AdvanTIG-211: A Randomized, Double-blind, Placebo-controlled, Phase II Study Evaluating the Efficacy and Safety of Ociperlimab (WCD118) Combined With Tislelizumab (VDT482) Plus Chemotherapy Versus Placebo Combined With Pembrolizumab Plus Chemotherapy as First-line Therapy for Participants With Advanced Triple Negative Breast Cancer (TNBC)

The primary scientific question of interest of this study is whether the combination of ociperlimab, tislelizumab and chemotherapy improves progression-free survival (PFS) compared to the combination of placebo, pembrolizumab and chemotherapy as first-line therapy for adult men and women with advanced triple negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD - L1) [combined positive score (CPS) ≥10], regardless of study treatment discontinuation or start of new anti-neoplastic therapy.

开始日期2023-09-15

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT05791097

/ Withdrawn临床3期

AdvanTIG-306: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Ociperlimab (WCD118/BGB-A1217) Combined With Tislelizumab (VDT482/BGB-A317) Plus Platinum-based Doublet Chemotherapy Versus Placebo Combined With Pembrolizumab Plus Platinum-based Doublet Chemotherapy as First-line Therapy for Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

The primary scientific question of interest is whether the addition of ociperlimab to platinum-based chemotherapy and tislelizumab improve progression-free survival (PFS) or overall survival (OS) compared to pembrolizumab and platinum-based chemotherapy as first-line therapy for participants with locally advanced or metastatic squamous or non-squamous NSCLC with PD-L1 expression of ≥1%.

开始日期2023-07-28

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT05577702

/ Completed临床2期

A Randomized, Open-Label, Multicenter, Phase 2, Umbrella Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations With and Without Chemotherapy as Neoadjuvant Treatment in Chinese Patients With Resectable Stage II to IIIA Non-Small Cell Lung Cancer

This is a randomized, open-label, multicenter, Phase 2, umbrella study to evaluate the preliminary efficacy, safety, and pharmacodynamics of tislelizumab as monotherapy and in combination with investigational agents as neoadjuvant treatment in Chinese participants with resectable Stage II to IIIA non-small cell lung cancer (NSCLC). The study is designed with the flexibility of adding treatment arms as new treatments become available or discontinuing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and of modifying the participant population.

开始日期2023-03-15

申办/合作机构

BeiGene Ltd.

100 项与欧司珀利单抗相关的临床结果

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100 项与欧司珀利单抗相关的专利（医药）

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项与欧司珀利单抗相关的文献（医药）

2024-05-01·Structure (London, England : 1993)

Structural insights into the unique pH-responsive characteristics of the anti-TIGIT therapeutic antibody Ociperlimab

Article

作者: Chen, Xin ; Li, Kang ; Zhang, Xiangxiang ; Xue, Liu ; Huang, Chichi ; Song, Jing ; Cheng, Liang ; Shen, Zhirong ; Sun, Jian ; Wang, Lai ; Zhang, Jing

TIGIT is mainly expressed on T cells and is an inhibitory checkpoint receptor that binds to its ligand PVR in the tumor microenvironment. Anti-TIGIT monoclonal antibodies (mAbs) such as Ociperlimab and Tiragolumab block the TIGIT-PVR interaction and are in clinical development. However, the molecular blockade mechanism of these mAbs remains elusive. Here, we report the crystal structures of TIGIT in complex with Ociperlimab_Fab and Tiragolumab_Fab revealing that both mAbs bind TIGIT with a large steric clash with PVR. Furthermore, several critical epitopic residues are identified. Interestingly, the binding affinity of Ociperlimab toward TIGIT increases approximately 17-fold when lowering the pH from 7.4 to 6.0. Our structure shows a strong electrostatic interaction between ASP103_HCDR3 and HIS76_TIGIT explaining the pH-responsive mechanism of Ociperlimab. In contrast, Tiragolumab does not show an acidic pH-dependent binding enhancement. Our results provide valuable information that could help to improve the efficacy of therapeutic antibodies for cancer treatment.

2023-10-01·Journal for immunotherapy of cancer

AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors

Article

作者: Rizwan, Ahsan ; Frentzas, Sophia ; Budha, Nageshwar ; Tan, Wei ; Zheng, Hao ; Meniawy, Tarek ; Kao, Steven ; de la Hoz Pedroza, Luz ; Gao, Rang

Background:

Ociperlimab, a novel, humanized monoclonal antibody (mAb), binds to T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT) with high affinity and specificity. Tislelizumab is an anti-programmed cell death protein 1 mAb. We report results from a phase I, first-in-human, dose escalation study evaluating the safety, pharmacokinetics (PK), and preliminary antitumor activity of ociperlimab plus tislelizumab in patients with advanced solid tumors.

Methods:

Eligible patients previously treated with standard systemic therapy, or for whom treatment was not available or tolerated, received ociperlimab intravenously on Cycle (C) 1 Day (D) 1 and tislelizumab 200 mg intravenously on C1 D8. If tolerated, patients received ociperlimab plus tislelizumab 200 mg sequentially on D29 and every 3 weeks (Q3W) thereafter until discontinuation. Dose escalation for ociperlimab was planned with four dose levels (50 mg, 150 mg, 450 mg, and 900 mg) according to a 3+3 design. An additional dose level of ociperlimab 1800 mg was also assessed. Primary endpoints were safety, determination of the maximum tolerated (or administered) dose, and the recommended phase II dose (RP2D). Secondary endpoints included overall response rate (ORR), duration of response (DoR), disease control rate (DCR) (Response Evaluation Criteria in Solid Tumors version 1.1), PK, and biomarker analysis.

Results:

At data cut-off (September 29, 2022), 32 patients had received ≥1 dose of ociperlimab plus tislelizumab 200 mg Q3W. The maximum administered dose was ociperlimab 1800 mg plus tislelizumab 200 mg Q3W. The median age of enrolled patients was 59.5 years (range: 31–79). Most patients (96.9%) experienced ≥1 treatment-emergent adverse event (TEAE); 62.5% of patients experienced ≥grade 3 TEAEs and 50.0% of patients experienced serious TEAEs. No dose limiting toxicity events were reported. The maximum tolerated dose was not reached. The RP2D was ociperlimab 900 mg plus tislelizumab 200 mg Q3W. Overall, ORR was 10.0%, median DoR was 3.6 months, and DCR was 50.0%.

Conclusions:

Ociperlimab plus tislelizumab was well tolerated in patients with advanced solid tumors, and preliminary antitumor activity was observed with 450 mg, 900 mg, and 1800 mg ociperlimab. Phase II/III trials of ociperlimab 900 mg plus tislelizumab 200 mg Q3W are underway in a range of solid tumors.

Trial registration number:

NCT04047862.

2022-11-01·Cancer control : journal of the Moffitt Cancer Center

Tislelizumab: A Modified Anti-tumor Programmed Death Receptor 1 Antibody

Article

作者: Geng, Qing ; Geng, Zhihua ; Hao, Bo ; Zhang, Lin

Tislelizumab is an anti-programmed death receptor 1 (PD-1) monoclonal immunoglobulin G 4 antibody developed by BeiGene. The structure of tislelizumab has been modified to maximally inhibit the binding of PD-1 to programmed death ligand 1 (PD-L1) and minimize the binding of tislelizumab to Fcγ receptors. In clinical studies, tislelizumab has shown preliminary anti-tumor effects in various solid tumors, such as Hodgkin’s lymphoma, urothelial carcinoma, lung cancer, gastric and esophageal cancer, liver cancer, nasopharyngeal carcinoma, colorectal cancer, and microsatellite instability-high/mismatch repair-deficient tumors. In addition, it also showed new promise in solid tumor treatment in combination with ociperlimab. Due to its satisfactory anti-tumor effects, tislelizumab has received approvals in China for the treatment of classical Hodgkin’s lymphoma, urothelial carcinoma, squamous non-small cell lung cancer, non-squamous non-small cell lung cancer, and hepatocellular carcinoma, and it is now under investigation for a new indication in microsatellite instability-high/mismatch repair-deficient tumors. Moreover, it has been granted orphan designations in hepatocellular carcinoma, esophageal cancer, and gastric cancer, including cancer of the gastroesophageal junction, by the US Food and Drug Administration. Tislelizumab has an acceptable safety profile; the most common adverse effects include fatigue, anemia, and decreased neutrophil count, while the most fatal events have been related to respiratory infection or failure, and hepatic injury. Tislelizumab has an economic advantage compared with other well-studied PD-1/PD-L1 inhibitors; thus, the introduction of it could provide clinical oncologists with an effective weapon against tumors and may alleviate the burden of cancer patients.

169

项与欧司珀利单抗相关的新闻（医药）

2025-03-27

·汇聚南药

国产创新药被退货事件频发！

得益于近年来医药政策改革、药审改革以及药品注册管理办法修订等一系列政策出台，国产创新药的研发陆续进入收获期。在此背景下，“出海”开始成为众多中国医药企业扩增收入、提升竞争力和品牌价值的重要发展战略。但值得注意的是，拓展海外市场荆棘丛生，不少药企遭遇了终止合作、以及退货。　　近日，三叶草生物发布公告，其全资附属公司三叶草香港，收到全球疫苗免疫联盟(Gavi)发出的单方面终止预购协议与索偿函。据了解，三叶草生物主要致力于开发新型疫苗及生物治疗候选产品。　　2021年6月，三叶草生物与Gavi订立了一份预购协议。根据协议，三叶草生物将提供多达4.14亿剂的重组蛋白新冠候选疫苗。2022年9月，三叶草生物与Gavi订立并签署预购协议的修订本。修订公告透露，三叶草生物已收到Gavi支付的2.24亿美元(约合人民币16.27亿元)，作为购买6400万剂订单所需的不可退回材料的预付款。　　当下，三叶草生物已明确表示将坚决抵抗Gavi的还款要求，但未来能否成功捍卫自身权益，还得看事件后续发展。　　实际上，退货、终止合作一直创新药及其产业链合作中的常态，石药集团、百济神州、君实生物、诺诚健华、基石药业等中国药企，都曾遭遇过License out合作终止的事情。如石药集团ADC创新药出海两年多，就于近期已被“退货”。　　2025年3月20日，美国一家做精准肿瘤药物的创新药企Elevation Oncology(以下简称“Elevation”)发布公告，宣布终止Claudin18.2 ADC新药EO-3021的开发项目，将资源集中投入到HER3 ADC新药EO-1022的推进中。据悉，EO-3021引自石药集团，为该集团自主研发的首款ADC药物，为创新(同类首创)的抗Claudin 18.2单克隆抗体药物偶联物。　　公告显示，Elevation终止E0-3021临床开发的决定是基于其临床Ⅰ期试验剂量递增和扩展阶段的数据未达到成功标准，不足以提供患者具有竞争力的获益风险比。　　2024年初，君实生物的TIGIT单克隆抗体被美国Coherus公司终止合作。随后在8月，和铂医药发布公告称，公司接到合作方Cullinan有关终止协议的通知，终止关于HBM7008在授权区域内的开发和商业化。　　2023年7月4日加科思于公告宣布，跨国药企艾伯维终止与公司签署的SHP2抑制剂许可及合作协议。艾伯维做出终止合作的决策主要原因是其内部资产及战略调整。7月11日，百济神州公告，全资间接子公司百济神州瑞士与诺华制药签署了《共同终止和释放协议》，百济神州瑞士重新获得了TIGIT抑制剂欧司珀利单抗开发、生产和商业化欧司珀利单抗的全部全球权利。　　总的来说，企业内部调整、市场竞争格局变化、临床数据进展，或某个突发的不可抗力因素，都有可能成为协议终止的因素。在此背景下，中国创新药企未来在合作中，需要更加关注协议的科学性、严谨性，以及为应对授权终止所预设的条款。喜欢我们文章的朋友点个“在看”和“赞”吧，不然微信推送规则改变，有可能每天都会错过我们哦~ 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。信息来源：制药网往期推荐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。

抗体药物偶联物引进/卖出疫苗并购临床2期

2025-03-06

·PRNewswire

TEPMETKO Continues to Strengthens its Position as a Leading METex14 Skipping NSCLC Therapy | DelveInsight

With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation. LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's " TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. EMD Serono's TEPMETKO (tepotinib) Overview TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment. Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation. The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time. Learn more about TEPMETKO projected market size for NSCLC @ TEPMETKO Market Potential Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently, 80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around 80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations. Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI), KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC. According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034). Discover more about the NSCLC market in detail @ Non-small Cell Lung Cancer Market Report Emerging Competitors of TEPMETKO The NSCLC pipeline is very robust with the promising therapies such as Telisotuzumab vedotin (AbbVie), Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), Eftilagimod alpha (Immutep), BNT311/GEN1046 (acasunlimab) (Genmab), V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck), Plinabulin + Docetaxel (BeyondSpring), Olomorasib (LY3537982) (Eli Lilly and Company), Zipalertinib (Cullinan Oncology/Taiho Pharma), Ceralasertib (AZD6738) (AstraZeneca), TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics), Sigvotatug vedotin (PF08046047) (Pfizer), ANKTIVA (N-803) (ImmunityBio), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Niraparib (GSK), Savolitinib (AstraZeneca/Hutchison MediPharma), TRODELVY (Gilead Sciences), Pyrotinib (Jiangsu HengRui Medicine), Ociperlimab (BGB-A1217) (BieGene), Volrustomig (AstraZeneca), Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics), Divarasib (GDC-6036) (Roche/Genentech), Tiragolumab (RG6058) (Roche), Sacituzumab Tirumotecan (Merck and Kelun-Biotech), JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio), Zongertinib (BI-1810631) (Boehringer Ingelheim), BAY 2927088 (Bayer), Serplulimab (HLX10) (Shanghai Henlius Biotech), Rilvegostomig (AZD2936) (AstraZeneca), MK-1084 (Merck, Taiho Pharmaceutical, and Astex), Domvanalimab (Arcus Biosciences and Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb), Belrestotug + JEMPERLI (iTeos Therapeutics and GSK), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), Cobolimab (GSK), Livmoniplimab (AbbVie), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), BNT327/PM8002 (Biotheus/BioNTech), HS-20117 (Hansoh BioMedical), IO102-IO103 + Pembrolizumab (IO Biotech), Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech), FF-10832 (FUJIFILM Corporation), BNT116 (BioNTechSE/Regeneron Pharmaceuticals), CAN-2409 (Candel Therapeutics), Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla), Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals), DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku), Lifileucel (Iovance Biotherapeutics), IBI363 (Innovent Biologics), Sotevtamab (AB-16B5) (Alethia Biotherapeutics), Avutometinib (VS6766) (Verastem Oncology), Vebreltinib (APL-101) (Apollomics), LP-300 (Lantern Pharma), JNJ-90301900 (Johnson & Johnson Innovative Medicine), AMG 193 (Amgen), Luveltamab tazevibulin (Sutro Biopharma), PRT3789 (Prelude Therapeutics), Disitamab vedotin (Seagen), PADCEV (enfortumab vedotin) (Astellas Pharma), RP1 (Replimune), TIVDAK (tisotumab vedotin) (Seagen), Zanidatamab (Jazz Pharmaceuticals), Utidelone injectable (UTD1) (Beijing Biostar Pharmaceuticals), REGN5093-M114 (Regeneron Pharmaceuticals), SLC-391 (SignalChem Lifesciences), fulzerasib (GenFleet), Davutamig (REGN5093) (Regeneron Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sabestomig (AZD7789) (AstraZeneca), Sasanlimab (Pfizer), Selvigaltin (GB1211) (Galecto Biotech), Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical), EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech), Pamvatamig (MCLA-129) (Merus), Zidesamtinib (NVL-520) (Nuvalent), NVL-655 (Nuvalent), RMC-4630 (Revolution Medicines), REQORSA (quaratusugene ozeplasmid) (Genprex), PDC*lung01 (PDC*line Pharma), Evalstotug (BA3071) (BioAtla and BeiGene), PT-112 (Promontory Therapeutics), MRT-2359 (Monte Rosa Therapeutics), GAIA-102 (GAIA BioMedicine), Rigosertib (Traws Pharma), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), ANS03 (Avistone Biotechnology), MYTX-011 (Mythic Therapeutics), A166 (Sichuan Kelun-Biotech Bio-pharmaceutical), Atamparib (BN-2397) (Ribon Therapeutics), DELTACEL (KB-GDT-01) (Kiromic BioPharma), Carotuximab (ENV-105) (Kairos Pharma), YL202 (MediLink Therapeutics), and others. To know more about the number of competing drugs in development, visit @ TEPMETKO Market Positioning Compared to Other Drugs Key Milestones of TEPMETKO In February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. In February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. In February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR. In October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations In March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy Discover how TEPMETKO is shaping the NSCLC treatment landscape @ TEPMETKO NSCLC TEPMETKO Market Dynamics TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available, enabling better identification of patients who would benefit from targeted treatments like TEPMETKO. A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of once-daily dosing compared to TABRECTA's twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally, broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position. Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but reimbursement and pricing strategies vary by market. Payer policies, along with the cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore, real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration. Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape. Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @ TEPMETKO Market Drug Report Table of Contents Related Reports Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. C-MET Metastatic Non-small Cell Lung Cancer Market C-MET Metastatic Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key C-MET mNSCLC companies, including Novartis, Merck, EMD Serono, AbbVie, Regeneron Pharmaceuticals, Mythic Therapeutics, Apollomics, Johnson & Johnson Innovation, Haihe Biopharma, among others. C-MET Non-small Cell Lung Cancer Pipeline C-MET Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key C-MET non-small cell lung cancer companies, including AbbVie, Janssen Research & Development, Beijing Pearl Biotechnology Limited Liability Company, Novartis, among others. 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上市批准免疫疗法优先审批

2025-01-15

·VIP说

百济神州，稳了！

一直“烧钱”的百济神州在扭亏的路上又迈出了关键一步。今日（1月14日）早间，百济神州发布公告称，公司首席执行官欧雷强在2025年1月13日（美国东部时间）的第43届摩根大通年度医疗健康大会（下称“2025JPM大会”）上提到，根据美国通用会计准则，公司预计将实现2025年全年经营利润为正，即营业收入大于营业成本、销售费用、管理费用及研发费用之总和。来源：百济神州2025JPM大会资料欧雷强在会上指出，经过15年的发展，百济神州已成为肿瘤学领域的创新者，并进入到了一个关键的转折点，目前公司正在准备进入下一阶段的全球增长。受上述消息影响，截至今日（1月14日）收盘，百济神州A股报178.6元/股，涨9.44%；港股报114.8元/股，涨7.22%。1月13日美股收盘，百济神州收涨4.47%。 01亏损近六百亿后“烧钱一哥”即将转亏为盈百济神州成立于2010年，2016年在纳斯达克上市，2018年港股上市，2021年科创板上市，是首家在美国纳斯达克、港交所与上交所三地上市的生物医药公司。由于创新药研发的“烧钱”属性，百济神州长期处于亏损状态。自2017年以来，百济神州连年亏损。2017年至2023年分别亏损9.82亿元、47.47亿元、69.15亿元、113.84亿元、97.48亿元、136.42亿元、67.16亿元，2024年前三季度亏损36.87亿元，累计亏损577.71亿元，烧钱能力可谓无人能及。创新药烧钱是共识，而百济神州一向舍得在研发上投入。2017年至2024年前三季度，百济神州的研发费用分别为20.17亿元、45.97亿元、65.88亿元、89.43亿元、95.38亿元、111.52亿元、128.13亿元、101.66亿元。从2022年起，百济神州研发费用超过百亿。但值得一提的是，在成本管控上，百济神州仍在坚持“去CRO化”，2025JPM大会上，其公开数据表示，自2019年起，百济神州通过CRO执行的临床试验占比一路下降，从77%降至2024年的5%。来源：百济神州2025JPM大会资料事实上，在官宣全年经营利润转正的消息之前，百济神州的财报已经有扭亏的迹象。美股财报显示，2024年第二季度百济神州GAAP（非美国公认会计原则）经营亏损同比下降66%。按非GAAP计算，公司实现经调整经营利润达4800万美元。 2024年三季报显示，按美国通用会计准则（GAAP），百济神州经营亏损同比收窄10%。另外，去除股份支付费用、折旧及摊销费用等非现金项目影响后，经调整经营利润达6600万美元。彼时，百济神州称，公司已连续2个季度实现非GAAP经营利润盈利。当前百济神州已有 11 款新药获批上市，其中有 3 款是自主研发的，分别是替雷利珠单抗（PD-1 抑制剂）、泽布替尼（BTK 抑制剂）和帕米帕利（PARP 抑制剂）。百济神州业绩的增长目前主要得益于两款已经商业化的肿瘤药物。2024年三季报显示，2024年前三季度，PD-1肿瘤药替雷利珠单抗（商品名：百泽安）销售额总计11.69亿元，同比增长11.7%。目前百泽安已在42个国家和地区获批，全球已有超过130万患者接受了治疗。另一款核心产品是BTK抑制剂泽布替尼（商品名：百悦泽），这款血液肿瘤药物已在全球70多个市场获批，2024年第三季度全球销售额总计49.14亿元，同比增长91.1%。 02 肿瘤治疗进入关键拐点在2025JPM大会上，百济神州表示，随着2024年Q3单季度营收首次突破10亿美元、泽布替尼（Brukinsa）一线适应症的获批、2024年将13个新分子实体（NMEs）推进临床、30+临床肿瘤管线正在推进等一系列里程碑进展的实现，表明公司在全球肿瘤治疗领域的布局正处于一个关键的拐点。2025年，百济神州将继续强化和巩固血液学领域的领导力、推进一系列肿瘤学的研发管线。来源：百济神州2025JPM大会资料在泽布替尼的基础上，百济神州正在通过固定持续时间（fixed-duration）的泽布替尼 + sonrotoclax（BCL-2抑制剂）、BTK CDAC +/- 泽布替尼/sonrotoclax、其他fixed-duration联合疗法以及临床管线加强在CLL领域的实力。此外，该公司还正在将产品组合拓展至其他适应症领域，包括急性髓系白血病/骨髓增生异常综合征（AML/MDS）、多发性骨髓瘤（MM）、RT（Richter’s Transformation）、大B细胞淋巴瘤（LBCL），且多种临床前资产有望进入临床阶段，包括免疫细胞接合器、iPSC衍生细胞疗法、CDACs等。在本次JPM大会上，百济神州还披露了截至2025年1月6日的最新研发管线，包括25+款处于1期临床研究阶段的早期管线，以及15+处于2期和3期阶段的管线，涵盖了小分子、抗体、抗体偶联药物（ADC）、CDAC等多种分子类型。来源：百济神州2025JPM大会资料其中，百济神州重点展示了其中处于1期临床阶段的7款“高潜力”的早期研发管线，包括：BGB-43395（CDK4i）、BGB-53038（泛KRAS抑制剂）、BG-C9074 （B7H4 ADC）、BGB-60366（EGFR CDAC）、BGB-58067（PRMT5抑制剂）+MAT2A抑制剂、BGB-45035（IRAK4 CDAC），百济神州认为它们将在肺癌、乳腺癌、胃肠道癌症以及自身免疫性疾病的治疗中发挥重要作用。百济神州还在会上透露了2025~2026年实现一系列产品进展，包括： BTK抑制剂泽布替尼：针对初治MCL患者的MANGROVE 3期临床研究在2025年下半年实现中期PFS分析； BCL-2抑制剂sonrotoclax：针对R/R MCL、R/R CLL的3期临床研究启动，同时读出2期临床研究数据，并有望递交加速批准（AA）监管申请； BTK CDAC：启动针对R/R CLL的3期临床研究；抗PD-1单抗替雷利珠单抗：有望在中国、美国、欧盟、日本等国家和地区实现多个新适应症的提交和批准，此外百济神州还计划启动替雷利珠单抗皮下注射剂型针对1线胃癌（GC）适应症的3期临床研究；泽尼达妥单抗（zanidatamab，HER2双抗）+替雷利珠单抗：一线治疗HER2+胃食管腺癌（GEA）适应症的3期HERIZON-301研究读出； Imdelltra（tarlatamab，靶向DLL3和CD3的BiTE，与安进合作开发）：二线线治疗小细胞肺癌的3期临床研究读出；欧司珀利单抗（ociperlimab，TIGIT）：一线治疗非小细胞肺癌的3期AdvanTIG-302研究实现中期OS分析。 —END—

财报

100 项与欧司珀利单抗相关的药物交易

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研发状态

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
局部晚期非小细胞肺癌	临床3期	美国	BeiGene Ltd.	2021-06-17
局部晚期非小细胞肺癌	临床3期	中国	BeiGene Ltd.	2021-06-17
局部晚期非小细胞肺癌	临床3期	澳大利亚	BeiGene Ltd.	2021-06-17
局部晚期非小细胞肺癌	临床3期	西班牙	BeiGene Ltd.	2021-06-17
局部晚期非小细胞肺癌	临床3期	中国台湾	BeiGene Ltd.	2021-06-17
不可切除的非小细胞肺癌	临床3期	美国	BeiGene Ltd.	2021-06-17
不可切除的非小细胞肺癌	临床3期	中国	BeiGene Ltd.	2021-06-17
不可切除的非小细胞肺癌	临床3期	澳大利亚	BeiGene Ltd.	2021-06-17
不可切除的非小细胞肺癌	临床3期	西班牙	BeiGene Ltd.	2021-06-17
不可切除的非小细胞肺癌	临床3期	中国台湾	BeiGene Ltd.	2021-06-17

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临床结果

适应症

分期

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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


NCT04732494 (AdvanTIG-203, CTgov)	临床2期	转移性食管鳞状细胞癌	125	Tislelizumab+Ociperlimab (Arm A: Tislelizumab Plus Ociperlimab)	壓壓構築艱築壓衊鑰艱 = 壓積顧簾鑰醖憲壓襯鹹夢鏇願醖鏇觸範製壓鹽 (齋淵製製築築鑰夢鬱鏇, 齋築鑰鏇鏇構蓋願齋積 ~ 構簾鏇鬱艱積選壓衊選) 更多	-	2025-03-25
				Placebo+Tislelizumab (Arm B: Tislelizumab Plus Placebo)	壓壓構築艱築壓衊鑰艱 = 遞鹹遞餘積選遞鹹範範夢鏇願醖鏇觸範製壓鹽 (齋淵製製築築鑰夢鬱鏇, 齋醖艱醖鏇廠獵鏇艱餘 ~ 鹽醖製選願鏇壓遞蓋範) 更多
NCT04948697 (AdvanTIG-206, CTgov)	临床2期	晚期肝细胞癌	94	Tislelizumab+BAT1706+Ociperlimab (Arm A: Ociperlimab + Tislelizumab + BAT1706)	簾壓衊壓膚網網夢廠窪 = 餘願衊蓋範艱繭獵襯願憲醖艱選鏇製顧壓願顧 (廠鬱餘餘壓膚選壓顧願, 獵獵蓋範廠餘獵構夢積 ~ 憲壓艱窪蓋夢夢願網窪) 更多	-	2025-03-25
				Tislelizumab+BAT1706 (Arm B: Tislelizumab + BAT1706)	簾壓衊壓膚網網夢廠窪 = 餘夢醖觸蓋窪襯積夢醖憲醖艱選鏇製顧壓願顧 (廠鬱餘餘壓膚選壓顧願, 憲簾獵鑰網鑰顧鏇窪廠 ~ 蓋艱鹹願鏇顧夢鏇夢糧) 更多
NCT04866017 (CTgov)	临床3期	不可切除的非小细胞肺癌 \| 局部晚期非小细胞肺癌	63	Radiotherapy+Tislelizumab+Ociperlimab (Ociperlimab + Tislelizumab + cCRT)	膚製繭鏇製願遞簾製繭 = 鑰餘廠製憲廠餘鹽衊製壓窪齋壓窪鹽膚糧糧鏇 (憲膚蓋製鏇構襯醖窪鬱, 糧願衊蓋鑰窪餘網鏇積 ~ 簾網願夢鏇構糧蓋構簾) 更多	-	2024-10-31
				Radiotherapy+Tislelizumab (Tislelizumab + cCRT)	膚製繭鏇製願遞簾製繭 = 遞鹹鏇選網蓋鏇鹽願簾壓窪齋壓窪鹽膚糧糧鏇 (憲膚蓋製鏇構襯醖窪鬱, 壓窪觸艱醖窪衊鑰窪壓 ~ 壓遞顧範選淵獵積鹽衊) 更多
NCT04952597 (AdvanTIG-204, CTgov)	临床2期	小细胞肺癌	126	Concurrent Chemoradiotherapy+Tislelizumab+Ociperlimab (Arm A: Ociperlimab + Tislelizumab)	築窪憲選鑰範築憲壓鬱(窪壓獵衊膚構構觸鏇範) = 膚衊繭簾構願鑰夢衊餘餘構積製糧獵鹽鹹襯遞 (願構艱製製壓壓蓋鏇製, 顧憲襯鑰艱築廠選廠鬱 ~ 艱壓鏇鹽餘願鏇鏇願淵) 更多	-	2024-09-19
				Concurrent Chemoradiotherapy+Tislelizumab (Arm B: Tislelizumab)	築窪憲選鑰範築憲壓鬱(窪壓獵衊膚構構觸鏇範) = 窪積築餘糧積襯鬱觸衊餘構積製糧獵鹽鹹襯遞 (願構艱製製壓壓蓋鏇製, 繭蓋鹽鏇壓願網窪壓襯 ~ 餘簾艱選積觸餘廠遞範) 更多
NCT04952597 (AdvanTIG-204, AACR2024) 人工标引	临床2期	小细胞肺癌	126	ociperlimaberlimab 90tislelizumab + tislelizumab [200 mg IV Q3W] + cCRT for 4 cycles, then ociperlimab + tislelizumab)	鏇廠遞構選餘顧餘繭夢(鏇構憲膚衊簾壓鹹顧襯) = 鹽獵衊築衊壓積觸糧遞醖觸衊鬱構願繭醖廠鹽 (鹽積製顧淵繭製構網鹽 ) 更多	积极	2024-04-05
				tislelizumablizumab + cCRT for 4 cycles, then tislelizumab)	鏇廠遞構選餘顧餘繭夢(鏇構憲膚衊簾壓鹹顧襯) = 憲顧鏇願艱壓遞鬱鹽製醖觸衊鬱構願繭醖廠鹽 (鹽積製顧淵繭製構網鹽 ) 更多
NCT04693234 (AdvanTIG-202, ESMO 12023 \| ESMO 22023) 人工标引	临床2期	宫颈癌二线 PD-L1	178	Tislelizumab 200 mg + Ociperlimab 900 mg	築構淵艱餘鬱廠壓夢餘(構遞糧壓鑰膚遞選顧選) = 壓糧範簾壓艱憲衊顧壓網鹹壓膚鑰繭願醖構繭 (願窪壓範糧築構衊鑰積, 15.8 ~ 30.3) 更多	积极	2023-10-22
				Tislelizumab 200 mg + Ociperlimab 900 mg (PD-L1 +)	築構淵艱餘鬱廠壓夢餘(構遞糧壓鑰膚遞選顧選) = 顧蓋獵鬱淵鹽淵餘襯壓網鹹壓膚鑰繭願醖構繭 (願窪壓範糧築構衊鑰積, 17.2 ~ 36.9) 更多
NCT04732494 (AdvanTIG-203, ESMO 12023 \| ESMO 22023) 人工标引	临床2期	PD-L1阳性食管鳞状细胞癌二线 PD-L1 High Expression	125	Ociperlimab (OCI) + Tislelizumab (TIS)	鏇範構襯襯觸鑰窪顧憲(範壓鹽衊壓構築鏇廠積) = 鬱窪壓壓獵鑰獵糧構願製鹹網鹽繭鹽構淵獵糧 (鹽築齋簾範構糧簾膚繭 ) 更多	不佳	2023-10-21
				Placebo + Tislelizumab (TIS)	鏇範構襯襯觸鑰窪顧憲(範壓鹽衊壓構築鏇廠積) = 夢選網製獵繭膚簾範齋製鹹網鹽繭鹽構淵獵糧 (鹽築齋簾範構糧簾膚繭 ) 更多
NCT04948697 (AdvanTIG-206, ESMO 12023 \| ESMO 22023) 人工标引	临床2期	晚期肝细胞癌	94	Ociperlimab + Tislelizumab + BAT1706	積鹹壓遞選膚鬱範壓鬱(廠齋簾衊蓋夢遞觸糧製) = 壓範願構餘製築構積築網淵蓋衊膚夢鹹醖鹽膚 (製鏇鏇夢遞簾壓鏇衊廠, 23.7 ~ 48.7) 更多	积极	2023-10-21
				Tislelizumab + BAT1706	積鹹壓遞選膚鬱範壓鬱(廠齋簾衊蓋夢遞觸糧製) = 鹽糧構繭遞憲網膚鬱鏇網淵蓋衊膚夢鹹醖鹽膚 (製鏇鏇夢遞簾壓鏇衊廠, 21.1 ~ 56.3) 更多
NCT04047862 (AdvanTIG-105, Pubmed \| J Immunother Cancer)	临床1期	晚期恶性实体瘤	32	Ociperlimab 50 mg	網蓋蓋艱襯窪顧醖艱鑰(餘齋鑰範觸遞顧遞鑰憲) = 製餘壓鏇膚鏇觸範壓簾齋構鏇鬱顧廠鑰鏇製齋 (蓋淵簾網選餘簾鏇積艱 ) 更多	积极	2023-10-01
				Ociperlimab 150 mg	網蓋蓋艱襯窪顧醖艱鑰(餘齋鑰範觸遞顧遞鑰憲) = 顧願觸繭繭築醖蓋衊顧齋構鏇鬱顧廠鑰鏇製齋 (蓋淵簾網選餘簾鏇積艱 ) 更多
NCT04047862 (BGB-900-105, ASCO 12023 \| ASCO 22023) 人工标引	临床1期	胃腺癌 \| 胃食管交界处恶性肿瘤	60	Ociperlimab+Tislelizumab+chemotherapy	糧壓簾製糧遞願鹹餘遞(憲艱夢遞糧襯觸鑰構糧) = 憲遞餘築淵窪觸顧選繭醖衊網鑰壓顧鹹醖餘廠 (製糧鹽繭構觸獵鬱觸窪, 37.5 ~ 64.1) 更多	积极	2023-05-26
				Ociperlimab+Tislelizumab+chemotherapy (PD-L1 tumor area positivity (TAP) score ≥5%)	糧壓簾製糧遞願鹹餘遞(憲艱夢遞糧襯觸鑰構糧) = 鬱繭窪願構齋繭鏇遞餘醖衊網鑰壓顧鹹醖餘廠 (製糧鹽繭構觸獵鬱觸窪, 38.8 ~ 77.6)