Fabhalta and Vanrafia Phase III analyses, Fabhalta real-world treatment pattern data, and zigakibart Phase I/II trial showcase strength of IgA nephropathy (IgAN) portfolioC3 glomerulopathy (C3G) studies add to body of evidence of Fabhalta long-term safety and efficacy profile in native and post-transplant disease recurrence patients V-INCEPTION analyses highlight Leqvio adherence and goal attainment data when initiated early in post-acute coronary syndrome patientsLp(a) data underscore importance of early ...

证券研究报告 | 2025年11月3日 创新药盘点系列报告（23） ——MNC药企在心血管领域密集布局，聚焦PCSK9及Lp(a)两大靶点 行业研究 · 行业专题 投资评级：优于大市（维持评级） 证券分析师：马千里 010-88005445 maqianli@guosen.com.cn S0980521070001 证券分析师：陈曦炳 0755-81982939 chenxibing@guosen.com.cn S0980521120001 证券分析师：彭思宇 0755-81982723 pengsiyu@guosen.com.cn S0980521060003 请务必阅读正文之后的免责声明及其项下所有内容 摘要 医药生物 · 生物制品 请务必阅读正文之后的免责声明及其项下所有内容 2 ◼ ASCVD疾病负担沉重，血脂异常是重要的始动因素。ASCVD（Atherosclerotic Cardiovascular Disease，动脉粥样硬化心血管疾病）是一类由动 脉粥样硬化引起的累及全身血管和心脏疾病的总称，包括冠状动脉疾病/冠心病、脑血管相关疾病、外周动脉疾病等。ASCVD是全球范围内首要 致死原因之一，根 ...

Core Viewpoint - The 2025 National Medical Insurance Directory negotiations are ongoing, focusing on pricing discussions for innovative drugs, particularly in the chronic disease medication sector [1] Group 1: Negotiation Details - The third day of the national negotiations began at approximately 1:40 PM, with participation from companies such as Novartis, Gensai, Roche, and Betta Pharmaceuticals [1] - The morning session emphasized negotiations on chronic disease medications, with Eli Lilly and Sinopharm bringing significant products to the discussions [1]

Core Insights - The conference call is focused on the Novartis Immunology Portfolio Update, indicating a strategic emphasis on immunology within the company's product offerings [1] Group 1 - The call is being recorded and will be available for later access on the company's website, highlighting transparency and investor engagement [1] - Ms. Isabella Zinck from Investor Relations is leading the call, suggesting a structured approach to investor communication [1]

Novartis Immunology Portfolio Update Conference Call Summary Company Overview - **Company**: Novartis - **Focus**: Immunology portfolio, including recent developments and product launches Key Industry Insights - **Immunology Market**: Over 10% of the global population suffers from immune-mediated conditions, which are chronic and progressive, leading to significant physical and psychological burdens on patients [4][5][6] - **Market Opportunity**: Chronic spontaneous urticaria (CSU) market is approximately half the size of the psoriasis market, with around 10 million patients treated for CSU, 50% of whom are uncontrolled on antihistamines [16][17] Core Product Developments Rapsodo (Remibrutinib) - **Approval**: Approved by the FDA on September 30th as the only targeted BTK inhibitor for CSU [15][16] - **Indication**: For adult patients with CSU who remain symptomatic despite H1 antihistamine treatment [16] - **Market Positioning**: Positioned as the next oral option after antihistamine failure, with a clean safety profile and no routine lab monitoring required [16][18] - **Clinical Data**: Demonstrated long-term safety and efficacy with a fast onset of action; 50% of patients achieved well-controlled disease at week 12 [19][20] - **Launch Strategy**: Initial uptake expected from allergists, followed by dermatologists; targeting 400,000 CSU patients uncontrolled on antihistamines [22][24] Yanalumab - **Indication**: Targeting Sjogren's disease, a severe systemic autoimmune disease with significant unmet needs [30][34] - **Clinical Trials**: Two phase 3 studies (Neptunus I and II) showed statistically significant improvement in disease activity measured by the SDI score [42][49] - **Mechanism of Action**: Afucosylated fully human monoclonal antibody targeting the BAF receptor, leading to B cell depletion and improved patient outcomes [40][49] - **Future Potential**: Expected to expand into other B-cell-driven diseases, including systemic lupus erythematosus (SLE) and lupus nephritis, with readouts anticipated in 2027 [56][57] Strategic Focus Areas - **Core Areas of Focus**: Immunodermatology, systemic autoimmunity, allergic conditions, and various arthritides [5][6] - **Innovation Strategy**: Emphasis on internal innovation and external acquisitions to enhance the immunology portfolio, such as the acquisition of an anti-IL-15 antibody [8][9] - **Patient-Centric Approach**: Focus on understanding disease mechanisms and patient journeys to develop meaningful treatments [7][10] Market Dynamics - **Patient Burden**: Chronic conditions like Sjogren's disease lead to significant quality of life impairments, with many patients experiencing mental health disorders [18][30] - **Diagnosis Challenges**: Delays in diagnosis often exceed four years, complicating treatment pathways [33][34] - **Treatment Landscape**: Current treatment options are limited, with many relying on off-label therapies, highlighting the need for approved therapies [34][35] Conclusion - **Pipeline Potential**: Novartis is positioned to leverage its immunology pipeline for significant market opportunities, with Rapsodo and Yanalumab as key products driving future growth [58][59] - **Commitment to Innovation**: The company is dedicated to addressing high unmet needs in immunology through innovative therapies and strategic market engagement [58][59]

Core Insights - Novartis is a global healthcare company based in Switzerland, known for its innovative medicines and treatments, competing with major pharmaceutical companies like Pfizer and Roche [1] - CFRA has set a price target of $126 for Novartis, indicating a potential increase of about 2.16% from its current trading price of $123.33 [1][5] - Zacks Investment Research highlights Novartis as a top value stock for long-term investment, emphasizing its strong market position [2][5] Stock Performance - The current stock price of Novartis is $123.12, reflecting a decrease of $0.31 or -0.25% [3] - Over the past year, Novartis has reached a high of $133.55 and a low of $96.06, with a market capitalization of approximately $240.22 billion [4] - The stock has traded between $121.65 and $123.91 today, with a trading volume of 1,552,411 shares on the NYSE [4]

Core Insights - Novartis is recognized for its innovative medicines and treatments, operating in pharmaceuticals and oncology, and competes with major companies like Pfizer and Roche [1][5] - CFRA maintains a "Hold" rating for Novartis with a current stock price of $123.56 and a price target of $126, indicating stability [1][5] - Zacks Investment Research highlights Novartis as a top value stock for long-term investment, emphasizing its strong market position [2][5] Stock Performance - Currently, Novartis (NVS) is trading at $123.59, showing a slight increase of 0.16, or 0.13%, with fluctuations between $121.65 and $123.91 on the day [3] - Over the past year, the stock has reached a high of $133.55 and a low of $96.06, indicating volatility but potential for growth [3] Market Capitalization and Trading Activity - Novartis has a market capitalization of approximately $241.14 billion, reflecting its significant presence in the healthcare industry [4][5] - The trading volume is 1,377,675 shares, suggesting continued investor interest and activity in the stock [4]

Core Insights - Novartis reported Q3 2025 earnings, with total revenue for the first three quarters reaching $41.196 billion, an 11% year-over-year increase [1] - Q3 revenue was $13.909 billion, reflecting a 7% year-over-year growth, while net profit for the quarter was $3.93 billion, up 25% [1] - Revenue from the Chinese market for the first three quarters amounted to $3.2 billion, a 5% increase year-over-year [1] Product Performance - The breast cancer treatment drug Kisqali (ribociclib) saw a significant revenue increase of 68% in Q3 compared to the same period last year [1] - Kesimpta (ofatumumab), a treatment for multiple sclerosis, generated $1.22 billion in revenue for the quarter, marking a 44% year-over-year growth [1] - Pluvicto (lutetium [177Lu] vipivotide tetraxetan) reported sales of $564 million during the period, a 45% increase from Q3 2024 [1] - Long-acting PCSK9 product Leqvio (inclisiran) achieved total revenue of $863 million for the first three quarters, a substantial increase of 61% year-over-year [1]

Core Insights - Novartis presented new data on ianalumab for Sjögren's disease, highlighting its potential to significantly improve disease activity and reduce patient burden in Phase III trials [1][2][4] Clinical Trial Results - Ianalumab 300 mg monthly showed a clinically meaningful benefit in the NEPTUNUS-1 and NEPTUNUS-2 Phase III trials, with a greater reduction in disease activity compared to placebo, sustained through Week 52 [2][4] - Statistically significant improvement in the primary endpoint, ESSDAI, was observed at Week 48, with numerical improvements noted as early as Week 16 [4][5] - Secondary outcome measures also showed consistent numerical improvements, including physician- and patient-reported outcomes, although some did not reach statistical significance [5][7] Mechanism of Action - Ianalumab is a fully human monoclonal antibody that depletes B-cells and inhibits their activation and survival via BAFF-R blockade, addressing the B-cell dysfunction central to Sjögren's disease [3][9] Future Plans - Novartis plans to submit ianalumab for regulatory approval globally in early 2026, aiming to establish it as the first targeted treatment for Sjögren's disease [5][4] Disease Overview - Sjögren's disease is a systemic autoimmune condition affecting approximately 0.25% of the population, with a higher prevalence in women, leading to significant symptoms such as dryness, fatigue, and pain [10]

NEPTUNUS-1 and NEPTUNUS-2 achieved primary objective of reduced disease activity and provided clinically meaningful benefit1 Data showed consistent improvements across secondary outcome measures, and a favorable safety profile1  Novartis plans to submit to health authorities globally in early 2026 If approved, ianalumab could become first targeted treatment for this heterogeneous, systemic autoimmune disease Basel, October 29, 2025 – Novartis today presented new ianalumab data in Sjögren’s disease, the seco ...