An Open-label, Single-arm, Multicenter, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of Plonmarlimab in Subjects With Relapsed/Refractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis (Also Known as Macrophage Activation Syndrome [MAS])

A study designed to evaluate the efficacy, safety, immunogenicity, PK, and PD characteristics of Plonmarlimab in patients with relapsed/refractory rheumatic and immunologic disease-associated MAS, and to explore biomarkers related to the efficacy of Plonmarlimab.

开始日期2025-11-21

申办/合作机构

天境生物药业（杭州）股份有限公司

NCT07034209

/ Completed临床2期

An Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetic Characteristics, and Immunogenicity of Plonmarlimab in Subjects With Rheumatic and Immunological Disease-associated Haemophagocytic Lymphohistiocytosis (HLH) (Also Known as Macrophage Activation Syndrome (MAS))

This study adopts an open-label, single-arm, multicenter design to evaluate the efficacy, safety, tolerability, immunogenicity, and PK characteristics of Plonmarlimab administration in patients with rheumatic and immunological disease-associated HLH (MAS), and to explore biomarkers related to the efficacy of Plonmarlimab.

开始日期2023-04-07

申办/合作机构

天境生物药业（杭州）股份有限公司

ChiCTR2500107345

/ Completed临床2期IIT

An open, single-arm, multicenter clinical study to evaluate the efficacy, safety, tolerability, pharmacokinetic profile, and immunogenicity of plonmarlimab in subjects with rheumato-immune disease-associated hemophagocytic lymphohistiocytosis /macrophage activation syndrome

开始日期2022-10-01

申办/合作机构

天境生物药业（杭州）股份有限公司

100 项与普那利单抗相关的临床结果

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100 项与普那利单抗相关的转化医学

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100 项与普那利单抗相关的专利（医药）

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项与普那利单抗相关的文献（医药）

2025-12-01·Life Science Alliance

Lnk/Sh2b3 regulates initiation and severity of autoimmune insulitis and contributes to diabetes risk

Article

作者: Tenno, Mari ; Takaki, Satoshi

The Lnk/Sh2b3 adaptor protein functions as a regulatory molecule for cytokine signaling in lymphohematopoiesis. A missense variant of the LNK/SH2B3 gene is reportedly a risk variant common to several autoimmune diseases, including type 1 diabetes (T1D). However, roles of Lnk in T1D development remain elusive. We found that Lnk−/− mice showed increased susceptibility to diabetes following treatment with fairly low doses of streptozotocin, manifested by hyperglycemia and insulitis accompanied by accumulation of CD8+ T-cells and loss of pancreatic β cells. The high susceptibility of Lnk−/− mice to islet damage was abolished in crosses with Rag2−/− mice lacking lymphocytes or MyD88−/− mice carrying various defects in activation of innate immune cells. In Lnk−/− mice pancreata, dendritic cell (DC) fractions were altered and showed augmented expression of CD40 and IL-27. Treatment with anti-CD40L or anti-GM-CSF antibodies suppressed β cell damage and prevented diabetes. Thus, Lnk regulates T-cell priming and expansion via GM-CSF- and possibly IL-27-dependent activation of pancreatic DCs after islet damage.

2025-12-01·Current Hematologic Malignancy Reports

The Role of Inflammation in CMML Pathobiology and Progression

Review

作者: Padron, Eric ; Neupane, Niraj

PURPOSE OF REVIEW:

Chronic myelomonocytic leukemia (CMML) is a clonal hematopoietic malignancy characterized by monocytosis and dysplasia. While mutations in genes like TET2 and SRSF2 have helped us understand its molecular foundations, the role of inflammation in driving disease behavior is becoming increasingly evident. This review explores the role of inflammation in the biology and clinical progression of CMML, with a focus on its impact on disease initiation, progression, and potential therapeutic strategies.

RECENT FINDINGS:

Recent studies have shown that inflammatory cytokines, especially IL-6, TNF-α, and IL-8, are not just bystanders but active participants in promoting clonal hematopoiesis, immune dysregulation, and bone marrow dysfunction in CMML. Patients with systemic inflammation or autoimmune conditions are at a higher risk of developing CMML, suggesting a potential causal relationship. On the therapeutic front, drugs targeting cytokine pathways, such as ruxolitinib (a JAK inhibitor) and lenzilumab (an anti-GM-CSF antibody), have shown early promise in modifying disease activity and improving symptoms. Inflammation plays a central role in CMML, from disease onset to transformation into acute leukemia. Understanding and targeting these inflammatory circuits may not only help slow disease progression but also improve quality of life for patients. As our knowledge grows, incorporating inflammation into both our diagnostic frameworks and treatment approaches will likely become standard in the care of CMML.

2025-11-01·Contemporary Clinical Trials

Design of RESOLVE Lung, a multinational Phase 2, randomized, placebo-controlled trial of the anti-GM-CSF monoclonal antibody namilumab in patients with chronic pulmonary sarcoidosis

Article

作者: Lin, Min ; Birring, Surinder S ; van den Blink, Bernt ; Reiss, Theodore F ; Petit, Chantal M ; Baughman, Robert P ; Dansky, Hayes M ; Wijsenbeek-Lourens, Marlies S

BACKGROUND:

Pulmonary sarcoidosis is a rare inflammatory disease associated with morbidity and mortality. In light of limited treatment options, oral corticosteroids (OCS), off-label immunosuppressive therapies (IST) and tumor necrosis factor alpha inhibitors are standard of care. However, due to tolerability concerns with long-term use of OCS and IST, novel treatment options are needed. Namilumab is a potent, investigational granulocyte macrophage colony-stimulating factor humanized monoclonal antibody, that can potentially downregulate the granulomatous response, with favorable tolerability observed across clinical studies.

STUDY DESIGN:

In this double-blind, 26-week, placebo-controlled trial, with an optional 28-week, open-label extension, approximately 100 patients will be randomized in a 1:1 ratio to receive 150 mg namilumab or placebo via subcutaneous injection. Eligible patients have active, chronic pulmonary sarcoidosis (CPS; assessed by clinical and radiologic parameters) poorly regulated by OCS and/or ISTs or failed or intolerant to treatment. At randomization, ISTs will be stopped and OCS tapered.

OBJECTIVE:

The objective of this trial is to evaluate the efficacy and safety of namilumab in patients with active CPS. The primary endpoint is the proportion of patients requiring rescue treatment during the double-blind period due to worsening sarcoidosis. Secondary endpoints include assessment of lung function, respiratory symptoms, and corticosteroid burden. Additionally, quality-of-life assessments, serum biomarkers, and a composite clinical benefit endpoint will be explored.

DISCUSSION:

This study will be one of the largest Phase 2 trials in the last decade for active CPS. Data from this trial will potentially provide valuable insights into disease endpoints, patient selection, and optimizing trial design.

项与普那利单抗相关的新闻（医药）

2026-01-15

·PRNewswire

Hemophagocytic Lymphohistiocytosis Market Poised for Phenomenal Expansion in the US at a CAGR of 24.5% During the Forecast Period (2025-2034) | DelveInsight

The hemophagocytic lymphohistiocytosis market is expected to increase due to the launch of emerging therapies, such as plonmarlimab (TJ Biopharma), ELA026 (Electra Therapeutics), MAS825 (Novartis), tadekinig alfa (r-hIL-18BP) (AB2 Bio), and others, as well as label expansions of current therapies. This is because of the higher patient burden, approval of newer therapies with high cost, and broader acceptance and availability of newly approved therapies. LAS VEGAS, Jan. 15, 2026 /PRNewswire/ -- DelveInsight's Hemophagocytic Lymphohistiocytosis Market Insights report includes a comprehensive understanding of current treatment practices, hemophagocytic lymphohistiocytosis emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Hemophagocytic Lymphohistiocytosis Market Summary The market size for hemophagocytic lymphohistiocytosis was found to be USD 140 million in the United States in 2024. The HLH market remains highly unmet, with conventional therapies leading to high mortality (20–30% before HSCT) and only about 60% long-term survival due to toxicity, treatment failure, and relapse risk. Among the 7MM countries, there were 5,100 incident cases of HLH in the US in 2024. Leading hemophagocytic lymphohistiocytosis companies, such as TJ Biopharma, AB2 Bio, Electra Therapeutics, Novartis, and others, are developing new hemophagocytic lymphohistiocytosis treatment drugs that can be available in the hemophagocytic lymphohistiocytosis market in the coming years. The promising hemophagocytic lymphohistiocytosis therapies in clinical trials include Plonmarlimab (TJM2/TJ003234), Tadekinig alfa (r-hIL-18BP), ELA026, MAS 825, and others. Discover the new hemophagocytic lymphohistiocytosis treatment @ Key Factors Driving the Growth of the Hemophagocytic Lymphohistiocytosis Market Rising HLH Incidence: The increasing incidence of HLH, often triggered by underlying infections, autoimmune diseases, malignancies, or immuno-oncology treatments, has expanded the pool of patients needing diagnosis and therapy. Advances in Diagnostics and Early Detection: Improvements in diagnostic technologies, including genetic testing, immunologic profiling, and next-generation sequencing, enable earlier and more accurate detection of HLH. This allows timely intervention, which is critical given the rapid, life-threatening course of HLH. GAMIFANT Maintains First-in-Class Position in HLH: GAMIFANT (Sobi) remains the only approved therapy for primary HLH (since 2018) and has recently expanded its label, gaining US FDA approval in June 2025 for MAS associated with Still's disease. Following this approval, GAMIFANT has demonstrated stronger-than-projected market uptake, with double-digit growth in Constant Exchange Rates (CER). The company plans to pursue EU regulatory submission in 2026, indicating continued strategic expansion of its HLH and MAS portfolio. Launch of Emerging HLH Drugs: The dynamics of the HLH market are expected to change in the coming years due to the launch of emerging therapies such as plonmarlimab (TJ Biopharma), ELA026 (Electra Therapeutics), MAS825 (Novartis), tadekinig alfa (r-hIL-18BP) (AB2 Bio), and others. Hemophagocytic Lymphohistiocytosis Market Analysis Management of HLH necessitates a comprehensive, multimodal strategy that integrates immunosuppressive, cytotoxic, and targeted therapies to control hyperinflammation, limit pathological immune activation, and restore immune homeostasis. Therapeutic decisions are guided by disease severity and the underlying trigger, with early, aggressive intervention essential to prevent irreversible organ damage. High-dose corticosteroids, particularly dexamethasone, constitute a foundational component of HLH treatment due to their potent anti-inflammatory effects and ability to suppress cytokine-mediated tissue injury. Etoposide-based regimens remain a cornerstone of first-line therapy, as they effectively eradicate cytotoxic lymphocytes and macrophages that are excessively activated and drive disease pathology. Immunosuppressive agents such as cyclosporine are commonly employed to suppress T-cell activation and reduce cytokine release, thereby dampening immune overactivation. Targeted biologic therapies, including rituximab for EBV-associated HLH and monoclonal antibodies such as alemtuzumab or antithymocyte globulin in refractory disease, enable more selective immune modulation. When infections serve as triggering factors, concurrent antimicrobial therapy, including antivirals and antibiotics, is critical to address both the precipitating cause and the downstream inflammatory cascade. Collectively, these treatment approaches aim to achieve disease stabilization and control, allowing eligible patients to proceed to definitive curative options such as hematopoietic stem cell transplantation (HSCT). GAMIFANT demonstrated strong commercial momentum in Q3 2025, generating USD 66.6 million in revenue, a 98% year-over-year increase. Revenue growth was driven by rising patient adoption, a favorable product mix, and the successful U.S. launch for macrophage activation syndrome (MAS) in Still's disease, making GAMIFANT the first approved therapy for both pediatric and adult patients. This milestone highlights GAMIFANT's broader applicability across the HLH–MAS disease spectrum and reinforces its long-term growth potential. Regulatory momentum remains positive, while active compassionate-use programs in Europe continue to reflect sustained clinician demand. Looking ahead, GAMIFANT revenues are expected to grow at a low double-digit CAGR at constant exchange rates, supported by global market expansion, improved patient access, and continued uptake across both MAS and HLH indications. Hemophagocytic Lymphohistiocytosis Competitive Landscape The pipeline of HLH is very scarce, with only three emerging therapies: plonmarlimab (TJ Biopharma), ELA026 (Electra Therapeutics), MAS825 (Novartis), and tadekinig alfa (r-hIL-18BP) (AB2 Bio). Despite all being in late-stage development, this underscores the scarcity of therapeutic innovation in this space. AB2 Bio's Tadekinig alfa is an innovative recombinant human IL-18 binding protein (IL-18BP) that neutralizes IL-18, a key pro-inflammatory cytokine. Under normal physiological conditions, endogenous IL-18BP is present in excess, maintaining circulating free IL-18 at undetectable levels. In certain autoinflammatory disorders, this regulatory balance is disrupted, leading to elevated systemic free IL-18 and severe pathological hyperinflammation. Tadekinig alfa re-establishes this balance by sequestering excess free IL-18, thereby attenuating inflammatory responses. This mechanism represents a novel and promising therapeutic strategy for autoimmune and inflammatory diseases characterized by elevated systemic IL-18 levels. The therapy is currently being evaluated in a Phase III clinical trial. Electra Therapeutics' ELA026 is a monoclonal antibody developed to treat severe inflammatory diseases driven by dysregulated myeloid cells and T-lymphocytes. It selectively and rapidly depletes the circulating inflammatory myeloid cells and T cells responsible for disease pathology, while preserving the CD47/SIRPα immune checkpoint pathway. ELA026 is presently in Phase II/III clinical development. The anticipated launch of these emerging therapies are poised to transform the hemophagocytic lymphohistiocytosis market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the hemophagocytic lymphohistiocytosis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about the hemophagocytic lymphohistiocytosis drugs @ Hemophagocytic Lymphohistiocytosis Drugs Market Recent Developments in the Hemophagocytic Lymphohistiocytosis Market In October 2025, Electra Therapeutics announced that the first patients had been dosed in the SURPASS study, a pivotal Phase II/III clinical trial evaluating ELA026, the first investigational therapy designed to broadly treat secondary HLH. In June 2025, Sobi announced that the US FDA approved emapalumab for the treatment of adult and pediatric (newborn and older) patients with HLH/MAS in known or suspected Still's disease, including sJIA, with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. What is Hemophagocytic Lymphohistiocytosis? Hemophagocytic lymphohistiocytosis is a rare, life-threatening immune system disorder characterized by extreme and uncontrolled immune activation. In HLH, immune cells, particularly macrophages and lymphocytes, become overactive and release excessive amounts of inflammatory cytokines, leading to a "cytokine storm" that causes widespread tissue damage and organ failure. The condition can be inherited (primary HLH) due to genetic defects affecting immune regulation, or acquired (secondary HLH) and triggered by infections, malignancies, autoimmune diseases, or other immune challenges. Clinically, HLH often presents with persistent high fever, enlarged liver and spleen, cytopenias, liver dysfunction, and markedly elevated inflammatory markers. Without prompt diagnosis and treatment, HLH can rapidly progress and is frequently fatal. Hemophagocytic Lymphohistiocytosis Epidemiology Segmentation The hemophagocytic lymphohistiocytosis epidemiology section provides insights into the historical and current hemophagocytic lymphohistiocytosis patient pool and forecasted trends for the leading markets. The commonest single disease entities were lymphoma, SLE, and sJIA. There has been evidence of clinically diagnosed HIV, EBV, or CMV infection either in the health record or on the death certificate in 2.3%, 8.9%, and 3.3%, respectively. The hemophagocytic lymphohistiocytosis treatment market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets, segmented into: Total Incident Cases of HLH Total Incident Cases of HLH by Type Incident Cases of HLH by Gender Incident Cases of Familial HLH by Mutation Incident Cases of Acquired HLH by Etiology Total Treated Cases of HLH Scope of the Hemophagocytic Lymphohistiocytosis Market Report Therapeutic Assessment: Hemophagocytic Lymphohistiocytosis current marketed and emerging therapies Hemophagocytic Lymphohistiocytosis Market Dynamics: Key Market Forecast Assumptions of Emerging Hemophagocytic Lymphohistiocytosis Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Hemophagocytic Lymphohistiocytosis Market Access and Reimbursement Download the report to understand what is the latest research on hemophagocytic lymphohistiocytosis @ New Hemophagocytic Lymphohistiocytosis Medication Table of Contents Related Reports Hemophagocytic Lymphohistiocytosis Clinical Trial Analysis Hemophagocytic Lymphohistiocytosis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HLH companies, including Chia Tai Tianqing Pharmaceutical Group, Bellicum Pharmaceuticals, Atara Biotherapeutics, Incyte Corporation, Alpine Immune Sciences, Expression Therapeutics, among others. Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Clinical Trial Analysis Systemic Lupus Erythematosus Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key SLE companies, including Roche, Biogen, Viatris Inc., Novartis, Qilu Pharmaceutical, ImmuPharma, Beijing Mabworks Biotech Co., Ltd., Zenas Biopharma, AbbVie, Beijing InnoCare Pharma Tech Co., Ltd., Alumis Inc., Galapagos NV, Palleon Pharmaceuticals, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Johnson & Johnson, Merck KGaA, Resolve Therapeutics, ILTOO Pharma, Argenx, Cartesian Therapeutics, Keymed Biosciences Co.Ltd, BioSenic, Eisai, Vertex Pharmaceuticals, Kyverna Therapeutics, Miltenyi Biomedicine, Astrazeneca, Otsuka Pharmaceutical, Fresh Tracks Therapeutics, among others. Macrophage Activation Syndrome Market Macrophage Activation Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key MAS companies, including Electra Therapeutics, TJ Biopharma, AB2 Bio, Novartis, Deepcure, Sobi, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

上市批准免疫疗法临床3期

2025-10-21

·小红书

天境生物：中国创新药的第三条路

当新桥生物选择资本平台化时，天境生物正用全产业链演绎着更动人的故事。这不仅是两家"同根生"企业的分道扬镳，更是中国创新药发展路径的哲学思辨。天境用一年两轮10亿融资证明：在资本寒冬里，真正的价值永远来自扎实的临床管线。六个临床后期产品组成的接力方阵，像精心编排的交响乐章——菲泽妥单抗在CD38靶点另辟蹊径，普那利单抗在自免领域填补空白，GLP-1则精准踩中代谢风口。但最令人着迷的是其"矛盾统一"的战略美学。既做FIC又搞me-too，既深耕中国又布局全球，既自建产能又借力商业化。这种看似贪婪的"全都要"，实则是经过精密计算的生存艺术。当同行在BD与自研间左右为难时，天境用多元创新破解了这道行业悖论。其杭州GMP基地的万升级产能，藏着更深的产业智慧。在供应链安全成为全球议题的今天，自主可控的产能就是创新药的"诺亚方舟"。而将依坦生长激素交给济川药业这类决策，则展现了难得的商业克制——知道什么该紧握，什么该放手。普那利单抗的闪电推进更值得玩味。从获得突破性疗法到启动三期仅用数月，这种效率背后是拆分带来的"心理重启效应"。有时候，企业需要的不是更多资源，而是更轻的包袱。豆浆博士点评：作为CMO，我见过太多"要么全自研要么全引进"的极端案例。天境这种"战略骑墙派"反而展现了成熟药企的智慧——就像好的厨师既会种菜也会挑现成食材。他们的产品矩阵让我想起瑞士军刀：每个工具都不完美，但组合起来就是生存神器。不过要提醒的是，当六个产品同时冲刺BLA时，团队可能会像同时杂耍六个火把的街头艺人——刺激，但需要极强的平衡力。 #医学博士 #医药 #新药研发 #战略性新兴产业 #产业发展趋势 #绿色能源转型 #生态多样性 #创新药 #药企 #生命科学

抗体药物偶联物突破性疗法临床3期

2025-10-09

·维亚生物

VIVA朋友圈丨天境生物完成近6亿元融资，加速创新药商业化与全球化进程

中国杭州，2025年9月30日——由维亚生物参与投资的天境生物（TJ Biopharma）（以下简称“天境”或“公司”），一家专注于自身免疫疾病、肿瘤及代谢疾病领域创新生物药药物发现、临床开发、生产和合作商业化的全链条生物科技公司，宣布成功完成近6亿元人民币的C2轮融资。本轮融资由中金资本旗下基金领投，沂景资本、东方富海、之科基金、椿灵投资、新毅投资等机构跟投，老股东和达投资、清松资本、屹远投资及钱塘城发亦持续加码。本轮融资充分彰显了资本市场对天境生物差异化创新管线、全产业链布局及多元化收入模式的高度认可。此次募集的资金将重点用于推动第一梯队产品的三期临床试验与上市申报，加速第二梯队全球创新候选药物的研发。战略重组成效卓著构建稳健基本盘与多元收入引擎自2024年初完成战略重组以来，天境生物已成功转型为一家兼具创新深度与商业广度的全链条、平台型生物科技企业。公司通过“即将上市产品商业化+ 创新产品对外授权（BD）+CDMO服务”的多元化收入模式，有效平衡了创新研发的投入与风险，构筑了稳健的商业基本盘。重组至今，公司已高效达成多项关键里程碑，充分展现了卓越的运营与执行能力。重要进展包括：与法国赛诺菲公司就尤莱利单抗大中华区权益达成总价值约17亿元人民币的战略合作；成功递交两款产品的上市申请，包括依坦生长激素α以及菲泽妥单抗（多发性骨髓瘤适应症）；与美国渤健公司合作，在中国启动菲泽妥单抗治疗IgA肾病和原发性膜性肾病的国际多中心三期临床研究；普那利单抗获国家药品监督管理局药品审评中心突破性治疗药物认定，并已启动三期临床试验。创新管线进入收获期多款重磅产品临近商业化天境生物凭借其丰富且高度差异化的产品管线，构筑了强大的核心竞争力，形成了清晰的双梯队布局：第一梯队产品管线（Best-in-Class潜力）凭借六款处于上市申报及临床后期阶段的重磅产品，公司彰显出巨大的近中期商业化潜力。菲泽妥单抗（Felzartamab）：一款具有差异化优势的首个地产化CD38抗体，其针对多发性骨髓瘤适应症的上市申请已获受理，并在自身免疫疾病领域展现出“Pipeline-in-product”的巨大潜力。公司与渤健合作推进的IgA肾病及膜性肾病的国际多中心三期临床已获得CDE批准，正在启动中。依坦生长激素α（Eftansomatropin Alfa）：一款创新全融合蛋白长效生长激素，其上市许可申请已获受理。通过加速该产品的地产化进程及合作伙伴济川药业卓越的商业化能力，有望在中国高速增长的儿童生长激素市场中占据领先地位。 Efmedaglutide Alfa（TJ103/TG103）：与石药集团合作开发的长效GLP-1融合蛋白，剑指庞大的代谢疾病市场，计划于2025年申报上市。尤莱利单抗（Uliledlimab, CD73）：用于非小细胞肺癌（NSCLC）一线治疗，其生物标志物驱动的临床研究已获得优异数据，并于2024年9月与赛诺菲达成总价值约17亿元人民币的大中华区战略合作并按计划推进两项NSCLC一线治疗的临床研究。普那利单抗（Plonmarlimab, GM-CSF）：针对巨噬细胞活化综合征（MAS）及痛风性关节炎，其中MAS适应症于2024年9月获得中国国家药品监督管理局（NMPA）突破性治疗品种认定并已启动三期临床研究；痛风性关节炎也将于近期启动二/三期临床研究。 Givastomig（CLDN18.2x4-1BB双抗）：全球首创的双特异性抗体，其联合PD-1及化疗在胃癌一线治疗中展现出卓越的疗效（客观缓解率83%）与安全性，疗效覆盖Claudin18.2低中高表达的胃癌患者；天境生物拥有该产品的大中华区权益并计划于近期开展下一阶段临床研究。第二梯队全球创新管线（First-in-Class潜力）依托自主研发的IG Plus综合技术平台，包括条件性激活4-1BB双抗、遮蔽肽前药等前沿技术，公司布局了TJ-C64B等系列"全球首创"项目，以及抗体-细胞因子、抗体-小分子偶联药物等新一代创新药物。这些候选药物预计将于2025-2026年陆续进入临床试验阶段，为公司提供持续的全球授权交易动能和长期价值。全产业链闭环能力为商业化成功保驾护航天境生物将地产化作为核心公司战略之一，通过持续优化生产工艺、有效降低制造成本并严格确保质量可控，成功构建了覆盖研发至商业化的全链条价值平台，形成了独特的差异化竞争优势。杭州生产基地作为公司核心资产，一期基地已全面投入运营，严格遵循中美欧GMP标准，并成功通过多家国际药企审计，完成多个项目的全球技术转移。目前，菲泽妥、依坦等核心产品的本土化生产已实质性落地该基地。随着2024年8月药品生产许可证（A证）的获批，公司已构建起从研发到生产的端到端地产化能力，为持续降低成本、提升供应链可控性奠定坚实基础。地产化战略不仅为即将上市的产品提供了稳定供应保障，更为公司商业化成功奠定了坚实基础，由此构筑的差异化竞争壁垒，已成为天境生物在创新药领域实现持续领先的关键优势。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等领域创新疗法的全链条生物科技公司。公司立足中国，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，成功构建了具有差异化优势的多梯队临床产品管线和临床前管线，其中第一梯队两款产品（菲泽妥单抗和依坦生长激素α）已进入产品上市受理阶段，另外三款创新产品预计于2025年进入三期临床阶段。凭借与济川药业、石药集团、赛诺菲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。如需了解更多信息，请访问：TJBio.com。相关推荐免责声明与孵化企业相关的信息由孵化企业提供, 未经本公司独立验证任何情况下, 本公司不对由于本新闻稿资料不准确或疏漏或使用本新闻稿资料引致的损失和损害承担任何直接和间接的责任(不论是民事侵权行为、合约责任或其他)。维亚生物（01873. HK）成立于2008年，向全球创新药研发企业提供从早期基于结构的药物研发到商业化药物生产的一站式综合服务。凭借在基于结构的药物研发（SBDD）技术领域的领先优势，我们向全球合作伙伴提供新药研究阶段的CRO服务，搭建了X射线蛋白晶体技术、冷冻电镜技术（Cryo-EM）、DNA编码化合物库技术（DEL）、亲和力质谱筛选技术（ASMS）、表面等离子共振技术（SPR）、氢氘交换质谱技术（HDX-MS）、AIDD/CADD等多个先进技术平台，并有资深药物化学家与药物发现生物专家领军的团队提供药物设计、药物化学（H2L，LO）、化合物合成、化学分析及纯化、公斤级放大及多肽合成及相应的生物活性测试服务。通过子公司朗华制药，我们提供从临床前开发到商业化生产的一站式CMC/CDMO解决方案。同时，我们专注于发现、投资高潜力生物医药初创公司，以独创的技术服务换取股权（EFS）的商业模式，解决未满足的临床需求。联系我们：info@vivabiotech.com

临床3期突破性疗法申请上市ASH会议

100 项与普那利单抗相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
噬血细胞性淋巴组织细胞增多症	临床3期	中国	天境生物药业（杭州）股份有限公司	2025-11-21
巨噬细胞活化综合征	临床3期	中国	天境生物药业（杭州）股份有限公司	2025-11-21
新型冠状病毒感染	临床3期	美国	I-Mab Biopharma US Ltd.	2020-04-11
类风湿关节炎	临床1期	中国	I-Mab Biopharma US Ltd.	2020-08-06
类风湿关节炎	临床1期	中国	天境生物科技（上海）有限公司	2020-08-06
痛风性关节炎	临床申请批准	中国	天境生物药业（杭州）股份有限公司	2023-05-05

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临床结果

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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


NCT04341116 (CTgov)	临床2/3期	新型冠状病毒感染	149	TJ003234 (TJ003234 6mg/kg (Part 1))	鏇願壓壓淵構願鹽齋衊(壓醖鏇顧簾遞鹽鏇觸壓) = 繭簾鹽遞壓蓋遞憲構鹽憲襯鬱壓積積糧衊衊憲 (糧蓋齋蓋糧窪簾鹽醖獵, 憲鏇壓衊鏇淵範糧遞鹽 ~ 衊膚遞憲蓋淵夢糧淵糧) 更多	-	2023-05-06
				Placebo (Placebo (Part 1))	鏇願壓壓淵構願鹽齋衊(壓醖鏇顧簾遞鹽鏇觸壓) = 顧顧積鹽鏇壓遞積積蓋憲襯鬱壓積積糧衊衊憲 (糧蓋齋蓋糧窪簾鹽醖獵, 獵膚觸製窪顧襯廠壓鹽 ~ 選餘範簾蓋廠廠願範獵) 更多
NCT04341116 (PRNewswire) 人工标引	临床2/3期	新型冠状病毒感染	91	Plonmarlimab	齋獵範願窪鹽範鬱廠觸(蓋憲艱餘簾獵築簾範願) = 鑰艱網網糧窪夢廠築構窪蓋積構繭範艱鬱鑰齋 (願壓醖醖窪鬱窪窪齋繭 ) 更多	积极	2021-08-11
				Placebo	齋獵範願窪鹽範鬱廠觸(蓋憲艱餘簾獵築簾範願) = 簾鏇獵鏇積膚壓憲膚構窪蓋積構繭範艱鬱鑰齋 (願壓醖醖窪鬱窪窪齋繭 ) 更多