Evobrutinib

PRESS RELEASE AB SCIENCE RECEIVES JAPANESE PATENT PROTECTION FOR THE USE OF MASITINIB IN PROGRESSIVE FORMS OF MULTIPLE SCLEROSIS (MS) UNTIL 2041 THIS IS THE FIRST COUNTRY DELIVERING THE MS PATENT MASITINIB HAS UNIQUE AND COMPETITIVE POSITIONING IN PROGRESSIVE FORMS OF MULTIPLE SCLEROSIS DUE TO ITS DISTINCTIVE SAFETY AND EFFICACY PROFILE AND MECANISM OF ACTIONS TARGETING BOTH MICROGLIA AND MAST CELLS Paris, January 21, 2026, 6pm CET AB Science SA (Euronext - FR0010557264 - AB) today announced that the Japanese Patent Office has formally granted a patent for methods of treating progressive multiple sclerosis (MS) with its lead compound masitinib. This new patent (JP 7788154) ensures intellectual property protection for masitinib until February 2041. This is the first country to deliver the patent to protect the use of masitinib in progressive forms of MS. AB Science has followed for the protection of masitinib in progressive forms of MS the same methodology as for the use of masitinib in ALS. This last patent was granted everywhere in the world. AB Science is optimistic in its chance to receive the protection of the use of masitinib in progressive MS worldwide. The same secondary medical use patent strategy is pursued for several indications, including amyotrophic lateral sclerosis until 2037 (with 5 years possible extension), progressive forms of MS and Alzheimer’s Disease until 2041, sickle cell disease until 2040, and prostate cancer until 2042, severe mastocytosis until 2036. Masitinib unique and competitive positioning in progressive forms of MS, both primary progressive multiple sclerosis (PPMS) and non-active secondary progressive multiple sclerosis (nSPMS) Masitinib is positioned as a treatment of progressive MS patients, including the subvariants of PPMS and nSPMS. The development of masitinib in progressive forms of multiple sclerosis is based on the positive phase 2b/3 study (AB07002) and confirmatory phase 3 MAXIMS study (AB20009) Study AB07002 (656 enrolled patients) achieved its primary analysis endpoint, showing a statistically significant reduction in the cumulative change in EDSS with masitinib 4.5 mg/kg/day (p=0.0256) [1]. This treatment effect was consistent for both PPMS and nSPMS. Masitinib significantly reduced the risk of first disability progression by 42% and improved manual dexterity, as measured by the 9-hole peg test (p=0.0388). Furthermore, the risk of reaching an Expanded Disability Status Scale (EDSS) score of 7.0, indicating a level of disability severe enough to confine the patient to a wheelchair, was significantly reduced (p=0.0093). Masitinib’s safety was consistent with the known risk pro masitinib, with no increased risk of infection. Study AB20009 (MAXIMS) is a randomized, double-blind, phase 3 study of masitinib 4.5 mg/kg/day in patients with PPMS and nSPMS. The objective of this study is to confirm the positive results of study AB07002. Study AB20009 will enroll patients with an EDSS score of 3.0-6.0, disease progression within 2 years of randomization, and the absence of T1 Gadolinium-enhancing brain lesions. The primary endpoint of this study is the effect of masitinib on the time to confirmed disability progression over 96 weeks, with progression defined as a 1-point worsening when the EDSS baseline score is ≤5.5 or a 0.5-point worsening if the EDSS baseline score is >5.5. Masitinib safety pro based on a large database The safety pro masitinib is well characterized based on a safety population of more than 4,300 patients, including close to 2,000 patients receiving masitinib for more than 6 months and 1,200 patients receiving masitinib for more than a year. Interestingly, masitinib does not target B-cells, unlike BTK inhibitors, another class of tyrosine kinase inhibitors developed for multiple sclerosis. Targeting B cells, which are not a therapeutic target in progressive forms of multiple sclerosis, is associated with an increased risk of infection and immunological changes. Safety population Patients exposed to Masitinib All ≤ 3 months More than 3 months More than 6 months More than 1 year More than 2 years All 4,318 1,674 2,644 1,924 1,255 560 Healthy volunteers 96 96 0 0 0 0 Non-oncology subjects 2,184 565 1,619 1,307 958 453 Oncology subjects 2,038 1,013 1,025 617 297 107 ICH Topic E1 requirements for non-orphan drugs 1,500 300-600 100 Masitinib is the first in class and only drug in phase 3 designed to specifically target both mast cells and microglia, with strong evidence that this dual targeting the innate immune system is an effective strategy for the treatment of progressive forms of multiple sclerosis Masitinib is a first-in-class oral tyrosine kinase inhibitor, capable of slowing functional decline in progressive MS by selectively targeting the innate immune system through both mast cells and microglia, and without any apparent negative impact on B-cell or T-cell activity. Masitinib has demonstrated the ability to decrease serum neurofilament light chain (NfL) concentration in an animal model of MS, and by extension, possibly neuronal damage [2]. Masitinib targets microglia and mast cells, both of which play crucial roles in progressive MS and the experimental autoimmune encephalomyelitis (EAE) model of MS, as evidenced by numerous publications [3-13]. There is a strong medical need for the progressive forms of multiple sclerosis Multiple Sclerosis is an autoimmune disease of the central nervous system that affects more than 100,000 people in France and for which no definitive treatment exists to date. It is characterized by progressive degradation of the nerve cells of the central nervous system by the patient's immune system and comes in two main forms. The relapsing-remitting form (RRMS) is characterized by relapses of the disease. During these relapses, patients experience the onset of new symptoms or worsening of existing symptoms. These flare-ups are usually followed by recovery periods of varying lengths, after which some symptoms may persist. Relapsing-remitting forms of multiple sclerosis are mostly associated with dysfunction of adaptive immunity 1 (B and T cells). The progressive form (PPMS and nSPMS) is characterized by a constant and regular worsening of the symptoms of the disease without a distinct relapse or period of recovery. The rate of onset of severe, disabling, and irreversible disability is much higher in the progressive forms of the disease than in the relapsing-remitting forms. In progressive multiple sclerosis, innate 2 immune cells, such as macrophages, microglia, and mast cells, play a major role. To date, the vast majority of treatments for the management of multiple sclerosis target the patient's adaptive immune system and, therefore, mainly apply to relapsing-remitting forms of the disease. However, patients with progressive forms of the disease currently account for approximately 50% of MS cases. The medical need in PPMS remains very high, following mixed results from BTK inhibitors in multiple sclerosis. Tolebrutinib (Sanofi) failed in phase 3 studies in RRMS and PPMS, while showing a positive result in nSPMS that nonetheless resulted in an FDA Complete Response Letter due to significant safety concerns, including a high risk of fatal drug-induced liver injury. Evobrutinib (Merck/EMD Serono) and fenebrutinib (Roche/Genentech) failed to demonstrate efficacy in RRMS Phase 3 trials, with fenebrutinib showing only non-inferiority to ocrelizumab in PPMS. Consequently, evobrutinib development was discontinued. Remibrutinib (Novartis) is the only BTK inhibitor with ongoing phase 3 trials in RRMS. References [1] Vermersch P, et al. Efficacy and Safety of Masitinib in Progressive Forms of Multiple Sclerosis: A Randomized, Phase 3, Clinical Trial. Neurol Neuroimmunol Neuroinflamm. 2022 Feb 21;9(3):e1148. [2] Hermine O, et al. Tyrosine kinase inhibitor, masitinib, limits neuronal damage, as measured by serum neurofilament light chain concentration in a model of neuroimmune-driven neurodegenerative disease. PLoS One. 2025;20(5):e0322199. [3] Sandhu JK, Kulka M. Decoding Mast Cell-Microglia Communication in Neurodegenerative Diseases. Int J Mol Sci. 2021 Jan 22;22(3):1093. [4] Pinke KH, et al. Should mast cells be considered therapeutic targets in multiple sclerosis? Neural Regen Res. 2020 Nov;15(11):1995-2007. [5] Pinke KH, et al. Calming Down Mast Cells with Ketotifen: A Potential Strategy for Multiple Sclerosis Therapy? Neurotherapeutics. 2020 Jan;17(1):218-234. [6] Brown MA, Weinberg RB. Mast Cells and Innate Lymphoid Cells: Underappreciated Players in CNS Autoimmune Demyelinating Disease. Front Immunol. 2018;9:514. [7] Skaper SD, Facci L, Zusso M, Giusti P. An Inflammation-Centric View of Neurological Disease: Beyond the Neuron Front Cell Neurosci. 2018;12:72. [8] Hendriksen E, et al. Mast cells in neuroinflammation and brain disorders Neurosci Biobehav Rev. 2017;79:119-133. [9] Elieh-Ali-Komi D, Cao Y. Role of Mast Cells in the Pathogenesis of Multiple Sclerosis and Experimental Autoimmune Encephalomyelitis. Clin Rev Allergy Immunol. 2017;52(3):436-445. [10] Conti P, Kempuraj D. Important role of mast cells in multiple sclerosis. Mult Scler Relat Disord. 2016;5:77-80. [11] Skaper SD, Facci L, Giusti P. Mast cells, glia and neuroinflammation: partners in crime?. Immunology. 2014;141(3):314-327. [12] Skaper SD, et al. Microglia and mast cells: two tracks on the road to neuroinflammation. FASEB J. 2012;26(8):3103-3117. [13] Zappulla JP, Arock M, Mars LT, Liblau RS. Mast cells: new targets for multiple sclerosis therapy?. J Neuroimmunol. 2002;131(1-2):5-20. About AB Science Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment. AB Science has developed a proprietary portfolio of molecules and the Company’s lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB). Further information is available on AB Science’s website: . Forward-looking Statements - AB Science This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance. These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations. For additional information, please contact: AB Science Financial Communication & Media Relations investors@ab-science.com 1 Adaptive immunity corresponds to the immune protection that an individual builds over the course of his or her life according to the pathogens to which his or her organism is exposed. 2 An individual's innate immunity represents his immune protection from birth. Attachment MS Patent JP VENG VF

摩根大通是生物制药业务年度的正式开端。在旧金山联合广场附近几个街区内，新的联系被建立起来，老朋友们重聚。白天连续两场30分钟的会议和每晚的招待会之间，我太累了，无法跟上在圣弗朗西斯威斯汀举行的演讲。     所以在回波士顿的航班上，我（在大量人工智能协助下）总结了全球23家顶级制药公司的每场JPM演讲和炉边谈话。这里是完整的指南——这样你就能和我一起了解新闻进展。 涵盖公司: Eli Lilly, Johnson & Johnson, AbbVie, Roche, AstraZeneca, Merck & Co., Novartis, Novo Nordisk, Amgen, Gilead Sciences, Pfizer, Vertex, Bristol-Myers Squibb, Sanofi, Regeneron, Merck KGaA / EMD Serono, UCB, Takeda, Bayer, Daiichi Sankyo, Biogen, Astellas 1. 礼来（Eli Lilly | LLY） 公司概况市值约9690亿美元（截至 2026.01.15）2024 年营收约 450 亿美元      战略重点肥胖/心代谢为新时代战略核心，从单一产品转向全面组合在全球13个制造基地投资 550 亿美元75% 以上新临床药物布局在非胰高血糖素类途径2025 年实现 39 笔 BD 交易，部署资金超过 40 亿美元与 NVIDIA 合作，AI 加速平台能比行业同行快约 3.5 年  管线亮点与未来催化剂心代谢：Tirzepatide 扩展适应症（OSA、心血管、肾脏、肝脏、疼痛）口服 GLP-1：Orforglipron神经科学：Donanemab（阿尔茨海默）、Remternetug肿瘤学：Imlunestrant、Pirtobrutinib、Olomorasib 等其他进阶项目包括 siRNA、ADC、放射配体疗法等  2. 强生（Johnson & Johnson | JNJ） 战略信息CEO 对 未来 5-7% 年度销售增长持乐观预期从政策主导的年份转向重视基础执行未来将有约 12 个产品在 6 大核心治疗领域陆续上市  管线更新核心催化剂包括口服IL-23拮抗剂Icotrokinra，预计 2026 年推出  3. 艾伯维（AbbVie | ABBV） 战略信息对长远增长具有“清晰可见路径”免疫学产品 Skyrizi + Rinvoq 在 2027 年的组合收入指引达 310 亿美元强调肿瘤业务的潜在价值被市场低估      管线亮点Emrelis（c-Met ADC）获 FDA 批准用于 NSCLC部分 in-China 血癌资产通过授权模式 (最高 10.6 亿美元) 上线  4. 罗氏（Roche | RHHBY） 战略信息目标到 2030 年成为全球肥胖治疗前三大公司强调内部研发引擎，除 Carmot 27 亿美元收购外少有大规模并购预计 2026 年将有 10 个关键 III 期读出  产品与管线肥胖/代谢类资产进入晚期Vabysmo（视网膜疾病）和 Ocrevus（MS）继续贡献增长  5. 阿斯利康（AstraZeneca | AZN） 战略信息2030 年营收目标已从      ~670 亿美元提升至 ~800 亿美元拥有 104 个 III 期试验，其中 37 个为晚期项目积极收购 AI 公司 Modela，加强计算病理与研发效率  重点管线Baxdrostat（高血压）、Camizestrant（乳腺癌）、Garadacimab（遗传性血管性水肿）      6. 默克 & Co.（Merck & Co. | MRK） 战略信息面对 KEYTRUDA 专利悬崖（2028），积极通过新创新填补增长缺口新增长机会超过 700 亿美元预计 2026-2027 年有大量 III 期读出  管线亮点HIV、炎症、肿瘤及眼科等多领域布局核心包括 WINREVAIR、ENFLONSIA 等 late-stage 项目  7. 诺华（Novartis | NVS） 战略信息过去几年维持 ~7% 销售 CAGR2026-2030 年指导净销售 CAGR 5-6%实现 38.7% 利润率，并计划恢复至 40%+ 重点资产与管线多个潜在多十亿峰值产品，如 ianalumab、pelacarsen、drugs for IgAN 等  8. 诺和诺德（Novo Nordisk | NVO） 战略信息新 CEO Doustdar 主导战略调整推出首款口服肥胖药 Wegovy（显著体重下降率）扩大直达患者渠道与合作伙伴网络      管线亮点CagriSema、Amycretin 等多款肥胖/代谢资产推进中失去 Metsera 标的争夺战，但战略仍聚焦 external deals 9. 安进（Amgen | AMGN） 战略信息通过心血管、骨健康、罕见病、炎症等 6 大增长驱动因子实现稳健成长2025 年营收与 EPS 均保持健康增长AI 在 R&D/运营/商业化全流程渗透  管线重点MariTide（每月 T2D 疗法）、Repatha（CV 风险降低）、肿瘤与生物类似药布局  10. 吉利德科学（Gilead Sciences | GILD） 战略信息HIV/病毒学长期领导地位稳固预计管线为历年最强  管线与项目CAR-T 资产      Anito-cel 正向 FDA 提交Trodelvy 标签扩展及 Yeztugo 加速市场渗透  11. 辉瑞（Pfizer | PFE） 战略信息聚焦成本效率、2028 年后增长与 AI2026 年目标收入约 610 亿美元      管线亮点超长作用 GLP-1、ELREXFIO、Lyme 疫苗、TALZENNA + XTANDI 联合疗法等  12. 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Merck KGaA / EMD Serono（默克德国 | 非 MRK） 战略主题聚焦 免疫、肿瘤、神经      三大治疗领域明确将 精准医学与生物标志物分层      作为核心竞争壁垒加强与学术机构及初创公司的早期合作 主要管线Evobrutinib（BTK 抑制剂）：多发性硬化（MS）Xevinapant：头颈癌放化疗联合免疫调节和 DNA 修复相关新机制项目 关键催化剂BTK 项目在 MS 领域的长期安全性与差异化数据肿瘤联合疗法的 III 期结果 18. UCB（优时比 | UCB） 战略主题明确定位为 “专注免疫与神经的精品创新药公司”战略核心是 高置信度靶点 + 快速全球商业化AI 主要用于抗体工程和适应症拓展建模 主要管线Bimekizumab：银屑病、银屑病关节炎持续放量Zilucoplan：重症肌无力Dapirolizumab：系统性红斑狼疮（SLE） 关键催化剂Bimekizumab 在更多免疫适应症的全球扩展神经免疫资产的长期差异化验证 19. Takeda（武田制药 | TAK） 战略主题战略聚焦四大领域：胃肠道、罕见病、血浆衍生物、肿瘤明确强调 现金流纪律 + 高 ROI 管线对外 BD 偏好中后期、机制已验证项目 主要管线Narcolepsy（嗜睡症）新机制项目炎症性肠病（IBD）新一代靶点血液肿瘤及细胞治疗布局 关键催化剂IBD 管线的 II/III 期转折点中枢神经系统（CNS）项目的概念验证数据 20. Bayer（拜耳 | BAYRY） 战略主题明确将制药业务重塑为“高创新密度、低管线冗余”在经历结构调整后，强调研发效率与选择性投资AI 用于临床试验患者筛选与真实世界数据分析 主要管线Asundexian（FXIa 抑制剂）：心血管疾病肿瘤学与细胞疗法项目女性健康与心肾代谢交叉领域 关键催化剂FXIa 项目在抗凝领域的差异化安全性数据管线“去农业化”后的盈利能力改善 21. Daiichi Sankyo（第一三共 | DSNKY） 战略主题明确自身为 “全球 ADC 领导者”所有资源高度聚焦 ADC 技术平台与适应症拓展与阿斯利康（AZ）合作被视为行业标杆级 BD 案例 主要管线Enhertu（DS-8201）：乳腺癌、肺癌、胃癌多适应症Dato-DXd：肺癌、乳腺癌多个新一代 ADC（不同 linker / payload） 关键催化剂Enhertu 在一线治疗中的进一步前移ADC 管线的适应症矩阵扩展 22. Biogen（百健 | BIIB） 战略主题从“阿尔茨单一故事”转向 多支柱神经科学公司重点包括 神经退行性疾病 + 罕见神经病精简成本结构，聚焦高价值项目 主要管线Leqembi（AD）：长期真实世界数据Zuranolone：抑郁症BIIB100 / BIIB131：ALS、SMA 关键催化剂AD 药物的长期临床获益与支付体系接受度罕见神经病资产的注册性进展 23. Astellas Pharma（安斯泰来 | ALPMY） 战略主题战略核心是 “First-in-Class / Best-in-Class”高度重视 细胞疗法、基因疗法、靶向蛋白降解AI 主要用于蛋白结构与药效预测 主要管线Zolbetuximab：胃癌ASP3082（KRAS G12D PROTAC）眼科与泌尿领域持续创新 关键催化剂KRAS G12D 项目的人体概念验证数据肿瘤资产在亚洲与全球市场的协同放量 原文链接： https://open.substack.com/pub/liangchang/p/i-summarized-23-global-pharma-presentations?utm_campaign=post&utm_medium=web 本文为《I Summarized 23 Global Pharma Presentations at JPM 2026》的中文翻译，本翻译已注明来源与作者，未修改原文核心观点。若原著作权人认为使用不当，请联系本公众号，将立即删除并致歉。