Phase III Double Blinded Trial of Immune-Based Therapy With a Live Biotherapeutic MO-03 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma [BioFront Trial]

This phase III trial compares the effect of adding live biotherapy, MO-03, to standard of care (SOC) immunotherapy, including ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, to SOC immunotherapy alone in treating patients with clear cell renal cell cancer that may have spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started to other places in the body (metastatic). Studies have shown that gut health (the gut microbiome) may impact the effectiveness of immunotherapy. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. MO-03, a type of biotherapy, contains material from living organisms that may help keep the digestive tract healthy and may help to increase the effect of immunotherapy. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are a type of angiogenesis inhibitor and tyrosine kinase inhibitor (TKI) that block certain proteins which may help keep tumor cells from growing and may also help prevent the growth of new blood vessels that tumors need to grow. Adding MO-03 to SOC immunotherapy may be more effective than SOC immunotherapy alone in treating patients with advanced or metastatic clear cell renal cell cancer.

开始日期2026-06-10

申办/合作机构

SWOG

[+1]

CTR20261145

/ Active, not recruitingN/A

在中国健康参与者空腹状态下单次口服阿昔替尼片(规格：5mg)的一项单中心、随机、开放、两制剂、两序列、四周期、完全重复交叉生物等效性试验

主要研究目的考察中国健康参与者空腹条件下单次口服阿昔替尼片受试制剂(规格：5mg，生产企业：江西山香药业有限公司)及参比制剂(商品名：英立达®，规格：5mg，持证商：Pfizer Europe MA EEIG)后的药代动力学特征，评价两制剂在空腹条件下是否具有生物等效性。次要研究目的评价阿昔替尼片受试制剂(规格：5mg)及参比制剂(商品名：英立达®，规格：5mg)在健康参与者中的安全性。

开始日期2026-04-29

申办/合作机构

江西山香药业有限公司

100 项与阿昔替尼相关的临床结果

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100 项与阿昔替尼相关的转化医学

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100 项与阿昔替尼相关的专利（医药）

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2,024

项与阿昔替尼相关的文献（医药）

2026-12-01·CURRENT TREATMENT OPTIONS IN ONCOLOGY

Systemic Therapy for Salivary Gland Cancers: A Review of Targeted and Chemotherapeutic Approaches

Review

作者: Chintakuntlawar, Ashish ; Hintze, Justin M

OPINION STATEMENT:

Systemic therapy for recurrent and metastatic salivary gland malignancies (SGMs) remains a major therapeutic challenge. Traditional chemotherapy offers modest response rates with limited durability, and its role is largely palliative. The most meaningful advances have occurred in biomarker-selected subgroups: androgen receptor blockade for AR-positive salivary duct carcinoma and HER2-directed therapy for HER2-positive tumors have demonstrated superior response rates and survival (often exceeding 50%), compared with the single digit response rates seen with unselected chemotherapy or tyrosine kinase inhibitors. Small-molecule tyrosine kinase inhibitors such as lenvatinib and axitinib may provide disease stabilization in adenoid cystic carcinoma, although tumor shrinkage is uncommon and toxicity limits their long-term use. Immunotherapy as a single agent has been disappointing, but durable responses in select patients and modest activity with combination regimens suggest it may have a future role when rationally paired with other agents. In our practice, comprehensive molecular profiling is essential at the time of recurrence to identify actionable alterations, prioritize targeted therapy where available, and guide clinical trial enrollment. For most patients without a targetable alteration, platinum-based combinations remain the pragmatic choice, though expectations for benefit should be tempered. Future strategies will likely hinge on optimizing biomarker-driven therapies, expanding access to antibody-drug conjugates, and pursuing collaborative trial designs to overcome the rarity and heterogeneity of these tumors.

2026-06-01·UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

An integrated restricted mean survival time-based evaluation of efficacy, toxicity, and cost in first-line immunotherapy regimens for metastatic renal cell carcinoma

Article

作者: Ishiyama, Yudai ; Kanumuambidi, Jean-Pierre ; Balaji, K C ; Bandyk, Mark ; McGrath, Joseph ; Rosales, Reynier D Rodriguez ; Venkatesh, Arjun

PURPOSES:

To evaluate first-line metastatic renal cell carcinoma regimens using restricted mean survival time (RMST), which directly conveys absolute survival benefit, integrated with toxicity and cost.

MATERIALS AND METHODS:

Four pivotal phase 3 randomized trials comparing immune-based combinations were analyzed. Overall survival (OS) and progression-free survival (PFS) were reconstructed from published data, and absolute benefit from the control was expressed as the difference in RMST (dRMST). Drug cost, grade ≥3 adverse events (AEs; symptomatic and any), and high-dose corticosteroid (HDS) use were normalized per RMST month gained. Correlations between hazard ratio (HR) and dRMST were assessed. Principal component analysis (PCA) using incremental RMST, total incremental cost, and symptomatic grade ≥3 AEs was performed to explore multidimensional trade-offs.

RESULTS:

OS dRMST gains were greatest with nivolumab-cabozantinib (4.15 months), followed by lenvatinib-pembrolizumab (3.53), nivolumab-ipilimumab (2.75), and pembrolizumab-axitinib (2.68). PFS gains were 10.07, 6.49, 4.39, and 1.44 months, respectively. dRMST strongly correlated with (1 - HR) for PFS (R² = 0.988, p = 0.006) and showed a positive trend for OS (R² = 0.890, p = 0.056). OS cost per month gained ranged from $52,207 (nivolumab-ipilimumab) to $293,168 (lenvatinib-pembrolizumab), whereas PFS cost per month gained was relatively consistent ($99,701-$111,721). Symptomatic grade ≥3 AEs per OS month gained were lowest with nivolumab-cabozantinib (<1%) and highest with lenvatinib-pembrolizumab (6%). PCA demonstrated distinct multidimensional positioning among regimens, with differing alignment of 3 factors between OS and PFS.

CONCLUSIONS:

Integrated RMST-based analyses reveal clinically relevant trade-offs across regimens and distinct multidimensional profiles that may inform comparative treatment interpretation.

2026-06-01·NEOPLASIA

Assessing axitinib-induced differential responses in tumor vascularization and oxygenation with combined optoacoustic angiography and diffuse optical spectroscopy

Article

作者: Razansky, Daniel ; Glyavina, Anna ; Khochenkova, Yulia ; Akhmedzhanova, Ksenia ; Vodeneev, Vladimir ; Maslennikova, Anna ; Turchin, Ilya ; Nerush, Anastasiya ; Yudintsev, Andrey ; Khochenkov, Dmitry ; Volovetskiy, Artur ; Korobov, Artemii ; Subochev, Pavel ; Orlova, Anna ; Liu, Wei ; Kurnikov, Alexey

Efficacy of antiangiogenic treatments is often linked to the complex interplay between tumor vascularization and oxygenation. Yet their relationship remains difficult to assess in vivo due to limitations of conventional clinical imaging techniques. We used a combination of noninvasive optoacoustic (OA) angiography and diffuse optical spectroscopy (DOS) to investigate the effects of the antiangiogenic therapy on vascular structure and oxygenation in subcutaneous xenograft model of Colo320 colon adenocarcinoma. Axitinib, a tyrosine kinase inhibitor targeting VEGF receptors, was administered into animals at 50 mg/kg, five days per week for four weeks. Raster-scan OA imaging was performed using 532 nm pulsed laser source and a wideband polyvinylidene difluoride (PVDF) detector. DOS measurements were conducted using a fiber-optic-based reflectance system. Immunohistochemical (IHC) analysis for CD31 and the hypoxia marker pimonidazole was used for validation. Axitinib treatment resulted in a thirtyfold reduction in the median tumor volume. OA imaging revealed reductions in volumetric vessel fraction and projected vessel area, while DOS showed a transient increase in blood oxygen saturation. IHC confirmed a decrease in microvessel density post-treatment and indicated larger hypoxic areas in treated tumors compared to controls at the experimental endpoint. The newly introduced approach thus facilitates experimental studies aiming at optimization of antiangiogenic treatment regimens and their subsequent combination with other treatment modalities, such as radiation therapy, where effectiveness may strongly depend on the vascular network condition and tumor oxygenation levels.

1,078

项与阿昔替尼相关的新闻（医药）

2026-05-26

·PRNewswire

Over 40 Studies Featuring Akeso's Innovative Oncology Agents to Be Presented at ASCO 2026: Ivonescimab's HARMONi-6 Overall Survival Data Selected for Plenary Session

HONG KONG, May 26, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that more than 40 clinical studies of its oncology portfolio will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2 in Chicago, Illinois. Notably, the presentations include one Late-Breaking Abstract (LBA) selected for the prestigious Plenary Session, alongside four Oral or Rapid Oral presentations. The datasets featured at ASCO 2026 primarily highlight the Company's core first-in-class bispecific antibodies — cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF) — along with other novel therapeutic antibodies such as ligufalimab, a next-generation CD47 monoclonal antibody. These presentations include several potentially practice-changing datasets across multiple tumor types. A pivotal highlight will be the Phase III overall survival (OS) results from the HARMONi-6 study, evaluating the survival advantage of ivonescimab combined with chemotherapy versus a PD-1 inhibitor combined with chemotherapy in the first-line setting for advanced squamous non-small cell lung cancer (sq-NSCLC). Additional notable presentations feature ivonescimab in small-cell lung cancer (SCLC) that has progressed after first-line chemoimmunotherapy, ivonescimab plus chemotherapy in first-line metastatic colorectal cancer (mCRC) from a global Phase II interim analysis, alongside cadonilimab-based regimens in renal cell carcinoma, melanoma, colorectal cancer, head and neck cancer, gynecologic malignancies, and biliary tract cancer. The maturity and breadth of these datasets underscore the success of Akeso's innovation engine, demonstrating the clinical benefits of the Company's differentiated bispecific antibody platform to the international oncology community. Key Presentations Plenary Session Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in previously untreated advanced squamous non-small cell lung cancer: Overall survival results of the Phase 3 HARMONi-6 study Abstract: LBA4 Session: Plenary Session Date/Time (CDT): May 31, 2026, 2:47 PM–2:59 PM Presenter: Professor Shun Lu, Shanghai Chest Hospital Oral Presentation Efficacy and safety of ivonescimab combined with liposomal irinotecan in patients with small-cell lung cancer (SCLC) progressing after first-line chemoimmunotherapy: A multicenter, Phase 2 study Abstract: 8007 Date: June 2, 2026 Presenter: Professor Yun Fan, Zhejiang Cancer Hospital Oral Presentation A prospective, multicenter, Phase Ib/II trial of first-line cadonilimab plus axitinib in advanced non–clear cell renal cell carcinoma Abstract: 4501 Date: June 2, 2026 Presenter: Dr. Junru Chen, West China Hospital, Sichuan University Rapid Oral Presentation Neoadjuvant ivonescimab (AK112, a PD-1/VEGF bispecific antibody) combined with nab-paclitaxel and cisplatin for resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC): An exploratory Phase II study Abstract: 6014 Date: June 2, 2026 Presenter: Professor Kunyu Yang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Rapid Oral Presentation Cadonilimab or ivonescimab plus axitinib in metastatic mucosal melanoma: Results from a Phase Ib trial Abstract: 9516 Date: May 31, 2026 Presenter: Professor Lili Mao, Peking University Cancer Hospital International Multicenter Phase II Study Ivonescimab (ivo) with oxaliplatin + fluorouracil (5-FU) + leucovorin calcium (mFOLFOX6) for patients (pts) with unresectable metastatic colorectal cancer (mCRC): A phase II study Abstract: 3576 Date: May 30, 2026 First Author: David Berz, MD, PhD, Department of Oncology, Valkyrie Clinical Trials, Inc About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has established a robust R&D innovation ecosystem centered on its Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms. Supported by a global-standard GMP manufacturing infrastructure and a highly efficient, integrated commercialization model, the company has evolved into a globally competitive biopharmaceutical focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 27 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. Forward-Looking Statements This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. SOURCE Akeso, Inc. 21% more press release views with Request a Demo

ASCO会议临床2期临床3期临床结果免疫疗法

2026-05-26

·康方生物Akeso

40+项创新研究成果将在ASCO盛大发布！依沃西HARMONi-6研究OS数据在Plenary Session重磅报告+4项Oral

2026年美国临床肿瘤学会（ASCO）年会‌将于‌2026年5月29日至6月2日‌在‌美国芝加哥‌举行。康方生物（9926.HK）自主研发的创新药物共计40多项临床研究成果将在大会上盛大发布，包括1项入选Plenary Session环节的Late-Breaking Abstract（LBA）和4项口头报告。本次在ASCO发布研究成果的新药，主要为公司全球首创双抗新药核心产品卡度尼利(PD-1/CTLA-4)和依沃西(PD-1/VEGF)，以及下一代CD47单抗莱法利等全球新药物，多项研究成果展现出突破性的临床价值。这些成果包括依沃西联合化疗一线治疗sq-NSCLC的III期OS数据（vs PD-1单抗+化疗，HARMONi-6研究）、依沃西疗法治疗一线化免联合治疗进展的SCLC的II期研究成果、依沃西疗法一线治疗不可切除转移性结直肠癌（mCRC）的国际多中心II期研究期中分析数据等；卡度尼利疗法在肾癌、黑色素瘤、肠癌、头颈癌、妇科肿瘤、胆道癌等领域的优秀研究成果。丰硕而高水平的研发成果密集发布，彰显了康方生物新药自主创新的全球领先性和高效率，更是国际学术界对公司创新能力和创新成果高认可度的体现。亮点前瞻： Late-Breaking Abstract（LBA）： Ivonescimab plus chemotherapy versus Tislelizumab plus chemotherapy in previously untreated advanced squamous non-small cell lung cancer: Overall survival results of the Phase 3 HARMONi-6 依沃西联合化疗对比替雷利珠单抗联合化疗一线治疗晚期sq-NSCLC：Ⅲ期HARMONi-6研究总生存期（OS）结果报告编号：LBA4 报告环节：Plenary Session 美国时间：May 31, 2026 2:47 PM-2:59 PM CDT 北京时间：2026年6月1日凌晨 3:47-3:59 讲讲者者：上海市胸科医院肺部肿瘤临床医学中心主任、终身教授陆舜教授口头报告（Oral）： Efficacy and Safety of Ivonescimab Combined with Liposomal Irinotecan in Patients with Small-Cell Lung Cancer (SCLC) Progressing after First-Line Chemoimmunotherapy: A Multicenter, Phase 2 Study 依沃西联合脂质体伊立替康治疗一线化免联合方案进展后的小细胞肺癌（SCLC）患者的疗效与安全性：一项多中心、II 期临床研究报告编号：Abstract 8007 美国时间：Jun 2, 2026 讲讲者者：浙江省肿瘤医院范云教授口头报告（Oral）： A prospective, multi-center, phase Ib/II trial of first-line cadonilimab plus axitinib in advanced non–clear cell renal cell carcinoma 卡度尼利联合阿昔替尼一线治疗晚期非透明细胞肾细胞癌的前瞻性、多中心 Ib/II 期临床研究报告编号：Abstract 4501 美国时间：Jun 2, 2026 讲讲者者：四川大学华西医院陈俊儒快速口头报告（Rapid Oral） Neoadjuvant Ivonescimab (AK112, a PD-1/VEGF Bispecific Antibody) Combined with nab-paclitaxel and cisplatin (AP) for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC): An Exploratory Phase II Study 依沃西联合白蛋白紫杉醇与顺铂新辅助治疗可切除局部晚期头颈部鳞状细胞癌（LA-HNSCC）的探索性II期临床研究报告编号：Abstract 6014 美国时间：Jun 2, 2026 讲讲者者：华中科技大学同济医学院讲讲者者：附属协和医院杨坤禹教授快速口头报告（Rapid Oral） Cadonilimab or ivonescimab plus axitinib in metastatic mucosal melanoma: Results from a phase Ib trial 卡度尼利或依沃西联合阿昔替尼治疗转移性黏膜黑色素瘤：一项Ib期临床研究结果报告编号：Abstract 9516 美国时间：May 31, 2026 讲讲者者：北京大学肿瘤医院讲讲者者：毛丽丽教授国际多中心II期研究 Ivonescimab (ivo) with oxaliplatin + fluorouracil (5-FU) + leucovorin calcium (mFOLFOX6) for patients (pts) with unresectable metastatic colorectal cancer (mCRC): A phase 2 study 依沃西联合奥沙利铂+氟尿嘧啶（5-FU）+亚叶酸钙（mFOLFOX6方案）治疗不可切除转移性结直肠癌（mCRC）患者的II期临床研究报告编号：Abstract 3576 美国时间：May 30, 2026 第一作者：Valkyrie Clinical Trials, Inc 讲讲者者：David Berz, MD, PhD 说明：本文作为康方生物的新闻发布，用于披露公司最新进展，并非产品推广广告，不构成康方生物的信息披露或投资建议。关于康方生物康方生物（9926.HK）是一家集研究、开发、生产及商业化全球首创或同类最佳创新生物新药于一体的领先企业。自2012年成立以来，公司始终以患者为中心，以临床价值为导向，打造了独有的端对端康方全方位新药研究开发平台，建立了以Tetrabody双抗/多抗技术、Dual-Shield ADC、Dual-Lock TCE、Tissue-Smart siRNA、细胞治疗及Flex-Nano mRNA等技术为核心的研发创新体系，国际化标准的GMP生产体系和运作模式先进的商业化体系，成为了在全球范围内具有竞争力的生物医药创新公司。公司已开发了50个以上用于治疗肿瘤、自身免疫、炎症、代谢疾病等重大疾病的创新候选药物，27个新药已进入临床（包括15个双抗/多抗/双抗ADC），7个新药已在商业化销售，2个新药4个适应症的上市申请处于审评审批阶段。康方生物是全球迄今唯一拥有2个肿瘤免疫双抗新药的制药公司： 2022年6月，公司全球首创的PD-1/CTLA-4双抗卡度尼利获批上市，是全球首个获批的肿瘤免疫治疗双抗新药，也是中国第一个双特异性抗体新药。目前卡度尼利一线治疗胃癌、一线治疗宫颈癌和治疗复发/转移性宫颈癌的适应症已获批，12个注册性/III期临床正在开展。 2024年5月，公司全球首创的PD-1/VEGF双抗新药依沃西获批上市，用于EGFR-TKI治疗进展的局部晚期或转移性nsq-NSCLC，成为全球首个获批的“肿瘤免疫+抗血管生成”机制双抗新药。同期，依沃西在与全球“药王”帕博利珠单抗的随机、双盲、对照一线治疗PD-L1阳性NSCLC的“头对头”III期临床研究中获得显著阳性结果，依沃西可降低患者疾病进展/死亡风险达49%，依沃西成为全球首个在头对头III期临床研究中证明疗效显著优于“药王”帕博利珠单抗的药物。基于该研究结果，依沃西该项适应症于2025年4月获批上市，成为一线肺癌治疗新的标准治疗方案，为患者提供全新更优的“去化疗”选择。目前依沃西有15项注册性/III期临床已开展/启动，包括5项国际多中心注册性III期临床研究。 2024年12月，卡度尼利和依沃西均通过医保谈判被纳入国家新版医保目录。2025年12月，除派安普利新获批的一线肝细胞癌适应症，康方生物5个自主商业化自研新药的其余全部获批适应症均已纳入国家医保目录。此外，基于公司在肿瘤免疫双抗领域取得的全球领先优势，公司正全力推进IO2.0+ADC2.0全球战略，构建“跨代”式国际竞争优势。目前，公司自主研发的首个双抗ADC药物Trop2/Nectin4 ADC（AK146D1）、新一代Her3 ADC（AK138D1）联合卡度尼利和依沃西治疗实体瘤II期临床研究正在开展。此前，该组合疗法 I 期临床已获美国 FDA 和中国 NMPA 批准开展。后续一系列自研新一代ADC/双抗ADC也将相继进入临床开发阶段。这将助力公司产品组合在全球范围内建立“跨代”式的竞争战略优势。国际市场开发是康方生物核心发展战略，继2015年开中国先河将自主研发的CTLA-4单抗权益许可给默沙东公司之后，2022年12月，公司再次创造中国纪录，以50亿美金+2位数百分比销售提成的方案，将依沃西部分海外权益许可给美国Summit公司，该合作创下了彼时中国新药对外许可的最高交易金额纪录。此外，派安普利单抗治疗鼻咽癌的两项适应症于2025年4月获得美国食品药品监督管理局（FDA）批准上市。公司自身免疫相关疾病及中枢神经系统疾病治疗领域也已全面进入商业化发展阶段：伊努西单抗(PCSK9)治疗高胆固醇血症两项适应症获批销售；依若奇单抗(IL-12/IL-23)治疗中重度斑块状银屑病成人患者适应症获批上市销售；此外，古莫奇单抗(IL-17)和曼多奇单抗(IL-4R)多项III期临床研究成功，正处于上市审评阶段。公司各领域产品协同效应和战略组合力进一步提升。康方生物期望通过高效及突破性的研发创新，开发国际首创及同类药物最佳疗法的新药，为全球患者提供更优疾病解决方案，成为全球领先的生物制药企业。往期推荐产品动态康方5个新药所有适应症全部谈判成功，纳入国家医保：2个首创双抗新增一线适应症及3个新药首次进医保临床进展 HARMONi-A OS最终分析显示：依沃西达到OS临床终点，取得具有临床意义和统计学显著的OS获益产品动态依沃西联合化疗1L治疗sq-NSCLC的上市申请获NMPA受理数据发布 HARMONi研究发布：PFS HR=0.52，OS HR=0.79 依沃西2L+ EGFRm NSCLC国际多中心III期产品动态卡度尼利获批第三项适应症：一线宫颈癌全人群产品动态依沃西一线治疗NSCLC获批上市（全球首个对比帕博利珠单抗获显著阳性结果的III期研究）产品动态派安普利2个适应症美国重磅上市！获FDA批准用于晚期鼻咽癌治疗临床进展康方首个双抗ADC（Trop2/Nectin4 ADC）临床入组，“IO+ADC”2.0 迭代战略加速推进临床进展康方非肿瘤领域首个双抗IL-4Rα/ST2（AK139）IND获受理，剑指呼吸系统及皮肤疾病领域临床进展头对头度伐利尤单抗方案，依沃西方案一线治疗胆道肿瘤III期临床完成首例患者入组临床进展全球首个CD47单抗实体瘤III期临床首例入组：依沃西联合莱法利一线治疗HNSCC（对比帕博利珠单抗）数据发布 IGCS 2024 LBA & 《柳叶刀》主刊，卡度尼利1L宫颈癌III期研究PFS和OS双阳性结果重磅发布产品动态卡度尼利第二个适应症获批：一线胃癌全人群数据发布全球首个对比帕博利珠单抗取得显著阳性结果的随机对照大III期研究——依沃西HARMONi-2重磅研究成果在WCLC发表临床进展卡度尼利联合方案治疗uHCC的III期临床研究完成首例患者入组临床进展针对PD-1/L1治疗进展晚期胃癌，卡度尼利+普络西（VEGFR-2）联合疗法Ⅲ期临床完成首例入组数据发布 ASCO Oral & JAMA主刊丨Ⅲ期HARMONi-A研究重磅公布，依沃西疗法有望改变EGFR-TKI进展肺癌全球治疗标准临床进展国际多中心注册性III期研究HARMONi-3中国启动：依沃西单抗联合化疗对比帕博利珠单抗联合化疗1L治疗sq-NSCLC 产品动态高达50亿美金！康方生物与Summit就PD-1/VEGF双抗依沃西达成合作和许可协议产品动态全球首个肿瘤免疫治疗双抗——开坦尼®（PD-1/CTLA-4双抗，卡度尼利）获批上市

2026-05-25

·珐成浩鑫

【P村情报】一周生物 “药” 闻（2026.5.18-5.22）

NEWS（5.18-5.22） //// 【P村情报】是珐成浩鑫诚意推出的资讯板块。我们汇总生物医药行业一周的重要新闻，帮助各位看官梳理热点、把握趋势，了解行业最新动向。 5/18 ■ 阿斯利康全新机制降压药获批上市阿斯利康宣布Baxdrostat（商品名：Baxfendy）的上市申请已获得FDA批准，用于联合其它降压药治疗难以控制的高血压。该药物是首个获批上市的醛固酮合成酶（ALDOS）抑制剂。Baxdrostat是CinCor Pharma开发的一种靶向ALDOS（由CYP11B2基因编码）的潜在first in class、高选择性、强效口服小分子抑制剂，旨在通过抑制肾上腺中醛固酮合成的最后3个限速步骤来降低醛固酮水平。2023年1月，阿斯利康以18亿美元的总交易额收购CinCor Pharma。 ■ 复宏汉霖引进国产三代EGFR-TKI 复宏汉霖宣布与正大丰海及其旗下江苏创特达成战略合作。根据约定，复宏汉霖将获得由江苏创特自主研发的口服小分子三代EGFR激酶抑制剂（TKI）FHND9041（奥达替尼）在中国内地及澳门地区的独占性商业化权益及开发权利，包括所有用于人类疾病治疗的适应症，并获得该产品在美国和日本市场的优先合作权。根据协议，江苏创特将获得首付款及销售里程碑付款。此外，江苏创特还将享有基于未来产品销售额计算的阶梯式特许权使用费（Royalty）。在产品注册方面，FHND9041的上市注册申请（NDA）已于2026年2月获得中国国家药品监督管理局药品审评中心（CDE）受理，拟定适应症为EGFR 19号外显子缺失（19del）非小细胞肺癌（NSCLC）的一线治疗。 ■ 拜耳肺癌新药获FDA优先审评拜耳宣布塞伐艾替尼的新适应症被FDA纳入优先审评，用于一线治疗携带HER2（ERBB2）激活突变的晚期非小细胞肺癌（NSCLC）成人患者。塞伐艾替尼是拜耳开发的一款口服非共价可逆选择性酪氨酸激酶抑制剂，对携带EGFR和HER2突变（包括HER2 exon 20插入突变）的肿瘤有抑制活性。2025年11月19日，塞伐艾替尼首次在美国获批上市，用于治疗经FDA批准的伴随诊断设备证明肿瘤携带HER2（ERBB2）酪氨酸激酶结构域（TKD）激活突变并且接受过系统治疗的局部晚期或转移性非鳞状NSCLC成人患者。 5/20 ■ 康桥资本与GHO Capital宣布合并，打造全球最大的医疗健康投资平台亚洲最大的专注于医疗健康行业投资的资产管理机构康桥资本与欧洲领先的医疗健康专业投资机构 Global Healthcare Opportunities宣布，双方已签署合并协议，将共同组建全球规模最大的医疗健康投资资产管理平台。合并后资产管理规模（AUM）将超过210亿美元。此次合并汇聚两家长期深耕医疗健康领域的头部投资机构。双方秉持共同使命，致力于在全球范围内推动医疗服务向更优质、更高效、更可及的方向发展。合并后的平台将在北美、欧洲及亚太地区设有13个办公室，拥有200余名投资及运营专业人士，三大区域合计占全球医疗健康研发投入约90%。依托更广泛的全球布局、网络与资源协同，合并后的平台将更敏锐地把握由创新驱动的结构性增长机遇。 ■ 国内首款，默沙东重磅“K药”拟纳入突破性疗法据中国国家药品审评中心（CDE）官网最新公示，默沙东研发（中国）有限公司申报的MK-3475A注射液（俗称K 药）拟纳入突破性治疗品种。拟定适应为：帕博利珠单抗联合MK-1084用于一线治疗PD-L1 TPS ≥50%且有KRAS G12C突变的NSCLC患者。公开资料显示，皮下帕博利珠单抗（MK-3475A）由帕博利珠单抗与 Berahyaluronidase alfa（ALT-B4）组成，Berahyaluronidase alfa 是韩国 Alteogen 公司开发和生产的一种重组人透明质酸酶变体。透明质酸是皮肤和皮下组织细胞外基质的主要成分，会形成高黏度的「凝胶屏障」，限制大分子药物的扩散。在皮下注射抗体药物中使用透明质酸酶可降解透明质酸，降低组织黏度，促进药物扩散和吸收，显著增加皮下给药的注射量。 5/21 ■ 「信迪利单抗+呋喹替尼」第二项适应症获批上市国家药监局（NMPA）网站显示，信迪利单抗和呋喹替尼联合疗法的新适应症上市申请获批，用于治疗既往接受过一种酪氨酸激酶抑制剂（TKI）治疗失败的局部晚期或转移性的肾细胞癌患者。此次获批是基于FRUSICA-2研究的数据。该研究是一项随机、开放式标签、阳性对照的注册研究，旨在评估信迪利单抗和呋喹替尼联合疗法对比阿昔替尼或依维莫司单药疗法用于二线治疗晚期肾细胞癌的疗效和安全性。 ■ 正大天晴IDH1抑制剂拟纳入优先审评 CDE网站显示，正大天晴的IDH1抑制剂TQB3454拟纳入优先审评，用于治疗经吉西他滨和氟尿嘧啶类方案治疗失败的伴IDH1突变的局部晚期、复发和/或转移性胆道癌患者。2026年3月，TQB3454治疗伴IDH1突变晚期胆道癌的III期临床研究（TQB3454-III-01）在预设的期中分析中达到主要终点，即无进展生存期（PFS）、总生存期（OS）均达到方案预设的优效界值。这是全球第二个、国内第一个IDH1抑制剂在胆道癌取得成功的III期临床研究，同时也是第一个完成III期研究的国产IDH1抑制剂。 ■ 齐鲁制药阿贝西利片仿制药获批上市国家药监局（NMPA）网站显示，齐鲁制药的阿贝西利片仿制药获批上市申请。这是第二款获批上市的阿贝西利片仿制药。科睿药业的阿贝西利片已在本月初获批上市。原研阿贝西利是礼来开发的一款CDK4/6抑制剂，通过抑制细胞周期蛋白D诱导乳腺癌细胞衰老和凋亡。2017年9月，阿贝西利片剂首次在美国获批上市，并于2020年12月在中国获批上市。 ■ 石药集团布地奈德肠溶胶囊获批石药集团宣布其开发的布地奈德肠溶胶囊（4mg）已获得中华人民共和国国家药品监督管理局颁发的药品注册批件。布地奈德是一种皮质类固醇，具有强效的糖皮质激素活性和较弱的盐皮质激素活性，首过代谢程度极高。布地奈德可抑制位于回肠派尔集合淋巴结中的黏膜B细胞的增生和其向浆细胞的分化，从而抑制半乳糖缺陷的IgA1抗体（「Gd-IgA1」）的产生。 ■ 扬子江药业成人失眠新药孟平®（法赞雷生片）获批上市国家药品监督管理局发布信息：批准江苏海岸药业有限公司申报的1类创新药法赞雷生片（商品名：孟平）上市，用于治疗以入睡困难和/或睡眠维持困难为特征的成人失眠患者。该药品上市为患者提供了新的治疗选择。双重食欲素受体拮抗剂是第四代抗失眠药，相较于传统失眠药物，食欲素受体拮抗剂可凭借独特机制，减少唤醒驱动、诱导睡眠发生、且不改变睡眠结构，没有次日残留效应和药物依赖性，可以很好弥补前三代药物的不足。 ■ 强生重症肌无力新药在华获批上市强生宣布，旗下全人源新生儿Fc受体（FcRn）拮抗剂尼卡利单抗注射液（商品名：安力威®）已获国家药品监督管理局（NMPA）批准，联合常规治疗药物用于治疗全身型重症肌无力。该药物也是中国首个且目前唯一获批用于治疗12岁及以上青少年和成人自身抗体（AChR或MuSK）阳性的全身型重症肌无力（gMG）的FcRn拮抗剂。抗AChR及抗MuSK抗体阳性患者占全部抗体阳性gMG患者的90%及以上。 ■ 勃林格殷格翰口服肺癌一线疗法获批上市勃林格殷格翰与中国生物制药（HK1177）共同宣布，双方在中国大陆联合推广的圣赫途®（中文通用名：宗艾替尼片，英文通用名：zongertinib）获得中国国家药品监督管理局（NMPA）批准，单药适用于治疗存在HER2（ERBB2）酪氨酸激酶结构域激活突变的不可切除的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。 ■ HS-10504片（第四代EGFR-TKI ）获NMPA批准纳入突破性治疗药物翰森制药集团有限公司宣布，公司自主研发的第四代表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）HS-10504片获中国国家药品监督管理局(NMPA)批准纳入突破性治疗药物，拟定适应症为用于经EGFR-TKI治疗失败后伴EGFR C797S突变的局部晚期或转移性非小细胞肺癌（NSCLC）。HS-10504片是一种新型、高效、高选择性的第四代EGFR-TKI，目前正在NSCLC患者中进行临床开发。在2026年4月举行的美国癌症研究协会年会（AACR）上，HS-10504片用于经EGFR-TKI治疗后的晚期NSCLC的积极研究结果以口头报告形式发布。 ■ 国内第二款干细胞药物附条件批准上市申请获受理 CDE官网公示，江苏睿源生物技术有限公司的干细胞产品RY_SW01细胞注射液申请附条件批准上市获受理。这是国内继铂生卓越的艾米迈托赛之后的第二款申请附条件批准上市的干细胞产品。从信息上推测目前该款产品申请上市的适应是系统性硬化症。该适应症一种以局限性或弥漫性皮肤增厚、纤维化为特征的全身性自身免疫病，属于一种潜在致命性罕见病，会导致畸形或残疾，并导致皮肤（硬皮病）、肺（SSc-ILD）和其它器官出现瘢痕。 5/22 ■ 全球首个ADC获批一线治疗TNBC 第一三共和阿斯利康共同宣布德达博妥单抗的补充生物制剂许可申请（sBLA）获得FDA批准，用于一线治疗不适合接受PD-1/PD-L1药物治疗的不可切除或转移性三阴性乳腺癌（TNBC）。这是首个获批一线治疗TNBC的ADC药物。德达博妥单抗（Dato-DXd）是一款TROP2 ADC，由第一三共研制并由阿斯利康和第一三共合作开发和商业化。2025年1月，该药物首次在美国获批上市，用于治疗既往接受过内分泌治疗且在晚期疾病阶段接受过至少一线化疗的不可切除或转移性的激素受体（HR）阳性、HER2阴性（IHC 0、IHC 1+或IHC 2+/ISH-）乳腺癌成人患者。2025年8月，该药物首次在中国获批上市。编辑及审定：市场部

100 项与阿昔替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03218	阿昔替尼	L01XE17	DB06626

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
转移性肾细胞癌	中国	Pfizer Europe MA EEIG	2025-04-22
不可切除的肾细胞癌	中国	Pfizer Europe MA EEIG	2025-04-22
肾细胞癌	日本	Pfizer Japan, Inc.	2012-06-29
晚期肾细胞癌	美国	PF Prism CV	2012-01-27

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
II型糖原贮积病	临床3期	美国	Ocular Therapeutix, Inc.	2026-04-01
非增殖性糖尿病视网膜病变	临床3期	美国	Ocular Therapeutix, Inc.	2025-11-17
湿性年龄相关性黄斑变性	临床3期	美国	Ocular Therapeutix, Inc.	2024-01-29
湿性年龄相关性黄斑变性	临床3期	阿根廷	Ocular Therapeutix, Inc.	2024-01-29
局部晚期肾细胞癌	临床3期	-	Merck Sharp & Dohme LLC	2016-09-16
晚期癌症	临床3期	德国	Pfizer Inc.	2011-11-01
晚期癌症	临床3期	意大利	Pfizer Inc.	2011-11-01
晚期癌症	临床3期	西班牙	Pfizer Inc.	2011-11-01
晚期癌症	临床3期	英国	Pfizer Inc.	2011-11-01
神经内分泌肿瘤	临床3期	德国	Pfizer Inc.	2011-11-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01744249 (AXINET trial (GETNE1107) \| AXINET, CTgov)	临床2/3期	神经内分泌肿瘤 \| 晚期癌症 \| 无功能的胰腺内分泌肿瘤	256	Sandostatin LAR+Axitinib (Axitinib + Sandostatin LAR)	夢鏇夢獵窪製鏇積膚醖(壓積選鹹築醖齋願淵夢) = 醖壓鹽鏇範膚鹽壓憲範蓋艱觸鑰願遞齋繭製蓋 (鏇選齋鏇壓鬱壓淵醖簾, 獵選範齋獵鹽鏇淵餘壓 ~ 遞選顧憲壓壓積膚顧築) 更多	-	2026-04-28
				Placebo+Sandostatin LAR (Placebo + Sandostatin LAR)	夢鏇夢獵窪製鏇積膚醖(壓積選鹹築醖齋願淵夢) = 鬱遞製築壓製醖窪範壓蓋艱觸鑰願遞齋繭製蓋 (鏇選齋鏇壓鬱壓淵醖簾, 鏇壓醖壓鹹簾餘憲製醖 ~ 蓋鹽願衊製艱遞蓋淵鏇) 更多
NCT01744249 (AXINET, Pubmed \| J Clin Oncol)	临床3期	晚期胰腺神经内分泌肿瘤 Ki-67 index	256	Axitinib + Axitinibde LAR	網繭鏇壓餘觸願獵衊糧(鑰齋夢鹽願夢醖願夢鬱) = 簾鹽積廠襯製範築鬱淵壓糧膚蓋鏇簾鏇構夢餘 (蓋願積壓製築齋鏇憲範 ) 更多	不佳	2026-03-20
				Placebo + Octreotide LAR	網繭鏇壓餘觸願獵衊糧(鑰齋夢鹽願夢醖願夢鬱) = 鹽鬱構製廠觸鬱蓋簾獵壓糧膚蓋鏇簾鏇構夢餘 (蓋願積壓製築齋鏇憲範 ) 更多
NCT04698213 (Tide-A, ASCO_GU2026)	临床3期	转移性肾细胞癌	824	Intermittent Axitinib+Avelumab	範壓齋醖願構觸夢憲構(鏇選簾餘艱獵顧鹽鹽製) = 鹹鹹範鹽網鹹壓鏇築淵鑰膚憲鬱範齋積積願蓋 (齋繭顧壓醖顧衊願廠衊 )	不佳	2026-02-26
ASCO_GU2026	N/A	肾细胞癌一线	632	Pembrolizumab-axitinib (PA)	窪鏇鹽齋壓製鏇鑰範構(餘鏇齋襯壓鏇壓醖簾襯) = 醖鹹鏇製蓋積網願觸觸遞齋艱網簾憲齋觸鹹繭 (構選簾鹹餘簾鹽糧構願 ) 更多	积极	2026-02-26
				Pembrolizumab-lenvatinib (PL)	窪鏇鹽齋壓製鏇鑰範構(餘鏇齋襯壓鏇壓醖簾襯) = 築顧廠糧廠糧鹽淵選蓋遞齋艱網簾憲齋觸鹹繭 (構選簾鹹餘簾鹽糧構願 ) 更多
NCT06223958 (SOL-1, Company_Website) 人工标引	临床3期	湿性年龄相关性黄斑变性	344	AXPAXLI 0.45mg	鬱簾膚窪顧顧獵願遞願(選餘構築餘壓衊鏇繭淵) = 顧夢鬱鑰構築遞艱積窪襯糧淵餘願選獵窪壓齋 (顧壓衊顧鏇夢簾糧選網 ) 达到更多	优效	2026-02-17
				aflibercept (2 mg)	鬱簾膚窪顧顧獵願遞願(選餘構築餘壓衊鏇繭淵) = 餘齋蓋願鏇廠鑰繭製顧襯糧淵餘願選獵窪壓齋 (顧壓衊顧鏇夢簾糧選網 ) 达到更多
ESMO_ASIA2025	N/A	转移性肾细胞癌一线	194	IO-IO (nivolumab + ipilimumab)	積廠獵獵艱積壓憲願簾(鹹糧鏇鬱鏇遞餘簾顧網) = 觸繭鬱簾餘鹽鹽夢廠齋憲鹽繭鏇餘襯壓鑰衊構 (壓積夢憲蓋衊鹹衊醖艱, 1.0 ~ 55.9) 更多	积极	2025-12-05
				IO-TKI (pembrolizumab + axitinib or lenvatinib or nivolumab + cabozantinib)	積廠獵獵艱積壓憲願簾(鹹糧鏇鬱鏇遞餘簾顧網) = 膚築製鹹築糧餘餘願範憲鹽繭鏇餘襯壓鑰衊構 (壓積夢憲蓋衊鹹衊醖艱, 1.0 ~ 45.2) 更多
ASN2025	N/A	晚期肾细胞癌一线	886	Axitinib plus Avelumab	憲積築蓋鑰觸廠餘繭鹹(選觸鹹餘觸鏇願鏇襯簾) = 艱廠襯夢壓獵獵鏇鏇廠窪鹹廠選廠廠淵鬱衊淵 (構廠廠製繭鏇糧餘構繭 ) 更多	积极	2025-11-08
				Sunitinib	築餘鏇繭蓋淵築憲鹽窪(獵製衊餘醖淵獵鹹範憲) = 獵鬱鹽觸製獵積襯觸壓製襯網夢選觸鬱積齋獵 (窪積構獵醖鹽淵衊鬱遞 )
NCT04370509 (CTgov)	临床2期	转移性肾细胞癌 \| 晚期肾细胞癌 \| 肾细胞癌 ... 更多	6	Cytoreductive Nephrectomy (CN)+Pembrolizumab	觸製構蓋積顧淵鬱壓範 = 鑰淵範衊窪築襯廠製鑰觸廠窪憲醖窪鑰築夢膚 (鬱夢鬱窪糧齋齋廠獵鬱, 襯廠窪鏇糧襯觸鹹夢網 ~ 積簾觸蓋製網膚簾糧衊) 更多	-	2025-11-05
NCT02684006 (JAVELIN Renal 101, ESMO2025)	临床3期	肾细胞癌 \| 非小细胞肺癌	824	Atezolizumab	醖鏇鏇淵淵鬱醖鹹廠淵(廠窪願衊鹹顧範襯醖廠) = 襯鬱構構齋積繭襯襯壓選艱遞獵淵膚餘網遞艱 (觸築餘衊淵艱鑰餘襯襯, 22 ~ 33)	积极	2025-10-17
NCT02684006 (JAVELIN Renal 101, ESMO2025)	临床2/3期	转移性肾细胞癌 sMAdCAM-1	1,051	Avelumab + Axitinib	築鹹構窪鬱鬱製憲積憲(構願網壓鹹簾網獵淵遞): HR = 0.59 (95.0% CI, 0.41 ~ 0.85), P-Value = 0.004 更多	积极	2025-10-17
				Sunitinib