In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies.
The main goal of the study is to learn about the effect felzartamab has on the buildup of IgA clusters in the kidneys. The main question that researchers want to answer is:
• How much does the buildup of IgA in the kidney change from the start of the study to Week 36? Researchers will also learn about the effect felzartamab has on kidney health by measuring protein levels in the urine and the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how the body processes the drug.
The study will be done as follows:
* Participants will be screened to check if they can join the study.
* This is an open-label study, which means both the researchers and the participants will know that all participants are receiving felzartamab.
* Participants will receive felzartamab as intravenous (IV) infusions.
* Participants will have kidney biopsies done over the course of the study to help measure changes in the health of the kidneys.
* Participants will have multiple scheduled study visits over about 104 weeks. An extra study visit may be needed if a participant decides to leave the study early.
* In total, participants will stay in the study for about 2 years (up to 112 weeks).

开始日期2026-11-16

申办/合作机构

Biogen, Inc.

NCT07722546

/ Recruiting临床2期

A Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab Compared to Placebo in Adult Participants With Graves' Disease

In this study, researchers will learn more about the use of felzartamab in participants with Graves' Disease, also known as GD. GD is an autoimmune disease, which means the body's immune system attacks its own healthy cells. In people with GD, the immune system produces abnormal antibodies, called thyroid-stimulating hormone receptor antibodies (TRAb), that attack the thyroid gland. This causes the thyroid to become too active and produce too much hormone, a condition called hyperthyroidism.
Participants with GD are often treated with anti-thyroid drugs, or ATDs, which are medicines that help bring thyroid hormone levels back to normal. Felzartamab is designed to target certain immune cells that produce the abnormal TRAb antibodies.
The main goal of the study is to learn whether felzartamab can help bring thyroid hormone levels back to normal and allow participants to stop taking ATDs. Participants will receive either felzartamab or placebo during the study. A placebo looks like the study drug but contains no real medicine.
The main question that researchers want to answer is:
• How many participants have normal thyroid levels without receiving any ATD medicine at Week 24?
Researchers will also learn more about the safety of felzartamab and how the body processes the drug.
The study will be done as follows:
* Participants will be screened to check if they can join the study.
* This is a double-blind study, which means neither the participants, study doctor, or site staff will know if participants are receiving felzartamab or a placebo.
* Participants will be placed into 1 of 3 groups. Two groups will receive felzartamab while the other receives placebo.
* Participants will receive felzartamab or placebo as intravenous (IV) infusions, which are slow injections into a vein using a needle. The Treatment Period will last 20 weeks.
* During the Treatment Period, the study doctor may gradually lower the dose of the ATD if a participant's thyroid levels become normal.
* Afterwards, participants will enter a follow-up period which will last 12 weeks.
* In total, participants will have 22 study visits. Participants will stay in the study for about 9 months (up to 36 weeks).

开始日期2026-07-30

申办/合作机构

Biogen, Inc.

NCT07444489

/ Enrolling by invitation临床3期

An Open-Label Long-Term Extension Study of Felzartamab in Participants With Antibody-Mediated Rejection or Microvascular Inflammation Previously Enrolled in TRANSCEND or TRANSPIRE

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and then developed antibody-mediated rejection (AMR) or microvascular inflammation (MVI). AMR happens when the body's immune system creates donor-specific antibodies (DSAs) that attack the transplanted kidney. In late AMR, this typically happens more than 6 months after the kidney transplant. MVI is a condition where the small blood vessels in the transplanted kidney become inflamed. MVI can happen with or without DSAs. Both AMR and MVI can cause the transplanted kidney to stop working properly.
Two earlier studies looked at felzartamab in kidney transplant recipients. Study 299AR301 (TRANSCEND) (NCT06685757) included participants with AMR. Study 299AR201 (TRANSPIRE) (NCT07219043) included participants with MVI.
This study, 299AR302-299AR301 LTE, is a long-term extension of both of these "parent" studies. Participants who join this study will have the opportunity to receive felzartamab for up to 4 more years after completing their parent study.
The goal of this study is to learn more about the long-term safety and effects of felzartamab in people with kidney transplants. This study is part of a group of studies looking at long-term felzartamab use in people with organ transplants. This study is a substudy of the main study 299AR302.
The main question researchers will answer relate to safety. Namely, how many participants have adverse events during the study and how lab test results change over time. Adverse events are health problems that may or may not be caused by the study drug.
Researchers will perform kidney biopsies to track kidney health. Researchers will also study how felzartamab affects kidney inflammation, kidney function, immune activity, and overall health.
The study will be done as follows:
* Participants who complete the final visit of the treatment period in one of the parent studies can enroll in this study. This includes participants who stopped receiving felzartamab early but still attended their final visits.
* Participants who did not stop receiving felzartamab in their parent study will continue to receive felzartamab for up to 4 more years in this study. Participants may also stop felzartamab during this study at any time.
* Participants who stopped receiving felzartamab in their parent study will only attend study visits for health monitoring- they will not receive felzartamab.
* Felzartamab will be given as an intravenous (IV) infusion, which is a slow injection into a vein using a needle.
* Participants receiving felzartamab may have up to 27 study visits over 200 weeks with an additional safety follow-up visit after their final dose.
* Participants who are not receiving felzartamab may have up to 9 study visits over 200 weeks.

开始日期2026-04-16

申办/合作机构

Biogen, Inc.

100 项与菲泽妥单抗相关的临床结果

登录后查看更多信息

100 项与菲泽妥单抗相关的转化医学

登录后查看更多信息

100 项与菲泽妥单抗相关的专利（医药）

登录后查看更多信息

项与菲泽妥单抗相关的文献（医药）

2026-10-01·Lancet Haematology

Felzartamab plus lenalidomide–dexamethasone versus lenalidomide–dexamethasone for relapsed or refractory multiple myeloma: an open-label, parallel-controlled, randomised, phase 3 trial

Article

作者: Yang, Tonghua ; Huang, Shang-Yi ; Liang, Bin ; Zhu, Andrew X ; Shao, Zonghong ; Chen, Lijuan ; Fang, Baijun ; Yang, Ping ; Wang, Qingming ; Teng, Chieh-Lin ; Wu, Minfang ; Wei, Yongqiang ; Mi, Jianqing ; Meng, Yuan ; Xia, Zhongjun ; Jin, Jie ; Chen, Wenming ; Wang, Hao-Yuan ; Wang, Hongxiang ; Gao, Sujun ; Li, Yajun ; Zeng, Pengyun ; Chen, Bing ; Wang, Ming-Chung ; Huang, Jinwen ; Xi, Yaming ; Wu, Huijing ; Wu, Suijing ; Luo, Jun ; Cai, Zhen ; Yang, Yanli ; Wang, Shunqing ; Fu, Chengcheng ; Li, Yan ; Zhong, Liye ; Dai, Mingshen ; Zhu, Fangbing ; Li, Juan ; Wang, Yafei ; Liu, Hong ; Shang, Jingjing ; Chang, Chunkang ; Zhou, Zeping ; Huang, Zhongxia ; Du, Xin ; He, Haiyan ; Wu, Depei ; Chen, Xi ; Ko, Po-Shen ; Liu, Yan ; Zhan, Rong ; Zhou, Hui ; Fu, Weijun

BACKGROUND:

Complement-dependent cytotoxicity (CDC) of CD38 monoclonal antibodies has been associated with infusion-related reactions and might contribute to reduced clinical efficacy of CDC-reliant CD38 antibodies, particularly in patients with relapsed or refractory multiple myeloma with 1q21+. We aimed to evaluate felzartamab, a novel anti-CD38 monoclonal antibody that retains potent antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis while exhibiting markedly attenuated CDC activity in Chinese patients with relapsed or refractory multiple myeloma.

METHODS:

In this open-label, parallel-controlled, randomised, phase 3 trial conducted at 41 hospitals in China, adults aged 18 years or older with relapsed or refractory multiple myeloma who had received at least one previous line of systemic therapy, and were not refractory to lenalidomide were enrolled. Patients were randomly assigned (2:1) through a central interactive web response system, stratified by International Staging System stage, number of previous lines of therapy, and previous lenalidomide exposure, to receive intravenous felzartamab (16 mg/kg on days 1 and 4 during week 1, weekly week 2-12, every 2 weeks week 13-24, and every 4 weeks thereafter) plus once daily lenalidomide (25 mg orally on days 1-21 of each 28-day cycle) and once weekly oral dexamethasone (40 mg for patients aged ≤75 years and 20 mg for those >75 years) or lenalidomide and dexamethasone alone. The primary endpoint was progression-free survival, defined as the time from randomisation to disease progression or death from any cause, whichever occurred first, assessed by an independent review committee in the full analysis set (all randomly assigned patients who received at least one dose of study treatment). Safety was assessed in all patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov (NCT03952091) and is closed to enrolment.

FINDINGS:

Between March 27, 2019, and Oct 20, 2021, 390 patients were assessed for eligibility, 295 of whom were enrolled and randomly assigned to felzartamab plus lenalidomide-dexamethasone (n=195) or lenalidomide-dexamethasone (n=100). The full analysis set included 289 patients (191 in the felzartamab plus lenalidomide-dexamethasone group and 98 in the lenalidomide-dexamethasone group). 185 (64%) of 289 patients were male, 104 (36%) were female, and all were of Asian ethnicity. At a median follow-up of 34·5 months (IQR 16·8-40·2) in the felzartamab plus lenalidomide-dexamethasone group and 28·7 months (10·8-38·8) in the lenalidomide-dexamethasone group, median progression-free survival was 18·9 months (95% CI 13·6-24·0) with felzartamab plus lenalidomide-dexamethasone versus 10·4 months (5·8-13·9) with lenalidomide-dexamethasone (hazard ratio 0·62 [95% CI 0·45-0·86]; p=0·0035). The most common grade 3-4 adverse events were neutropenia (105 [55%] of 192 vs 22 [23%] of 97), lymphopenia (79 [41%] vs 15 [15%]), leukopenia (74 [39%] vs 11 [11%]), thrombocytopenia (49 [26%] vs 11 [11%]), pneumonia (44 [23%] vs 13 [13%]), anaemia (33 [17%] vs 19 [20%]), hypokalaemia (30 [16%] vs ten [10%]), and upper respiratory tract infection (15 [8%] vs two [2%]). The most common serious adverse event was pneumonia (42 [22%] vs ten [10%]). Treatment-related deaths occurred in 11 (6%) of 192 patients in the felzartamab plus lenalidomide-dexamethasone group (five of unknown cause [possibly related to treatment], two due to pneumonia, one due to febrile infection, one due to cardiac arrest, one due to cerebral infarction, and one due to pneumonitis) and two (2%) of 97 patients in the lenalidomide-dexamethasone group (one due to pneumonia and one due to a fall]).

INTERPRETATION:

Felzartamab plus lenalidomide-dexamethasone significantly prolonged progression-free survival compared with lenalidomide-dexamethasone alone, supporting felzartamab plus lenalidomide-dexamethasone as a potential new treatment option for Chinese patients with relapsed or refractory multiple myeloma.

FUNDING:

TJ Biopharma.

2026-06-01·Kidney International Reports

Prospective Cohort Study of Felzartamab in Rituximab-Resistant Primary Membranous Nephropathy

Article

作者: Pecoraro, Francesco ; Trillini, Matias ; Podestà, Manuel Alfredo ; Stucchi, Nadia ; Villa, Alessandro ; Diadei, Olimpia ; Portalupi, Valentina ; Todeschini, Marta ; Mister, Marilena ; Nozza, Silvia ; Marasà, Maddalena ; Casiraghi, Federica ; Prandini, Silvia ; Rubis, Nadia ; Peracchi, Tobia ; Ruggenenti, Piero ; Martinetti, Davide ; Fidone, Diego ; Gennarini, Alessia ; Carrara, Fabiola ; Remuzzi, Giuseppe

Introduction:

Approximately 30% of patients with primary membranous nephropathy (MN) and nephrotic syndrome (NS) fail rituximab treatment through mechanisms that could be overcome by the human IgG₁ monoclonal anti-CD38 antibody, felzartamab.

Methods:

In this prospective, single-arm, single-center, open-label trial, 10 consenting Caucasian adult patients with MN, rituximab-resistant NS, and estimated glomerular filtration rate (GFR) > 30 ml/min per 1.73 m² received a 5-month, 9-dose course of 16 mg/kg felzartamab infusions at the Nephrology Unit of Bergamo Hospital, Italy between November 9, 2021 and February 1, 2023 and were followed up with for 24 months. Clinical and laboratory parameters were evaluated at baseline, 1, 2, 5, 6, 9, 18, and 24 months, whereas GFR as well as albumin and IgG fractional clearances were measured at baseline and at 6, 9, 12, 18, and 24 months posttreatment. The primary outcome was 24-hour proteinuria (median of 3 consecutive measurements) at 12 months.

Results:

Twelve-month 24-hour proteinuria was similar to baseline. Linear-mixed model analyses showed no significant time-dependent changes in 24-hour proteinuria and albuminuria; serum total-protein, albumin, creatinine and lipid levels, GFR and albumin fractional clearances. Circulating anti-phospholipase A₂ receptor (PLA₂R) antibodies transiently decreased but were never depleted. All considered Igs transiently decreased up to month 12, and recovered to baseline thereafter. Felzartamab deeply and persistently decreased natural killer (NK), B cells, and antigen-inexperienced transitional B cells; however, it did not affect CD20-expressing memory B cells, plasmablasts, and plasma cells. Treatment was safe and well-tolerated.

Conclusion:

One course of felzartamab was safe and well-tolerated, but ineffective in patients with MN and rituximab-resistant NS, possibly because of the inability to persistently deplete nephritogenic autoantibody-producing CD38-expressing B cells.

2026-04-01·TRANSPLANTATION

Updates on Kidney Transplantation From the World Transplant Congress 2025

Review

作者: Cravedi, Paolo ; Noble, Johan

The World Transplant Congress 2025 showcased pivotal advances shaping the future of transplantation. Global efforts to expand access to transplantation accelerated on multiple fronts. Machine perfusion has progressed from an experimental approach to an emerging clinical standard: the Central Preservation and Assessment Service to Optimize Donor Kidney Allocation trial confirmed its value in rescuing discarded kidneys and explored its potential for ex vivo organ repair. For highly sensitized patients, novel desensitization regimens incorporating new proteasome inhibitors and anti-CD38 antibodies (daratumumab, felzartamab) effectively reduced donor-specific antibodies, enabling transplantation in previously ineligible candidates. Improving long-term graft survival remains a central goal, with new immunosuppressive strategies beginning to redefine the therapeutic landscape. Anti-CD38 antibodies also show promise in treating antibody-mediated rejection, while early trials of costimulatory blockade, including anti-CD28, suggest a pathway toward safe tacrolimus minimization or withdrawal. Finally, growing emphasis on novel endpoints and biomarkers reflects a shift toward precision medicine. Artificial intelligence tools that integrate multiomics data are emerging as powerful predictors of graft outcomes. Collectively, these innovations address critical challenges of organ shortage, rejection, and individualized care, charting the next era in transplantation.

554

项与菲泽妥单抗相关的新闻（医药）

2026-10-29

·爱研守护

多发性骨髓瘤：菲泽妥单抗联合治疗，把中位PFS从10.4延长到18.9个月

深耕肿瘤医学科普，温暖陪伴抗癌之路解读前沿临床资讯，守护每一份生命希望温馨提醒：文章后面有抗CD38人源化单克隆抗体SG301的免费临床试验，复发/难治性多发性骨髓瘤患者可申请参加。近日，在《The Lancet Haematology》期刊上，发表了Felzartamab（菲泽妥单抗）联合来那度胺-地塞米松对比来那度胺-地塞米松治疗复发或难治性多发性骨髓瘤的一项平行对照III期试验数据[1]。 2019年3月27日至2021年10月20日期间，评估了390例既往接受过至少一线全身治疗且来那度胺非难治的复发或难治性多发性骨髓瘤成人患者，其中295例被纳入并随机分配至felzartamab联合来那度胺-地塞米松组（n=195）或来那度胺-地塞米松组（n=100）。在felzartamab联合来那度胺-地塞米松组中位随访34.5个月，来那度胺-地塞米松组中位随访28.7个月时，felzartamab联合来那度胺-地塞米松组的中位无进展生存期为18.9个月，而来那度胺-地塞米松组为10.4个月（风险比0.62）。 Felzartamab联合来那度胺-地塞米松与来那度胺-地塞米松单药相比显著延长了无进展生存期，支持felzartamab联合来那度胺-地塞米松作为中国复发或难治性多发性骨髓瘤患者潜在的新治疗选择。菲泽妥单抗产品介绍菲泽妥单抗是一款靶向CD38的人源单克隆抗体。2026年8月，国家药品监督管理局批准天境生物药业（杭州）股份有限公司申报的注射用菲泽妥单抗（商品名：境斐）上市，该品种联合来那度胺和地塞米松用于既往至少接受过一线治疗的多发性骨髓瘤成年患者[2]。目前，国内有其他多发性骨髓瘤临床试验进行中，例如：杭州尚健生物的抗CD38人源化单克隆抗体SG301。 01 SG301联合泊马度胺、地塞米松临床试验进行中在CDE官网显示[3]，一项评价SG301注射液联合泊马度胺和地塞米松对比安慰剂联合泊马度胺和地塞米松治疗复发/难治性多发性骨髓瘤有效性和安全性的随机、对照、双盲、多中心Ⅲ期临床试验正在进行中，复发/难治性多发性骨髓瘤患者可申请免费参加。 SG301单药临床数据在2024年美国血液学会（ASH）年会上，公布了SG301在复发/难治性多发性骨髓瘤患者的I期临床数据[4]。截至2024年3月7日，共有61例RRMM患者入组该试验，中位年龄为64岁。在13例可评估疗效的患者中，对于接受8mg/kg（推荐的II期剂量）SG301治疗的非髓外多发性骨髓瘤患者，客观缓解率（ORR）为30.8%，其中非常好的部分缓解率（VGPR）及以上缓解率为23.1%。初治患者，需要制定治疗方案；或经治患者病情变化，面临复发/难治/转移，需要更换治疗方案时，常规标准治疗之外，新药临床试验也是一种可能的选择，也正是参加临床试验的合适时机。想了解更多肿瘤临床试验，请咨询医学部老师。北京凯石国际医疗技术有限公司介绍北京凯石国际医疗技术有限公司，是专注于肿瘤临床试验咨询的正规医疗信息服务机构，深耕实体瘤与恶性血液肿瘤临床试验，依托专业医学团队，打造合规、专业、高效的肿瘤临床试验咨询服务体系，致力于为肿瘤患者和家属，提供客观、可落地的临床试验资讯服务，是国内值得信赖的肿瘤临床试验专业服务企业。公司核心业务聚焦全类型肿瘤临床试验咨询服务，覆盖全面的肿瘤病种，兼顾实体肿瘤与恶性血液肿瘤两大领域。目前有CAR-T、TIL等细胞疗法，PD-1/PD-L1等免疫治疗药物，小分子抑制剂、双抗、单抗、ADC等靶向药物的临床试验正在进行中。正在招募肺癌、食管癌、肝癌、胃癌、结直肠癌、宫颈癌、卵巢癌、乳腺癌、胆管癌、子宫内膜癌、黑色素瘤、肉瘤、恶性血液疾病、淋巴瘤等各种恶性肿瘤，想要了解或者参加临床试验项目，可以咨询我们医学部的老师。为了让更多人了解，恳请各位朋友花一两秒钟帮我们点亮文章底部右下方的【小手】和【爱心】，谢谢大家！参考文献： 1.Haiyan He，Jingjing Shang，Yafei Wang，et al.Felzartamab plus lenalidomide–dexamethasone versus lenalidomide–dexamethasone for relapsed or refractory multiple myeloma: an open-label, parallel-controlled, randomised, phase 3 trial [J].The Lancet Haematology Volume 13, Issue 10，E722-E736，October 2026. 2.国家药监局批准注射用菲泽妥单抗上市，2026-08-13. https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20260813143615187.html 3.国家药品监督管理局药品审评中心（CDE）官网. 4.Ying Tian,Keshu Zhou,Quande Lin 2,et al. SG301,a Novel Anti-CD38 Monoclonal Antibody, in Patients with Relapsed/Refractory Multiple Myeloma: A First-in-Human, Multicenter, Phase 1 Trial [J].2024年ASH.

2026-10-28

·和达金服集团

转载丨钱塘和达产业基金投资企业天境生物宣布创新双特异性抗体TJ-C64B完成首例患者给药

本文由天境生物TJBIO授权转载 10月26日，钱塘和达产业基金投资企业天境生物（TJ Biopharma）宣布，公司自主研发的创新Claudin 6 (CLDN6) × 4-1BB双特异性抗体TJ-C64B已在中国开展的一期临床研究中完成首例患者给药，正式进入临床开发阶段。 - TJ-C64B是天境生物拥有全球权益、全球开发进展领先的一款自研CLDN6 × 4-1BB双特异性抗体 - 完成首例患者给药标志着TJ-C64B正式进入临床开发阶段，公司下一代创新管线达成又一重要里程碑天境生物（TJ Biopharma）今日宣布，公司自主研发的创新Claudin 6 (CLDN6) × 4-1BB双特异性抗体TJ-C64B已在中国开展的一期临床研究中完成首例患者给药，正式进入临床开发阶段。 CLDN6在卵巢癌、子宫内膜癌、胃癌和部分肺癌等实体瘤中特异性高表达，几乎不在正常人体组织中表达。CLDN6表达阳性肿瘤患者预后更差，目前尚无针对性疗法，临床需求巨大。 TJ-C64B是天境生物拥有全球权益、全球领先的CLDN6 × 4-1BB双抗，也是公司基于AntibodyPLUS技术平台旗下4-1BB条件性激活平台打造的新一代创新管线又一代表性产品。该产品通过靶向CLDN6的特异性抗体将4-1BB激动活性定位于肿瘤病灶内，旨在实现肿瘤局部免疫激活，规避传统4-1BB激动剂可能引发的肝毒性及全身免疫毒性风险；TJ-C64B同时采用功能型IgG1 Fc，还可介导NK细胞和巨噬细胞通过ADCC、ADCP机制，直接杀伤肿瘤细胞，同时特异性清除肿瘤调节性T细胞，通过多重机制发挥抗肿瘤作用。临床前研究显示，TJ-C64B实现了CLDN6表达依赖性的精准4‑1BB 激活；在多项动物模型中表现出强效且持久的抗肿瘤效果；非临床安全性研究证实其具有良好的耐受性，凸显其优异的临床转化和开发潜力。本项一期临床研究旨在评估TJ-C64B在CLDN6阳性晚期实体瘤患者中的安全性、耐受性、药代动力学、药效学及初步抗肿瘤活性。研究将首先开展单药剂量递增，随后计划在卵巢癌、子宫内膜癌和胃癌等患者群体中进一步开展剂量扩展研究。 TJ-C64B一期临床研究主要研究者、中国药科大学附属上海高博肿瘤医院院长、首席科学家李进教授表示：“CLDN6阳性实体瘤预后较差，目前针对这一靶点的有效治疗选择仍然有限。TJ-C64B采用CLDN6依赖的4-1BB条件性激活机制，为更加精准地激活肿瘤免疫提供了新的探索方向。早期临床研究是验证创新机制能否转化为患者获益的关键环节。我们期待发挥专业临床研究能力，高质量、高效率地推进这一创新分子的临床开发。” 天境生物首席科学官陈曦博士表示：“TJ-C64B顺利完成首例患者给药，是公司下一代创新管线进入临床开发阶段的又一重要里程碑。TJ-C64B处于CLDN6 × 4-1BB领域全球开发第一梯队，体现了天境生物持续打造具有差异化和全球领先潜力创新资产的能力。随着第一梯队产品迈入商业化阶段，我们正在加快推动更多全球创新产品进入临床，构建保障公司长期增长的多梯队产品组合。我们将继续依托AntibodyPLUS平台，加快双抗、三抗、免疫细胞因子及抗体偶联药物等下一代创新管线的临床开发及全球价值实现。” 为进一步加快TJ-C64B的临床开发及长期价值实现，公司近期与高博医疗集团及上海外联发商务咨询有限公司（UDC）达成创新药管线研发合作，将依托各方在临床研究及产业生态资源优势，共同加速推进TJ-C64B的早期临床开发和商务拓展。关于TJ-C64B TJ-C64B是天境生物自主研发的一款CLDN6 × 4-1BB双特异性抗体。该产品通过CLDN6介导的肿瘤局部4-1BB条件性激活，促进T细胞、自然杀伤细胞和巨噬细胞等多类免疫细胞参与抗肿瘤应答；同时，其功能型IgG1 Fc可介导ADCC和ADCP效应，直接清除CLDN6阳性肿瘤细胞及肿瘤微环境中的4-1BB高表达调节性T细胞。TJ-C64B正在探索开发用于治疗CLDN6阳性的卵巢癌、子宫内膜癌、胃癌及其他晚期实体瘤。关于天境生物天境生物（TJ Biopharma）是一家聚焦于自身免疫疾病、肿瘤免疫和代谢疾病领域创新疗法的全链条生物科技公司。公司立足中国，聚焦全球创新药的药物发现、临床开发、生物药生产以及产品上市和合作商业化，已建成涵盖上海、北京研发中心和杭州GMP生产基地在内的产业链闭环。公司基于多年的积累，已构建起具有差异化优势的“双梯队”创新药管线：第一梯队包括已进入产品上市审评阶段的产品，以及处于注册性临床研究或即将启动三期临床的后期项目；第二梯队则由基于公司AntibodyPLUS技术平台开发的更多具有first-in-class潜力的创新药项目组成，目前正陆续推进至一期临床或临床申报阶段。凭借与济川药业、石药集团、赛诺菲、渤健等合作伙伴的共同开发和商业化合作，以及持续性的创新产品授权交易、生物药委托生产服务和产品合作销售等多元化的可持续收入模式，天境生物正加速推进创新药管线的国际化以及在中国的研发生产及产品上市一体化进程。钱塘和达产业基金钱塘和达产业基金是钱塘（新）区创新产业投资主体，由钱塘科创集团旗下和达金服及下属私募基金管理人运营管理。钱塘和达产业基金成立9年以来，以市场化投资方式发挥专业投资基金投资和投后赋能培育能力，从精准服务生物医药产业，陪跑中国医药港，到实现“全域主导产业”“企业全生命周期”的全覆盖，为区域创新产业发展营造资本生态。截至2026上半年，钱塘和达产业基金已发起设立或合作设立子基金73只，实缴出资110亿元。其中，出资超42亿元与各类机构设立合作子基金53只，合作规模超525亿元，投资方向覆盖钱塘区“车药芯化智”五大主导产业，打造高质量投资朋友圈；出资超61亿元设立了十余只直投基金，共投资100余个次项目，已退出金额超28亿，同时有4个项目已上市，另有十余家企业已递表申报；基金获得第十届医疗健康投资卓悦榜“年度创新医药最佳机构奖” 、36氪2026“中国最受关注政府引导基金TOP30”及2025“中国最受市场关注有限合伙人TOP30”“中国最受关注政府引导基金TOP30”、出类“2025年度中国最佳直投LP TOP20”“2025年度中国最佳回报LP TOP10”、投中“2025年度中国最佳私募股权投资引导基金TOP30”等荣誉。旗下私募基金管理人和达投资管理凭借优秀管理业绩先后获评“2022浙江新锐投资机构”、2023-2025年度“浙江创业投资机构TOP50”、第九届医疗健康投资卓悦榜“年度创新医药最佳投资机构”“年度IVD与生命科学最佳投资机构”、36氪2026及2025“中国生命科学产业投资机构TOP20”、清科“2025年中国国资投资机构50强”“2025年中国医疗健康领域投资机构30强”、2025年度“4+1”专项基群“医疗健康赛道最佳投资奖”等荣誉。已投企业天境杭州、碧澄能源分别获评2025年度投中榜“中国医疗及健康服务产业最佳生物医药领域投资案例TOP10”“中国碳中和产业最佳投资案例TOP10”，恩和科技获评福布斯中国“2026人工智能科技企业TOP 50”及“杭州新八骏”。钱塘和达产业基金于2020年9月首次投资天境生物；2024年2月其基金管理人和达投资管理的浙江省“4+1”基金牵头参与天境杭州超5亿元C1轮融资，助力天境生物完成重大战略重组；2025年9月，浙江省“4+1”基金再次投资天境生物，支持其完成近6亿元人民币的C2轮融资。在天境生物从量变到质变的关键拐点，钱塘和达产业基金持续加码，助力其加速发展，实现转型升级。声明本文仅供交流探讨之用，不作任何投资建议。如需转载或引用本文的任何内容，请注明出处。本文部分图片来源于网络，版权归原作者所有，如有不当请联系后台。推荐阅读 01 再添硬科技力量！奥视微Micro‑LED微显示项目迁入钱塘 02 双榜连登！再次荣登36氪创投研究院产业投资专业榜单 03 卓悦榜丨钱塘和达产业基金携在管省“4+1”大健康基金荣膺2026医疗健康投资卓悦榜“创新医药最佳机构奖”“医疗健康最佳新锐投资机构”奖 04 钱塘和达产业基金再次荣登母基金周刊“2026投资机构软实力排行榜”,获“区县级母基金 TOP30” 05 转载丨钱塘和达产业基金投资企业天境生物宣布菲泽妥单抗在中国获批上市（全球首次获批），依坦生长激素α地产化上市申请获国家药监局受理

2026-10-28

·Firstwordpharma

CEO says Biogen has 'returned to growth' as newer drugs, Apellis drive Q3 beat

Biogen said Wednesday that third-quarter revenues rose 11% year-over-year to $2.8 billion, beating analyst expectations of $2.6 billion, as its newer medicines, including those added through its $5.6-billion acquisition of Apellis Pharmaceuticals, helped offset declines in its legacy multiple sclerosis (MS) business."Our third-quarter results demonstrate that Biogen has returned to growth," stated CEO Chris Viehbacher. Seven of eight products in the pharma's growth portfolio grew by double digits, including spinal muscular atrophy drug Spinraza (nusinersen), which saw sales jump 23% to $461 million thanks to more patients converting to the high-dose regimen. Analysts were projecting $400 million.IQLIK outpacing IV launchRevenue for Eisai-partnered Alzheimer's treatment Leqembi increased 67% to $202 million – the Japanese drugmaker records global in-market sales of the drug – with $107 million of that in the US. The global figure edged past estimates of $199 million.Moreover, the Leqembi IQLIK subcutaneous formulation – approved for maintenance dosing last year and more recently as an at-home starting dose – has been outpacing Leqembi's original intravenous (IV) launch "by three and a half and [Eli Lilly's] Kisunla by six times," according to Alisha Alaimo, who heads Biogen North America operations, though she cautioned it was still early days.Alaimo noted that while the majority of IQLIK use comes from Leqembi IV prescription writers, Biogen is "now seeing writers who have never written an [anti-amyloid therapy] before, never wrote Kisunla, never wrote [Leqembi IV]. They're writing IQLIK – and we are also seeing physicians who have only ever written Kisunla write IQLIK." She called that "a dynamic change," especially in areas with long drive times, citing the West Coast as the fastest uptake given its geography and the "convenience factor."Apellis momentumMeanwhile, Biogen also reported the first full-quarter of sales for geographic atrophy treatment Syfovre and complement inhibitor Empaveli since the Apellis deal closed in May. Syfovre generated $191 million and Empaveli $52 million, for respective gains of 27% and 92% year-over-year."I think we've really realised a synergy between the folks from Apellis who've joined the Biogen teams," said Viehbacher on an analyst call Wednesday. "They've come together and when I look at Syfovre and Empaveli you can see 37% year-over-year growth of $243 million, that's already on a run rate of $1 billion."Overall, Biogen said the growth portfolio accounted for roughly two-thirds of its core pharmaceutical revenue. MS drug sales fell 13% in the quarter to $919 million.The company is keeping its full-year outlook for mid-single-digit revenue growth in 2026, but raised the lower end of its full-year adjusted earnings guidance by 20 cents, which now falls between $12.20 and $13 per share.Five key readoutsViehbacher also highlighted early-stage work as now being one of Biogen's key priorities, calling it "one of the most important and often most neglected areas of our industry." He admitted "we were not necessarily very good with that" — the company had gone three years without a single IND – but he says there has been "a radical overhaul of the whole research and early development area."The ambition is to have at least 20 programmes in early-stage development over the next few years. "This is a big shift in how we operate because Biogen historically has looked at things on an asset-by-asset basis," Viehbacher said.The company has five registrational study readouts on the horizon over the next year. Two Phase III trials of litifilimab, a IgG1 monoclonal antibody, are due in systemic lupus by year-end, with a third in cutaneous lupus to follow in the first half of 2027. That same half-year should also bring results from a Phase III study of felzartamab, a CD38-targeting antibody in development for antibody-mediated rejection (AMR) in kidney transplant recipients.Phase III results for zorevunersen, an antisense oligonucleotide it is co-developing with Stoke Therapeutics to treat Dravet syndrome, are expected towards the end of next year.

并购临床3期上市批准临床结果寡核苷酸

100 项与菲泽妥单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16375

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
多发性骨髓瘤	中国	天境生物药业（杭州）股份有限公司	2026-08-11

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
微血管疾病	临床3期	美国	Biogen, Inc.	2026-04-16
微血管疾病	临床3期	加拿大	Biogen, Inc.	2026-04-16
特发性膜性肾病	临床3期	美国	天境生物药业（杭州）股份有限公司	2025-05-22
特发性膜性肾病	临床3期	美国	Biogen, Inc.	2025-05-22
特发性膜性肾病	临床3期	中国	Biogen, Inc.	2025-05-22
特发性膜性肾病	临床3期	日本	Biogen, Inc.	2025-05-22
特发性膜性肾病	临床3期	日本	天境生物药业（杭州）股份有限公司	2025-05-22
特发性膜性肾病	临床3期	阿根廷	Biogen, Inc.	2025-05-22
特发性膜性肾病	临床3期	阿根廷	天境生物药业（杭州）股份有限公司	2025-05-22
特发性膜性肾病	临床3期	澳大利亚	Biogen, Inc.	2025-05-22

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


NCT03952091 (Pubmed \| Lancet Haematol)	临床3期	难治性多发性骨髓瘤	295	Felzartamab plus lenalidomide-dexamethasone	鹹衊鑰製蓋構糧簾鑰壓(鬱鏇糧積繭醖願齋襯醖) = neutropenia (105 [55%] of 192 vs 22 [23%] of 97), lymphopenia (79 [41%] vs 15 [15%]), leukopenia (74 [39%] vs 11 [11%]), thrombocytopenia (49 [26%] vs 11 [11%]), pneumonia (44 [23%] vs 13 [13%]), anaemia (33 [17%] vs 19 [20%]), hypokalaemia (30 [16%] vs ten [10%]), and upper respiratory tract infection (15 [8%] vs two [2%]). 網淵鏇窪獵廠鏇壓構齋 (鑰積衊淵憲構獵積鏇淵 ) 更多	积极	2026-10-01
				Lenalidomide-dexamethasone
NCT05065970 (IGNAZ, CTgov)	临床2期	免疫球蛋白a肾病	54	Placebo (Part 1: Placebo)	選繭獵簾膚遞顧獵積餘(餘鹽鬱衊遞簾衊範選蓋) = 簾築繭窪襯窪鹹窪窪醖鑰獵獵襯觸鹹顧壓蓋製 (遞鏇窪製廠選壓網鬱糧, 19.43) 更多	-	2026-04-28
				Placebo+Felzartamab (Part 1: Felzartamab Dosing Arm M1)	選繭獵簾膚遞顧獵積餘(餘鹽鬱衊遞簾衊範選蓋) = 構鏇構壓築憲構鹹醖積鑰獵獵襯觸鹹顧壓蓋製 (遞鏇窪製廠選壓網鬱糧, 19.41) 更多
NCT05065970 (IGNAZ, ISN WCN2026)	临床2期	免疫球蛋白a肾病	54	Felzartamab, 2 doses in 15 days	鹹鏇醖構願獵夢積鑰夢(淵築網鏇襯鬱膚鑰獵襯) = 製醖鹹願壓淵壓顧簾醖構鹹顧蓋顧繭繭鹽糧鹹 (築蓋鹽夢構齋繭衊顧遞 ) 更多	积极	2026-04-01
NCT05065970 (IGNAZ, ASN2025)	临床2期	免疫球蛋白a肾病	54	Felzartamab	憲憲鑰膚醖積網衊積鑰(選鹹淵觸艱衊築廠廠選) = 觸淵廠醖範餘積遞遞鹹餘積網遞襯製蓋齋鑰餘 (醖鹽淵鏇窪鏇鏇鑰餘築 ) 更多	积极	2025-11-07
NCT05065970 (IGNAZ, Pubmed \| Kidney Int \| ASN2025)	临床2期	免疫球蛋白a肾病	54	Felzartamab 2-dose	襯壓鬱觸餘鏇齋製願襯(獵壓窪衊壓窪鏇鏇鏇繭) = Felzartamab safety was consistent with prior observations; adverse events were predominantly grade 1 or 2. 艱齋醖廠窪窪積鑰觸艱 (積夢選壓壓獵醖鬱鬱憲 )	积极	2025-10-01
				Felzartamab 5-dose
NCT05065970 (IGNAZ, ASN2024) 人工标引	临床2期	免疫球蛋白a肾病	54	Felzartamab (2 doses in 15 days)	鑰淵鑰獵憲鏇顧範齋蓋(餘鏇蓋襯窪選願網鑰醖) = Treatment with felzartamab led to rapid, clinically meaningful reductions in UPCR vs PBO, with the greatest effect in the M3 arm. 範鏇糧構鏇顧鏇憲積淵 (製夢鑰簾鬱範廠繭選獵 ) 更多	积极	2024-10-26
				Felzartamab (5 doses in 2 months)
NCT04145440 (M-PLACE, Pubmed) 人工标引	临床1/2期	特发性膜性肾病 anti-Phospholipase A2 receptor autoantibody-positive	31	Felzartamab 16 mg/kg	鑰糧繭襯壓顧壓夢鹽鑰(廠繭襯繭夢餘鹽製蓋簾) = 襯鹽窪窪願糧糧簾淵襯鬱鏇鏇廠築鬱觸製獵顧 (遞選糧製餘艱遞壓觸齋 ) 更多	积极	2024-06-20
				Felzartamab 16 mg/kg (newly diagnosed or relapsed PMN)	憲繭範觸簾窪範夢獵築(餘鹽襯選餘淵齋醖糧觸) = 鹹壓艱夢蓋蓋淵襯齋壓齋顧餘鬱獵糧遞糧願鏇 (襯鹹顧襯蓋膚憲繭憲範 )
NCT05021484 (NEWS) 人工标引	临床2期	肾移植排斥反应	22	Felzartamab	艱餘鹽遞觸憲築觸鹹鏇(醖淵淵鏇艱簾觸餘壓構) = felzartamab showing an acceptable safety profile and most adverse events being mild or moderate. 簾艱夢廠獵網製簾衊鏇 (簾繭壓廠願積網鏇遞選 )	积极	2024-05-27
				Placebo
NCT05065970 (IGNAZ, PRNewswire) 人工标引	临床2期	免疫球蛋白a肾病	54	Felzartamab	廠膚餘範觸網願選糧鹽(淵糧廠齋鬱餘選願蓋淵) = 窪窪積鑰選窪製艱獵廠顧糧鑰蓋壓窪願鏇顧艱 (廠獵網觸製衊夢範簾鬱 )	积极	2024-05-24
				Placebo	-
NCT04145440 (M-PLACE, ASN2023) 人工标引	临床1/2期	特发性膜性肾病一线	31	Felzartamab	齋鹽齋鹹鹽餘製遞觸範(選憲壓窪窪顧淵繭積醖) = 齋衊網構糧鑰糧醖鬱鬱餘鑰製蓋襯範醖觸鹹醖 (襯選襯齋窪觸蓋窪願餘 ) 更多	积极	2023-11-02
				Felzartamab (newly diagnosed or relapsed patients)	築夢醖獵餘艱選餘鏇網(淵網廠鏇鬱構廠膚衊鑰) = 範網憲糧蓋顧蓋醖餘製獵齋廠糧齋顧觸醖積構 (窪廠艱繭願遞顧憲襯簾 ) 更多