Pralatrexate and Bendamustine With 3 Gy TBI as a New Reduced Intensity Conditioning (RIC) Regimen for Allogeneic HCT for T-Cell Lymphoma Patients Who Are in Untreated R/R, or in Remission With MRD

This phase I/II trial studies the side effects and best dose of pralatrexate in combination with bendamustine and total-body irradiation (TBI) followed by a donor stem cell transplant in treating patients with T-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Pralatrexate may block the growth of cancer cells and cause them to die. It is a type of dihydrofolate reductase (DHFR) inhibitor. Bendamustine may damage the DNA in cancer cells and cause them to die. It is a type of alkylating agent and a type of antimetabolite. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TBI is a type of radiation therapy that is given to the entire body. Giving pralatrexate with bendamustine and TBI before a donor stem cell transplant may help kill cancer cells in the body and help make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.

开始日期2026-05-01

申办/合作机构

Fred Hutchinson Cancer Research Center

ChiCTR2600121256

/ Not yet recruiting临床2期IIT

Multicenter, Single-Arm, Phase 2 study of Bendamustine Monotherapy in Relapsed/Refractory T-Cell Large Granular Lymphocytic Leukemia

开始日期2026-04-01

申办/合作机构-

NCT07498959

/ RecruitingN/A

Testicular Cancer Treatment: Assessing Quality of Life in Good Prognosis Metastastic Disease

The goal of this prospective observational study is to learn about the short- and long-term effects of treating men over the age of 18 with good prognosis metastatic testicular cancer with either primary retropertioneal lymph node dissection, RPLND, (for low-stage metastastic seminoma) or three doses of chemotherapy for metastastic seminoma or nonseminoma. The main question it aims to answer is:
Does primary RPLND lower the risk of side-effects compared to receiving chemotherapy?

开始日期2026-03-19

申办/合作机构

Sahlgrenska Universitetssjukhuset

[+5]

100 项与盐酸苯达莫司汀相关的临床结果

登录后查看更多信息

100 项与盐酸苯达莫司汀相关的转化医学

登录后查看更多信息

100 项与盐酸苯达莫司汀相关的专利（医药）

登录后查看更多信息

2,543

项与盐酸苯达莫司汀相关的文献（医药）

2026-03-01·Cancer Medicine

Reduced‐Dose Bendamustine as a First‐Line Treatment of Follicular Lymphoma Is Associated With Poorer Prognosis

Article

作者: Mukae, Junichi ; Noguchi, Yuma ; Yamamoto, Masahide ; Kumagai, Takashi ; Oshikawa, Gaku ; Saito, Tatsuya ; Mori, Takehiko ; Osada, Yuki ; Toyota, Shigeo ; Takahata, Atsushi ; Tanaka, Keisuke ; Mizuchi, Daisuke ; Yamamoto, Koh ; Okada, Keigo ; Suzuki, Ken

ABSTRACT:

The dose of bendamustine used to treat previously untreated follicular lymphoma (FL) is sometimes reduced based on various clinical considerations, but the impact of such dose reductions on outcomes is unclear. We retrospectively analyzed 92 untreated FL patients treated with bendamustine at seven institutions in Japan. Dose reduction was defined as receiving less than 90% of the planned total dose of 1080 mg/m 2 over six cycles. Patients with disease progression observed at ≤ 180 days of treatment initiation were defined as primary bendamustine‐refractory (PBR). The 3‐year overall survival (OS) and progression‐free survival (PFS) were 87.1% and 71.8%, respectively. Seven patients were classified as PBR, six of whom received bendamustine at full dose without dose reduction, and they had significantly worse OS with 3‐year OS of 38.1%. We excluded the PBR cases from subsequent analyses of the dose intensity's prognostic significance. The dose‐reduction group had a significantly lower CR rate (93.0% vs. 74.4%, p = 0.032). Similarly, the 3‐year PFS was significantly worse in the dose‐reduction group (86.8% vs. 68.1%, p = 0.005). In univariate and multivariate analyses, dose reduction was associated with inferior PFS. In an analysis limited to patients who completed all six courses, the CR rate was comparable between the two groups, but 3‐year PFS was significantly worse in the dose‐reduction group (86.8% vs. 68.7%, p = 0.041). Furthermore, even among patients who achieved CR, the 3‐year PFS tended to be poorer in the dose‐reduction group (85.7% vs. 72.7%, p = 0.062). These findings suggest that PBR cases are resistant to bendamustine itself regardless of the dose intensity. In contrast, among responders including those who achieved CR, dose reduction was associated with poorer PFS, indicating that maintaining treatment intensity is important for improving prognosis in the treatment of bendamustine‐responsive FL patients.

2026-03-01·Indian Journal of Hematology and Blood Transfusion

Clinical Characteristics and Treatment Outcomes of Patients with Waldenstrom Macroglobulinemia

Article

作者: Khadwal, Alka ; Lekshmon, K S ; Bal, Amanjit ; Malhotra, Pankaj ; Jain, Arihant ; Mallik, Nabhajit ; Singh, Charanpreet ; Rastogi, Pulkit ; Reddy, Pradeep ; Prakash, Gaurav

Waldenstrom macroglobulinemia (WM) is a rare B-cell lympho-proliferative disorder. There is limited data from India regarding the characteristics and outcomes of patients with WM. We describe here the patients with WM treated at our center over the course of the past 15 years. This was a single center, retrospective analysis. Patients fulfilling the diagnosis of WM who were treated at our center between 2009 and 2023 were included in the study. Fifty-five patients were included in the study for analysis. The median age was 62 years with a Male: Female ratio of 3.2:1. Most patients (n = 42; 76.4%) had symptoms attributable to WM, while 5 patients (9.1%) had Immunoglobulin M (IgM) related symptoms and 8 patients (14.5%) had both. The median hemoglobin of the cohort was 7.4 g/dl and the median serum IgM level was 4.87 g/L. MYD88 mutation testing was done in 30 patients and was positive in 16 (53.3%). The most common first line therapy was chemo-immunotherapy (n = 36; 65.5%). Most common chemo-immunotherapy was Bendamustine-Rituximab followed by Rituximab-Cyclophosphamide-Dexamethasone. The overall response rate and major response rate to front-line therapy was 78.2% and 69.1% respectively. The median follow-up for the entire cohort was 30 months. Fourteen patients died during follow-up with the most common cause being progressive disease (n = 6; 42.9%). The median Event-free Survival, Time to Next therapy and Overall Survival were 45 months, 51 months and 150 months respectively. In our WM case series from India, we found a low incidence of MYD88 mutations with comparable treatment outcomes to western literature.

2026-03-01·Clinical Lymphoma Myeloma & Leukemia

Persistent COVID-19 in Patients With Hematological Malignancies: A Focused Review in the Omicron Era

Review

作者: Ando, Miki ; Yasuda, Hajime ; Ando, Jun

COVID-19 is a threat to patients with hematological malignancies (HM) even in the Omicron era, because mortality rates are still high in HM patients, and a significant number of patients develop a protracted disease course called "persistent COVID-19 (pCOVID-19)" which can continue for weeks to months. pCOVID-19 can be life-threatening by itself, but also drastically affects the disease course of the underlying HM by delaying or terminating chemotherapy. Also, patients with pCOVID-19 can be potentially contagious, and timing of ending isolation is a dilemma the hematology ward faces. Furthermore, pCOVID-19 has been reported to lead to acquisition of SARS-CoV-2 multidrug-resistant mutations, which is an alarming issue for both the patient and public health. The optimal management method of pCOVID-19 is currently unknown, and because HM patients are excluded from randomized clinical trials, evidence is limited to case reports and small case series. We carried out a comprehensive literature review of Omicron pCOVID-19 occurring in HM patients, compiled the scattered evidence, and provide practical recommendations which can be of guide to clinicians. Main topics discussed within this review include efficacy of vaccinations in HM patients, risk factors for developing pCOVID-19 (B-cell depleting agents, bendamustine + rituximab therapy, bispecific T-cell engagers, etc.), treatment of pCOVID-19 including extended/sequential/combination therapy incorporating antivirals (nirmatrelvir/ritonavir, remdesivir, molnupiravir, and ensitrelvir) and convalescent plasma/intravenous immunoglobulin therapy, monitoring pCOVID-19 with reverse transcription (RT)-PCR, and optimal target cycle threshold values as goals of therapy.

783

项与盐酸苯达莫司汀相关的新闻（医药）

2026-04-10

·药学进展

行业动态 | 国内获批适应症数量最多的利妥昔单抗，复宏汉霖汉利康®新增两项适应症获批

“ 点击蓝字关注我们国内获批适应症数量最多的利妥昔单抗，复宏汉霖汉利康®新增两项适应症获批 PPS 2026年4月9日，复宏汉霖（2696.HK）宣布，公司自主开发和生产的汉利康®（利妥昔单抗）用于非霍奇金淋巴瘤下的两项新增适应症的补充申请获国家药品监督管理局（NMPA）批准。作为中国首个生物类似药，汉利康®已全面覆盖原研利妥昔单抗在国内获批上市的全部适应症，包括非霍奇金淋巴瘤、慢性淋巴细胞白血病，以及原研未在华获批的类风湿关节炎，成为国内获批适应症数量最多*的利妥昔单抗。根据国家癌症中心2022年发布的全国癌症报告，中国每年新发淋巴瘤近10万例1，其中约70%为非霍奇金淋巴瘤。弥漫大B细胞淋巴瘤（DLBCL）是其最常见的侵袭性亚型，预后相对更差。汉利康®是复宏汉霖自主开发的首个单抗生物药，同时也是中国首个根据2015年发布的《生物类似药研发与评价技术指导原则（试行）》开发并批准上市的生物类似药。已开展的相似性研究结果证明，汉利康®和参照利妥昔单抗在结构、生物学特性和临床药代动力学/药效动力学方面高度相似，且在弥漫大B细胞淋巴瘤治疗中具有等效性，其关键Ⅲ期HLX01-NHL03研究结果已于2024年1月正式发表于国际权威期刊BMC Cancer。此前，汉利康®已在DLBCL获批四项适应症，此次国内新增获批的两项适应症分别为联合维泊妥珠单抗、环磷酰胺、多柔比星和泼尼松适用于治疗既往未经治疗的DLBCL成人患者；及联合苯达莫司汀和维泊妥珠单抗适用于不适合接受造血干细胞移植的复发或难治性DLBCL成人患者，覆盖了DLBCL一线及复发/难治两大关键治疗节点。围绕该产品，复宏汉霖积极携手商业合作伙伴持续拓展海内外市场。汉利康®在国内的商业销售由复星医药附属公司复星曜泓负责。目前，汉利康®已正式纳入国家医保目录，累计惠及超过40万名中国患者。据统计，以汉利康®为代表的利妥昔单抗上市后，中国DLBCL患者接受免疫化疗的比例提升了40%，基层医院淋巴瘤诊疗能力同步增强。药物经济学研究也显示，在初治DLBCL患者中，相较于原研利妥昔单抗，汉利康®（H-CHOP）在10年内能带来更多的质量调整生命年（QALYs），同时显著节约医疗资源。针对海外市场，复宏汉霖积极携手Abbott、Boston Oncology、Eurofarma和FARMA DE COLOMBIA等生物制药企业合作伙伴，全力加速全球布局，并已于多个拉美国家获批上市。未来，复宏汉霖将继续秉持以患者为中心的理念，不断加速产品的商业化落地和可及，使高质量可负担的产品惠及更多患者。参考文献及注释： 1. ZHENG R S, CHEN R, HAN B F, et al. Cancer incidence and mortality in China, 2022[J]. Zhonghua Zhong Liu Za Zhi, 2024, 46(3):221-231. * “最多”是指截至2026年4月9日文章来源：复宏汉霖美编排版：王子怡文章审核：宋抒昊王子怡罗琪【免责声明】以上内容来源于互联网，不代表本平台立场或观点；如有侵犯作者著作权，请及时与我们联系（Tel：025-83271227，或直接在微信平台留言），我们将及时更正或删除。《药学进展》杂志由教育部主管、中国药科大学主办，中国科技核心期刊（中国科技论文统计源期刊）。刊物以反映药学科研领域的新方法、新成果、新进展、新趋势为宗旨，以综述、评述、行业发展报告为特色，以药学学科进展、技术进展、新药研发各环节技术信息为重点，是一本专注于医药科技前沿与产业动态的专业媒体。《药学进展》注重内容策划、加强组稿约稿、深度挖掘、分析药学信息资源、在药学学科进展、科研思路方法、靶点机制探讨、新药研发报告、临床用药分析、国际医药前沿等方面初具特色；特别是医药信息内容以科学前沿与国家战略需求相合，更加突出前瞻性、权威性、时效性、新颖性、系统性、实战性。根据最新统计数据，刊物篇均下载率连续三年蝉联我国医药期刊榜首，复合影响因子1.311，具有较高的影响力。《药学进展》编委会由国家重大专项化学药总师陈凯先院士担任主编，编委由新药研发技术链政府监管部门、高校科研院所、制药企业、临床医院、CRO、金融资本及知识产权相关机构近两百位极具影响力的专家组成。联系《药学进展》↓↓↓ 编辑部官网：pps.cpu.edu.cn；邮箱：yxjz@163.com；电话：025-83271227。欢迎投稿、订阅！往期推荐聚焦“第七届药学前沿学术论坛暨《药学进展》编委会会议” 聚力前沿赛道，共启学术新程：第七届药学前沿学术论坛在南京隆重启幕承学术匠心，启时代新章：《药学进展》第七届编委会、第三届青年编委会成立大会在宁召开聚焦“兴药为民·2023生物医药创新融合发展大会”“兴药为民·2023生物医药创新融合发展大会”盛大启幕！院士专家齐聚杭城，绘就生物医药前沿赛道新蓝图“兴药强刊”青年学者论坛暨《药学进展》第二届青年编委会议成功召开“兴药为民·2023生物医药创新融合发展大会”路演专场圆满收官！校企合作新旅程已启航我知道你在看哟

2026-04-09

·一点资讯

国内获批适应症数量最多的利妥昔单抗，汉利康新增两项适应症获批

2026年4月9日，复星医药子公司复宏汉霖（2696.HK）宣布，公司自主开发和生产的汉利康（利妥昔单抗）用于非霍奇金淋巴瘤下的两项新增适应症的补充申请获国家药品监督管理局（NMPA）批准。作为中国首个生物类似药，汉利康已全面覆盖原研利妥昔单抗在国内获批上市的全部适应症，包括非霍奇金淋巴瘤、慢性淋巴细胞白血病，以及原研未在华获批的类风湿关节炎，成为国内获批适应症数量最多*的利妥昔单抗。1，其中约70%为非霍奇金淋巴瘤。弥漫大B细胞淋巴瘤（DLBCL）是其最常见的侵袭性亚型，预后相对更差。汉利康是复宏汉霖自主开发的首个单抗生物药，同时也是中国首个根据2015年发布的《生物类似药研发与评价技术指导原则（试行）》开发并批准上市的生物类似药。已开展的相似性研究结果证明，汉利康和参照利妥昔单抗在结构、生物学特性和临床药代动力学/药效动力学方面高度相似，且在弥漫大B细胞淋巴瘤治疗中具有等效性，其关键Ⅲ期HLX01-NHL03研究结果已于2024年1月正式发表于国际权威期刊BMC Cancer。此前，汉利康已在DLBCL获批四项适应症，此次国内新增获批的两项适应症分别为联合维泊妥珠单抗、环磷酰胺、多柔比星和泼尼松适用于治疗既往未经治疗的DLBCL成人患者；及联合苯达莫司汀和维泊妥珠单抗适用于不适合接受造血干细胞移植的复发或难治性DLBCL成人患者，覆盖了DLBCL一线及复发/难治两大关键治疗节点。围绕该产品，复宏汉霖积极携手商业合作伙伴持续拓展海内外市场。汉利康在国内的商业销售由复星医药附属公司复星曜泓负责。目前，汉利康已正式纳入国家医保目录，累计惠及超过40万名中国患者。据统计，以汉利康为代表的利妥昔单抗上市后，我国DLBCL患者接受免疫化疗的比例提升了40%，基层医院淋巴瘤诊疗能力同步增强。药物经济学研究也显示，在初治DLBCL患者中，相较于原研利妥昔单抗，汉利康（H-CHOP）在10年内能带来更多的质量调整生命年（QALYs），同时显著节约医疗资源。针对海外市场，复宏汉霖积极携手Abbott、Boston Oncology、Eurofarma和FARMA DE COLOMBIA等生物制药企业合作伙伴，全力加速全球布局，并已于多个拉美国家获批上市。未来，复宏汉霖将继续秉持以患者为中心的理念，不断加速产品的商业化落地和可及，使高质量可负担的产品惠及更多患者。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化创新生物制药企业，致力于为全球患者提供高品质、可负担的生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域。自2010年成立以来，公司已构建涵盖全球研发、临床、注册、生产及商业化的全产业链平台，拥有全球员工近4,000人，并在中国、美国和日本等多地设有运营及分支机构。依托生物类似药形成的稳健现金流反哺创新研发，复宏汉霖正稳步迈入“全球化2.0”阶段，持续打造可复制、可持续的全球增长模式。截至2026年初，公司共有10款产品在全球60余个国家和地区获批上市，其中7款已在中国获批。在欧美主流生物药市场，复宏汉霖亦取得多项里程碑式突破，已有4款产品获得美国FDA批准、4款产品获得欧盟EC批准，充分体现了公司在研发体系、质量管理及生产能力方面已全面对标国际最高标准。在创新驱动方面，复宏汉霖依托上海、美国等多地协同布局的研发体系，构建了多元化、平台化的创新技术矩阵，覆盖免疫检查点抑制剂、免疫细胞衔接器（包括多特异性TCE）、抗体偶联药物（ADC）以及AI驱动的早期研发平台等前沿方向。目前，公司拥有50余项处于早期阶段的创新资产，其中约70%具备同类最佳（Best-in-Class）潜力，并在全球同步推进30余项临床研究。核心产品H药汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）作为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，正加速全球布局，已在全球40余个市场获批上市；同时，多款潜力创新资产，包括PD-L1 ADC HLX43及新表位HER2单抗HLX22正全面推进全球关键性临床研究。依托通过中、欧、美三地GMP认证的生产体系，复宏汉霖已建成总产能达84,000升的生物药生产平台，形成覆盖全球六大洲的稳定供应网络。未来，复宏汉霖将始终坚持以患者为中心，聚焦未满足的临床需求，持续推动创新成果向临床价值与患者可及转化，在全球生物医药创新生态中创造长期而稳健的价值。The rituximab with the most approved indications domestically, Henlius' HANLIKANG has obtained approvals for two additional indicationsOn April 9, 2026, Henlius (2696.HK) announced that the supplemental application for two new indications under non-Hodgkin's lymphoma of HANLIKANG (rituximab), independently developed and manufactured by the company, was approved by the National Medical Products Administration (NMPA). As China's first biosimilar, HANLIKANG has fully covered all indications of the original rituximab approved for marketing in China, including non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis, which was not approved for the original drug in China, making it the rituximab with the most approved indications* in the country.1 with approximately 70% being non-Hodgkin's lymphoma. Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive subtype, with relatively poorer prognosis. HANLIKANG is Henlius's first independently developed monoclonal antibody biopharmaceutical and also China's first biosimilar developed and approved for marketing based on the Technical Guideline for the Research, Development and Evaluation of Biosimilars (“Tentative”) issued in 2015.Similarity study results have demonstrated that HANLIKANG and reference rituximab are highly similar in structure, biological characteristics, and clinical pharmacokinetics/pharmacodynamics, and exhibit equivalence in the treatment of diffuse large B-cell lymphoma. The key Phase 3 HLX01-NHL03 study results were officially published in the international authoritative journal BMC Cancer in January 2024. Previously, HANLIKANG had been approved for four indications in DLBCL. The two newly approved indications in China are: 1. In combination with polatuzumab vedotin, cyclophosphamide, doxorubicin, and prednisone for the treatment of previously untreated adult patients with DLBCL. 2. In combination with bendamustine and polatuzumab vedotin for the treatment of adult patients with relapsed or refractory DLBCL who are not candidates for hematopoietic stem cell transplant. covering both first-line and relapsed/refractory key therapeutic nodes in DLBCL.Additionally, HANLIKANG’s development, manufacturing and the quality management system are in line with global standards. Xuhui Facility, the manufacturing facility for HANLIKANG, has obtained Good Manufacturing Practice (GMP) certifications from both China and the EU, making it the first plant in China that has obtained dual GMP certifications from China and Europe to manufacture self-developed antibodies. Also, the facility has successfully passed the on-site inspection conducted by NMPA, the European Medicines Agency (EMA), the EU qualified person, and PIC/S members Indonesia Food and Drug Administration (BPOM) and Brazilian National Health Surveillance Agency (ANVISA), as well as multiple international business partners.Henlius actively collaborates with commercial partners to continuously expand domestic and international markets for this product. In China, the commercial sales of HANLIKANG are managed by Fosun Pharma. Currently, HANLIKANG has been officially included in China’s National Reimbursement Drug List (NRDL), benefiting over 400,000 Chinese patients cumulatively. According to statistics, after the launch of rituximab including HANLIKANG, the proportion of DLBCL patients receiving immunochemotherapy in China increased by 40%, and the lymphoma diagnosis and treatment capabilities of primary hospitals were simultaneously enhanced. Pharmacoeconomic studies also show that in newly treated DLBCL patients, compared to the original rituximab, HANLIKANG (H-CHOP) can bring more quality-adjusted life years (QALYs) within 10 years while significantly saving medical resources. For overseas markets, Henlius actively collaborates with biopharmaceutical company partners such as Abbott, Boston Oncology, Eurofarma, and FARMA DE COLOMBIA to accelerate global expansion, with approvals for marketing already obtained in several Latin American countries.In the future, Henlius will continue to uphold a patient-centered philosophy, accelerating the commercialization and accessibility of its products to benefit more patients with high-quality and affordable treatments.About HenliusShanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including seven approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and four products approved by the European Commission (EC), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and has been approved in more than 40 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22—are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.To learn more about Henlius, visit and connect with us on LinkedIn at R S, CHEN R, HAN B F, et al. Cancer incidence and mortality in China, 2022[J]. Zhonghua Zhong Liu Za Zhi, 2024, 46(3):221-231.* “最多”是指截至2026年4月9日

上市批准生物类似药临床3期

2026-04-09

·henlius.com

国内获批适应症数量最多的利妥昔单抗，复宏汉霖汉利康®新增两项适应症获批

2026年4月9日，复宏汉霖（2696.HK）宣布，公司自主开发和生产的汉利康®（利妥昔单抗）用于非霍奇金淋巴瘤下的两项新增适应症的补充申请获国家药品监督管理局（NMPA）批准。作为中国首个生物类似药，汉利康®已全面覆盖原研利妥昔单抗在国内获批上市的全部适应症，包括非霍奇金淋巴瘤、慢性淋巴细胞白血病，以及原研未在华获批的类风湿关节炎，成为国内获批适应症数量最多*的利妥昔单抗。根据国家癌症中心2022年发布的全国癌症报告，我国每年新发淋巴瘤近10万例1，其中约70%为非霍奇金淋巴瘤。弥漫大B细胞淋巴瘤（DLBCL）是其最常见的侵袭性亚型，预后相对更差。汉利康®是复宏汉霖自主开发的首个单抗生物药，同时也是中国首个根据2015年发布的《生物类似药研发与评价技术指导原则（试行）》开发并批准上市的生物类似药。已开展的相似性研究结果证明，汉利康®和参照利妥昔单抗在结构、生物学特性和临床药代动力学/药效动力学方面高度相似，且在弥漫大B细胞淋巴瘤治疗中具有等效性，其关键Ⅲ期HLX01-NHL03研究结果已于2024年1月正式发表于国际权威期刊BMC Cancer。此前，汉利康®已在DLBCL获批四项适应症，此次国内新增获批的两项适应症分别为联合维泊妥珠单抗、环磷酰胺、多柔比星和泼尼松适用于治疗既往未经治疗的DLBCL成人患者；及联合苯达莫司汀和维泊妥珠单抗适用于不适合接受造血干细胞移植的复发或难治性DLBCL成人患者，覆盖了DLBCL一线及复发/难治两大关键治疗节点。围绕该产品，复宏汉霖积极携手商业合作伙伴持续拓展海内外市场。汉利康®在国内的商业销售由复星医药附属公司复星曜泓负责。目前，汉利康®已正式纳入国家医保目录，累计惠及超过40万名中国患者。据统计，以汉利康®为代表的利妥昔单抗上市后，我国DLBCL患者接受免疫化疗的比例提升了40%，基层医院淋巴瘤诊疗能力同步增强。药物经济学研究也显示，在初治DLBCL患者中，相较于原研利妥昔单抗，汉利康®（H-CHOP）在10年内能带来更多的质量调整生命年（QALYs），同时显著节约医疗资源。针对海外市场，复宏汉霖积极携手Abbott、Boston Oncology、Eurofarma和FARMA DE COLOMBIA等生物制药企业合作伙伴，全力加速全球布局，并已于多个拉美国家获批上市。未来，复宏汉霖将继续秉持以患者为中心的理念，不断加速产品的商业化落地和可及，使高质量可负担的产品惠及更多患者。参考文献及注释 1. ZHENG R S, CHEN R, HAN B F, et al. Cancer incidence and mortality in China, 2022[J]. Zhonghua Zhong Liu Za Zhi, 2024, 46(3):221-231. * “最多”是指截至2026年4月9日

上市批准临床3期生物类似药免疫疗法

100 项与盐酸苯达莫司汀相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D07085	盐酸苯达莫司汀	L01AA09	DB06769

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
弥漫性大B细胞淋巴瘤	日本	SymBio Pharmaceuticals Ltd.	2021-04-28
淋巴细胞白血病	日本	SymBio Pharmaceuticals Ltd.	2016-08-26
惰性B细胞非霍奇金淋巴瘤	美国	Eagle Pharmaceuticals, Inc.	2015-12-07
套细胞淋巴瘤	日本	SymBio Pharmaceuticals Ltd.	2010-10-27
惰性非霍奇金淋巴瘤	奥地利	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	比利时	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	保加利亚	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	德国	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	意大利	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	卢森堡	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	荷兰	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	葡萄牙	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	斯洛伐克	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	西班牙	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	奥地利	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	比利时	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	保加利亚	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	德国	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	意大利	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	卢森堡	Pharma& Schweiz GmbH	2010-07-15

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
难治性B细胞淋巴瘤	临床3期	中国	-	2010-04-01
复发性慢性淋巴细胞白血病	临床3期	德国	Mundipharma Research GmbH & Co. KG	2001-09-01
难治性经典霍奇金淋巴瘤	临床2期	美国	Bristol Myers Squibb Co.	2018-11-26
CD30阳性T细胞淋巴瘤	临床2期	瑞士	Mundipharma Medical Co.	2018-09-01
复发性经典霍奇金淋巴瘤	临床2期	美国	Bristol Myers Squibb Co.	2017-03-28
复发性经典霍奇金淋巴瘤	临床2期	加拿大	Bristol Myers Squibb Co.	2017-03-28
复发性经典霍奇金淋巴瘤	临床2期	捷克	Bristol Myers Squibb Co.	2017-03-28
复发性经典霍奇金淋巴瘤	临床2期	法国	Bristol Myers Squibb Co.	2017-03-28
复发性经典霍奇金淋巴瘤	临床2期	德国	Bristol Myers Squibb Co.	2017-03-28
复发性经典霍奇金淋巴瘤	临床2期	爱尔兰	Bristol Myers Squibb Co.	2017-03-28

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Tandem Meetings ASTCT and CIBMTR2026	N/A	Carney复合症	634	Bendamustine	廠積願觸齋夢鏇範艱鏇(餘鑰顧夢網壓蓋積壓鏇): RR = 0.93, P-Value = 0.5 更多	积极	2026-02-04
				Fludarabine/Cyclophosphamide
ASH2025	N/A	B细胞淋巴瘤	38	Bendamustine + Fludarabine + Cyclophosphamide	鹽艱選鏇觸襯蓋餘鹹夢(選築壓築網範蓋艱蓋齋) = 夢艱積繭繭積鑰襯膚遞糧鏇糧淵糧繭糧夢蓋壓 (憲鏇壓衊窪觸膚襯夢製 ) 更多	积极	2025-12-06
ASH2025	N/A	难治性经典霍奇金淋巴瘤	8	BeGEV regimen	構範夢鹽壓鏇願繭廠齋(蓋憲築願膚淵壓選鹹構) = The most frequent BeGEV-related adverse event was grade 1-2 neutropenia (occurring in 2/8 patients, 25.0%). No bendamustine-related toxicities such as alopecia or peripheral neuropathy were observed. 願憲膚築鬱簾築觸蓋齋 (淵襯齋鹹夢襯窪糧簾積 ) 更多	积极	2025-12-06
ASH2025	N/A	滤泡性淋巴瘤 centroblast	129	Bendamustine-based immunochemotherapy (ICT) (SUVmax >12)	願範鏇蓋鏇鬱襯齋選廠(鏇糧製顧衊齋廠願鑰製) = 餘觸鏇鏇範鏇選膚淵淵繭膚繭範選醖鹹選艱憲 (齋鑰襯蓋壓鏇範鬱繭範 )	积极	2025-12-06
				Bendamustine-based immunochemotherapy (ICT) (TMTV >510cm3)	願範鏇蓋鏇鬱襯齋選廠(鏇糧製顧衊齋廠願鑰製) = 窪製選簾齋鹹鬱簾膚憲繭膚繭範選醖鹹選艱憲 (齋鑰襯蓋壓鏇範鬱繭範 )
ASH2025	N/A	血液肿瘤	634	Bendamustine	膚壓範夢衊獵築糧遞襯(鹹繭齋淵餘夢鏇鏇製齋): RR = 1.07 (95.0% CI, 0.99 ~ 1.16), P-Value = 0.09 更多	积极	2025-12-06
				Fludarabine/Cyclophosphamide
NCT01332968 (GALLIUM, ASH2025)	临床3期	滤泡性淋巴瘤一线 EZH2 mutation \| CREBBP mutation	1,575	Bendamustine	艱窪願鬱顧觸夢衊顧製(積獵觸壓鬱範遞鏇鏇餘): HR = 0.62, P-Value = 0.27 更多	积极	2025-12-06
				CHOP- or CVP-based immunochemotherapies
ASH2025	N/A	套细胞淋巴瘤一线	132	bendamustine and rituximab (BR)	廠範鏇願艱顧築選廠衊(襯衊觸願齋鏇餘築糧鏇) = 顧艱窪獵衊範憲蓋膚醖鹹製壓鹹蓋繭觸糧鏇鑰 (積遞範憲糧衊繭蓋繭夢 ) 更多	积极	2025-12-06
				rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)	廠範鏇願艱顧築選廠衊(襯衊觸願齋鏇餘築糧鏇) = 構網選選淵選膚壓鹹願鹹製壓鹹蓋繭觸糧鏇鑰 (積遞範憲糧衊繭蓋繭夢 ) 更多
NCT06245629 (ASH2025)	N/A	复发性多发性骨髓瘤	86	Bortezomib-bendamustine-melphalan	製選繭鹽網鏇壓齋廠餘(淵遞壓鬱積繭鑰選鑰範) = 獵窪鹽構窪鏇遞蓋壓積淵網願糧積齋夢壓餘鑰 (選鑰糧襯製壓積淵醖鹹 ) 更多	积极	2025-12-06
				High-dose melphalan	製選繭鹽網鏇壓齋廠餘(淵遞壓鬱積繭鑰選鑰範) = 夢鹹膚夢選簾壓憲鏇簾淵網願糧積齋夢壓餘鑰 (選鑰糧襯製壓積淵醖鹹 ) 更多
ASH2025	N/A	一线 TP53 mutation/deletion	23	Zanubrutinib + Bendamustine + Rituximab	遞構齋鬱鹽艱鹹夢憲糧(壓襯製獵遞獵構夢衊網) = 憲鬱觸餘窪網衊夢夢築鏇鑰鏇網鏇糧選夢積衊 (淵鏇淵齋選顧網襯餘製 ) 更多	积极	2025-12-06
NCT04624906 (BRAWm, ASH2025)	临床2期	巨球蛋白血症一线	63	Bendamustine+Rituximab+Acalabrutinib	網衊醖窪鏇構憲願積積(襯艱蓋蓋餘夢齋觸製簾) = 夢襯壓觸齋餘築製壓繭鏇廠衊鏇鹹廠夢範憲鬱 (壓願蓋範遞襯築衊襯蓋 )	积极	2025-12-06
				Bendamustine+Rituximab+Acalabrutinib (≥70 years old)	網衊醖窪鏇構憲願積積(襯艱蓋蓋餘夢齋觸製簾) = 餘襯齋鹹鹽糧憲鑰鏇艱鏇廠衊鏇鹹廠夢範憲鬱 (壓願蓋範遞襯築衊襯蓋 ) 更多