更新于：2024-05-01

Thymoma

胸腺瘤

更新于：2024-05-01

基本信息

别名

Primary thymic epithelial neoplasm、Primary thymic epithelial tumor、THYMOMA

+ [14]

简介

A neoplasm originating from thymic tissue, usually benign, and frequently encapsulated. Although it is occasionally invasive, metastases are extremely rare. It consists of any type of thymic epithelial cell as well as lymphocytes that are usually abundant. Malignant lymphomas that involve the thymus, e.g., lymphosarcoma, Hodgkin's disease (previously termed granulomatous thymoma), should not be regarded as thymoma. (From Stedman, 25th ed)

关联

项与胸腺瘤相关的药物

Linperlisib

林普利塞

靶点

PI3Kδ

作用机制

PI3Kδ抑制剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2022-11-08

Penpulimab

派安普利单抗

靶点

PD-1

作用机制

PD-1抑制剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2021-08-03

Selinexor

塞利尼索

靶点

XPO1

作用机制

XPO1抑制剂

在研机构

National Cancer Institute [+8]

原研机构

Karyopharm Therapeutics, Inc.

在研适应症

浆细胞骨髓瘤难治 [+77]

非在研适应症

急性早幼粒细胞白血病 [+32]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2019-07-03

122

项与胸腺瘤相关的临床试验

NCT06248515 / Recruiting临床2期IIT

A Phase II Parallel Arm Study of SACITUZUMAB GOVITECAN-HZIY in Patients With Advanced Thymoma and Thymic Carcinoma

The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in adult patients with advanced thymoma and thymic carcinoma after progressing on at least one prior line of therapy.
The main question it aims to answer is:
• What is the overall response rate (ORR) in patients with advanced thymoma and thymic carcinoma?
Participants will:
receive a fixed dose of 10 mg/kg given intravenously, once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity
have regular blood tests, scans, and examinations to monitor their health.
have blood and a biopsy of their tumor for research purposes.

开始日期2024-05-01

申办/合作机构

Georgetown University Hospital

[+1]

ChiCTR2400081313 / SuspendedN/AIIT

Evaluation of the efficacy of surgery compared to chemotherapy for pleural dissemination of thymoma

开始日期2024-03-01

申办/合作机构

上海市胸科医院

NCT06221501 / Not yet recruiting临床2期IIT

Safety and Efficacy of Perioperative Efgartigimod Combined With Thymectomy for Thymoma and Myasthenia Gravis: A Prospective, Single-arm Study

It is evidenced that efgartigimod can rapidly and significantly improve the symptoms of myasthenia gravis. The global multicenter clinical trials hace confirmed that efgartigimod is safe and well tolerated. Few case reports showed that perioperative efgartigimod combined with thymectomy was safe and feasible. However, there was no sufficient data on safety and efficacy of this regimen in the treatment for patients with myasthenia gravis and thymomas. Therefore, this trial aims to evaluate the efficacy and safety of perioperative efgartigimod and thymectomy for patients with myasthenia gravis and thymomas.

开始日期2024-02-01

申办/合作机构

复旦大学附属中山医院

100 项与胸腺瘤相关的临床结果

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100 项与胸腺瘤相关的转化医学

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0 项与胸腺瘤相关的专利（医药）

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9,722

项与胸腺瘤相关的文献（医药）

2024-02-22·Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology

Comorbidity in myasthenia gravis: multicentric, hospital-based, and controlled study of 178 Italian patients.

Article

作者: Vincenzo Di Stefano ; Salvatore Iacono ; Massimiliano Militello ; Olga Leone ; Marianna Gabriella Rispoli ; Laura Ferri ; Paola Ajdinaj ; Placido Lanza ; Antonino Lupica ; Grazia Crescimanno ; Roberto Monastero ; Antonio Di Muzio ; Filippo Brighina

BACKGROUND:

Myasthenia gravis (MG) is an autoimmune disorder with fluctuating weakness that causes significant disability and morbidity. Comorbidities may influence the course of MG, particularly in specific subgroups. The aim of this study is to investigate the frequency of comorbidities in MG patients compared to healthy controls (HC) and to evaluate their distribution according to age at disease onset, sex, and disease severity.

METHODS:

MG patients attending the University Hospital "Paolo Giaccone" in Palermo and "SS Annunziata" Hospital in Chieti were enrolled; HC were enrolled from the general population. Non-parametric statistics and logistic regression were used to assess the association of specific comorbidities according to age at disease onset, sex, disease subtypes, and severity of the disease.

RESULTS:

A total of 356 subjects were included in the study: 178 MG patients (46% F; median age 60 years [51-71]) and 178 sex- and age-matched HC (46% F, median age 59 years [50-66]). Overall, 86% of MG patients and 76% of HC suffered from comorbidities, and MG patients had a higher number of comorbidities compared to HC. Patients with late-onset suffered from more comorbidities than those with early-onset MG. Hypertension was more common in male patients with MG, while thymic hyperplasia, osteoporosis, and autoimmune diseases were more common in females. Respiratory disorders and thymoma were more common in patients with more severe disease (p < 0.05 for all comparisons).

CONCLUSION:

MG patients, particularly those with late onset, showed a higher prevalence of comorbidities than HC. Assessment of comorbidities in MG is an essential issue to identify the appropriate treatment and achieve the best management.

2024-02-19·BMC infectious diseases

Clinical and genomic evaluations of a persistent fatal SARS-CoV-2 infection in a goods syndrome patient: a case report.

Article

作者: Payam Tabarsi ; Ali Maleki ; Zahra Abtahian ; Alieh Khabbaz ; Zahra Fereydouni ; Jahangir Rezaie ; Mahsa Tavakoli ; Parastoo Yektay Sanati ; Mostafa Salehi-Vaziri

The coronavirus disease of 2019 (COVID-19) resulted from an infection by severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) which is the main cause of acute respiratory distress syndrome (ARDS) in global population from 2019 on. It may contribute to higher rate of death among the patients with immunodeficiency based on recent reports. In addition, Good syndrome (GS) as a result of thymoma removal might cause in some long-lasting microbial infections. We described clinical aspects and viral mutations on a case of GS suffering from COVID-19. A 46-year-old man with fever, common respiratory disease symptoms and positive COVID-19 polymerase chain reaction (PCR) test, with the history of thymoma removal surgery was admitted to Masih Daneshvari Hospital, Tehran, Iran. Lung radiographs and oxygen saturation measurement disclosed considerable implication resulted in application of several anti-microbial medication. The delta variant (B.1.617.2 (21 J Clade)) was the strain isolated from the patient by sequencing methods done by the COVID-19 National Reference Laboratory (CNRL), Pasteur Institute of Iran, while the dominant strain circulated mostly among population was Omicron (B.1.1.529) at the time of sampling. Unfortunately, the patient had passed away a month later by sudden respiratory failure progressed in refractory septic shock. Despite the fact that opportunistic infections may lead the GS patients to a major health problematic condition, unusual persistent of infections such as non-dominant variant of SARS-Cov-2 could be observed through the disease timeline. Therefore, a fully screening of thymoma plus intra-host evolution monitoring of SARS-CoV-2 is highly recommended in immunocompromised patients.

2024-02-19·Current computer-aided drug design

Natural Compound Dioscin Targeting Multiple Cancer Pathways through its High Affinity Binding to B Cell Lymphoma-2.

Article

作者: Shweta Gulia ; Prakash Chandra ; Asmita Das

OBJECTIVE:

The study aimed to explore the crucial genes involved in cancer-related biological processes, including EMT, autophagy, apoptosis, anoikis, and metastasis. It also sought to identify common genes among the pathways linked to these biological processes, determine the level of Bcl-2 expression in various types of cancers, and find a potent inhibitor of Bcl-2 among natural compounds.

METHODS:

Common genes involved in the pathways related to EMT, autophagy, apoptosis, anoikis, and metastasis were explored, and the level of the most frequently overexpressed gene that was Bcl-2, in various types of cancers was analyzed by gene expression analysis. A set of 102 natural compounds was sorted according to their docking scores using molecular docking and filtering. The top-ranked molecule was chosen for additional molecular dynamics (MD) simulation for 100 ns. Differential gene expression analysis was performed for Dioscin using GEO2R.

RESULTS:

The study identified four common genes, Bcl-2, Bax, BIRC3, and CHUK, among the pathways linked to EMT, autophagy, apoptosis, anoikis, and metastasis. Bcl-2 was highly overexpressed in many cancers, including Acute Myeloid Leukemia, Diffuse large B cell lymphoma, and Thymoma. The Dioscin structure in the Bcl-2 binding site received the highest docking score and the most relevant interactions. Dioscin's determined binding free energy by MM/GBSA was -52.21 kcal/mol, while the same calculated by MM/PBSA was -9.18 kcal/mol. A p-value of less than 0.05 was used to determine the statistical significance of the analysis performed using GEO2R. It was observed that Dioscin downregulates Bcl-2, BIRC3, and CHUK and upregulates the pro-apoptotic protein Bax.

CONCLUSION:

The study concluded that Dioscin has the potential to act as a protein inhibitor, with a noteworthy value of binding free energy and relevant interactions with the Bcl-2 binding site. Dioscin might be a good alternative for targeting multiple cancer pathways through a single target.

项与胸腺瘤相关的新闻（医药）

2024-04-02

·GlobeNewswire-Health Care

OncoC4 Expands Scientific Advisory Board with Appointment of Heather A. Wakelee, MD, FASCO

Dr. Wakelee is a world-renowned expert in the research and treatment of lung cancerOncoC4’s SAB now includes 6 distinguished scientists, industry experts, and key opinion leaders in oncology and immunotherapy ROCKVILLE, Md., April 02, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc. (“OncoC4”), a late-stage biopharmaceutical company developing novel medicines for cancer, today announced the appointment of thoracic medical oncologist Heather A. Wakelee, MD, FASCO to the OncoC4 Scientific Advisory Board (SAB) made up of distinguished scientists, industry experts, and key opinion leaders in oncology and immunotherapy. Dr. Wakelee, currently a Professor of Medicine and Chief of the Division of Oncology at Stanford University, and Deputy Director of the Stanford Cancer Institute, brings over 20 years of experience in clinical strategy. “We are honored to welcome Heather to the OncoC4 SAB, an international expert with decades of leadership experience in the treatment of lung cancer,” said Yang Liu, PhD, Co-Founder, CEO and CSO of OncoC4. “Her research and clinical understanding in thoracic oncology will provide invaluable guidance as we advance multiple clinical products, including gotistobart, a late-stage next-generation CTLA-4 inhibitor for immunotherapy-resistant non-small cell lung cancer.” Dr. Wakelee added, "OncoC4 is developing novel immunotherapies targeting CTLA-4 and CD24 to break cancer resistance. By leveraging universal pathways, OncoC4 has the potential to change the treatment paradigm for many common and aggressive cancers with high unmet needs. I am excited to join the OncoC4 SAB at this important stage, and partner with the team to help shape the clinical development of their innovative clinical and preclinical pipeline.” Heather A. Wakelee, MD, FASCO brings over 20 years of clinical experience specializing in the treatment of lung cancer, thymoma, and mesothelioma. Currently she serves as Deputy Director of the Stanford Cancer Institute and is the Division Chief of Medical Oncology. She was the President of the International Association for the Study of Lung Cancer (IASLC) and is active in several national and international organizations related to lung cancer and thymoma. She remains actively engaged in lung cancer and thymoma clinical trials, translational work and population sciences used to explore these diseases. She is the Principal Investigator on numerous clinical trials and has held advisory board roles with multiple international pharmaceutical companies. Dr. Wakelee is a board-certified physician in medical oncology. She completed a fellowship in oncology and a residency in internal medicine at Stanford University. She holds a medical degree from Johns Hopkins University, and a Bachelor of Arts from Princeton University in Molecular Biology. OncoC4’s SAB, made up of transformative leaders in cancer and immunology include: Michael Caligiuri, MD (Chair) – President, City of Hope Medical Center An international leader in hematology and oncology and Fellow of the National Academy of Medicine who also served as President of the American Association for Cancer Research (AACR) Lieping Chen, PhD – Endowed Professor, Yale University Fellow of the National Academy of Science (NAS) whose discovery of B7H1/PD-L1 ushered in a new era in patient care of cancer Jeffrey S Weber, MD PhD – Deputy Director, New York University Cancer Fellow of the AACR Academy who performed the first randomized studies that unequivocally demonstrated the power of immunotherapy to treat cancer Kunliang Guan, PhD – Emeritus Professor, University of California, San Diego (UCSD) OncoC4 co-founder who was awarded the John D. and Catherine D. MacArthur Fellowship for his pioneering contributions in key cancer biology pathways Kun He, PhD – President R&G, US Master statistician responsible for overseeing the final statistical review of pivotal studies during his time at the Food and Drug Agency (FDA) Heather A. Wakelee, MD, FASCO – Professor of Medicine and Chief of the Division of Oncology at Stanford University, and Deputy Director of the Stanford Cancer Institute Past President of the IASLC and global expert in the clinical treatment of thoracic malignancies About OncoC4Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologics for the potential treatment of cancer. Its most advanced program is BNT316/ONC392 (gotistobart), a Phase 3, next generation anti-CTLA-4 antibody that is designed to allow CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In addition, OncoC4 has two first-in-class clinical stage siglec 10 programs, including AI071, a Phase 2 ready siglec 10 agonist designed for difficult to treat immune related adverse events, and ONC841, a Phase 1 ready siglec 10 antagonist for the treatment of solid tumors. OncoC4’s portfolio also includes preclinical programs targeting the CD24 cancer immune evasion pathway. More information: www.oncoc4.com. CONTACTS OncoC4Investor Contact:Alexandra FoliasLifeSci Advisorsafolias@lifesciadvisors.comMedia Contact:Mari PurpuraLifeSci Advisorsmpurpura@lifesciadvisors.com

高管变更免疫疗法临床1期临床3期AACR会议

2024-03-29

·美通社

康宁杰瑞公布2023年度全年业绩及近期业务进展

苏州 2024年3月29日 /美通社/ -- 康宁杰瑞生物制药（股票代码：9966.HK）公布了截至2023年12月31日的2023年度全年业绩和近期业务进展。康宁杰瑞董事长兼总裁徐霆博士表示： "2023年，康宁杰瑞继续以临床需求为目标，坚持差异化创新。公司已有一个上市和三个处于注册临床阶段的产品。我们将持续完善我们的抗体工程平台，开发安全有效的抗肿瘤新药。同时加速临床开发、产品上市和国际合作。" 财务概览 2023年度实现总收入218.77百万元人民币，同比增长31.12%。 2023年度实现产品收入195.55百万元人民币，同比增长32.54%。 2023年度研发开支407.52百万元人民币，同比下降12.97%。 2023年度总亏损210.59百万元人民币，同比下降35.35%。完成1次资本市场配售，净募集资金约329.21百万元人民币。财务状况稳健，截至2023年12月31日现金储备为1407.24百万元人民币。业务摘要一、产品管线公司具有显著差异化优势和强大国际竞争力的产品管线，涵盖单域抗体/单抗、多功能抗体及抗体偶联物等抗肿瘤新药，其中1个产品KN035（全球首个皮下注射PD-(L)1抑制剂恩沃利单抗注射液，商品名：恩维达 ® ）已在中国获批上市，3个产品处于后期临床开发阶段，丰富的早期研发管线中2个新药分子已进入临床研究阶段。 KN046 一种BsAb免疫检查点抑制剂，同时靶向两个免疫检查点PD-L1及CTLA-4，是具有潜在突破性的新一代肿瘤免疫重磅药物。KN046已在中国、美国及澳大利亚开展近20项涵盖非小细胞肺癌、胰腺癌、胸腺癌、肝癌、食管鳞癌、三阴乳腺癌等10多类肿瘤处于不同阶段的临床研究，结果显示患者获得生存获益的优势。目前KN046多项注册临床研究正在进行中。报告期内主要进展 2023年5月，关于KN046联合含铂化疗治疗晚期不可切除或转移性鳞状非小细胞肺癌（sq NSCLC）患者的Ⅲ期临床研究，独立数据监察委员会建议研究继续进行并进一步收集后续的总生存期（OS）随访数据，直至最终OS分析。 2023年6月，KN046治疗晚期实体肿瘤（尤其是鼻咽癌）的Ⅰ期临床研究结果，在线发表于国际癌症免疫疗法协会（Society for Immunotherapy of Cancer, SITC）官方期刊 Journal for ImmunoTherapy of Cancer （JITC）。研究结果表明KN046对晚期实体瘤患者具有良好的耐受性和抗肿瘤疗效。 2023年7月，KN046单药治疗晚期非小细胞肺癌的Ⅱ期临床研究结果，在线发表于国际肿瘤领域知名期刊 European Journal of Cancer 。研究结果表明KN046 3mg/kg和5mg/kg单药治疗既往铂类化疗失败或不耐受的鳞状和非鳞状晚期非小细胞肺癌患者，具有良好的疗效和安全性。 KN046联合阿昔替尼一线治疗晚期非小细胞肺癌的Ⅱ期临床研究取得了良好的耐受性、疗效及安全性信号。相关结果于2023年10月在欧洲肿瘤内科学会（ESMO）大会上展示。 KN046治疗非小细胞肺癌的Ⅰ期及Ⅱ期临床研究取得了对既往免疫检查点抑制剂（ICI）治疗失败的非小细胞肺癌患者良好的耐受性及OS获益。相关结果于2023年10月在ESMO大会上展示。 KN046在联合化疗治疗非小细胞肺癌的临床研究中，对经表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（EGFR-TKI(s)）治疗失败的EGFR敏感性突变晚期非小细胞肺癌患者显示疗效和OS获益及良好的安全性。相关结果于2023年10月在ESMO大会上展示。 KN046用于治疗经一线化疗后疾病进展的复发或转移性胸腺癌患者的Ⅱ期临床研究取得了对至少接受过一线化疗的胸腺癌患者良好的抗肿瘤活性及耐受性结果，该研究截至数据截止日期2023年8月30日，中位OS未成熟，显示出令人鼓舞的生存获益信号。相关结果于2023年10月在ESMO大会上展示。 2023年11月，关于KN046联合白蛋白紫杉醇╱吉西他滨对照安慰剂联合白蛋白紫杉醇╱吉西他滨治疗未接受系统性治疗的局部晚期不可切除或转移性胰腺导管腺癌的Ⅲ期临床研究的期中分析，独立数据监察委员会建议研究继续进行并进一步收集后续OS数据，直至最终OS分析。报告期后进展 KN046联合白蛋白紫杉醇一线治疗晚期三阴乳腺癌的Ⅱ期临床研究取得了令人鼓舞的PFS及OS获益、良好的耐受性及可控的安全性。相关结果于2024年2月发表于国际知名期刊 Nature Communications 。 KN046联合化疗一线治疗转移性非小细胞肺癌的Ⅱ期临床研究显示疗效可观且耐受性好，相关结果于2024年3月在Cell子刊 Cell Reports Medicine 全文发表。 2024年预期里程碑 KN046联合化疗一线治疗鳞状非小细胞肺癌Ⅲ期临床研究进行OS最终分析。 KN046联合化疗一线治疗晚期胰腺癌Ⅲ期临床研究进行OS最终分析。 KN046联合阿昔替尼治疗晚期非小细胞肺癌Ⅱ期临床研究相关数据读出，并预计于2024年10月在ESMO发布。 KN026 新一代HER2双抗，可以同时结合两种不同的经临床验证的HER2表位，从而产生潜在的卓越疗效。临床研究结果表明，KN026对之前重度治疗的HER2表达肿瘤患者显示出良好的初步疗效及安全性。报告期内主要进展 2023年5月，KN026联合注射用多西他赛（白蛋白结合型）用于一线治疗HER2 阳性复发转移性乳腺癌的Ⅲ临床研究获国家药监局批准。 2023年6月，KN026联合KN046用于治疗乳腺癌或GC/GEJ以外的局部晚期不可切除或转移性HER2阳性实体瘤的Ⅱ临床研究结果在2023年美国临床肿瘤学会（ASCO）年会上公布。研究结果表明在入组的26例患者中，在客观响应率，无进展生存期，12个月的生存率和安全性方面相比现有疗法都显著获益。 2023年7月，KN026联合注射用多西他赛（白蛋白结合型, HB1801）一线治疗HER2阳性复发或转移性乳腺癌的Ⅲ期临床研究完成首例患者给药。 KN026联合多西他赛一线治疗HER2阳性复发或转移性乳腺癌的Ⅱ期临床研究显示出良好的疗效和耐受性。相关结果于2023年10月在ESMO大会上展示。 KN026联合多西他赛用于HER2阳性早期或局部晚期乳腺癌的新辅助治疗的Ⅱ期临床研究，显示出良好的临床效果，具有可接受和可控的安全性。相关结果于2023年10月在ESMO大会上展示。 2023年11月，KN026联合化疗用于治疗经一线标准治疗（曲妥珠单抗联合化疗）失败的HER2阳性胃癌（及胃食管结合部癌）患者获得国家药监局药品审评中心的突破性疗法认定。 KN026联合多西他赛一线治疗HER2阳性复发或转移性乳腺癌的临床研究取得了良好的耐受性及临床获益。相关结果于2023年12月在第46届圣安东尼奥乳腺癌大会（SABCS）上展示。 JSKN003 一种利用康宁杰瑞特有的糖基定点偶联平台研发的HER2双抗ADC，较同类药物具有更好的血清稳定性、更强的旁观者杀伤效应和同等的肿瘤杀伤活性，有效地扩大了治疗窗。报告期内主要进展 2023年3月，JSKN003治疗晚期实体瘤的中国Ⅰa/Ⅰb期临床研究完成首例患者给药，之后该临床研究获其组长单位的伦理委员会进一步批准调整为Ⅰ/Ⅱ期临床研究。截至2023年10月26日，JSKN003在澳大利亚进行的Ⅰ期临床研究中，对HER2表达实体瘤患者显示出初步疗效和良好的耐受性。相关数据于2023年11月16日以公告形式发布。 2023年12月，JSKN003治疗晚期HER2低表达乳腺癌的Ⅲ期临床研究完成首例患者给药。 2024年预期里程碑新增2个注册临床研究。 JSKN003澳大利亚治疗HER2表达晚期实体瘤的Ⅰa期（剂量递增期）临床研究数据于2024年4月举行的美国癌症研究协会（AACR）年会上展示。 JSKN003澳大利亚Ⅰ期临床研究和中国Ⅰ/Ⅱ期临床研究部分数据预计于2024年6月在ASCO年会发布。 JSKN003澳大利亚Ⅰ期临床研究和中国Ⅰ/Ⅱ期临床研究中的乳腺癌数据预计于2024年12月在SABCS发布。 KN035（恩沃利单抗，恩维达 ® ）一种创新抗肿瘤免疫治疗药物，是全球首个及目前唯一获批上市的皮下注射PD-L1抑制剂，也是中国第一个针对跨瘤种适应症的免疫治疗药物、首个国产PD-L1药物。具有有效性、安全性、便利性、依从性及较低医疗成本等优势。KN035正在中国和美国进行多项关键性临床研究。报告期内主要进展 2023年6月，合作伙伴TRACON Pharmaceuticals,Inc.公布了KN035在美国进行的ENVASARCⅡ期关键临床研究六个月独立数据监察委员会审查的积极结果。 2023年8月，KN035用于可切除非小细胞肺癌患者的新辅助治疗╱辅助治疗的Ⅲ期临床研究IND获国家药监局批准，并于2023年12月完成首例患者给药。 2023年10月，KN035联合仑伐替尼对比卡铂-紫杉醇化疗用于一线治疗错配修复完整（pMMR）晚期或复发性子宫内膜癌患者的Ⅲ期临床研究IND获得美国食品药品监督管理局（FDA）批准。 2023年11月，KN035联合仑伐替尼治疗既往至少一线含铂化疗失败或不能耐受的非微卫星高度不稳定（MSI-H）/非错配修复基因缺陷型（dMMR）晚期子宫内膜癌获国家药监局CDE授予突破性疗法认定。报告期后进展康宁杰瑞及3D Medicines就KN035与Glenmark达成协议，授予Glenmark在印度、亚太地区（除新加坡、泰国、马来西亚）、中东和非洲、俄罗斯、独联体和拉丁美洲的肿瘤适应症开发和商业化独家许可权益。有关KN035开发及商业化费用由Glenmark自行承担，康宁杰瑞保留于地区内外为任何目的而生产KN035的独家权利。 JSKN033 一种由JSKN003和恩沃利单抗组成的皮下注射复方制剂。 2023年12月，JSKN033用于治疗HER2表达晚期或转移性实体瘤的Ⅰ/Ⅱ期临床研究获澳大利亚Bellberry临床研究伦理委员会批准。2024年3月完成首例患者给药。 2024年预期完成澳大利亚Ⅰ期临床研究剂量爬坡阶段。 JSKN016 一种靶向HER3与TROP2的双抗ADC，可诱导TROP2或HER3阳性的肿瘤细胞死亡。 JSKN016用于治疗晚期恶性实体瘤的临床研究申请于2024年3月获国家药监局CDE批准，将在中国开展Ⅰ期临床研究。 KN052 一种创新PD-L1/OX40双特异性抗体，能同时结合PD-L1与OX40，通过阻断PD-L1/PD-1通路有效逆转肿瘤诱导的免疫抑制，并通过激动OX40促进免疫反应。 2023年2月，与斯微（上海）生物科技股份有限公司建立战略合作伙伴关系，重点开展肿瘤领域双特异性抗体药物（KN052）及mRNA疫苗药物的临床研发合作。 2023年4月，KN052临床前研究结果在2023年美国癌症研究协会年会（AACR）Late-Breaking Research首次公布。临床前研究显示，KN052具有可接受的药代动力学与安全性，抗肿瘤活性明显强于两个单靶点对照抗体单用及联用。 KN019 一种基于CTLA-4的免疫抑制剂融合蛋白，在自身免疫性疾病及肿瘤免疫治疗引起的免疫失调中具有潜在的广泛应用。 2023年11月，KN019的皮下注射制剂获得国家药监局的IND批准，用于临床开发。二、生产基地公司药物研发与产业化基地占地75亩，生产线配备符合中国国家药监局、FDA及欧洲药品管理局有关GMP监管规定的世界一流的设备。目前拥有ADC在内的多种工程化抗体药物生产线，已有原液生产规模达12,000L，制剂年产能超280万支，为肿瘤患者提供安全、疗效好、成本可控的创新药。2024年将推动ADC药物研发及生产工艺的升级。三、其他摘要 2023年11月，康宁杰瑞入选"中国医药创新企业100强"、"中国医药上市公司ESG竞争力TOP20"榜单。有关上述内容的更多信息，请参阅本公司在香港联交所及公司官网上发布的 2023年度业绩公告。关于康宁杰瑞康宁杰瑞是一家创新型生物制药公司，致力于发现、开发、生产和商业化世界一流的抗肿瘤药物，为患者提供创新生物疗法。2019年12月12日，公司在香港联交所主板上市（股票代码：9966.HK）。康宁杰瑞创建了具有自主知识产权的蛋白质/抗体工程、抗体筛选、多模块/多功能抗体修饰等生物大分子药物研发和生产技术平台。打造了具有显著差异化优势和强大国际竞争力的产品管线，涵盖单域抗体/单抗、多功能抗体及抗体偶联物等抗肿瘤创新药：其中1个产品KN035（全球首个皮下注射PD-(L)1抑制剂，恩沃利单抗注射液，商品名：恩维达 ® ）已于2021年在中国获批上市，成为肿瘤患者广泛可及的药物； 3个产品处于后期临床开发阶段；HER2双抗KN026获中国NMPA突破性疗法认定。并且公司拥有丰富的早期研发管线，其中2个新药分子已进入临床研究阶段。 "康达病患，瑞济万家"。康宁杰瑞始终聚焦未满足的临床需求，不断开发安全、负担得起、具有全球竞争优势的抗肿瘤药物，惠及患者。

AACR会议财报临床1期临床2期

2024-03-11

·精准药物

2024年度更新|全癌种获批靶向及免疫药物汇总一览

随着“精准医学”概念的提出，针对不同患者个体特征定制个性化治疗方案越来越受到临床上的重视。基于此，近年来对肿瘤相关的分子靶点的研究逐步深入，分子靶向药物的开发也取得了长足的进展。而在2023年各大药企纷纷加大了创新药的研发投入，无论是对于罕见靶点的深入开发，抑或是新型疗法的临床概念验证，在这一年均有着众多里程牌式的突破。中国原研新药也大放异彩，众多新适应症获批临床。例如，PD-1/L1抑制剂信迪利单抗、斯鲁利单抗、阿得贝利单抗、替雷利珠单抗、赛帕利单抗、卡瑞利珠单抗等在多个实体瘤中获批新适应症；同时，贝福替尼、伊鲁阿克、舒沃替尼、谷美替尼、吡咯替尼等众多靶向药物也为肺癌、乳腺癌患者提供了更多治疗方案的选择。除此以外，还有众多国内外获批药物及疗法百花齐放，涉及单抗、双抗、ADC、TCR疗法等，覆盖了常见的实体瘤及血液肿瘤类型，大大改写了现存治疗方案，有效提高了肿瘤患者的生存周期。小编根据可查询到的公开信息，整理了截止目前，在肿瘤靶向与免疫治疗领域，经FDA/NMPA获批及NCCN/CSCO指南推荐的20余个癌种的药物进行了总结，并附2023年医保纳入情况及医保适应症等相关信息。在此将汇总信息分享给各位战斗在抗肿瘤一线的医务工作者、患者及家属，以期惠及更多肿瘤患者，为推动抗肿瘤治疗进展贡献出一份力量。1. 呼吸系统1.1非小细胞肺癌1.2小细胞肺癌2. 消化系统2.1结直肠癌2.2胃癌2.3食管癌2.4胃肠道间质瘤2.5肝细胞癌2.6胰腺癌2.7胆道肿瘤3. 妇科肿瘤3.1卵巢癌、输卵管癌、腹膜癌3.2宫颈癌3.3子宫内膜癌4. 泌尿生殖系统4.1肾癌4.2膀胱癌（含尿路上皮癌）4.3前列腺癌5. 乳腺癌与体表肿瘤5.1乳腺癌5.2黑色素瘤5.3基底细胞癌5.4默克尔细胞癌6. 头颈部肿瘤6.1甲状腺癌6.2头颈癌7. 骨与软组织肉瘤软组织肉瘤7.1硬纤维瘤（侵袭性纤维瘤病）7.2腺泡状软组织肉瘤（ASPS）7.3血管肉瘤7.4伴有纤维肉瘤转化的隆突性皮肤纤维肉瘤（DFSP）7.5上皮样肉瘤7.6炎性肌纤维母细胞瘤（IMT）7.7血管周上皮样细胞肿瘤/复发性血管平滑肌脂肪瘤/淋巴管平滑肌瘤病7.8孤立性纤维瘤7.9色素沉着绒毛结节性滑膜炎/腱鞘巨细胞瘤7.10腹膜后高分化/去分化脂肪肉瘤骨肿瘤7.11脊索瘤7.12尤文肉瘤7.13骨巨细胞瘤7.14骨肉瘤/高级别未分化多形性肉瘤7.15软骨肉瘤8. 中枢神经系统肿瘤9. 血液肿瘤和淋巴瘤9.1淋巴瘤9.2白血病9.3多发性骨髓瘤10. 其他肿瘤10.1神经内分泌肿瘤10.2胸腺瘤/癌11. 泛肿瘤靶向、免疫药物声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

抗体药物偶联物免疫疗法