国信证券发布研报称，全球抗凝药市场规模超200亿美元，现有的抗凝药物在预防血栓的同时，会带来 额外的出血风险;抗凝血药物的有效性(抗血栓能力)和安全性(减少出血风险)仍有提升空间。FXI/FXIa有 望成为现有抗凝血药物的升级和补充，具备百亿美金以上的潜在市场空间。建议关注恒瑞医药 (600276.SH，01276)：FXI单抗SHR-2004进入3期临床，在国产分子中领先;并关注拥有FXI小核酸药物管 线的公司。 国信证券主要观点如下： FXI小核酸药物可能具备差异化的竞争优势 FXI小核酸药物仍处在较早期的研发阶段，瑞博生物的SR059、靖因药业的SRSD107正进行2期临床研 究。早期的PK/PD数据显示，FXI siRNA药物对于FXI活性有高效的抑制，并且可能做到Q3M的注射周 期，能为慢病用药带来依从性的优势。 风险提示：临床结果不及预期的风险、临床进度不及预期的风险、海外开发不及预期的风险、商业化不 及预期的风险。 FXI/FXIa抑制剂有望成为安全性更优的抗凝药物 现有抗凝血药物均作用于凝血的共同通路，FXI仅参与内源性凝血通路以及血栓的正反馈放大，抑制 FXI活性有望在抗凝血的同时减少出血的 ...

国信证券主要观点如下： 国信证券发布研报称，全球抗凝药市场规模超200亿美元，现有的抗凝药物在预防血栓的同时，会带来 额外的出血风险;抗凝血药物的有效性(抗血栓能力)和安全性(减少出血风险)仍有提升空间。FXI/FXIa有 望成为现有抗凝血药物的升级和补充，具备百亿美金以上的潜在市场空间。建议关注恒瑞医药 （600276）(600276.SH，01276)：FXI单抗SHR-2004进入3期临床，在国产分子中领先;并关注拥有FXI小 核酸药物管线的公司。 风险提示：临床结果不及预期的风险、临床进度不及预期的风险、海外开发不及预期的风险、商业化不 及预期的风险。 近期，拜耳的asundexian在卒中二级预防的3期临床中取得优效，成为首个达到关键临床主要临床终点的 FXI/FXIa抑制剂。此前，asundexian在房颤患者的卒中预防的3期临床中未达到有效性终点，milvexian在 ACS患者中相比安慰剂同样未达到优效。根据现有临床数据，FXI/FXIa抑制剂相比于DOACs体现出显 著的安全性优势，可能在高出血风险的患者中占据竞争优势。另一方面，在内源性凝血通路的作用占主 导地位的适应症中，FXI/FXIa ...

Investment Rating - The report maintains an "Outperform" rating for the industry [1] Core Insights - The global anticoagulant market exceeds $20 billion, primarily driven by stroke prevention in atrial fibrillation patients, with other indications including VTE prevention after knee/hip replacement and prevention of ischemic complications in myocardial infarction [2][5] - FXI/FXIa inhibitors are expected to become safer anticoagulants, as they target the intrinsic pathway of coagulation, potentially reducing bleeding risks while maintaining efficacy [2][21] - Several FXI/FXIa inhibitors are in clinical stages, with promising safety profiles demonstrated in various indications, including Bayer's asundexian achieving key clinical endpoints in secondary stroke prevention [2][26] - FXI small nucleic acid drugs may offer differentiated competitive advantages, with early-stage clinical data showing effective FXI activity suppression and potential for improved patient compliance [2][26] Summary by Sections Anticoagulant Drugs: Applications and Market Size - Anticoagulants are used in various medical scenarios, with a global market size exceeding $20 billion, driven by stroke prevention in atrial fibrillation patients [5][7] - Current anticoagulants include DOACs and low molecular weight heparins, with existing drugs presenting bleeding risks alongside their efficacy [5][21] FXI Inhibitors as Next-Generation Anticoagulants - FXI inhibitors are positioned to challenge standard treatments, with clinical trials indicating superior safety profiles compared to existing DOACs [2][26] - Notably, Bayer's asundexian has shown efficacy in secondary stroke prevention, marking a significant advancement in the field [2][69] Domestic FXI Small Nucleic Acid Drug Development Progress - Domestic companies are advancing in FXI small nucleic acid drug development, with promising early clinical results indicating effective FXI suppression and potential for improved dosing schedules [2][26] Investment Recommendations - FXI/FXIa inhibitors are projected to represent an upgrade and complement to existing anticoagulants, with a potential market space exceeding $10 billion [2][26] - The report suggests focusing on companies like HengRui Medicine, which is leading in domestic FXI monoclonal antibody development [2][26]

Core Insights - Bayer's shares increased by 12.1% following the Solicitor General's support for a Supreme Court review of its Roundup weedkiller case, indicating potential positive influence on the court's consideration of Bayer's petition [1][9] - The company has faced numerous lawsuits related to Roundup, with significant litigation costs incurred due to allegations that glyphosate, the active ingredient, caused cancer [2][3] Litigation Overview - Bayer acquired Roundup through the 2018 buyout of Monsanto, which has been the subject of multiple lawsuits alleging cancer risks associated with glyphosate [2] - As of October 15, 2025, 28 Roundup-related trials have concluded, with Monsanto winning 17 cases, while plaintiffs received compensatory damages in the others [4] - Bayer has reserved $7.6 billion (€6.5 billion) for glyphosate litigation as of September 30, 2025, accounting for potential settlements and appeals [7] Recent Developments - Bayer filed a petition with the U.S. Supreme Court in April 2025, seeking clarification on federal versus state law regarding failure-to-warn claims in glyphosate litigation [5] - In June 2025, the U.S. Supreme Court requested the Solicitor General's opinion on the case, while Bayer settled approximately 17,000 claims [6] Financial Performance - Bayer's stock has surged 101.3% year-to-date, significantly outperforming the industry growth of 16.1%, driven by new drug approvals and positive pipeline developments [8] - Key drugs such as Nubeqa and Kerendia are contributing to growth in Bayer's pharmaceuticals division, offsetting declines in Xarelto sales [10] Drug Approvals and Pipeline Progress - The European Commission approved elinzanetant for treating vasomotor symptoms associated with menopause, expanding Bayer's product offerings [12] - The FDA granted accelerated approval to Hyrnuo for specific lung cancer treatments, further enhancing Bayer's portfolio [13] - Bayer's pipeline candidate asundexian showed promising results in a late-stage study for secondary stroke prevention, with plans for global marketing authorization applications [14][15]

Investment Rating - The report indicates a positive investment outlook for the oral FXIa inhibitor asundexian, particularly following its successful Phase III trial results for preventing recurrent strokes [21][25]. Core Insights - The oral FXIa inhibitor asundexian has shown significant efficacy in reducing the risk of ischemic stroke in patients with non-cardioembolic ischemic stroke or high-risk transient ischemic attack, achieving its primary efficacy and safety endpoints in the OCEANIC-STROKE study [21][25]. - The report highlights the potential of FXI inhibitors to provide safer anticoagulation options with lower bleeding risks compared to traditional anticoagulants [9][10]. - The report discusses the diverse potential indications for FXI/XIa inhibitors, including prevention of venous thromboembolism (VTE) in orthopedic surgeries, stroke prevention in atrial fibrillation patients, and treatment of cancer-associated VTE [13][10]. Summary by Sections Section 1: Focus on Innovative Drugs - The report reviews the recent advancements in innovative drugs, particularly in the anticoagulant space, emphasizing the role of FXI inhibitors [4][5]. Section 2: Mechanism of Action - FXIa plays a crucial role in pathological thrombus formation while having a limited role in hemostasis, making it an ideal target for developing safer anticoagulants [9][10]. Section 3: Clinical Development Progress - Asundexian has successfully completed Phase III trials, while other FXIa inhibitors like milvexian have faced challenges, including trial terminations due to efficacy concerns [30][33]. - The report details the ongoing clinical trials for various FXI inhibitors, including those by companies like Bayer, BMS, and Regeneron, highlighting their respective stages of development and potential applications [20][39][45]. Section 4: Market Potential - The report underscores the significant market potential for FXI inhibitors, given the high incidence of stroke and VTE, with approximately 12 million people affected by stroke annually worldwide [25][21].

Core Insights - Bristol Myers Squibb (BMY) received European Commission approval for Breyanzi, expanding its label to include treatment for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor [1][9] Group 1: Breyanzi Approval and Indications - The latest approval marks the fourth for Breyanzi in Europe, which is already approved for several other indications including relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBCL) [2] - Breyanzi is indicated for patients who relapsed within 12 months of first-line chemoimmunotherapy or are refractory to it, as well as for those with relapsed or refractory DLBCL, PMBCL, and FL3B after two or more lines of therapy [3] Group 2: Clinical Trial Results - The approval is based on the TRANSCEND NHL 001 trial results, where 82.7% of patients responded to Breyanzi, with 71.6% achieving a complete response, and 41.2% of patients maintained their response at 24 months [4][9] Group 3: Pipeline Expansion and Market Impact - Bristol Myers is focusing on expanding its pipeline due to the negative impact of generics on its legacy portfolio, including Revlimid and Pomalyst [5] - The company’s shares gained 3.3% following positive data from Bayer's cardiovascular candidate asundexian, which may boost investor confidence in BMY's own cardiovascular candidate, milvexian [6][8] Group 4: Discontinuation of Librexia Study - Bristol Myers and Johnson & Johnson decided to discontinue the late-stage Librexia study for milvexian after an interim analysis indicated it was unlikely to meet primary efficacy endpoints, although two other studies for milvexian will continue [10][11]

Core Insights - Bristol Myers Squibb (BMY) received European Commission (EC) approval for Breyanzi (lisocabtagene maraleucel), expanding its label to include treatment for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor [2][10] - This marks the fourth approval for Breyanzi in Europe, which is already approved for several other lymphoma types [3][4] Approval Details - The latest EC approval is based on the MCL cohort results from the TRANSCEND NHL 001 trial, where 82.7% of patients responded to Breyanzi, and 71.6% achieved a complete response [5][10] - Sustained clinical benefits were observed, with 50.8% of patients remaining in response at 24 months [5][10] Pipeline Expansion - Bristol Myers is actively seeking to expand its pipeline due to the negative impact of generics on its legacy products like Revlimid, Pomalyst, Sprycel, and Abraxane [6] - The approval of new drugs and label expansions for existing drugs is expected to diversify its portfolio [6] Market Reaction - Shares of BMY increased by 3.3% following positive news from Bayer regarding its cardiovascular candidate asundexian, which met primary efficacy and safety endpoints in a late-stage study [7][9] - The success of Bayer's study has raised investor optimism for BMY's cardiovascular candidate, milvexian, in secondary stroke prevention [9] Study Discontinuation - Bristol Myers and Johnson & Johnson announced the discontinuation of the late-stage Librexia study for milvexian after an interim analysis indicated it was unlikely to meet primary efficacy endpoints [11] - However, two other late-stage studies for milvexian are set to continue, with top-line data expected in 2026 [12]

Core Viewpoint - Bayer is experiencing a significant turnaround in 2025, with its stock price increasing over 59% year-to-date, making it the top performer among established multinational corporations (MNCs) [1] Group 1: Financial Performance - Bayer's stock price surged by 10.91% following the announcement of the successful Phase III trial of its FXIa inhibitor, asundexian, which significantly reduced the risk of stroke recurrence without increasing major bleeding rates [2][5] - The company has seen a dramatic recovery from a market capitalization decline of over 70% since its peak in 2015, with current market value at approximately €34.6 billion [6] - Bayer's pharmaceutical segment is expected to benefit significantly from asundexian, with projected annual sales reaching €3 billion if approved [5] Group 2: Product Development - Asundexian's success marks the first successful Phase III trial for FXIa inhibitors, providing a much-needed boost to Bayer's pharmaceutical pipeline [4][5] - Bayer has also received FDA approval for Elinzanetant, expected to achieve peak annual sales exceeding €1 billion, and Acoramidis, which has rapidly captured about 50% of the new brand prescription market share in Germany [11] Group 3: Strategic Reforms - Bayer has initiated the Dynamic Shared Ownership (DSO) reform to streamline operations, aiming for annual cost savings of approximately €2 billion by 2026 [6][7] - The company has reduced its workforce by 13% as part of its restructuring efforts, with a total of 13,500 employees laid off since early 2024 [7] - Bayer's strategy has shifted from a broad approach to a more focused one, concentrating on four core areas: oncology, cardiovascular, neurology, and rare diseases [11] Group 4: Future Outlook - Bayer's "must-win battle" plan aims to restore growth in its pharmaceutical business by launching new drugs and optimizing operations by 2027 [10][12] - The company faces ongoing challenges, including managing litigation and debt, which will be critical for its long-term success [13]

Core Insights - Bayer AG's pipeline candidate asundexian has successfully met primary efficacy and safety endpoints in the late-stage OCEANIC-STROKE Study for secondary stroke prevention [1][9] - The study demonstrated that asundexian 50 mg once daily significantly reduced the risk of ischemic stroke compared to placebo when combined with antiplatelet therapy [1][4] - Bayer plans to submit marketing authorization applications globally for asundexian following the positive study results [2][9] Study Details - The OCEANIC-STROKE study was a phase III randomized, placebo-controlled, double-blind trial evaluating asundexian's efficacy and safety in preventing ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack [3] - Results indicated that asundexian showed superiority over placebo in reducing ischemic stroke risk without increasing the rate of ISTH major bleeding [4][9] - Approximately 12 million people experience a stroke annually worldwide, with 20-30% at risk for recurrent strokes [4] Market Context - Despite existing therapies, the risk of recurrent strokes remains significant, with one in five stroke survivors experiencing another stroke within five years [5] - Stroke is the second leading cause of death globally, and recurrent ischemic events are often more disabling and associated with higher mortality [5] - The FDA has granted Fast Track Designation to asundexian, which could significantly enhance Bayer's pharmaceutical portfolio given the prevalence of secondary stroke [6] Bayer's Pharmaceutical Strategy - Bayer is actively working to broaden and diversify its pharmaceutical business, with recent progress noted in its key drugs, including Nubeqa for cancer and Kerendia for chronic kidney disease [7] - The decline in sales of Xarelto, co-developed with Johnson & Johnson, is being offset by growth from these key drugs [7][8] - Bayer is also pursuing label expansions for Nubeqa and Kerendia, which could further drive sales growth [8] Stock Performance - Year-to-date, Bayer's shares have surged by 62.7%, significantly outperforming the industry average gain of 16% [10]

Core Insights - Bayer AG's Phase 3 OCEANIC-STROKE study results for asundexian show significant efficacy in reducing ischemic stroke risk compared to placebo [1][2] - The study met primary efficacy and safety endpoints, with no increase in major bleeding risk observed [2][4] - The positive results for asundexian may have implications for Bristol Myers Squibb's milvexian program, especially after the recent halt of the LIBREXIA-ACS trial [5] Efficacy and Safety - Asundexian 50 mg once daily significantly reduced ischemic stroke risk in patients post non-cardioembolic ischemic stroke or high-risk transient ischemic attack [2] - No increase in ISTH major bleeding risk was noted with asundexian compared to placebo when combined with antiplatelet therapy [4] Industry Implications - The positive read-through from Bayer's trial is seen as beneficial for Bristol Myers Squibb's ongoing milvexian program, which faced setbacks [5] - Questions remain regarding the optimal dosing of milvexian in ongoing studies, particularly in relation to the doses used in the LIBREXIA-STROKE and LIBREXIA-AF studies [6] Comparative Analysis - Bayer's asundexian achieved approximately 91% factor XIa inhibition at the 50 mg QD dose, while Bristol Myers has not disclosed the inhibition levels for milvexian [7] - Previous studies indicated that asundexian was inferior to Eliquis despite high factor XIa inhibition, raising concerns about dosing adequacy [8] Market Reaction - Following the news, Bristol Myers Squibb's stock rose by 4.57% to $48.37 [9]