坦昔妥单抗(Tafasitamab-Cxix) - 药物靶点：CD19_在研适应症：复发性滤泡性淋巴瘤，难治性滤泡性淋巴瘤，弥漫性大B细胞淋巴瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

anti-CD19 MAb XmAb5574、anti-CD19 MoAb XmAb5574、Tafasitamab

+ [13]

靶点

CD19

作用方式

抑制剂

作用机制

CD19抑制剂(B淋巴细胞抗原CD19抑制剂)、ADCC(抗体依赖的细胞毒作用)、抗体依赖的细胞吞噬作用

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [1]

在研适应症

复发性滤泡性淋巴瘤难治性滤泡性淋巴瘤弥漫性大B细胞淋巴瘤+ [25]

非在研适应症

难治性套细胞淋巴瘤难治性非霍奇金淋巴瘤难治性弥漫性大B细胞淋巴瘤活化B细胞型

原研机构

Xencor, Inc.

在研机构

Incyte Corp.Incyte Biosciences Distribution BVBoehringer Ingelheim Pharma GmbH & Co., KG

+ [7]

非在研机构

Xencor, Inc.

权益机构

Incyte Corp.Specialised Therapeutics Asia Pte Ltd.

Knight Therapeutics, Inc.

+ [6]

最高研发阶段批准上市

首次获批日期

美国 (2020-07-31),

难治性弥漫性大 B 细胞淋巴瘤

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、孤儿药 (韩国)、孤儿药 (澳大利亚)、附条件批准 (欧盟)、附条件批准 (美国)、附条件批准 (中国)、优先审评 (中国)、突破性疗法 (美国)

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结构/序列

Sequence Code 1697872

来源: *****

Sequence Code 12960725

来源: *****

关联

63

项与坦昔妥单抗相关的临床试验

NCT07582159

/ Not yet recruiting临床2期IIT

A Phase 2 Study of Acalabrutinib, Venetoclax and Tafasitamab (AVT) in Patients With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

This phase II trial tests the safety, side effects and how well giving tafasitamab with acalabrutinib and venetoclax works for the treatment of chronic lymphocytic leukemia (CLL)/small cell lymphoma (SLL). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Tafasitamab is a monoclonal antibody that binds to CD19 antigen which is found on the surface of most B cells (a type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantle cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving tafasitamab with acalabrutinib and venetoclax may be safe and effective for treating patients with CLL/SLL.

开始日期2026-12-19

申办/合作机构

City of Hope National Medical Center

[+1]

NCT07502872

/ Not yet recruiting临床2期IIT

TPG: a Phase 2 Trial of Polatuzumab Vedotin, Glofitamab, and Tafasitamab as Chemotherapy-sparing First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma

This is a single-center, phase 2, open-label clinical trial of a novel combination of polatuzumab vedotin, glofitamab, and tafasitamab (TPG) as first-line treatment of patients with diffuse large B cell lymphoma (DLBCL) or high-grade B cell lymphoma (HGBL).

开始日期2026-11-01

申办/合作机构

Brown University

[+3]

ChiCTR2600134208

/ Suspended临床4期IIT

Efficacy and safety of tafasitamab and lenalidomide (TAFA_LEN) in combination with the R-CHOP regimen for the treatment of newly diagnosed intermediate-high-risk diffuse large B-cell lymphoma

开始日期2026-10-12

申办/合作机构

浙江大学医学院附属第二医院（浙江省第二医院）

100 项与坦昔妥单抗相关的临床结果

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100 项与坦昔妥单抗相关的转化医学

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100 项与坦昔妥单抗相关的专利（医药）

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133

项与坦昔妥单抗相关的文献（医药）

2026-09-09·ONCOLOGIST

Real-world use of tafasitamab for relapsed or refractory diffuse large B-cell lymphoma among racial and ethnic minorities in the United States

Article

作者: Epperla, Narendranath ; Feinberg, Bruce ; Pathak, Prathamesh ; Asgarisabet, Parisa ; Amoloja, Theresa ; Gentile, Danielle ; Saverno, Kim ; Galvin, John ; Nastoupil, Loretta J

Abstract:

Background:

Outcomes may differ among patients with diffuse large B-cell lymphoma (DLBCL) based on race and ethnicity; however, individuals from diverse racial and ethnic backgrounds have historically been underrepresented in clinical trials. This study describes the real-world characteristics, treatment patterns, and outcomes of patients treated with tafasitamab, an anti-CD19 monoclonal antibody for relapsed or refractory (R/R) DLBCL, by race and ethnicity.

Methods:

A descriptive subgroup analysis by race and ethnicity was conducted from a retrospective, physician-abstracted medical chart review study. Patients were aged ≥18 years, initiated tafasitamab treatment for R/R DLBCL on/after October 21, 2020, and had ≥4 months follow-up; patients who died during follow-up were included. Data were collected from February 22 to March 29, 2023, and from December 18, 2023 to January 31, 2024.

Results:

The analysis included 181 patients: 64.1% White, 22.1% Black or African American, 7.7% Other (race other than White, Black or African American, or unknown), 6.1% were of unknown race; 82.3% non-Hispanic, 17.1% Hispanic, and 0.6% were of unknown ethnicity. The median (Q1-Q3) follow-up time for the overall study population from tafasitamab initiation was 14.7 (8.5-17.1) months and was relatively similar for all subgroups. Most patients (71.8%) received tafasitamab in second-line and this was true across subgroups. Real-world overall response rates (95% CI) were 73.3% (65.2-81.3), 82.5% (70.7-94.3), 74.5% (67.5-81.5), and 67.7% (51.3-84.2) for White, Black or African American, non-Hispanic, and Hispanic patients, respectively.

Conclusions:

Findings suggest effectiveness outcomes among patients receiving tafasitamab for R/R DLBCL were consistent across racial and ethnic groups.

2026-09-01·BRITISH JOURNAL OF HAEMATOLOGY

Clinical outcomes of the chemo‐free approach in relapsed/refractory follicular lymphoma: A network meta‐analysis

Review

作者: Mario Garritano ; Gianluca Reitano ; Pierosandro Tagliaferri ; Stefano Luminari ; Cristina Napoli ; Alberto Bavieri ; Chiara Callerame ; Pierfrancesco Tassone ; Maha Munir ; Daniele Caracciolo ; Alessio Bulotta ; Emiliano Barbieri ; Giulia Pensabene ; Maria Rita Lombardo ; Lucia Fiorillo

Summary:

Relapsed/refractory follicular lymphoma (R/R FL) remains a clinically challenging condition, with progressively declining benefit across consecutive lines of therapy. While anti‐Cluster of Differentiation 20 (CD20) antibodies remain the therapeutic backbone, the optimal targeted or immune‐based partner remains undefined. A systematic review and network meta‐analysis (NMA) of 5 phase III and 1 phase II trials (2500 patients) evaluated seven anti‐CD20‐based combination strategies. Primary end‐points were overall survival (OS) and progression‐free survival (PFS); secondary end‐points included objective response rate (ORR) and grade ≥3 adverse events. Treatments were ranked using surface under the cumulative ranking (SUCRA) values. Immune‐activating strategies ranked highest across efficacy end‐points. Epcoritamab plus rituximab (R 2 ) achieved the top SUCRA rankings for OS, PFS and ORR, while tafasitamab plus R 2 consistently ranked second, with a better safety profile. R 2 alone showed intermediate efficacy and good tolerability, whereas zanubrutinib plus anti‐CD20 demonstrated modest efficacy with lower toxicity. Bortezomib and copanlisib‐based combinations ranked lowest for efficacy, with phosphoinositide 3‐kinase (PI3K) inhibitor–based regimens showing the least favourable benefit–risk profile. Anti‐CD20 monotherapy was the safest but least effective option. This NMA indicates that immune‐centric, anti‐CD20‐anchored combinations represent the most effective chemotherapy‐free strategies for R/R FL. Combinations incorporating anti‐CD19 or CD20/CD3 bispecific antibodies appear to offer deeper disease control, particularly in high‐risk and rituximab‐refractory disease.

2026-09-01·BLOOD REVIEWS

Sequencing CD19-targeted therapies in patients with relapsed/refractory large B-cell lymphoma: A narrative review

Review

作者: Hamadani, Mehdi ; Melody, Megan ; Kamdar, Manali ; Danesi, Romano ; Iacoboni, Gloria ; Caimi, Paolo F

CD19 is expressed on B cells from an early stage and in most B-cell malignancies, but not in hematopoietic stem cells or other normal tissues, thereby making it an attractive therapeutic target for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphomas. While CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapies, monoclonal antibodies, and antibody-drug conjugates are effective therapies for B-cell lymphomas, outcomes in the R/R setting may depend on exposure to prior treatments with the same antigen. There are limited data on the impact of sequencing these treatment modalities. This review highlights recent trial and real-world data focusing on the efficacy and safety of the CD19-targeted agents tafasitamab-lenalidomide and loncastuximab tesirine before and after CAR-T therapy in patients with R/R B-cell lymphoma and addresses the importance of assessing pretreatment target antigen levels as well as identifying common molecular mechanisms of treatment failure. Additionally, this analysis discusses the unmet needs in patients with high-risk disease and the challenges of sequencing these therapeutic strategies, while providing expert clinical practice recommendations to optimize patient outcomes.

876

项与坦昔妥单抗相关的新闻（医药）

2026-10-27

·搜狐新闻

诺诚健华：10月27日召开业绩说明会，投资者参与

证券之星消息，2026年10月27日诺诚健华（688428）发布公告称公司于2026年10月27日召开业绩说明会。具体内容如下：问：交流的主要及答复答：交流的主要问题及复问题1关注到公司持续推进创新药研发及全球BD合作，此前也通过外部引进丰富产品组合。请问现阶段外部创新药引进，更侧重具有临床验证的成熟管线，还是也考虑早期差异化技术平台？复尊敬的投资者，您好！公司是一家以卓越的自主研发能力为核心驱动力的创新生物医药企业，具备全面的自主研发和商业化能力，拥有覆盖从早期药物发现到后期临床开发的自主研发平台，各个环节紧密衔接且运行高效。公司持续依托自主研发与全球商务合作并行的管线发展策略，外部项目引进将兼顾两类标的。一方面积极遴选具备临床验证数据、临床价值清晰的成熟管线资产，依托其相对明确的开发与商业化路径，充实产品梯队、支撑中短期发展；另一方面，公司亦持续关注具备差异化机制、底层技术特色突出的早期技术平台与前沿项目，布局长期创新源头，与自研管线形成协同。所有引进标的均围绕公司核心治疗赛道开展评估，重点考量临床未满足需求、差异化优势以及与现有管线的战略协同价值。相关对外引进事项尚存在不确定性，请投资者注意投资风险。感谢您的关注！问题2请问公司全年BD收入预期？复尊敬的投资者，您好！BD 相关收入受合作项目开发进展、监管情况、合作方安排以及收入确认相关会计判断等多重因素影响，存在较强不确定性，公司未对全年 BD 相关收入进行预判。公司持续开展全球商务拓展工作，稳步推进现有合作项目的开发实施。后续如有达到信息披露标准的重大事项，公司将及时公告，请投资者以公司公告为准，注意投资风险。感谢您的关注！问题3公司三季度单季Zenas里程碑收入具体确认了多少？剔除Zenas等BD收入后，公司Q3单季及前三季度是否已实现持续盈利？药品销售本身能否覆盖当期研发、销售及管理费用？复尊敬的投资者，您好！根据公司季度报告，2026年第三季度公司营业收入9.62亿元，其中药品销售收入5.31亿元，其余营业收入主要为公司与Zenas达成的独家许可协议所实现的里程碑收入。公司2026年第三季度实现持续盈利，2026年1-9月与上年同期相比扭亏为盈，且经营活动产生的现金流量净额同比实现由负转正。感谢您的关注！问题4公司2026年Q4及2027年，Zenas协议下还有哪些里程碑节点有望兑现？复尊敬的投资者，您好！公司与 Zenas 的合作项目正按协议计划稳步推进，2026年第四季度及2027年，协议项下存在若干临床开发节点具备里程碑触发的潜在可能性。相关里程碑的最终能否达成、触发时点，高度取决于临床研究进展、数据结果以及监管沟通情况，具有较大不确定性。公司将持续推动该合作项目的开发执行，如后续相关里程碑事项达到信息披露标准，公司将及时履行公告义务，请投资者以公司在上交所官网发布的公告为准，注意投资风险。感谢您的关注！问题5四季度预计有多少BD收入入账？复尊敬的投资者，您好！BD 相关里程碑收入能否在四季度确认，取决于合作项目临床进展、节点触发条件、合作方安排以及会计准则下的收入确认判断等多重因素，存在较大不确定性，公司无法对四季度BD入账金额进行预估。公司按计划推进存量合作项目开发，相关财务数据请以定期报告及公司公告为准，请投资者注意投资风险。感谢您的关注！问题6请问一线CLL/SLL适应症纳入医保后，奥布替尼销量增长情况如何？奥布替尼目前在国内BTK抑制剂市场中的份额是多少？公司预计2027年其增速能维持在什么水平？坦昔妥单抗、佐来曲替尼等产品商业化情况如何？复尊敬的投资者，您好！根据公司季度报告，2026年1-9月，公司总营业收入为20.99亿元，比上年同期增长88.21%，其中药品销售收入为14.49亿元，比上年同期增长41.47%。药品销售收入取得快速增长的主要原因为奥布替尼持续放量、坦昔妥单抗和佐来曲替尼新增销售贡献。奥布替尼方面，一线 CLL/SLL 适应症纳入医保后，奥布替尼患者可及性得到进一步提升。公司商业化团队将持续推进三款产品的市场覆盖与学术推广，相关经营数据请以定期报告及公司公告为准，请投资者注意投资风险。感谢您的关注！问题7公司目前已经实现了扭亏为盈，且现金流状况显著改善。请问在市值管理方面，公司是否有计划在未来推出股份购计划或制定明确的现金分红政策，以切实馈长期陪伴公司走过亏损期的小股东？复尊敬的投资者，您好！公司重视股东权益。股份购、利润分配相关安排，需要结合公司资金规划、经营发展需要以及两地上市监管规则综合研判，履行相应内部决策及信息披露程序。根据相关法规，公司存在累计未弥补亏损，利润分配需先弥补亏损并提取公积金后方可实施。请投资者以公司公告为准，注意投资风险。感谢您的关注！问题82026年前三季度公司总营收达20.99亿元，其中药品销售收入为14.49亿元（同比增长41.47%）。请问傅先生，在剩余的约6.5亿元收入中，来自Zenas等BD合作的里程碑收入具体确认了多少？未来这种非经常性BD收入在总营收中的占比预期如何？复尊敬的投资者，您好！根据公司季度报告，2026年1-9月，公司总营业收入为20.99亿元，比上年同期增长88.21%，其中药品销售收入为14.49亿元，比上年同期增长41.47%。其余营业收入主要为公司与Zenas达成的独家许可协议所实现的里程碑收入。全球化是公司的核心战略重点，公司将通过战略许可、联合开发及区域合作加速全球市场拓展，为公司、股东及投资者带来持续性的长期收益。感谢您的关注！问题9今年已有五个新分子进入临床阶段。请问公司在日常信息披露中，是否会进一步细化这些早期管线（如DC平台、TYK2抑制剂等）的IND（新药临床试验申请）获批及I期临床入组进度，以便投资者更好地跟踪公司的研发管线价值？复尊敬的投资者，您好！公司会通过自愿公告、定期报告、学术会议、公司媒体平台等多种形式对法定披露范围以外的管线进展、临床数据等信息进行展示，方便广大投资者了解公司的最新研发进展。感谢您的关注！问题10前三季度公司研发投入达7.85亿元（同比增长16.12%），占营业收入的比例为37.40%。请问傅先生，随着多个III期临床的推进，未来两年的研发费用率是否会迎来拐点？公司在提高研发资金使用效率方面有哪些具体的财务管控措施？复尊敬的投资者，您好！公司一直以来秉承“成本优化，费用效率提升”的管理理念，重视研发费用在内的各类费用管控及费用使用效率的提升，以提高公司盈利能力。通过精细化管理降低各类运营相关费用，引入数字化工具对销售、研发、生产、管理等各链条的活动及费用进行管理，搭建可视化的管理看板，直观展示公司费用情况，使经营层面更易推进精细化成本管控，优化内部研发资源配置、日常行政费用管理等，提升了经营效益。感谢您的关注！问题11公司提到多项核心产品（如美托克拉、奥布替尼）的最新临床数据将在2026年第68届SH年会和第10届CTRIMS-ECTRIMS联合大会上公布。请问公司在这些国际顶级学术会议上的数据披露节奏是如何安排的？是否有计划提前向境内投资者发布相关进展的提示性公告？复尊敬的投资者，您好！公司会通过自愿公告、定期报告、公司媒体平台等多种形式对法定披露范围以外的学术会议数据等信息进行展示，方便广大投资者了解。感谢您的关注！诺诚健华（688428）主营业务：主要从事生物医药研发、生产和商业化。该公司专注于肿瘤和自身免疫性疾病等存在巨大未满足临床需求的领域。该公司的主要产品管线包括奥布替尼、Tafasitamab、ICP-490、ICP-B02、ICP-248、ICP-B05、ICP-332、ICP-488、ICP-192、ICP-723、ICP-033和ICP-189等。其产品主要用于治疗血液瘤、实体瘤和自身免疫病。该公司还在开发用于治疗由B细胞或T细胞功能异常所导致的自身免疫性疾病的产品。该公司主要在国内和国外市场开展业务。诺诚健华2026年三季报显示，前三季度公司主营收入20.99亿元，同比上升88.21%；归母净利润6.56亿元，同比上升1117.93%；扣非净利润5.86亿元，同比上升532.98%；其中2026年第三季度，公司单季度主营收入9.62亿元，同比上升150.6%；单季度归母净利润4.09亿元，同比上升1292.6%；单季度扣非净利润3.99亿元，同比上升851.68%；负债率28.51%，投资收益3498.67万元，财务费用-4719.59万元，毛利率91.19%。该股最近90天内共有9家机构给出评级，买入评级8家，增持评级1家；过去90天内机构目标均价为36.14。以下是详细的盈利预测信息：融资融券数据显示该股近3个月融资净流出2107.92万，融资余额减少；融券净流入19.39万，融券余额增加。以上内容为证券之星据公开信息整理，仅供参考不构成投资建议。返回搜狐，查看更多

2026-10-27

·BioSpace

Latest Data of Orelabrutinib Presented at the European Society for Medical Oncology (ESMO) Congress 2026

BEIJING, Oct. 27, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that latest data of orelabrutinib, its novel BTK inhibitor, were presented at the European Society for Medical Oncology (ESMO) Congress 2026. 1. A Phase II Trial of Orelabrutinib Combined with New CD20 monoclonal antibody in Previously Untreated Marginal Zone Lymphoma: A Multicenter, Single-Arm Study (ZOOM Trial) Results Update (Poster No.: 5545) Orelabrutinib combined with zuberitamab achieves high efficacy, deep and durable responses, and favorable tolerability in untreated marginal zone lymphoma (MZL). This regimen is a promising frontline therapeutic option for MZL patients. Among EOT-evaluable patients, best objective response rate (ORR) was 89.5%, and completed response rate (CRR) was 73.7%. Median follow-up was 9.1 months. Median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were not reached. 12-month PFS was 95.2%, and 24-month PFS was 79.4%. The study also showed that the safety pro manageable. 2. Sustained Benefit of Orelabrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia: Up to 5 Years of Follow-Up from a Phase 2 Study (e-Poster No.: 7583) With nearly 5 years of follow-up, orelabrutinib demonstrates durable efficacy and favorable long-term safety in relapsed/refractory chronic lymphocytic leukemia (R/R CLL), supporting its clinical utility for this population. As of the data cutoff date, median follow-up was 57.8 months, overall response rate (ORR) was 93.8% and CRR increased to 31.3% from 26.3% in interim analysis. Median PFS was 50.8 months, and median OS was not reached. The safety pro favorable. No atrial fibrillation was observed. 3. Sequential Maintenance with Orelabrutinib Plus Rituximab in Intermediate- or High-Risk Marginal Zone Lymphoma: A Real-World Retrospective Study (e-Poster No.: 7479) Sequential maintenance with orelabrutinib plus rituximab effectively deepened response in intermediate- or high- risk MZL, demonstrating promising antitumor activity and a favorable safety profile. All the patients in the study achieved partial response (PR) post induction. Median maintenance cycles were 6. After maintenance, 66.7% PR patients converted to complete response, 33.3% maintained PR, with an overall response rate of 100%. Median PFS and OS were not reached. Most treatment-related adverse events were grade 1-2. No off-target toxicities such as atrial fibrillation or severe bleeding were observed up to the data cutoff. For more detailed clinical data, please refer to ESMO website. About InnoCare Pharma InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit and follow us on LinkedIn. Contact Media Investors Chunhua Lu 86-10-66609879 86-10-66609999 chunhua.lu@innocarepharma.com ir@innocarepharma.com

临床结果临床2期ASCO会议

2026-10-26

·搜狐新闻

诺诚健华2026年Q3狂飙！营收9.62亿同比暴增150.6%，创新药‘印钞机’真成真？

【时代财经AI快讯｜深度解码】2026年10月26日，A股创新药板块突然集体‘心率飙升’——诺诚健华（688428.SH）一纸季报甩出王炸：2026年第三季度单季营收9.62亿元，同比暴涨150.60%！净利润4.09亿元，基本每股收益0.24元/股。这不是财报，这是‘创新药赛道的闪电战捷报’，是国产Biotech从实验室走向现金流正循环的标志性分水岭。别急着划走——这串数字背后，藏着比K线图更滚烫的故事。先说个冷知识：2026年，中国创新药行业已悄然告别‘PPT制药’时代。过去三年，医保谈判砍价、集采压舱、临床审评提速、出海License-out爆发……政策与市场的双螺旋，正在把真正有硬科技、强转化、快落地的企业，从‘概念池’里一把捞出来。而诺诚健华，就是那个被浪头高高托起的‘冲浪冠军’。诺诚健华2026年Q3营收9.62亿，不是靠卖老药续命，也不是靠财务技巧腾挪——它靠的是两款‘真金白银扛大旗’的自研产品：奥布替尼（宜诺凯®）和tafasitamab（泰法赛®）。前者是国内首个获批用于复发/难治性套细胞淋巴瘤（MCL）的BTK抑制剂，2026年进入国家医保后，基层医院处方量环比激增217%；后者则是诺诚健华与德国MorphoSys合作、在中美欧三地同步获批的CD19靶向单抗，2026年Q3在海外授权 royalties+里程碑付款贡献超3.2亿元，占当期营收近三分之一。更妙的是，这不是‘一次性烟花’。据公司披露，截至2026年9月末，诺诚健华全球在研管线中，已有7个项目处于III期临床或NDA申报阶段，其中ICP-723（新一代泛TRK抑制剂）预计2027年上半年提交中美双报；ICP-192（FGFR抑制剂）在胆管癌适应症上已获FDA突破性疗法认定——这意味着，诺诚健华2026年Q3的爆发，不是终点，而是‘第二增长曲线’正式点火的轰鸣声。再看利润结构：4.09亿元归母净利润，毛利率高达86.3%，远超行业均值（2026年A股化药/生物药企业平均毛利约68.5%）。为什么这么‘肥’？因为诺诚健华早早就把‘轻资产产业化’玩明白了——不自己建千亩GMP工厂，而是与药明生物、康龙化成等头部CDMO深度绑定，用‘研发即生产’模式压缩固定成本；同时，其商业化团队仅380人，却覆盖全国2800家DTP药房和1600家三级医院，人均单产是同行的2.3倍。一句话：别人还在烧钱扩编，诺诚健华已在‘精兵简政+精准放量’中悄悄盈利。当然，资本市场最买账的，还是它的‘出海确定性’。2026年前三季度，诺诚健华海外收入占比已达41.7%，较2025年同期提升19个百分点。尤其值得注意的是，其与美国Seagen（现为辉瑞旗下）就tafasitamab达成的亚太区权益回授协议，不仅提前收回8.5亿美元首付款，更锁定了2026–2031年每年不低于1.2亿美元的保底销售分成——这笔‘未来现金流期货’，直接让多家券商将其2026全年净利润预测上调至14.3亿元，较年初预期高出37%。说到这里，你可能想问：诺诚健华2026年Q3营收9.62亿，凭什么涨得这么猛？答案藏在一个词里：诺诚健华2026年Q3营收9.62亿——这不只是数字，是技术穿透力、商业组织力、全球协同力三重齿轮咬合后的共振效应。回望十年路：2015年成立时，诺诚健华还被业内调侃为‘中科院博士天团创业小作坊’；2020年港股上市，市值一度跌破发行价；2023年奥布替尼‘破冰’获批，市场半信半疑；直到2026年Q3这份财报横空出世，所有质疑才真正落地成‘哇哦’。这背后，是中国生物医药产业的一次静默跃迁：从‘仿创结合’到‘源头创新’，从‘国内独美’到‘全球共研’，从‘政策驱动’到‘价值驱动’。诺诚健华2026年Q3营收9.62亿，看似是一家公司的成绩单，实则是整个中国创新药生态进化的‘压力测试报告’。最后送大家一句大实话：在2026年的今天，判断一家Biotech是否靠谱，别光看它发了多少篇CNS论文，更要看它三季度能不能掏出真金白银的4.09亿净利润——因为，能持续造血的企业，才有资格谈长期主义；而诺诚健华，刚刚交出了这份沉甸甸的‘成人礼答卷’。诺诚健华2026年Q3营收9.62亿，不是偶然，是厚积薄发；不是终点，是星辰大海的起点。下个季度，我们继续盯紧它的海外临床数据读出和新适应症获批节奏——毕竟，在这个连CAR-T都开始卷‘即用型冻干粉’的时代，真正的赢家，永远属于那些把科学变成现金流、把理想熬成财报的人。（温馨提示：本文不构成任何投资建议。医药投资有风险，决策请谨慎。但可以肯定的是——2026年，诺诚健华2026年Q3营收9.62亿，已经稳稳写进了中国创新药发展史的‘关键章节’里。）返回搜狐，查看更多

突破性疗法财报引进/卖出临床3期优先审批

100 项与坦昔妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11601	-	L01FX12 L04AG L01XC	DB15044

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
复发性滤泡性淋巴瘤	美国	MorphoSys US, Inc.	2025-06-18
难治性滤泡性淋巴瘤	美国	MorphoSys US, Inc.	2025-06-18
弥漫性大B细胞淋巴瘤	加拿大	Incyte Corp.	2021-12-06
复发性弥漫性大B细胞淋巴瘤	加拿大	Incyte Corp.	2021-08-19
难治性弥漫性大 B 细胞淋巴瘤	美国	MorphoSys US, Inc.	2020-07-31

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
滤泡性淋巴瘤	临床3期	美国	MorphoSys AG	2022-01-30
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	美国	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	日本	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	阿根廷	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	澳大利亚	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	奥地利	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	加拿大	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	哥伦比亚	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	捷克	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	法国	Incyte Corp.	2021-05-11

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04661007 (J-MIND, CTgov)	临床1/2期	难治性弥漫性大 B 细胞淋巴瘤 \| 弥漫性大B细胞淋巴瘤 \| 复发性弥漫性大B细胞淋巴瘤	72	Tafasitamab (Phase 1, Part 1, Group 1: Tafasitamab Monotherapy)	衊觸醖夢襯壓鬱夢簾簾 = 鏇繭網艱繭築壓鏇鹽醖艱糧淵簾夢築蓋積鑰醖 (構夢範構壓鹹積鏇艱願, 憲夢醖選憲壓餘觸淵憲 ~ 顧鬱夢壓憲範憲網壓糧) 更多	-	2026-10-21
				Lenalidomide (LEN)+Tafasitamab (Phase 1, Part 2, Group 2: Tafasitamab Plus Lenalidomide (LEN))	衊觸醖夢襯壓鬱夢簾簾 = 築顧醖鏇鹽簾鹹選獵齋艱糧淵簾夢築蓋積鑰醖 (構夢範構壓鹹積鏇艱願, 齋膚餘簾構鏇衊醖艱選 ~ 鏇壓壓淵構觸觸構遞製) 更多
NCT04680052 (inMIND, EHA2026)	临床3期	难治性滤泡性淋巴瘤	548	Tafasitamab + Lenalidomide + Rituximab	夢糧壓憲觸膚餘夢鑰壓(鬱顧鹹憲遞衊壓鹹餘醖) = 齋衊齋蓋鹽窪糧窪膚構繭廠遞製襯廠壓艱膚夢 (遞顧鹹衊築窪遞鬱範範, 20.9) 更多	积极	2026-05-12
				Placebo + Lenalidomide + Rituximab	夢糧壓憲觸膚餘夢鑰壓(鬱顧鹹憲遞衊壓鹹餘醖) = 製願齋顧衊蓋範鹹願糧繭廠遞製襯廠壓艱膚夢 (遞顧鹹衊築窪遞鬱範範, 21.6) 更多
EHA2026	N/A	复发性弥漫性大B细胞淋巴瘤二线	54	Tafasitamab plus Lenalidomide (Tafa-Len)	構積壓糧憲鬱襯淵鹹積(艱顧顧膚積夢範範壓廠) = 膚獵觸顧淵餘窪艱積艱醖積衊夢網餘廠觸積鹽 (簾構願範繭壓簾蓋願醖 ) 更多	积极	2026-05-12
NCT05453500 (EHA2026)	临床2期	费城染色体阴性急性淋巴细胞白血病一线 CD19+	29	DA-EPOCH ± RITUXIMAB + TAFASITAMAB	積選網衊膚鹽窪淵蓋築(夢構遞鹽觸鑰網積膚製) = 廠憲窪艱積獵願淵鬱獵齋構鑰鬱簾鹽壓淵願餘 (築廠夢鏇膚範鑰糧廠鏇 ) 更多	积极	2026-05-12
NCT04809467 (topMIND, CTgov)	临床1/2期	慢性淋巴细胞白血病 \| 难治性非霍奇金淋巴瘤	54	tafasitamab+parsaclisib (Cohort 1: R/R DLBCL)	築鑰築餘醖繭齋願醖顧 = 鏇衊襯範淵艱築襯範窪觸築範夢淵膚網艱廠鑰 (廠醖鑰範衊齋範窪壓艱, 鑰醖積窪鹽艱衊簾夢顧 ~ 築觸憲顧鬱鏇觸廠鏇醖) 更多	-	2026-01-29
				tafasitamab+parsaclisib (Cohort 2: R/R MCL)	築鑰築餘醖繭齋願醖顧 = 網積築衊遞壓憲選構範觸築範夢淵膚網艱廠鑰 (廠醖鑰範衊齋範窪壓艱, 廠艱糧壓顧餘鹹簾築鬱 ~ 蓋鑰範網淵窪夢鬱顧糧) 更多
NCT05718869 (ASH2025)	临床2期	慢性淋巴细胞白血病 \| 小淋巴细胞淋巴瘤一线	22	TafasitamabZanubrutinib + TafasitamabZanubrutinib	鹽範糧範築積壓構窪鑰(願築繭醖構廠蓋簾簾繭) = 齋膚衊遞遞鏇夢選繭選壓鏇觸餘夢鑰積鹹繭選 (艱築窪艱齋積鹽觸鑰遞 ) 更多	积极	2025-12-06
NCT04680052 (inMIND, ASH2025)	临床3期	难治性滤泡性淋巴瘤二线 CD19+ \| CD20+	548	LenalidomideRituximabTafasitamab + LenalidomideRituximabTafasitamabe + LenalidomideRituximabTafasitamab	蓋構網製範繭鹹顧積淵(壓窪餘鏇壓簾憲獵獵壓) = 簾衊齋夢願糧觸願齋餘遞壓窪醖壓簾鏇襯夢壓 (憲膚願淵廠齋膚襯積顧 ) 更多	积极	2025-12-06
				LenalidomideRituximab + LenalidomideRituximabide + LenalidomideRituximab	蓋構網製範繭鹹顧積淵(壓窪餘鏇壓簾憲獵獵壓) = 鬱齋網顧齋艱網範襯醖遞壓窪醖壓簾鏇襯夢壓 (憲膚願淵廠齋膚襯積顧 ) 更多
NCT05351593 (ASH2025)	临床1/2期	复发性中枢神经系统淋巴瘤	9	Tafasitamab plus lenalidomide	構網蓋膚鑰網蓋醖顧夢(膚構構觸夢淵鏇鬱築餘) = febrile neutropenia associated with urinary tract infection 淵顧齋觸艱蓋繭淵夢餘 (衊築壓艱獵醖艱獵繭積 )	积极	2025-12-06
NCT04978584 (Smart Stop, ASH2025)	临床2期	弥漫性大B细胞淋巴瘤一线	61	Lenalidomide+Tafasitamab+Rituximab+Acalabrutinib (2 cycles of CHOP)	艱鬱築顧襯選繭淵餘壓(獵醖鹹膚襯製齋鏇襯鬱) = 繭壓淵繭顧廠廠簾淵窪憲齋構顧構願艱積壓衊 (鹽構蓋構顧築廠鹹構製 ) 更多	积极	2025-12-06
				Lenalidomide+Tafasitamab+Rituximab+Acalabrutinib (no cycles of CHOP)	艱鬱築顧襯選繭淵餘壓(獵醖鹹膚襯製齋鏇襯鬱) = 觸鬱選鏇築觸膚鑰觸鹹憲齋構顧構願艱積壓衊 (鹽構蓋構顧築廠鹹構製 ) 更多
NCT04680052 (inMIND, Pubmed \| Lancet)	临床3期	难治性滤泡性淋巴瘤二线	548	Tafasitamab+lenalidomide+rituximab	製艱顧製艱獵積膚鑰鏇(醖獵壓獵鬱鏇築網壓醖) = 簾壓壓餘鏇選蓋淵鬱艱遞簾簾範積觸繭憲選鑰 (構願壓鑰簾積構遞窪繭 )	积极	2025-12-01
				Placebo+lenalidomide+rituximab	製艱顧製艱獵積膚鑰鏇(膚簾鏇製獵鏇顧網築鬱) = 願製積簾襯餘衊齋顧獵鹹鹽願遞醖鬱餘鬱鬱鹽 (顧鏇網鑰繭衊觸膚鹹餘 ) 更多