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.

NCT07219043

/ Recruiting临床2期

A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Recipients of Kidney Transplants With Late Isolated Microvascular Inflammation (MVI)

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body. It can lead to serious kidney problems over time.
In many cases, MVI is caused by antibodies that attack the transplanted kidney. But in some people, MVI happens without these antibodies. This type of MVI is called isolated MVI. There are currently no approved treatments for isolated MVI.
The main goal of the study is to learn about the effect felzartamab has on inflammation in the transplanted kidney. The main question researchers want to answer is:
• How many participants have no signs of active inflammation in the transplanted kidney after 24 weeks of treatment with felzartamab?
Researchers will also study how felzartamab affects kidney function, immune activity, and overall health. They will monitor safety through kidney biopsies, lab tests, and by recording adverse events throughout the study.
Adverse events are health problems that may or may not be caused by the study drug.
The study will be done in 2 parts as follows:
* Participants will be randomly assigned to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
* In Part A, participants will receive their assigned drug for 24 weeks. Neither the researchers nor the participants will know who is receiving felzartamab or placebo.
* Part B will last another 28 weeks. All participants will receive felzartamab and both participants and researchers will know this.
* All treatments will be given by intravenous (IV) infusion at the study site.
* Participants will have kidney biopsies at the start of the study, at Week 24, and at Week 52 to help measure changes in inflammation.
* Participants will stay in the study for about 1 year.

开始日期2026-01-05

申办/合作机构

Biogen, Inc.

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项与菲泽妥单抗相关的文献（医药）

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 ; Marasà, Maddalena ; Nozza, Silvia ; Casiraghi, Federica ; Prandini, Silvia ; Peracchi, Tobia ; Rubis, Nadia ; 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.

2026-01-01·Journal of Immunology Research

Resolving the Interference of Anti‐CD38 Antibodies on Blood Compatibility Assays Using CD38 “Baitbodies” Approach

Article

作者: Hust, Michael ; Steinke, Stephan ; Garritsen, Hendrikus S P ; Gnann, Dianne Celine

Blood transfusion safety depends on swift blood compatibility testing. Alloantibodies recognizing these blood group antigens determine blood compatibility, and the transfusion of incompatible blood can lead to life‐threatening hemolytic transfusion reactions. Recently, the landscape of blood compatibility testing has been complicated due to the interference caused by therapeutic antibodies targeting CD38, a key target in cancer immunotherapy that is also expressed on red blood cells. The presence of anti‐CD38 antibodies in blood samples has been found to bind to test or donor red blood cells, resulting in false positive tests. This interference poses a serious risk as it can potentially mask immunogenic alloantibodies and cause delays in supplying safe blood products. We present the development and application of fragment crystallizable (Fc)‐fusion constructs, referred to as “baitbodies”, designed to neutralize anti‐CD38 antibodies and mitigate false positive test outcomes. The extracellular domain of CD38 was fused to the Fc domain of a murine immunoglobulin G. These baitbody constructs were thoroughly characterized and applied in both serological microcolumn agglutination and automated solid‐phase red cell adherence assays. The CD38‐mFc baitbody successfully prevented agglutination reactions induced by three clinically relevant anti‐CD38 monoclonal antibodies—daratumumab, felzartamab and isatuximab—in spiked samples. This allowed the detection of alloantibodies of the Rhesus, Kell and Duffy blood groups without interference. The CD38‐mFc construct also demonstrated potential in a head‐to‐head comparison with commercial mitigation reagents, DaraEx and Grifols sCD38. Finally, the CD38‐mFc baitbody effectively neutralized daratumumab in patient samples, preventing false positive test outcomes.

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2026-08-18

·聚创马特

新药速递：2026U4批了哪些新药？

截止目前今年批准的1类新药名单国家医保局初步遴选158个基层病种 2026年7—8月，国家药监局（NMPA）批准1类创新药（含中药1.1类）共11款、化学药品3类仿制药（视同过评）至少6款。下面按月份梳理，并对重点品种做产品分析。一、2026年7月：1类创新药8款集中落地1. 阿更葡糖钠注射液（奥美克松）申报企业：奥默医药 / 仙琚制药获批日期：7月14日类别：化药1类创新药适应症：拮抗罗库溴铵诱导的神经肌肉阻滞（全麻术后肌松恢复）机制亮点：新一代特异性肌松拮抗剂（环糊精衍生物），精准结合罗库溴铵形成无活性包合物临床价值：中国首个自主研发的靶向性肌松拮抗剂，打破默沙东舒更葡糖钠（布瑞亭）近20年全球垄断 2. 琥珀酸安维吖啶片（耄安通）申报企业：通化金马药业获批日期：7月14日类别：化药1类创新药适应症：轻、中度阿尔茨海默病（AD）症状治疗机制亮点：新型双胆碱酯酶抑制剂，同时抑制AChE和BChE，提升脑内乙酰胆碱浓度临床价值：国内首个获批的国产AD双重胆碱酯酶抑制化药1类创新药，研发历时约20年。 3. 奥普雷顿片（奥泽悦 / ORZEYFUL）申报企业：武田制药（Takeda）获批日期：7月21日类别：化药1类创新药，优先审评适应症：16岁及以上青少年和成人1型发作性睡病（NT1）机制亮点：全球首个口服选择性食欲素2型受体（OX2R）激动剂，从根源修复觉醒-睡眠周期紊乱临床价值：该药在中国率先获批，早于美日，是原创靶点创新药"中国首报首发"的代表案例 4. 琥珀酸思普可泮片（HSK39297）申报企业：四川海思科制药获批日期：7月21日类别：化药1类创新药，优先审评适应症：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。机制亮点：高效、高选择性口服补体B因子（CFB）小分子抑制剂，同时控制C3b介导的血管外溶血和末端补体介导的血管内溶血，实现"双重阻断"。临床价值：全球第三款获批CFB抑制剂，也是全球首个每日一次口服的CFB抑制剂，用药依从性显著优于需每日两次给药的伊普可泮和兰诺可泮。 5. 椒七止痛凝胶贴膏申报企业：湖南九典制药获批日期：7月29日类别：中药1.1类创新药适应症：膝骨关节炎寒凝血瘀证，症见关节疼痛、局部畏寒、得温痛减、活动不利、僵凝重滞；临床价值：中药复方外用制剂，具有温经散寒、活血止痛功效，偶见给药部位瘙痒、皮肤烧灼感等轻度反应。 6. 盐酸伊司特韦片（艾普司韦）申报企业：西湖制药（杭州）（西湖大学孵化）获批日期：7月29日类别：化药1类创新药，附条件批准适应症：成人轻型、中型新型冠状病毒感染（COVID-19）机制亮点：口服小分子3CL蛋白酶非共价抑制剂，单药即可起效，无需利托那韦联用临床价值：从IND获批到III期完成仅1年，被视为AI辅助加速研发并获批上市的口服新冠创新药代表案例 7. 舒地胰岛素注射液（瑞恒盈）申报企业：江苏恒瑞医药获批日期：7月29日类别：治疗用生物制品1类创新药适应症：成人2型糖尿病血糖控制。机制亮点：国内首个自主研发的长效胰岛素类似物原创1类新药。临床价值：两项III期研究显示HbA1c降幅与甘精胰岛素相当，夜间低血糖风险降低约35%，52周总低血糖风险降低约20%。 8. 瑞西奇拜单抗注射液（华亦净 / HB0034）申报企业：上海华奥泰生物 / 华海药业获批日期：7月29日类别：治疗用生物制品1类创新药，优先审评适应症：成人（体重≥40kg）泛发性脓疱型银屑病（GPP）发作；机制亮点：高亲和力IgG1型人源化单克隆抗体，精准靶向IL-36R；临床价值：国内首个自主研发获批的靶向IL-36R人源化单抗，打破勃林格殷格翰佩索利单抗的独家垄断；注册试验中单次静脉给药1周后86.4%患者达到脓疱清除/几乎清除。二、2026年8月：1类创新药3款 + 重点新适应症 1. 替恩戈替尼片（捷恩泰）申报企业：药捷安康（南京）科技股份有限公司；获批日期：8月11日类别：化药1类创新药，优先审评、附条件批准；适应症：既往接受过系统性治疗和FGFR抑制剂治疗、具有FGFR2融合或重排的晚期/转移性/不可手术切除胆管癌成人患者；临床价值：为经多线治疗后无药可用的FGFR2阳性胆管癌患者新增靶向治疗方案。 2. 小儿通便颗粒申报企业：济川药业集团有限公司获批日期：8月11日类别：中药1.1类创新药适应症：小儿便秘中医辨证属食积证，症见大便干结、排便困难、舌红苔厚腻、脉滑临床价值：《中药注册管理专门规定》发布后首个主治为证候的中药创新药，补齐儿科便秘专科中药用药短板。 3. 注射用菲泽妥单抗（境斐）申报企业：天境生物药业（杭州）获批日期：8月14日类别：治疗用生物制品1类创新药适应症：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（MM）成年患者。临床价值：天境生物首款商业化产品，全球范围内首次获批。三、同期值得关注的新适应症获批 1、依沃西单抗注射液（依达方，康方生物）：8月12日新增适应症，联合化疗一线治疗晚期鳞状非小细胞肺癌。 2、注射用德曲妥珠单抗（优赫得，第一三共/阿斯利康）：8月11日获批联合帕妥珠单抗一线治疗不可切除或转移性HER2阳性成人乳腺癌。四、2026年7—8月：化学药品3类仿制药（视同过评）获批代表 3类仿制药指境内申请人仿制境外已上市、境内未上市原研药品的化药，获批即视同通过一致性评价。本期内公开披露的代表品种如下： 1. 盐酸卡立哌嗪胶囊（1.5mg / 3mg）申报企业：浙江京新药业获批日期：7月2日类别：化药3类适应症：非典型抗精神病用药，多巴胺D2/D3受体部分激动剂 2. 伊布替尼片（0.14g / 420mg）申报企业：重庆华邦制药（华邦健康子公司）获批日期：7月31日公告类别：化药3类适应症：套细胞淋巴瘤、慢性淋巴细胞白血病/小淋巴细胞淋巴瘤、华氏巨球蛋白血症等备注：专利到期后将启动生产和销售 3. 恩格列净二甲双胍缓释片(III)（12.5mg / 1000mg）申报企业：复星万邦（江苏）医药（复星医药子公司）获批日期：8月3日公告类别：化药3类适应症：配合饮食控制和运动，用于正在接受恩格列净和二甲双胍治疗的2型糖尿病成人患者 4. 盐酸多巴酚丁胺注射液（5ml:100mg）申报企业：上海朝晖药业（复星医药子公司）获批日期：8月8日公告类别：化药3类适应症：用于器质性心脏病时心肌收缩力下降引起的心力衰竭，包括心脏直视手术后所致的低排血量综合征，作为短期支持治疗 5. 氨甲环酸氯化钠注射液（100ml:1.0g/0.7g）申报企业：湖北津药（津药药业子公司）获批日期：8月7日公告类别：化药3类适应症：急性或慢性、局限性或全身性原发性纤维蛋白溶解亢进所致的各种出血 6. 乳酸钠林格冲洗液（3000ml）申报企业：上海长征富民金山制药（华润双鹤子公司）获批日期：8月13日公告类别：化药3类适应症：允许使用无菌电解质溶液的一般冲洗备注：原研由美国贝朗研制，1986年在美国获批，未在中国获批；国内已批石家庄四药、上海长富五、马特药观1、类创新药聚焦罕见病与"全球新"靶点：奥普雷顿（OX2R激动剂）、思普可泮（口服CFB抑制剂）、瑞西奇拜（IL-36R单抗）均属全球差异化布局，其中奥普雷顿在中国先于美日获批。 2、AI制药与高校转化崭露头角：西湖制药伊司特韦被视为DEL技术+AI辅助加速研发并获批的口服新冠小分子代表。 3、中药1.1类创新药持续落地：椒七止痛凝胶贴膏、小儿通便颗粒、枣仁宁心滴丸相继获批，后者为《中药注册管理专门规定》后首个主治证候的中药创新药。 4、3类仿制药以"大品种+短缺药"为主：伊布替尼、恩格列净二甲双胍、多巴酚丁胺、氨甲环酸、乳酸钠林格等均属临床常用品种，获批后视同过评，有助于丰富企业抗肿瘤、糖尿病、急救与围术期产品线。天行健，君子以自强不息。 ---《周易》免责声明：本号内容仅供读者学习和交流。文章、图片等版权归原作者享有，如有侵权，请联系。 * 更多干货分析文章，点击下方关注即可 * 更多点击关注👆👆👆👆👆👆👆👆👆👆👆👆👆👆

2026-08-18

·汇聚南药

穿越潮水与风暴：天境生物的生存法则与兑现时刻

氨基观察-创新药组原创出品作者 | 武月 2026年的中国创新药赛道，正处在叙事逻辑切换的关键节点。多抗、小核酸等领域的交易热度仍在延续，新靶点、新管线的消息层出不穷，但市场的评价标准早已悄然转变：单纯的管线故事不再能撬动长期信心，临床推进的确定性、商业化落地的可行性、商业模式的闭环能力，正成为衡量创新药企价值的核心标尺。潮水退去后，谁在裸泳、谁在扎实布局，答案正愈发清晰。近期，菲泽妥单抗正式获得国家药监局批准上市，成为国内首个实现地产化的CD38抗体药物。若单独看待这一事件，不过是创新药管线推进的常规里程碑；但将时间线拉长至近半年，从创下中国区权益BD交易纪录，到依达格鲁肽完成第二项适应症申报上市，再到最新的依坦生长激素地产化BLA获受理，透过这一连串密集动作不难发现：天境生物这家公司，正步入一个成果集中释放的周期，其沉淀多年的能力体系，正在从战略布局转向价值兑现。这不是一次偶然的风口红利，而是一套完整商业逻辑的逐步验证。 / 01 / 菲泽妥单抗获批背后菲泽妥单抗的正式获批，对于天境生物而言，首先是一次自研与产业化能力的集中验证。作为国内首个地产化CD38抗体，这款产品从临床方案设计、试验推进，到BLA申报、生产工艺落地，全程由天境生物主导完成。这意味着，公司跑通了从研发到上市获批的完整路径，跨过了创新药企业最核心的一道能力门槛。而这款产品的商业价值，其实早在四个月前就已经得到了跨国药企的背书。4月21日，天境生物与渤健达成合作，后者以最高8.5亿美元的交易总额拿下菲泽妥单抗的中国区权益，其中1亿美元首付款，直接刷新了国内创新药单个分子权益交易的纪录。并且，若结合渤健此前收购HI-Bio，以18亿美元拿下菲泽妥单抗海外权益测算，中国区权益的估值占比已接近全球的三分之一，远超行业5%-15%的常规水平。相比交易金额，这笔合作的深层逻辑更值得剖析。渤健重金押注的，从来不止是一款多发性骨髓瘤产品的短期收益，更是CD38单抗在自免领域的广阔想象空间，以及提前卡位中国市场的战略先机。不同于抗CD20等传统B细胞疗法，CD38单抗能够直接靶向浆细胞与浆母细胞，清除产生致病性抗体的长寿命浆细胞，从源头干预自身免疫疾病的进程，潜在覆盖IgA肾病、系统性红斑狼疮、类风湿关节炎等数十种适应症。而中国恰恰是自免疾病的高发市场，仅IgA肾病存量患者就超过百万，现有治疗方案仍存在应答率不足、长期安全性有限等痛点，临床需求远未被满足。菲泽妥单抗本身的差异化特质，进一步放大了这一想象空间。该分子无补体介导的细胞毒性，输注反应风险更低，且不抑制CD38酶活性，在安全性上具备同类最佳潜力。对于渤健而言，牵手天境生物等于为其找到了打开中国市场的“快速通道”。一方面，天境生物高效推进了菲泽妥单抗多发性骨髓瘤适应症的临床与申报工作，在合作达成时已处于上市审评阶段；另一方面，依托已获批的适应症，渤健能够迅速搭建商业化体系，等到后续自免大适应症陆续推进上市时，整套体系早已成熟，进而带来效率优势。渤健相当于用一个适应症的先发优势，换来整个CD38自免管线的战略先手。并且，天境生物提前完成了菲泽妥单抗的地产化技术转移，杭州生产基地已具备符合中美欧GMP标准的商业化生产能力，这既是交易能够创纪录的重要支撑，也让天境生物能够深度参与产品的全生命周期价值分配。 / 02 / 第一梯队管线的集中兑现菲泽妥单抗的获批，是天境生物第一梯队管线兑现潮里最具标志性的节点。与此同时，依达格鲁肽与依坦生长激素两大产品的进展，进一步提高了公司的商业化确定性。依达格鲁肽的第二项适应症BLA申报已于此前完成，依托与石药集团的合作，这款GLP-1产品将由石药负责后续的商业化推广。石药在糖尿病、减重领域拥有深厚的渠道资源与市场经验，能够最大程度释放产品的商业潜力；而对天境生物而言，无需重资产投入销售团队，即可持续收获里程碑付款与销售分成。依坦生长激素的进展同样扎实。在宣布进口产品BLA撤回后，天境生物快速推进了地产化技术转移工作，目前地产化BLA已正式获得国家药监局受理，与济川药业的商业化合作也同步推进。生长激素是国内商业模式成熟、支付能力强的专科领域，济川药业在儿科与生长激素赛道的布局成熟，双方的合作同样锚定了低风险、高确定性的商业化路径。对于中国创新药行业而言，“商业化”从来都是一条划分发展阶段的分水岭，更是对企业资源调配能力的一次大考。尤其，不同治疗领域的商业化逻辑不尽相同，比如肿瘤药依赖院内学术推广与精准诊疗渠道，而代谢与儿科用药在此基础上，则更考验院外市场与患者教育。任何一家初涉商业化的创新药企，都很难在跨度极大的多治疗领域同时建立起出色的商业化团队，强行全栈布局，反而会分散资源、抬升成本，最终稀释产品的商业价值。这也是天境生物当下选择“合作商业化”策略的核心原因。天境生物即将商业化的三款产品，横跨肿瘤、自免、代谢、儿科四大领域，为此，其针对每款产品匹配对应赛道的头部合作伙伴，将终端市场推广的工作交给更擅长的合作方，自身则稳定收获里程碑付款与销售分成收益。这种策略的核心，是在不擅长的商业化环节做“减法”，在核心能力上做“加法”——通过合作规避跨领域商业化的试错成本，提前锁定确定性收入，同时将资金与精力聚焦在研发、生产、BD等环节，让公司能够将更多资源投入核心管线，以最大潜力开发第二梯队全球创新产品，进而创造更大价值。而立足当下，在行业整体从管线叙事转向价值兑现的背景下，天境生物近期的一系列产品商业化进展背后释放的信号，在于其正平稳跨过商业化门槛，步入收入兑现的新阶段。 / 03 / 更高的期待第一梯队管线的集中落地，回答了天境生物“当下价值几何”的问题；而真正支撑其长期想象力的，是其构建的一套从研发、临床到产业化的全链条能力闭环，以及与之匹配的梯队化管线布局与多元化收入结构。在不少企业选择将生产、CMC等环节外包、聚焦前端分子发现的背景下，天境生物走出了一条更具平衡特色的差异化路径——它并非简单追求全环节自建，而是将生产能力嵌入整体研发与商务战略，形成研发、生产、BD三者的产业链协同效应。研发端，其拥有自主技术平台，能够持续产出First-in-class分子；临床端，具备从早期到上市申报的全流程推进能力，保障管线高效推进；生产端，杭州总基地拥有符合国际标准的规模化产能，实现了关键原料药和制剂的自主可控，成为连接研发与商业化合作的关键枢纽。这本质是一种基于产业规律的战略布局，而非简单的资产模式选择。对于创新药企而言，生产能力从来不是孤立的成本项：向上，它能够支撑临床阶段的工艺开发与样品供应，加速研发管线的推进节奏，降低外包带来的沟通成本与工艺转移风险；向下，成熟的商业化产能不仅是BD合作中的核心议价筹码，也能够创造收入反哺公司研发。这套能力闭环，是天境生物管线梯队化接力的底层支撑，保障了增长的连续性。第一梯队的商业化和临床后期产品，负责短期的价值兑现与现金流支撑，为公司筑牢安全垫；第二梯队的全球新管线，则接棒长期增长与天花板突破。以TJ-C64B为代表的管线，均为公司自主平台研发、拥有全球权益的FIC分子，适应症选择与分子形态具备显著差异化，也是未来BD交易与全球市场拓展的核心资产。这种“商业化一批、临床推进一批、早期研发一批”的梯队结构，从根源上避免了管线断档的风险，让公司的发展始终有接续动力。与之匹配的，是三大收入模式的完整闭环验证。第一是BD收入，从与赛诺菲、石药、济川到渤健的四笔重磅合作，首付款与里程碑付款为公司提供了充足的现金流，能够支撑后续研发投入；第二是生产收入，依托自有产能，公司既能为合作产品提供商业化供药，获取稳定的生产端收益；也可承接外部CDMO订单，释放冗余产能的价值；第三则是销售里程碑与分成收入，多款产品上市后，公司将按照合作协议持续获取销售分成，销售额越高，分成比例同步提升，这是长期、可预测的现金流来源。三种收入模式分别对应短、中、长期的现金流供给，互为补充、形成闭环，打破了Biotech“靠融资续命、靠BD一次性变现”的传统模式，也让市场对天境生物的上限，有了更高的期待。 / 04 / 总结 2026年无疑是天境生物的成果大年，但这场密集的价值兑现，并非偶然的风口红利，而是其多年战略深耕的水到渠成。在不确定性极高的创新药行业，任何孤注一掷的押注都可能带来致命风险。天境生物的解法是：不追求全链条的完全自建，也不做只输出分子的“IP批发商”，而是将有限的资金与精力，重仓研发、生产、商业化三个环节中最具杠杆效应的核心部分，再通过产业合作补齐终端短板。这并非行业里最性感的路径，但却是最能穿越周期的选择。随着行业整体从管线叙事转向价值兑现，这套稳健且独特的增长逻辑，或许正是天境生物带给中国创新药行业深刻的启示所在。信息来源：氨基观察往期推荐 ! 免责声明 “汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。喜欢的点个“看一看”和"喜欢"吧不然微信推送规则改变，有可能每天都会错过我们哦~

2026-08-18

·今日头条

全球首批“杭州产”抗癌新药获批上市

【来源：都市快报】近日，杭州医药港传来消息：天境生物研发的注射用菲泽妥单抗（商品名：境斐^[®]），拿到了国家药品监督管理局的上市批准。这款药将联合来那度胺和地塞米松，用于治疗既往至少接受过一线治疗的多发性骨髓瘤成年患者。这是该产品在全球范围内的首次获批。境斐^[®]是一款靶向CD38的人源单克隆抗体，整个多发性骨髓瘤适应证的临床开发和注册申报，全部由天境生物在中国完成。 “10年前，这些药要等在国外上市了，再引进到中国重新做开发。现在反过来了。”天境生物董事长钱丽丽说。境斐^[®]的获批，让钱塘区今年上市的1类创新药增至3款，数量位列全省第一。截至目前，杭州医药港已集聚生物医药企业1800多家，累计4款1类创新药获批上市。另有138个创新药进入临床试验，数量居杭州市首位，其中14个药品已处于临床三期。声明：此文版权归原作者所有，若有来源错误或者侵犯您的合法权益，您可通过邮箱与我们取得联系，我们将及时进行处理。邮箱地址：jpbl@jp.jiupainews.com

100 项与菲泽妥单抗相关的药物交易

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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,

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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
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	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	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
特发性膜性肾病	临床3期	澳大利亚	天境生物药业（杭州）股份有限公司	2025-05-22

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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


NCT05065970 (IGNAZ, CTgov)	临床2期	免疫球蛋白a肾病	54	Placebo (Part 1: Placebo)	鑰築遞選構壓繭鑰蓋積(窪憲製簾壓膚積築網壓) = 繭鏇網窪膚憲範鏇鏇鏇顧廠範遞淵餘淵夢淵膚 (鏇餘淵襯遞鑰顧淵壓鏇, 19.43) 更多	-	2026-04-28
				Placebo+Felzartamab (Part 1: Felzartamab Dosing Arm M1)	鑰築遞選構壓繭鑰蓋積(窪憲製簾壓膚積築網壓) = 網簾壓範齋築鹹遞壓範顧廠範遞淵餘淵夢淵膚 (鏇餘淵襯遞鑰顧淵壓鏇, 19.41) 更多
NCT05065970 (IGNAZ, ASN2025)	临床2期	免疫球蛋白a肾病	54	Felzartamab	鹹糧淵膚遞選衊遞簾製(選膚襯構鏇夢窪蓋遞窪) = 製鑰築願鹹糧構鑰憲鏇獵膚鹹夢遞遞獵鹹廠壓 (鏇觸遞艱窪願簾蓋襯鏇 ) 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	鹽選艱窪壓鑰遞壓衊選(顧鹽鑰觸製廠壓壓鬱醖) = Felzartamab safety was consistent with prior observations; adverse events were predominantly grade 1 or 2. 築遞襯獵簾構築選餘壓 (觸鏇觸鹽壓鹽鏇觸觸夢 )	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)	襯襯憲廠憲夢遞鬱鬱選(範築醖鹽願衊遞鬱鬱衊) = Treatment with felzartamab led to rapid, clinically meaningful reductions in UPCR vs PBO, with the greatest effect in the M3 arm. 鹹憲憲夢鑰蓋廠製積顧 (範窪顧鹹齋獵簾遞繭蓋 ) 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	願壓廠鏇獵醖醖遞選構(簾顧壓築鹽鏇鬱鹹範獵) = 觸淵網範獵觸襯齋夢醖積糧鏇鏇膚鏇醖觸鬱構 (艱齋顧淵願範餘範製襯 ) 更多	积极	2024-06-20
				Felzartamab 16 mg/kg (newly diagnosed or relapsed PMN)	齋遞築願餘糧鹹糧鹽憲(夢構膚鹽蓋鏇簾壓構選) = 獵衊獵壓糧遞壓獵鏇願遞繭顧獵願襯廠繭範願 (鏇壓簾壓獵餘艱獵顧壓 )
NCT05021484 (NEWS) 人工标引	临床2期	肾移植排斥反应	22	Felzartamab	選繭鬱鏇糧鬱獵齋夢襯(壓觸願蓋餘齋願窪醖觸) = felzartamab showing an acceptable safety profile and most adverse events being mild or moderate. 夢膚糧糧夢齋艱膚觸構 (鹽鏇壓網憲壓餘糧觸齋 )	积极	2024-05-27
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NCT05065970 (IGNAZ, PRNewswire) 人工标引	临床2期	免疫球蛋白a肾病	54	Felzartamab	鏇簾窪觸醖艱壓製鬱觸(積鑰窪衊網淵窪憲製構) = 蓋築蓋壓鹹觸壓構構衊齋積鹽遞構艱積範選鏇 (壓鹹構顧衊窪餘遞繭艱 )	积极	2024-05-24
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NCT04145440 (M-PLACE, ASN2023) 人工标引	临床1/2期	特发性膜性肾病一线	31	Felzartamab	鏇淵願鏇淵顧膚醖餘膚(憲網膚製醖衊獵構鹽餘) = 齋淵鬱鑰襯憲廠顧顧鬱鑰醖選築醖網鬱製網窪 (衊醖網網範顧顧製壓蓋 ) 更多	积极	2023-11-02
				Felzartamab (newly diagnosed or relapsed patients)	願齋窪構餘糧膚網艱醖(觸範淵鑰鹽蓋襯夢鹽獵) = 膚窪簾齋艱艱憲衊繭鬱築蓋觸淵願膚觸壓鑰鑰 (壓選構齋繭醖糧獵築願 ) 更多
NCT04145440 (M-PLACE, ASN2023)	临床1/2期	特发性膜性肾病 aPLA2R+	31	Felzartamab (Cohort 1)	艱鬱範鬱糧鹹淵獵齋顧(窪壓簾蓋簾糧觸醖繭齋) = 網積願遞簾鑰醖鏇觸廠齋鹹選製網鹹鏇顧選齋 (願糧齋鏇製鬱觸艱製鹽 ) 更多	积极	2023-11-02
				Felzartamab (Cohort 2)	鏇襯築鹽獵壓壓範範獵(艱鹽糧積製鹹鹹鹽襯築) = 鑰網網顧糧網憲簾選顧蓋衊鹽繭壓淵夢窪齋範 (衊鬱觸鑰廠網範網襯網 ) 更多
NCT04145440 (M-PLACE, ASN2022)	临床1/2期	膜性肾小球肾炎 anti-PLA2R Abs	31	Felzartamab (MOR202) 16 mg/kg	淵窪繭餘齋鹽淵餘窪襯(構鹹夢顧廠築鬱鹹積觸) = 築鹽鹽窪範壓憲製醖壓憲積願鬱膚繭鬱膚淵淵 (襯餘壓積範膚糧選範觸 )	积极	2022-11-05