Novartis (NYSE:NVS) Update / Briefing November 20, 2025 04:15 AM ET Company ParticipantsNaresh Chouhan - PrincipalDianne Auclair Rocha - U.S. Therapeutic Area Head for CRMBob Baloh - Global Head of Neuroscience Biomedical ResearchReshema Kemps-Polanco - Chief Commercial Officer of the U.S. UnitVictor Bulto - President of the U.S. UnitRuchira Glaser - Global Head of CRM DevelopmentShaun Coughlin - Global Head of Cardiovascular and Metabolism Biomedical ResearchHarry Kirsch - CFOMukul Mehta - Head of Business ...

在互动平台表示，博生吉的CD7-CAR-T待产品获批以后，计划在一带一路国家进行直接申报上市的尝 试。至于欧美国家，博生吉公司已经和美国食品药品监督管理局（FDA）有过沟通，可能会使用中国的 临床数据在美国直接申报注册临床II期，通过合作伙伴在美国开展II期临床。商务拓展方面，可能会通 过对外授权或者合作开发的方式展开。 ...

据了解，此次撤回的研究摘要聚焦多发性骨髓瘤治疗领域，旨在通过"匹配调整间接比较法"（MAIC），将Carvykti的Cartitude-1、 Cartitude-4两项试验数据，与吉利德和Arcellx联合开发的BCMA靶向CAR-T疗法anito-cel的iMMagine-1试验数据进行对比分析。 据媒体报道，强生与其合作伙伴传奇生物于近日撤回了原计划在12月美国血液学会（ASH）年会上发表的一项研究摘要。核心内容为 对比双方合作的CAR-T疗法Carvykti与竞品的临床表现，撤回原因明确指向竞品公开数据不足。 传奇生物Carvykti业务负责人Alan Bash在三季度财报电话会议中公开表示，撤回摘要的核心原因是"anito-cel的公开数据有限"，经与研 究作者达成共识后做出该决定，并强调"期待未来有机会分享完整数据"。 第三方机构Leerink Partners在11月4日的报告中也曾指出，两款药物试验患者的关键预后变量存在持续差异，如是否使用过抗CD38抗 体、是否对最后一线治疗耐药等，直接对比数据本就存在难度。 作为血液学领域顶级学术会议，ASH年会的研究发布往往影响行业对药物价值的判断。此次撤 ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 reached $161.7 million, a 93% increase compared to Q3 2024 and a 15% increase over Q2 2025 [18] - Product revenue totaled $159.3 million, primarily driven by $152.9 million in US BRIUMVI net sales [18] - GAAP net income for Q3 2025 was $390.9 million, or $2.43 per diluted share, compared to $3.9 million, or $0.02 per diluted share, in the same period last year [20] Business Line Data and Key Metrics Changes - BRIUMVI's US net sales in Q3 totaled approximately $153 million, showing strong sequential and year-over-year growth [11] - The company reported that persistence and repeat prescribing of BRIUMVI exceeded expectations, reinforcing confidence in its clinical profile [11] Market Data and Key Metrics Changes - The anti-CD20 class now represents nearly $10 billion in annual US MS sales, with approximately half of all patients still on other types of disease-modifying therapies, indicating significant market opportunity [12] - The subcutaneous portion of the market is estimated to be about 35% to 40% and is expected to grow, potentially doubling the market opportunity for BRIUMVI [34] Company Strategy and Development Direction - The company is focused on continuing to innovate and improve outcomes for patients with MS, with two pivotal studies launched for BRIUMVI [5] - The strategic expansion of the commercial field organization has been emphasized to align with market opportunities and drive growth [14] - The company remains financially disciplined, completing a $100 million share repurchase program and authorizing another $100 million program [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in BRIUMVI's long-term potential, raising the full-year 2025 US BRIUMVI net revenue guidance from $570 million-$575 million to approximately $585 million [16] - The management highlighted the importance of patient retention and the impact of direct-to-consumer efforts on demand growth [25][50] Other Important Information - The company completed enrollment for the ENHANCE study and is on track to finish enrollment for the phase three subcutaneous BRIUMVI study in the first half of next year [6][7] - The third quarter marked the first full quarter of the national television campaign, which is expected to drive awareness and engagement [15] Q&A Session Summary Question: Guidance and Growth Expectations - A question was raised regarding the slight slowing of sequential growth expected in Q4 compared to previous years, with management noting that patient retention and field expansion are key factors supporting growth [24][25] Question: Demand from Permanent J Code - Inquiry about additional demand from the permanent J code was addressed, clarifying that the company has had a J code for several years [28][29] Question: Market Opportunity for Subcutaneous Products - A question was posed about the factors underpinning the estimate that subcutaneous products could double the market opportunity for BRIUMVI, with management explaining the current market dynamics and potential growth [34] Question: Inventory Channel Dynamics - Inquiry about inventory channel dynamics and gross to net changes revealed no notable changes in Q3, with the gross to net remaining within the provided range [38][40] Question: 2026 Trends and Deal Pursuits - Questions regarding 2026 trends highlighted the importance of new patient growth and the company's cautious approach to potential deals, emphasizing a high standard for ROI [49][51][52]

Group 1 - South Korean President Lee Jae-myung and Chinese President Xi Jinping emphasized the importance of stable and continuous relations between China and South Korea, aiming to enhance communication and cooperation to address challenges and promote regional peace and development [1] - The Chinese government is prioritizing the cultivation of new application scenarios in various industries, focusing on high-value areas and cross-regional integration to create a complete cycle from technological breakthroughs to industrial applications [2] - The Chinese Ministry of Commerce expressed hope for continued practical cooperation in trade and energy between China and Canada, following discussions between the two countries' trade ministers [3] Group 2 - The Chinese government is addressing issues related to the semiconductor supply chain, indicating that it will consider exemptions for exports based on the actual conditions of enterprises affected by external interventions [5] - The Ministry of Finance and the State Taxation Administration announced a tax exemption for value-added tax on standard gold transactions conducted through specific exchanges, aiming to support the gold trading sector [6] - The public fund industry is undergoing regulatory changes, with new guidelines emphasizing performance-based compensation for fund managers, particularly in cases of underperformance [7] Group 3 - The Chinese livestock industry is focusing on controlling pig production capacity, urging large enterprises to lead by example in adhering to national regulatory policies [8] - Li Auto is recalling 11,411 units of its MEGA 2024 electric vehicles due to insufficient coolant corrosion resistance, offering free replacements for affected components [9] Group 4 - The global foreign direct investment (FDI) saw a decline of 3% in the first half of the year, continuing a trend of low investment levels over the past two years [11] - Anshi China announced that it has established sufficient inventory to meet customer demand, ensuring stability in supply [12] - In October, the sales of new energy vehicles in China showed significant growth, with companies like Seres and BYD reporting year-on-year increases of 42.89% and 13.88%, respectively [13] Group 5 - Vanke A signed a framework agreement with Shenzhen Metro Group for a loan facility of up to 22 billion yuan, indicating ongoing financial collaboration [14] - Shengxin Lithium Energy plans to introduce strategic investors to raise up to 3.2 billion yuan, while Baichuan Energy aims to acquire a 22.86% stake in a robotics company for 215 million yuan [15] - Tianhua New Energy's actual controller plans to transfer 12.95% of shares to CATL at a discount of 19% from the closing price [16] Group 6 - Taiyuan Heavy Industry disclosed that its annual report contained false financial records, leading to a change in its stock designation to "ST Tai Heavy" [17] - The U.S. stock market saw collective gains across major indices, with the Nasdaq rising by 0.61% and the S&P 500 increasing by 0.26% [18] - Berkshire Hathaway reported a net profit of $30.796 billion for Q3 2025, significantly exceeding market expectations [19]

Core Viewpoint - The negotiation for the pricing of CAR-T drugs, including Huyuan Biotech's Nakialunase injection, has shown promising results, indicating a potential breakthrough in the commercial insurance innovative drug directory for 2025 [1] Group 1 - Huyuan Biotech's Nakialunase injection was approved for market launch in 2023, and it represents one of five CAR-T drugs that have passed the review for the commercial insurance innovative drug directory this year [1] - CAR-T therapies have been unable to enter the national medical insurance negotiation process for the past four years due to their high costs [1]

Group 1: Surgical Robotics - A record-breaking remote robotic surgery was successfully performed over a distance of 12,035 kilometers, certified by Guinness World Records as the "farthest distance for remote robotic surgery" [2] - The surgery was conducted by Dr. Leandro Totti in Kuwait using the Chinese-developed Jingfeng® surgical robot, demonstrating a bidirectional communication delay of only 199 milliseconds, ensuring precision and safety during the procedure [4] Group 2: Pharmaceutical Innovations - The first AI-enabled formulation drug in China, MTS-004, has successfully reached the primary endpoint of Phase III clinical trials, marking a significant milestone in the pharmaceutical industry [6] - MTS-004 is designed for the treatment of Pseudobulbar Affect (PBA) and features an orally disintegrating tablet formulation that improves patient compliance by dissolving quickly in the mouth without water [8] Group 3: Medical Devices - The GuiTracker® hard guidewire developed by Shanghai Shape Memory Alloy Materials Co., Ltd. has received approval for market launch, aimed at enhancing the performance of cardiovascular and peripheral vascular interventional surgeries [10] - The guidewire addresses clinical challenges by providing high support and stability, crucial for navigating complex vascular conditions during procedures [10] Group 4: Advanced Therapies - C-CAR168, a novel CAR-T therapy developed by Xibiman Biotechnology, has been selected as a breakthrough abstract for the 2025 American College of Rheumatology (ACR) Convergence, highlighting its potential in treating refractory autoimmune diseases [12][13] Group 5: Brain Research Initiatives - The China Brain Multi-omics Atlas Project (CBMAP) has officially launched, aiming to create a comprehensive molecular map of the human brain, focusing on the East Asian population [15] - M20 Genomics' VITA high-throughput single-cell full-length transcriptome platform has been chosen as a core method for this project, enabling high-quality analysis of precious brain tissue samples [19] Group 6: Medical Materials - The animal study results of UniPearls®, a new generation drug-loaded embolic microsphere, have been published in a leading biomaterials journal, demonstrating its effectiveness and safety for use in transarterial embolization [21][24] Group 7: Investment Landscape - Sequoia China has invested in over 200 innovative healthcare companies, covering various sectors including innovative drugs, medical devices, and digital healthcare, with more than 45 companies having completed IPOs [25]

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]

Kyverna Therapeutics Conference Call Summary Company Overview - **Company**: Kyverna Therapeutics (NasdaqGS:KYTX) - **Focus**: Development of KYV-101 for the treatment of generalized myasthenia gravis (GMG) Key Industry Insights - **Industry**: Biopharmaceuticals, specifically targeting autoimmune diseases - **Market Size**: Approximately 80,000 patients diagnosed with GMG in the U.S., with about 40,000 treated with immunosuppressants and having inadequate responses [doc id='25'][doc id='26'] Core Points and Arguments 1. **Positive Interim Data**: Kyverna announced promising interim data from the phase two portion of the KYSA-6 trial for KYV-101 in GMG patients, marking a significant milestone [doc id='2'][doc id='4] 2. **Patient Impact**: KYV-101 aims to provide durable, drug-free, and disease-free remissions for patients suffering from GMG, addressing significant unmet needs in symptom control [doc id='4'][doc id='5'] 3. **Mechanism of Action**: KYV-101 targets autoreactive B cells, aiming for a holistic immune reset, which is a fundamentally different approach compared to existing therapies [doc id='6'][doc id='9'] 4. **Efficacy Results**: - Achieved a mean reduction of 7.8 points in MG-ADL score at two weeks and sustained a mean reduction of 8 points at 24 weeks, exceeding clinically meaningful responses [doc id='13'] - 100% of patients achieved clinically meaningful responses in MG-ADL and QMG scores [doc id='15] 5. **Safety Profile**: KYV-101 demonstrated a well-tolerated safety profile with no high-grade CRS or ICANS observed, and manageable low-grade CRS events [doc id='17] 6. **Phase Three Trial Design**: The upcoming phase three trial is a global open-label randomized control trial, enrolling approximately 60 patients to establish superiority over standard care [doc id='20'][doc id='21'] 7. **Commercial Strategy**: Kyverna plans to leverage synergies from its neuroimmunology CAR-T franchise, including a first-in-class potential in stiff person syndrome (SPS) [doc id='26'][doc id='28'] Additional Important Insights - **Patient Demographics**: The trial enrolled patients with moderate to severe GMG, with an average disease burden of 5.3 years and a mean MG-ADL score of 11.2 [doc id='12'] - **Market Opportunity**: If approved, KYV-101 could compete directly with biologics, offering a potentially cost-effective and significant alternative for payers [doc id='25][doc id='26'] - **Long-term Follow-up**: The company anticipates growing its total addressable market to 40,000 patients over time as longer-term follow-up data is generated [doc id='26] - **Financial Position**: Kyverna has a strong balance sheet with cash into 2027, supporting near-term milestones including the phase three MG trial and SPS BLA filing [doc id='29] Conclusion Kyverna Therapeutics is positioned to potentially change the treatment paradigm for GMG with KYV-101, supported by promising interim data and a robust clinical and commercial strategy aimed at addressing significant unmet needs in the autoimmune disease market [doc id='81']

Core Viewpoint - WuXi AppTec's subsidiary WuXi Biologics has submitted data for the Phase I study of Relma-cel in adult patients with active systemic lupus erythematosus (SLE) to the National Medical Products Administration (NMPA) in China, marking a significant step in the development of CAR-T therapies for autoimmune diseases [1][4] Group 1: Study Overview - The Phase I study is a single-arm, open-label, multi-center, dose-exploration trial aimed at assessing the safety of Relma-cel in SLE patients, with an initial dose set at 50×10^6 CAR+T cells [1] - The study has enrolled 12 participants as of July 2025, focusing on safety, efficacy, pharmacokinetics, and pharmacodynamics across three dose levels: 50×10^6, 75×10^6, and 100×10^6 CAR+T cells [1][4] Group 2: Patient Demographics and Baseline Characteristics - All 12 enrolled patients were female, with a median age of 27 years and a median disease history of 9.5 years [2] - The patients exhibited moderate to severe active SLE, with 100% having renal involvement and other common organ systems affected including skin (50%) and hematologic systems (50%) [2] Group 3: Efficacy Results - Among the 12 patients evaluated for 6-month efficacy, 100% achieved SRI-4 response, 50% met LLDAS criteria, and 100% were drug-free [2] - Various disease activity metrics, including SLEDAI-2K and SELENA-SLEDAI scores, showed a downward trend, indicating significant therapeutic effects [2] Group 4: Safety Results - Initial safety results indicated that 11 out of 12 patients experienced grade 1 cytokine release syndrome (CRS), while one patient experienced grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS) [3] - No dose-limiting toxicities (DLT) were reported, suggesting a favorable safety profile for Relma-cel in treating moderate to severe active SLE [3][4] Group 5: Future Prospects - The ongoing study aims to gather longer follow-up data, with the potential for Relma-cel to advance to the biologics license application (BLA) stage [4] - As the first commercial CAR-T therapy approved for clinical trials in the SLE treatment space, Relma-cel demonstrates significant potential for providing breakthrough treatment options for SLE patients [4]