indicating a recovering financing environment for U.S. small and mid-sized biotech firms [4] - WuXi AppTec exceeded Q3 performance expectations and raised its full-year guidance, further confirming the positive outlook for the CXO industry [4] Group 5: ETF Size and Inflows - The latest size of the Hong Kong Innovative Drug Selected ETF reached 512 million yuan, marking a new high since its inception [4] - The ETF's share count also hit a record high of 574 million shares [4] - In the past five days, the ETF experienced continuous net inflows, with a peak single-day net inflow of 31.48 million yuan, totaling 82.81 million yuan in net inflows [4]

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology sector [6][30]. Core Insights - The pharmaceutical sector underperformed the overall market, with a slight increase of 0.58% in the biopharmaceutical sector compared to a 3.26% rise in the overall A-share market [2][33]. - Grail's multi-cancer early detection product, Galleri, achieved significant clinical milestones, with a positive predictive value (PPV) of 61.6%, a substantial increase from 38% in the previous Pathfinder 1 study [3][12][14]. - The report emphasizes the potential of Galleri to enhance existing screening protocols, increasing cancer detection rates significantly when combined with standard screenings [19][30]. Summary by Sections Market Performance - The overall A-share market rose by 3.26%, with the Shanghai Composite Index increasing by 3.24% and the ChiNext Index rising by 8.05%. The biopharmaceutical sector's performance was weaker, with a 0.58% increase [2][33]. Key Company Earnings Forecast and Investment Ratings - Major companies such as Mindray Medical, WuXi AppTec, and Aier Eye Hospital received an "Outperform" rating, with projected net profits for 2024 ranging from 1.4 billion to 116.7 billion yuan [5][30]. - The report highlights the expected growth in earnings for these companies, with Mindray Medical projected to have a PE ratio decreasing from 23.0 in 2024 to 18.5 in 2027 [5][30]. Clinical Developments - Grail's Pathfinder 2 study included approximately 35,000 participants, with 25,000 undergoing a pre-specified analysis. The study demonstrated a high specificity of 99.6% and a significant reduction in the time to diagnosis for positive cases [12][14][22]. - The report notes that 74% of the early-stage cancers detected by Galleri currently lack recommended screening methods, underscoring the product's potential impact on cancer detection [17][19]. Investment Strategy - The report suggests focusing on companies with strong innovation capabilities, such as Kelun Pharmaceutical and CanSino Biologics, as the market for innovative drugs continues to grow [42][44]. - It also highlights the potential for recovery in the medical device sector, driven by policy optimization and improving market conditions [43][44]. Recommendations - The report recommends several companies for investment, including Mindray Medical, WuXi AppTec, and Aier Eye Hospital, citing their strong market positions and growth potential [45][46].

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology sector [6][30]. Core Insights - The pharmaceutical sector underperformed the overall market, with a slight increase of 0.58% in the biopharmaceutical sector compared to a 3.26% rise in the total A-share market [2][33]. - Grail's multi-cancer early detection product, Galleri, achieved significant clinical milestones, with a positive predictive value (PPV) of 61.6%, a substantial increase from 38% in the previous Pathfinder 1 study [3][12]. - The report emphasizes the potential of Galleri to enhance existing screening protocols, with a sevenfold increase in total cancer detection when combined with standard screenings [19][30]. Summary by Sections Market Performance - The overall A-share market rose by 3.26%, with the Shanghai Composite Index increasing by 3.24% and the ChiNext Index rising by 8.05% [2][33]. - The biopharmaceutical sector's price-to-earnings (P/E) ratio stands at 38.35x, which is at the 80.28th percentile of its historical valuation over the past five years [2][38]. Key Company Earnings Forecasts and Investment Ratings - Major companies such as Mindray Medical, WuXi AppTec, and Aier Eye Hospital are rated as "Outperform" with projected earnings growth for 2024 ranging from 35.6 million to 116.7 million yuan [5][44]. - The report highlights the strong financial performance and growth potential of these companies, with Mindray Medical expected to maintain a P/E ratio of 23.0x in 2024 [5][44]. Clinical Developments - Grail's Pathfinder 2 study included approximately 35,000 participants, demonstrating the effectiveness of Galleri in early cancer detection [12][24]. - The study revealed that 53.5% of cancers detected by Galleri were in stages I or II, indicating the product's capability to identify cancers at an early stage [17][22]. Investment Strategy - The report suggests focusing on companies with high-quality innovation capabilities, particularly in the context of the increasing competitiveness of domestic innovative drugs in global markets [42][44]. - It recommends monitoring the clinical progress and commercial value of multi-cancer early detection technologies, particularly Galleri, as it approaches FDA approval [30][44].

Investment Rating - The report maintains a "Recommended" rating for the company [2][6]. Core Insights - The company is experiencing performance pressure, with a reported revenue of 4.109 billion yuan in H1 2025, a year-on-year decrease of 2.28%, and a net profit attributable to shareholders of -221 million yuan, indicating an expanded loss of 2.59% year-on-year [6]. - The company is focusing on AI-driven service upgrades and refined operations, with AI-related revenue contributing 1.4 billion yuan, accounting for 3.4% of total revenue [6]. - The long-term trend for the health checkup sector is positive, and the company, as a leading player, is expected to benefit from this trend [6]. Financial Performance Forecast - Revenue is projected to grow from 10,701.99 million yuan in 2024 to 14,349.66 million yuan in 2027, with a compound annual growth rate (CAGR) of 16.22% [2][8]. - The net profit attributable to shareholders is expected to increase from 282.24 million yuan in 2024 to 999.61 million yuan in 2027, reflecting a growth rate of 19.89% in 2027 [2][8]. - The gross margin is forecasted to remain stable, with slight improvements from 42.69% in 2025 to 43.13% in 2027 [2][8]. Key Financial Metrics - The company’s earnings per share (EPS) is expected to rise from 0.07 yuan in 2024 to 0.26 yuan in 2027 [2][8]. - The price-to-earnings (P/E) ratio is projected to decrease from 79.61 in 2024 to 22.48 in 2027, indicating improved valuation as earnings grow [2][8]. - The operating cash flow is anticipated to improve significantly, reaching 2.902 billion yuan by 2027 [7][8].

Investment Rating - The industry investment rating is optimistic (maintained) [1] Core Insights - Multi-cancer early detection (MCED) is recognized as a supplementary rather than a replacement method for existing cancer screening, addressing the limitations of current single-cancer screening methods [3][6] - Grail is highlighted as the most notable player in the multi-cancer early detection space, with significant clinical trial investments and a leading position in commercial progress [4][49] - The FDA emphasizes performance evaluation, focusing on analytical effectiveness, clinical efficacy, and risk-benefit ratios, while CMS requires legislative support for insurance coverage of MCED products [5] Summary by Sections Multi-Cancer Early Detection Overview - Current cancer screening methods have limitations, with only a few cancers having recommended screening methods, leaving about 70% of new cancer cases without standard screening [11] - MCED technology can screen for up to 50 types of cancer through a single blood draw, identifying molecular changes before symptoms appear, thus enhancing screening participation rates [6][15] Grail Company Overview - Grail, spun off from Illumina, has conducted over 380,000 clinical trials, making it a leader in the MCED field [49][43] - The company has invested over $3.5 billion in operational costs, establishing a strong brand recognition in the market [6][49] Clinical Data - Grail's MCED product, Galleri, has undergone extensive validation, achieving a sensitivity of 51.5% and a specificity of 99.5% [81] - The company plans to submit an FDA registration application in mid-2026, aiming to be the first MCED product to receive FDA approval [58] Commercialization Discussion - Grail's commercial progress is ahead of competitors, with over 15,000 doctors prescribing Galleri and partnerships with over 40 medical institutions [52] - The company achieved $126 million in revenue in 2024, with a projected growth of 20-30% in 2025 [55] Key Performance Indicators - The MCED tests are evaluated on high specificity, sensitivity, positive predictive value (PPV), and negative predictive value (NPV), which are crucial for reducing unnecessary follow-ups and improving early cancer detection [30][31] - Grail's Galleri has a PPV of 43% and aims to improve its performance metrics through ongoing clinical trials [81]

Group 1: Company Overview - Beilu Pharmaceutical's subsidiary, Shenzhen Yiwei Medical Technology Co., Ltd., focuses on brain disease early screening, precise diagnosis, and rehabilitation training, being the only AI enterprise in China with NMPA Class III certification in both neurodegenerative and cerebrovascular diseases [1] - Yiwei Medical's core products target stroke, Alzheimer's disease, cognitive disorders, and developmental disorders in youth, providing comprehensive solutions for screening, diagnosis, and rehabilitation [1] Group 2: National Policy Support - Recent national policies have significantly supported the development of precision diagnosis for brain diseases, aiming to train 500-1000 professionals annually and establish over 2100 cognitive disorder diagnosis centers by 2025 [2] - The National Health Commission emphasizes autism screening and intervention for children, enhancing screening, diagnosis, and intervention rates [3] Group 3: Product Development - Yiwei Medical has launched three main products: - Yiwei Brain Doctor, the first AI medical software for early Alzheimer's diagnosis, with both NMPA Class III and CE certifications [5] - Yiwei Smart Brain, a one-stop AI-assisted diagnosis platform for stroke, achieving dual certification from NMPA and FDA [5] - Yiwei Digital Therapy, integrating eye-tracking and VR technology for cognitive assessment and rehabilitation [5] Group 4: Business Model - Yiwei Medical offers a full-cycle service from screening to rehabilitation, collaborating with over 200 hospitals and health institutions, and exploring diverse revenue streams [6] - The company has introduced a comprehensive "brain routine" health check package and established digital rehabilitation centers in communities [6] Group 5: Financial Performance - In 2024, Beilu Pharmaceutical's revenue from contrast agents reached CNY 58.80 million, a 9.87% increase; diabetes products generated CNY 12.60 million, up 33.24%; while raw materials saw a decline of 20.83% to CNY 9.00 million [9] - The company anticipates continued growth across its business segments in 2025 [9] Group 6: International Expansion - Beilu Pharmaceutical's overseas revenue reached CNY 13.22 million in 2024, marking a 15.02% increase, with successful product exports to South America, Africa, and Asia [11] - The company is advancing its internationalization efforts with certifications in the EU and plans for further market expansion in Southeast Asia [11]

Group 1: Business Performance and Revenue - In 2024, the company achieved sales revenue of CNY 58,804.95 million for contrast agents, a year-on-year increase of 9.87% [1] - Sales revenue for hypoglycemic products reached CNY 12,598.34 million, growing by 33.24% year-on-year [1] - The company reported a decline in raw material sales revenue to CNY 9,003.14 million, down by 20.83% [1] - Sales revenue for traditional Chinese medicine preparations was CNY 16,844.68 million, reflecting a year-on-year growth of 19.65% [1] - The company’s overseas revenue for 2024 was CNY 13,216.14 million, marking a 15.02% increase [4] Group 2: Strategic Developments - The company continues to implement a "chemical + traditional Chinese medicine" dual-driven strategy, focusing on contrast agents, hypoglycemic drugs, and central nervous system traditional Chinese medicine [1] - The construction of the Cangzhou Phase III raw material production project has been completed, enhancing the production capacity for gadolinium and iodine contrast agents [2] - The Bozhou production base is progressing, with the first phase expected to start trial production and process validation within the year [3] Group 3: Market Expansion and Product Development - The company is expanding its market presence internationally, with successful exports of contrast agents and raw materials to South America, Africa, and Asia [4] - The company’s subsidiary, Haichang Pharmaceutical, is one of the few domestic producers with iodine contrast agent production qualifications, with an annual capacity of 1,000 tons [2] - The "MERCURY non-invasive blood test" technology developed by the affiliated company, Shihe Gene, allows for the screening of nine types of cancer from a single blood sample [7]

Group 1: Company Overview and Financial Performance - Beilu Pharmaceutical's contrast agent products generated sales revenue of 58,804.95 million yuan in 2024, representing a year-on-year growth of 9.87% [1] - The company achieved EU GMP and Brazil ANVISA GMP certifications for its production lines, supporting ongoing business growth [1] - The company plans to continue expanding its global market presence in 2025, focusing on steady growth in its contrast agent business [1] Group 2: Product Development and Innovation - The company has actively completed the bidding and registration processes for iodinated contrast agents, including Iohexol and Iopamidol [1] - In July 2024, the company received approval for Gadobutrol injection, which has been included in the national procurement list, enhancing market share and brand influence [1] Group 3: Medical Technology and Product Offerings - Yiwei Medical has launched three main products: - Yiwei-Brain Doctor, the first AI medical software for early Alzheimer's diagnosis, certified by both the National Medical Products Administration and CE [2] - Yiwei-Ruibrain, a comprehensive AI-assisted diagnosis platform for stroke, with dual certification from the National Medical Products Administration and FDA [2] - Yiwei-Digital Therapy, a cognitive assessment and rehabilitation product integrating eye-tracking and VR technologies [2] Group 4: Business Model and Market Strategy - Yiwei Medical focuses on precision diagnosis and treatment of brain diseases, offering a full-service model from screening to rehabilitation [3] - The company collaborates with health check institutions to provide a comprehensive "brain routine" health check package [3] - Yiwei Medical is exploring additional business models to expand market coverage and increase revenue streams [3] Group 5: Recent Developments in Partner Companies - Shihe Gene has made significant advancements in multi-cancer early screening technology, utilizing ultra-low depth whole genome sequencing and AI models [4] - The "Shihe Eagle Eye" product can screen for nine types of cancer with a single blood sample, significantly improving screening efficiency [4] - The product has received CE certification in the EU and breakthrough device designation from the FDA, outperforming international counterparts [4] Group 6: Industry Position and Competitive Advantage - Haichang Pharmaceutical is one of the few domestic companies with production capacity for iodinated contrast agent raw materials, with an annual output of 1,000 tons [5] - The recent approvals for Iopamidol and Iopromide raw materials enhance the company's competitive edge and product diversity [5]