Faricimab

The pharmaceutical industrys first multispecificantibody hit the market more than a decade ago. Now, the medicines are seeing a surge of interest as drugmakers and investors embrace the more-is-better approach for cancer or autoimmune diseases.These drugs,which include bispecifics and other multi-pronged approaches, builds on the therapeutic power of monoclonal antibodies by targeting two or more sites instead of one.The first bispecific therapy hit the market when the Food and Drug Administration cleared Amgens Blincyto in 2014. Since then, more than a dozen others have followed. Behind them in development are several tri-specific and higher-order multispecific antibodies, or msAbs.This newer generation of drugs has attracted industry interest due to promising clinical results and potentially improved safety profiles and pharmacokinetics, according to a report from Back Bay Life Science Advisors. The field has already generated two blockbusters: Genentechs Hemlibra, a hemophilia treatment, and Vabysmo, used to treat eye diseases. But more are expected to reach that billion-dollar threshold, said Peter Bak, a managing director at Back Bay and one of the reports authors.While all of the approved msAbs aside from Hemlibra and Vabysmo are cancer treatments, theres been a sizable shift in the pipeline toward autoimmune disease, thanks in part to the encouraging, albeit early findings seen with cell therapies.msABs' growing market potential250msAB candidates in clinical trials, 24 of which are in late-stage registrational studies.14msABs approved by the FDA (as of August 2025), including eight that have been approved since 2023.7msAB drugs in oncology on track to become blockbusters by 2030.Back Bay Life Science AdvisorsLupus is an area where there's been some interesting data generated by a couple academic groups, and now a lot of companies are rethinking their strategy, said Bak.Some believe that T cell engagers, which draw immune defenders to cancer cells, can also be used to tame the wayward B-cells that drive autoimmune disease. The hope is that these drugs will produce similar results to CAR-T, but at a lower cost, giving them a potential market advantage. In some cases, msAbs could treat patients who didnt respond to these other treatments, Bak said.In an area like systemic lupus erythematosus where there's not much activity, and there is pretty big unmet need, one could see it being used as a first line biologic, he added. Its going to be very indication specific.Investment influxThe potentially lucrative opportunity has drawn a flurry of investments. In the first half of 2025, immunology and inflammation msAb companies outraised their cancer-focused counterparts by $269 million, according to the report.Nearly 250 msAb candidates are now in trials, including 24 late-stage drugs, and dealmaking has accelerated. And transactions involving these drugs have been on par with deals for antibody drug conjugates (180 vs. 192 deals, respectively), another popular approach,for about the last five years, according to the report.Several companies are testing msAbs for autoimmune conditions. Roches Lunsumio, a bispecific targeting CD20 and CD3 and already approved for lymphoma, recently finished an early-stage trial in lupus, Bak noted.Amgen is testing Blincyto, its anti-CD19 x anti-CD3 bispecific T cell engager in phase 2 for both lupus with nephritis and refractory rheumatoid arthritis. Meanwhile, Cullinan Therapeutics bispecific T-cell engager,CLN-978, is in phase 1 trials for lupus and rheumatoid arthritis. Initial data from Cullinans trials are expected in the first half of 2026.The other asset that people are looking at thats in late-stage development is MoonLake [Immunotherapeutics] bispecific against two forms of IL-17, Bak said.Primary endpoint results for Moonlakes phase 3 program for hidradenitis suppurativa, a chronic autoimmune skin condition, are expected this month. If all goes as planned the company could file for approval in mid-2026.While interest in autoimmune research has accelerated, oncology indications are still garnering attention, including the bispecific and potential Keytruda rival, ivonescimab, which was developed by China-based Akeso and licensed to Summit Therapeutics. Companies are also exploring msAbs in neurology, neurodegenerative diseases and solid tumors.But there are manufacturing and other challenges to overcome. These drugs will also need to prove their worth compared to other ascending drugmaking strategies, such as radiopharmaceuticals,protein degradersand cell therapies.In hematology/oncology its already there. Its very much a commercial market where people are trying to optimize the dosing profiles and how its being delivered to patients, Bak said.Elsewhere, in areas such as autoimmune conditions,its very much a race to market right now, he added. '

罗氏于2025年9月22日在伦敦举办的制药业务日，全面展现了罗氏制药业务的战略布局、研发进展、管线动态及未来增长规划。     在战略层面，罗氏围绕肿瘤/血液学、神经学、免疫学、眼科、心血管/肾脏/代谢（CVRM）五大治疗领域（TA），以“开发变革性药物”为核心目标推进“2020-2029十年制药愿景”，截至2025年已上市10款变革性药物，晚期管线中67%项目具备“同类最优（BID）”潜力，平均管线峰值销售额较2023年提升55%，同时通过“研发卓越计划”优化资源分配，将约11亿瑞士法郎研发节约重新投入高潜力项目，加速管线推进。     研发方面，罗氏建立“研发门槛（TheBar）”评估体系，从未满足需求、靶点重要性、药理特性、治疗差异化、商业价值五大维度筛选项目，目前55%新分子实体（NME）符合标准；通过外部合作与收购（如收购89bio获取Pegozafermin、与Zealand Pharma合作开发Petrelintide）补充管线，2025年已有8款NME进入III期临床，涵盖阿尔茨海默病（Trontinemab）、帕金森病（Prasinezumab）、高血压（Zilebesiran）、肥胖症（CT-388）等领域。各治疗领域管线亮点突出：     技术创新方面：靶向递送技术：解决“难递送”靶点/组织难题   1.Brainshuttle™技术：用于神经疾病药物（如trontinemab、Brainshuttle CD20），通过靶向转铁蛋白受体1（TfR1），将药物血脑屏障穿透率提升8-10倍，突破AD、PD等中枢疾病的递送瓶颈；     2.Port Delivery Platform（PDP）：眼科长效递送系统，如Susvimo（雷珠单抗植入剂），每6个月给药1次，7年随访显示50%患者维持20/40视力，后续将整合VEGF×IL6双抗（DutaFab），实现“抗血管生成+抗炎”双效且减少注射次数。     神经学领域，Fenebrutinib（BTKi）在多发性硬化症（MS）中显示双机制疗效，Trontinemab（抗Aβ单抗）通过血脑屏障高效转运实现快速淀粉样蛋白清除，Prasinezumab（抗α-突触核蛋白单抗）有望成为首个帕金森病疾病修饰疗法；     免疫学领域，Gazyva（抗CD20单抗）在狼疮肾炎III期临床达主要终点，Afimkibart（抗TL1A单抗）在炎症性肠病（IBD）中展现深度缓解潜力，Sefaxersen（补体B因子反义寡核苷酸）针对IgA肾病进入III期；     眼科领域，Vabysmo（双抗）在视网膜血管疾病中持续提升市场份额，Susvimo（端口给药系统）实现每6个月给药，OpRegen（RPE细胞疗法）在地理萎缩中显示视力保护效果；     CVRM领域，构建以肥胖为核心的多元化管线，CT-388（GLP-1/GIP双激动剂）、Petrelintide（长效胰淀素类似物）、CT-996（口服GLP-1激动剂）等在I/II期临床中展现体重降低与代谢改善疗效，Zilebesiran（抗血管紧张素原siRNA）进入III期评估高血压心血管结局，Pegozafermin（FGF21类似物）在非酒精性脂肪性肝炎（MASH）中实现肝纤维化逆转。     商业与运营层面，未来增长依赖“在市产品稳步贡献+管线上市驱动”，聚焦CVRM领域的肥胖、高血压等大病种，计划成为肥胖治疗领域前三企业，结合诊断业务（如Elecsys®pTau217血液检测）与数字健康工具（远程监测、AI辅助决策），构建“诊断-治疗-监测”一体化患者服务体系，支撑长期增长。