Crovalimab

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 本周，海思科在创新药领域再度传来重磅消息，一系列新药进展令人瞩目，展现出其在医药创新领域的强大实力与无限潜力。共有4款化药1类新药获批临床，一款1类新药HSK39297片拟纳入优先审评，用于既往未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH）成人患者。 截图来源：CDE 13款1类新药获批临床，1款新药获批上市 在12月15日至16日这短短两天内，海思科在创新药研发上有注射用HSK55718、HSK36357胶囊、HSK50042片、HSK45019片这4款化药1类新药获批临床。 截图来源：中国药品审评数据库（查数据.找摩熵） 注射用HSK55718作为小分子非阿片类镇痛药，宛如一位精准的“疼痛终结者”，专为中、重度急性疼痛患者量身打造。 HSK36357胶囊是海思科自主研发的独家小分子药物，恰似一把开启肌营养不良症治疗之门的金钥匙。它聚焦贝氏/杜氏型肌营养不良症等罕见病，为这些长期被病魔困扰的患者及其家庭带来了希望的曙光。 HSK50042片作为口服、强效、高选择性小分子抑制剂，它的出现，填补了该领域治疗的部分空白，为患者带来了生命的转机，让每一次呼吸都变得更加顺畅和有力。 HSK45019片同样是海思科自主研发、拥有独立知识产权的小分子抑制剂，它专注于炎症性肠病，包括溃疡性结肠炎和克罗恩病。 今年以来，海思科的创新成果可谓硕果累累。有13款1类新药获批临床。此外有1款1类新药安瑞克芬注射液获批上市。这一系列丰硕成果，充分彰显出海思科在创新药研发领域的强大实力。  截图来源：摩熵医药中国药品审评数据库（查数据.找摩熵） 1 类新药拟纳入优先审评，多个适应症已被开发 HSK39297是一种高效、高选择性的口服补体因子B抑制剂，作用于补体旁路途径，兼具控制血管内、外溶血的双重潜力。其口服给药方式可显著提升患者用药便利性。目前，HSK39297已被开发用于PNH、IgA肾病、狼疮肾炎、免疫性血小板减少症等多个适应症，展现出广阔的应用前景。  截图来源：摩熵医药中国药品审评数据库（查数据.找摩熵） 在国内，尽管已有诺华的伊普可泮、罗氏的可伐利单抗和阿斯利康的依库珠单抗3款新药获批用于PNH，但HSK39297凭借其独特的优势和巨大的潜力，有望在激烈的市场竞争中脱颖而出，为患者带来新的治疗希望。 海思科以“创新”为内核，将创新研发投入视为企业发展的核心驱动力。2025年前三季度，其研发费用高达5.42亿元，同比增长43.5%。从研发进度来看，海思科的多款新药正朝着上市的目标稳步迈进。截至目前，公司有超30款1类新药获批进入临床研究阶段，其中HSK39297片（阵发性睡眠性血红蛋白尿症）HSK-31858片（非囊性纤维化支气管扩张）、HSK21542注射液（骨科手术后中至重度疼痛）等10款正处于Ⅲ期临床试验阶段，上市可期。新药的逐步推进，将为更多患者带来福音，为医药行业的发展注入新的活力，推动整个行业向更高水平迈进。 END 本文为原创文章，转载请留言获取授权 近期热门资源获取 中国临床试验趋势与国际多中心临床展望-202505 2024年医药企业综合实力排行榜-202505 中国带状疱疹疫苗行业分析报告-202505 2023H2-2024H1中国药品分析报告-202504 数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-202503 2024年中国1类新药靶点白皮书-202503 中国AI医疗健康企业创新发展百强榜单-202502 解码护肤抗衰：消费偏好洞察与市场格局分析-202502 2024年FDA批准上市的新药分析报告-202501 小分子化药白皮书（上）-202501 2024年中国医疗健康投融资全景洞察报告-202501 2024年医保谈判及市场分析报告-202501 近期更多摩熵咨询热门报告，识别下方二维码领取 联系我们，体验摩熵医药更多专业服务 会议 合作 园区 服务 数据库 咨询 定制 服务 媒体 合作 点击上方图片，即可开启摩熵化学数据查询 点击阅读原文，申请摩熵医药企业版免费试用！

Overall survival was twice as long for people treated with Columvi in combination with GemOx versus MabThera/Rituxan plus GemOx1This Columvi combination is available off-the-shelf and could offer a potentially curative treatment option for people with R/R DLBCL who are not candidates for transplantColumvi in combination with GemOx has now been approved in more than 50 countries worldwide and recommended in international treatment guidelines2-4 Basel, 8 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today three-year follow-up data from the pivotal phase III STARGLO study in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant (ASCT). After a median follow-up of 35.1 months, overall survival (OS) remained twice as long for people treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) plus GemOx (R-GemOx) (25.5 months versus 12.5 months, respectively [hazard ratio (HR)=0.60, 95% confidence interval (CI): 0.43-0.8]).1 Results were presented at the 67th American Society of Hematology Annual Meeting and Exposition, 6-9 December 2025 in Orlando, Florida, US. Subgroup analyses showed consistent results across clinically relevant subgroups of prior line of therapy and age.1 The greatest efficacy benefit was seen in people who had received one prior line of therapy (second line, 2L), with 54.6% still alive at 36 months follow-up.1 For these patients, median OS was not reached with Columvi in combination with GemOx versus 14.4 months (HR=0.58; 95% CI: 0.38-0.89) in the R-GemOx arm.1 Median progression-free survival (PFS) was 20.4 versus 5.5 months (HR=0.41; 95% CI: 0.25-0.65).1 In patients with 2L DLBCL with early relapse (within 12 months), who are typically harder to treat, the complete response rate was 56.0% and the 36 month OS rate was 46.1%.5 “At three years, we see flattening of the overall survival curve, suggesting the possibility of cure for relapsed/refractory DLBCL patients treated with glofitamab-GemOx,” said Jeremy Abramson, MD, Director, Jon and Jo Ann Hagler Center for Lymphoma at the Mass General Brigham Cancer Institute, US, and principal investigator of the STARGLO study. “These data continue to underscore the meaningful benefit of Glofitamab plus GemOx for patients after initial relapse, when fast and effective treatment is critical given the aggressive nature of this disease.” “By prolonging survival, this Columvi combination could offer people with relapsed or refractory DLBCL long-term remission, and potential additional time to spend with their loved ones without signs of disease or the need for continuous therapy,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The potential of Columvi in combination with GemOx continues to be recognised globally, with approvals in more than 50 countries around the world and inclusion in multiple international treatment guidelines.” Data add to the growing body of evidence supporting the value that this Columvi-based combination can bring to people with 2L+ DLBCL who are not candidates for ASCT or who face barriers accessing other treatment options. As an off-the-shelf and fixed-duration therapy, Columvi plus GemOx can be readily available for infusion in any setting, meaning patients could avoid crucial delays in starting treatment and allowing the possibility of a treatment-free period. The safety profile was unchanged with extended follow up; no new signals were identified, and safety of the combination was consistent with the known safety profiles of the individual medicines. Cytokine release syndrome (CRS) remained the most common adverse event in people treated with Columvi plus GemOx (44.8%; Grade 1: 32.0%, Grade 2: 10.5%, Grade 3: 2.3%).1 Immune recovery in the form of median B-cell and immunoglobulin M count was observed 18-24 months after end-of-treatment.1 Based on the STARGLO data, this Columvi combination is approved in more than 50 countries worldwide, including countries in the EU, the UK, Canada, Australia, China and Mexico, with additional submissions to health authorities ongoing*. Columvi in combination with GemOx is recommended in clinical practice guidelines including the European Society For Medical Oncology, European Hematology Association and the US National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) with category 1 evidence for people with 2L+ DLBCL.†2-4 The US Food and Drug Administration issued a Complete Response Letter for the supplemental Biologics License Application for Columvi in combination with GemOx for this indication. Roche is continuing to explore the potential of Columvi across other settings including first-line (1L) DLBCL and mantle cell lymphoma (MCL) to elevate treatment standards even further. This includes the phase III SKYGLO study investigating Columvi in combination with Polivy® (polatuzumab vedotin), MabThera/Rituxan, cyclophosphamide, doxorubicin and prednisone, in 1L DLBCL, which has recently completed enrolment. In R/R MCL, the phase III GLOBRYTE study evaluating Columvi as a single agent versus investigator’s choice of therapy is currently recruiting. About the STARGLO studyThe STARGLO study [GO41944; NCT04408638] is a phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi® (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Preclinical research indicated an increased antitumour effect when combining Columvi with GemOx over GemOx alone, so the STARGLO study was initiated to further explore the potential complementary effects of the treatment combination. Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability. About Columvi® (glofitamab)Columvi is a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell-engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma and mantle cell lymphoma. About diffuse large B-cell lymphoma (DLBCL)DLBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and the most common form, accounting for about one in three cases of NHL.6 Approximately 160,000 people worldwide are diagnosed with DLBCL each year, with comparable incidence rates across regions.7,8 Medical practices, including pathological classification, diagnosis, staging, initial treatment and relapse management, are similarly approached worldwide.8-11 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.12,13 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes. About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. *Countries that have approved Columvi in combination with GemOx in R/R DLBCL include: Argentina, Australia, Bahrain, Bosnia and Herzegovina, Canada, China, the European Union, Iceland, Lebanon, Liechtenstein, Macedonia, Malaysia, Mexico, New Zealand, Norway, Oman, Paraguay, Peru, Qatar, South Korea, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay. †NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. References[1] Abramson JS, et al. Sustained clinical benefit of glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab plus GemOx (R-GemOx) in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 3-year follow-up of STARGLO. Presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #5519.[2] Eyre TA, at al. Lymphomas: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2025;36(11):1263-1284.[3] Thieblemont C, et al. Large B-cell lymphoma (LBCL): EHA Clinical Practice Guidelines for diagnosis, treatment, and follow-up. HemaSphere. 2025;9:e70207.[4] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.1.2025.[5] Abdulhaq H, et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) vs rituximab (R)-GemOx in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Efficacy and safety in patient subgroups. Presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #3743.[6] UpToDate. Patient education: Diffuse large B cell lymphoma in adults (Beyond the Basics). [Internet; cited December 2025]. Available from: https://www.uptodate.com/contents/diffuse-large-b-cell-lymphoma-in-adults-beyond-the-basics.[7] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited December 2025]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.[8] Budde LE, et al. Characterizing the US Patient Population Receiving Rituximab with Gemcitabine and Oxaliplatin (R-GemOx) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma Using Real-World Data. Blood. 2024;144(1):2373.[9] Yamshon, et al. Outcomes of Relapsed or Refractory Diffuse Large B-Cell Lymphoma Treated With R-GemOx: A Multicenter Cohort Study. Hematol. 2025;100(4):606-615.[10] Sineshaw HM, Zettler CM, Prescott J, et al. Real-world patient characteristics, treatment patterns, and treatment outcomes of patients with diffuse large B-cell lymphoma by line of therapy. Cancer Med. 2024 Apr;13(7):e7173.[11] Koff JL, Larson MC, Martin P et al. LEO Consortium for Real World Evidence (CReWE): Outcomes after Second-Line Therapy in Large B-Cell Lymphoma by Treatment Era. Blood (2023) 142 (Supplement 1): 307.[12] Fabbri N, et al. Second-line treatment of diffuse large B-cell lymphoma: Evolution of options. Semin Hematol 2023; 60(5): 305–312.[13] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915Karsten KleinePhone: +41 79 461 86 83 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr. Bruno EschliPhone: +41 61 68-75284e-mail: bruno.eschli@roche.comDr Sabine BorngräberPhone: +41 61 68-88027e-mail: sabine.borngraeber@roche.com Dr. Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: kalm.loren@gene.com Attachment Media Investor Release Columvi STARGLO ASH English