来源：经济观察网 经济观察网 根据截至2026年2月20日的公开信息，罗氏公司（RHHBY.US / ROG.SW）近期值得关注的 事件主要围绕财务业绩、研发管线进展及市场动态展开： 业绩经营情况 2025年财报发布：罗氏于2026年1月29日公布2025年全年业绩，销售额达615.16亿瑞士法郎（约744亿美 元），按恒定汇率计算增长7%，核心营业利润增长13%。公司预计2026年销售额将实现中个位数增 长。股息提议：董事会提议将每股股息提高至9.80瑞士法郎，若获批准，将是连续第39年增加股息。 产品研发进展 新药申报与数据读出：2026年计划申报3款新分子实体（NMEs）并推出2项关键适应症。重点包括减重 药物CT-388的III期数据（48周体重减轻22.5%）、多发性硬化症药物fenebrutinib的III期结果，以及 giredestrant在乳腺癌领域的进展。减重领域布局：罗氏目标成为全球减重领域前三，2026年将公布5款 NMEs的III期数据，涉及GLP-1/GIP双重激动剂等。 行业政策现状 医保目录纳入：2025年12月，罗氏三款创新药（伊那利塞片、格菲妥单抗注射液等）首次纳入中国国家 ...

Summary of Zenas BioPharma Conference Call Company Overview - **Company**: Zenas BioPharma (NasdaqGS: ZBIO) - **Event**: Guggenheim Emerging Outlook Biotech Summit 2026 - **Date**: February 11, 2026 Key Points on IgG4-RD and Obexelimab - **Pipeline Focus**: The primary focus is on obexelimab and its application in IgG4-related disease (IgG4-RD) [2][3] - **INDIGO Phase 3 Study Results**: - Reported a **56% risk reduction** in time to disease flare with a hazard ratio of **0.4** [3] - Approximately **75% of patients** were free from flares, indicating strong efficacy [3] - In the open-label extension, **92% of evaluable patients** remained flare-free at six months [4] - **Safety Profile**: - Serious adverse events were comparable to placebo, with no significant increase in infections [4][5] - The subcutaneous administration showed similar injection site reactions to placebo, enhancing its safety profile [5] Market Research Insights - **Market Research Study**: Conducted with **80 participants**, primarily rheumatologists and gastroenterologists [6] - **Prescribing Likelihood**: - **64%** of physicians indicated they would likely prescribe obexelimab [8] - Expected market share allocation: **47%** for obexelimab, with the remainder split between Uplizna and rituximab [8] - **Patient Population Insights**: - Physicians reported treating an average of **18 patients** per year with IgG4-RD [6] - The drug is seen as suitable for older patients or those with concurrent illnesses [9] Commercialization Strategy - **Market Opportunity**: Estimated market size for IgG4-RD treatment in the U.S. is between **$3-$4 billion**, with expectations for obexelimab to exceed **$1 billion** in sales [41][42] - **Patient Population**: Approximately **20,000 diagnosed patients** in the U.S. currently, with potential for growth through increased education and diagnosis [40] - **Launch Timeline**: - BLA filing expected in **Q2 2026** for the U.S. and in the second half of the year for Europe [56] - Initial launch will feature prefilled syringes, followed by an autoinjector within a year [56] Lupus Program Insights - **Sunstone Study**: - Results expected in **Q4 2026**, focusing on the **BICLA primary endpoint** [62] - Emphasis on strict screening criteria to ensure a pure patient population for accurate results [65] - **Biomarker Program**: A gene pattern identified in **30% of lupus patients** may indicate higher responsiveness to treatment [80] BTK Inhibitor Insights - **Orelibrutinib**: Positioned as a potent option for progressive MS, with ongoing trials to demonstrate its efficacy [90] - **Comparison with Competitors**: Fenebrutinib showed promising results compared to Ocrevus, indicating a competitive landscape for BTK inhibitors [88] Future Developments - **New Molecules**: - TYK2 and IL-17 oral molecules are set to enter clinical trials soon, with promising characteristics noted [95][97] - **Rapid Development**: The IL-17 molecule is expected to move quickly through clinical phases, with outcomes anticipated by the end of the year [97] Conclusion - Zenas BioPharma is positioned to capitalize on its robust pipeline, particularly with obexelimab for IgG4-RD, and is preparing for significant market entry and expansion in the coming years. The company is also actively pursuing additional indications, including lupus and progressive MS, with a focus on safety and efficacy in patient populations.

Roche (OTCPK:RHHB.F) Conference Call Summary Company Overview - **Company**: Roche - **Focus**: Neurology, specifically Multiple Sclerosis (MS) treatments - **Key Products**: Ocrevus (ocrelizumab), fenebrutinib Core Industry Insights - **Multiple Sclerosis (MS)**: A significant unmet medical need exists, with approximately 30% of patients on low-efficacy treatments and continuing to progress [10][11] - **Treatment Paradigm**: Ocrevus has revolutionized MS treatment since its launch in 2017, being the first and only twice-yearly anti-CD20 approved for both relapsing and primary progressive MS (PPMS) [5][6] Key Points from the Call Fenebrutinib Development - **Phase 3 FENtrepid Results**: Fenebrutinib has shown non-inferiority to ocrelizumab in reducing disability progression in PPMS, with a 12% risk reduction in confirmed disability progression [24][25] - **Mechanism of Action**: Fenebrutinib is a non-covalent BTK inhibitor that addresses both relapsing and progressive MS biology, potentially impacting disability accumulation [13][39] - **Clinical Trial Design**: The FENtrepid study was a multicenter, randomized, double-blind trial comparing fenebrutinib to ocrelizumab, with a primary endpoint of confirmed disability progression [19][20] Ocrevus Franchise Update - **Current Usage**: Over 450,000 patients are currently treated with Ocrevus, which remains the leading new-to-brand medicine in MS [5][6] - **Ocrevus Zunovo**: A new subcutaneous formulation has shown significant uptake, contributing to over 50% of global growth in Q4 2025, with a projected CHF 2 billion incremental sales opportunity by 2029 [6][7] Safety and Efficacy - **Safety Profile**: Fenebrutinib showed a higher incidence of liver enzyme elevations compared to ocrelizumab, with 14% of patients in the fenebrutinib arm withdrawing due to adverse events, primarily related to liver enzyme elevations [30][34] - **Fatal Events**: There were more fatal events in the fenebrutinib arm (7) compared to ocrelizumab (1), but investigators assessed these as unrelated to the study drug [31][32] Future Outlook - **Pipeline Expansion**: Roche is advancing multiple molecules in neurology, including prasinezumab for Parkinson's and trontinemab for Alzheimer's, alongside fenebrutinib [10][12] - **High-Concentration Ocrevus**: A new formulation with an on-body injector is expected to launch in 2028, allowing for home administration [7][8] Additional Insights - **Market Positioning**: Fenebrutinib is positioned as a first-in-class oral therapy for both PPMS and relapsing MS, providing an alternative for patients who may not tolerate or have access to infusions [60][61] - **Clinical Practice**: The majority of patients in clinical practice are currently on ocrelizumab, with ongoing discussions about the potential for fenebrutinib to be used across a broader population of PPMS patients [69][70] Conclusion Roche's ongoing developments in the MS treatment landscape, particularly with fenebrutinib and the Ocrevus franchise, highlight the company's commitment to addressing significant unmet medical needs in neurology. The promising results from the FENtrepid study and the strategic expansion of their product offerings position Roche favorably in the competitive landscape of MS therapies.

Summary of Conference Call on Fenebrutinib and Multiple Sclerosis Pipeline Company and Industry Overview - The conference call focused on the phase 3 FENtrepid results for fenebrutinib, a treatment for primary progressive multiple sclerosis (PPMS), presented at ACTRIMS 2026. The discussion also included updates on the Ocrevus franchise and the broader multiple sclerosis (MS) pipeline [4][6]. Core Points and Arguments Fenebrutinib and Ocrevus - Fenebrutinib is positioned as a potential first-in-class and best-in-class treatment for both relapsing multiple sclerosis (RMS) and PPMS, with a dual mechanism of action targeting both relapsing and progressive disease biology [15][39]. - Ocrevus remains the leading treatment for MS, with 450,000 patients currently treated. It is the first and only twice-yearly anti-CD20 approved for both RMS and PPMS [7][10]. - The FENtrepid study demonstrated non-inferiority of fenebrutinib compared to ocrelizumab (Ocrevus) in reducing disability progression, achieving a 12% risk reduction in confirmed disability progression [27][39]. Clinical Data and Pipeline Updates - The FENtrepid study involved a well-established PPMS population, with a low presence of gadolinium-enhancing lesions, indicating a focus on progressive disease biology [25][26]. - Fenebrutinib showed a significant reduction in relapse rates, with approximately one relapse every 17 years reported in the FENhance 2 study [18]. - The MS pipeline includes other promising treatments, such as prasinezumab for Parkinson's disease and trontinemab for Alzheimer's disease, indicating a broad focus on neurodegenerative diseases [12][13]. Safety and Efficacy Concerns - There were concerns regarding liver enzyme elevations, with a higher frequency observed in the fenebrutinib arm compared to ocrelizumab. However, the majority of liver enzyme elevations resolved, and no confirmed Hy's Law cases were reported [32][35][39]. - Fatal events were reported in the fenebrutinib group, but investigators assessed them as unrelated to the study drug [33][39]. Additional Important Insights - The call highlighted the unmet medical need in MS, with about 30% of patients remaining on low-efficacy treatments and continuing to progress, underscoring the demand for new therapies [13][14]. - Fenebrutinib is expected to provide an oral treatment option, which may appeal to patients who prefer not to undergo infusions or injections [62][64]. - The potential for fenebrutinib to address both relapsing and progressive disease components positions it uniquely in the market, especially as the first oral high-efficacy treatment for both RMS and PPMS [64]. Conclusion - The conference call provided a comprehensive overview of fenebrutinib's clinical data, its positioning against existing treatments like Ocrevus, and the broader MS pipeline. The results from the FENtrepid study are promising, indicating potential for fenebrutinib to become a significant player in the treatment landscape for multiple sclerosis. The safety profile, particularly regarding liver enzyme elevations, will require ongoing monitoring as the drug moves closer to potential approval.

Core Insights - Roche's experimental drug fenebrutinib has successfully met its primary endpoint in a late-stage trial for patients with primary progressive multiple sclerosis [1] Company Summary - Roche is a Swiss pharmaceutical company that is advancing its research in multiple sclerosis treatments [1] - The successful trial results for fenebrutinib may enhance Roche's position in the competitive pharmaceutical market for neurological disorders [1] Industry Summary - The pharmaceutical industry is witnessing significant advancements in treatments for multiple sclerosis, particularly in progressive forms of the disease [1] - The success of fenebrutinib could lead to increased investment and interest in the development of similar therapies within the industry [1]

Core Insights - Roche announced that fenebrutinib, an investigational BTK inhibitor, met its primary endpoint of non-inferiority compared to OCREVUS in reducing disability progression in patients with primary progressive multiple sclerosis (PPMS), showing a 12% reduction in risk [1][5][6] Group 1: Study Results - The Phase III FENtrepid study involved 985 adult patients with PPMS, comparing daily oral fenebrutinib to intravenous OCREVUS for at least 120 weeks [7][12] - Fenebrutinib demonstrated a consistent treatment effect on the composite confirmed disability progression (cCDP12) across various patient subgroups, with curves separating as early as 24 weeks [1][2] - A post-hoc analysis indicated fenebrutinib was superior to OCREVUS on a composite endpoint, showing a 22% reduction in risk [3] Group 2: Treatment Effects - The strongest treatment effect was observed on the nine-hole peg test (9HPT), with a 26% reduction in the risk of worsening compared to OCREVUS [2] - Fenebrutinib showed a consistent clinical benefit in upper limb function, which is crucial for maintaining independence [3] Group 3: Safety Profile - Adverse events in the fenebrutinib group were comparable to OCREVUS, with infections occurring in 67.0% of patients on fenebrutinib versus 70.9% on OCREVUS [4] - Transient liver enzyme elevations were more frequent in the fenebrutinib group (13.3% vs 2.9% for OCREVUS), but all cases resolved after discontinuation [4] Group 4: Future Developments - Roche plans to submit regulatory applications for fenebrutinib in both PPMS and relapsing multiple sclerosis (RMS) following the readout of the second pivotal RMS study, FENhance 1, expected in mid-2026 [5][6]

Core Insights - Roche announced that fenebrutinib, an investigational BTK inhibitor, met its primary endpoint of non-inferiority compared to OCREVUS in reducing disability progression in patients with primary progressive multiple sclerosis (PPMS), showing a 12% reduction in risk of disability progression [1][5] - The treatment effect was consistent across patient subgroups and observed as early as 24 weeks, particularly benefiting upper limb function [3][5] Study Details - The FENtrepid study was a Phase III multicenter, randomized, double-blind trial involving 985 adult patients with PPMS, comparing daily oral fenebrutinib to intravenous OCREVUS for at least 120 weeks [7] - The primary endpoint was the time to onset of 12-week composite confirmed disability progression (cCDP12), which included measures of functional disability, walking speed, and upper limb function [8] Treatment Efficacy - Fenebrutinib demonstrated a 26% reduction in the risk of worsening upper limb function compared to OCREVUS [2] - A post-hoc analysis indicated fenebrutinib was superior to OCREVUS on a composite endpoint including two components of cCDP12, with a 22% reduction in risk [3] Safety Profile - Adverse events in the fenebrutinib group were comparable to OCREVUS, with infections occurring in 67.0% of patients on fenebrutinib versus 70.9% on OCREVUS [4] - Transient liver enzyme elevations were more common in the fenebrutinib group (13.3% vs 2.9% for OCREVUS), but all cases resolved after discontinuation of the drug [4] Future Developments - Roche plans to submit regulatory applications for fenebrutinib in both PPMS and relapsing multiple sclerosis (RMS) following the readout of the second pivotal RMS study, FENhance 1, expected in mid-2026 [5][6]

Core Insights - Genentech, a member of the Roche Group, announced that its investigational BTK inhibitor fenebrutinib met the primary endpoint of non-inferiority compared to Ocrevus in reducing disability progression in patients with primary progressive multiple sclerosis [1] Group 1 - The Phase III FENtrepid study demonstrated a 12% reduction in the risk of disability progression with fenebrutinib compared to Ocrevus [1]

Core Insights - Roche's adjusted operating profit increased by 5% in 2025, which was lower than expected due to the weakened US dollar, despite strong growth in its food allergy medicine Xolair and multiple sclerosis treatment Ocrevus [1] - The company's core operating profit reached SFr21.8bn ($28.4bn) in 2025, slightly below the market consensus of SFr22bn [1] Financial Performance - Total sales for Roche amounted to SFr61.5bn, reflecting a 7% change at constant exchange rates (CER), but only a 2% increase in Swiss Francs [2] - Core earnings per share were reported at SFr19.46, which is 1% below consensus estimates [2] - The appreciation of the Swiss Franc against other currencies, particularly the US dollar, significantly impacted reported results [2] Market Reaction - Investor response to Roche's financial results was lukewarm, with shares opening 0.6% lower at SFr336.3 on 29 January, down from SFr338.3 at the previous market close [3] - Roche's market capitalization stood at SFr272.6bn [3] Revenue Breakdown - Roche's pharmaceuticals division generated sales of SFr47.7bn, a 9% increase from 2024 [4] - Ocrevus was the top-selling drug, generating SFr7bn, while Vabysmo grew 12% year-over-year to SFr4.1bn, although this was 2% below consensus estimates [4] - Xolair experienced a significant growth of 32% in 2025, but biosimilar launches are anticipated in the second half of 2026 [4] Future Outlook - Roche's stock has seen an upward trend due to positive clinical data for pipeline products, including successful Phase III studies for fenebrutinib and promising Phase II data for obesity candidate CT-388 [5] - The company aims to launch 19 new molecular entities (NMEs) by 2030, as stated by CEO Thomas Schinecker [5]

Core Viewpoint - Roche and Sanofi's latest earnings met expectations, with both companies emphasizing the importance of developing new drugs to counteract the impending "patent cliff" facing the pharmaceutical industry [1][2]. Roche - Roche's sales grew by 8% in the fourth quarter, driven by blockbuster drugs like Ocrevus and Tecentriq [5]. - The company forecasts profit growth to outpace sales growth by 2026, with adjusted earnings per share expected to grow by high single digits at constant currencies [5]. - Roche plans to launch up to 19 new medicines by the end of the decade, focusing on late-stage development [3]. - The company is entering the obesity market with its weight-loss candidate CT-388, which showed a 22.5% weight reduction in Phase 2 trials, comparable to competitors [10]. - Roche has partnered with Zealand Pharma to co-develop the drug petrelintide, aiming to invest in next-generation obesity treatments [11]. Sanofi - Sanofi reported a 13% sales growth in the fourth quarter at constant currencies, with earnings per share of 1.53 euros ($1.20), exceeding forecasts [6]. - The company anticipates sales growth in the high single digits for 2026, with profit growth expected to be slightly higher than revenue [8]. - Sanofi's growth was supported by new medicines and its drug Dupixent, which reached a new quarterly high [8]. - The company announced a 1 billion euro share buyback, but investor focus remains on its research and development efforts [8]. - The need to expand the pipeline will be a key topic in Sanofi's earnings call, highlighting long-term R&D spending and potential M&A activities [9].