Pruvonertinib

53.3%的肺癌患者肿瘤显著缩小30%以上，其中还有幸运的患者肿瘤靶病灶全部消失，达到完全缓解（CR）！这款数据出色的国研创新药2025年7月在美国震感上市，用于既往经含铂化疗治疗时或治疗后出现疾病进展，存在表皮生长因子受体（ EGFR ）20号外显子插入突变（ exon20ins ）的局部晚期或转移性非小细胞肺癌（NSCLC）的成人患者，造福全球患者！ 对于肺癌患者来说，EGFR是最常见的靶点之一，其中约90%的患者存在“黄金”突变EGFR外显子19缺失（Ex19del）和外显子21（L858R）突变；还有一种罕见的 “钻石” 亚型--EGFR外显子20插入突变（EGFR ex20in）占了 4%~10% ，对既往的EGFR靶向药，化疗，免疫治疗等都没有理想的效果，预后很差。 近两年，针对这一曾经无药可治罕见靶点的新药突破不断，终于在2023年8月，中国研发的 1类创新药舒沃替尼片（Sunvozertinib，DZD9008）上市，用于经治的EGFR外显子20插入突变的非小细胞肺癌成年患者，打破了治疗困境， 成为 首款国研EGFR外显子20插入突变的靶向疗法 ，具有里程碑式的意义！ 超50%患者肿瘤显著缩小或消失！FDA批准国研肺癌新药舒沃替尼上市！ 近期，美国FDA也传来喜讯，批准sunvozertinib 上市，用于治疗化疗后出现 EGFR 外显子 20 插入突变的晚期/转移性 NSCLC。 此次获得优先审批是基于一项2 期关键研究 (WU-KONG1B，NCT03974022)卓越结果的支持。 根据2024年 ESMO 大会上公布的更新数据，截至 2024年 3 月 22 日，共有107 名 EGFR 20ins 且接受铂类化疗后进展的非小细胞肺癌患者被纳入疗效分析。其中，25.2% 患有基线脑转移，13.1% 接受过阿米万他单抗治疗，48.6% 接受过肿瘤免疫治疗，13.1% 接受过 EGFR TKI 治疗。 结果显示： 根据 IRC 评估，最佳客观缓解率（ORR）为 53.3%（44.9% 已确认，另有 3.7% 待确认）。其中包括完全反应 (CR；2.8%)、部分反应 (PR；50.5%)、病情稳定 (36.4%) 。中位随访时间为 7 个月，未达到 DoR，66.7% 的应答者仍有应答。 WU-KONG1B 的初步结果显示，无论在哪个亚组，sunvozertinib 对 EGFR 外显子 20ins 的晚期 NSCLC 均具有良好的抗肿瘤疗效。 EGFR20ins新药遍地开花，晚期患者迎来春天！ 除了上面介绍的强效药物，目前国内外在研的EGFR20ins靶向药物也遍地开花，取得了鼓舞人心的数据，已经有大量患者通过全球肿瘤医生网成功入组，逆转病情。 注：做了基因检测的病友可以拿出报告看看，一旦存在EGFR 20ins，可以马上联系全球肿瘤医生网医学部看看是否有机会接受国内新药治疗，看不懂的病友也可以致电全球肿瘤医生网医学部解读报告。 一、疾病控制率高达95%！国研创新药JMT101提供全新治疗策略 药物名称： JMT101 药物靶点： EGFR 研发公司： 石药集团 药物介绍： JMT101为人源化抗EGFR单克隆抗体，具有自主知识产权，该产品相较于国内外已上市同类产品西妥昔单抗、帕尼单抗等具有亲和力更高、免疫原性低、药效更优的特点。该产品已于2016年5月获得CFDA临床批件，现已进入I期临床研究，拟用于治疗非小细胞肺癌，结直肠癌等实体瘤。 2020 年 6 月 29 日至 2021 年 12 月 28 日期间，150 名 EGFR 20ins 阳性晚期 NSCLC 患者从中国 15 个研究中心入组了 1b 期试验，在121例可评估疗效的患者中，研究者评估的确认客观缓解率（ORR）为 36.4% ，疾病控制率（DCR）为 95.0% ！中位无进展生存期（mPFS）为8.2个月，肿瘤缩小率为 91.7% 。 在 53 名接受大量治疗的 NSCLC 患者亚组中，这些患者在铂类化疗后出现进展，并在二线治疗中接受 JMT101 治疗，确认的 ORR 为 34.0%，中位缓解持续时间 (mDOR) 为 13.3 个月，中位 PFS 为 9.2 个月。在这项研究中，62 名患者有脑转移，其中 80.6% 的患者之前未接受过治疗。在 16 名脑转移患者中，13 名 (81.3%) 的脑肿瘤缩小。颅内 DCR 为 87.5%，研究者评估的颅内 ORR 为 25.0%。 这项研究表明，JMT101 与阿法替尼或奥希替尼联合的双靶向方法具有良好的安全性和抗肿瘤活性。它在未经治疗的脑转移患者中也显示出希望，可能在未来提供一种新的治疗策略。 好消息是： JMT101治疗 EGFR 20 ins非小细胞肺癌期临床研究已在国内启动，目前正在招募患者，已经有大量患者通过全球肿瘤医生网医学部成功入组。 二、 100%患者肿瘤缩小或稳定！国研创新药PLB1004初战告捷 药物名称： PLB1004（安达替尼） 药物靶点： EGFR 研发公司： 鞍石生物 药物介绍： 中国原研、具有全球知识产权的新型单苯胺基嘧啶小分子EGFR抑制剂，可有效且不可逆地靶向外显子20插入突变，同时还有效针对经典 EGFR 突变 ExDel19、L858R 和 T790M，与野生型 EGFR 相比具有高度选择性。这款药物是在保持第三代EGFR TKI药效优势的前提下，针对EGFR Ex20插入设计的全新一代EGFR TKI。 PLB-1004 在非小细胞肺癌患者外显子 20 插入突变的首次人体剂量递增和扩展研究的中期结果公布，在所有剂量组中，可评估的26名患者确认的客观缓解率为 57.7%（15/26） ，疾病控制率（DCR） 高达100% （26/26）。这意味着超过一半的的晚期患者接受治疗后肿瘤显著缩小30%以上，并且所有的患者肿瘤都达到不同程度的缩小或控制稳定。令人振奋的是，15例达到部分缓解（肿瘤至少缩小30%）受试者中，3例受试者缓解持续时间已超过240天，仍在持续获益。 三、疾病控制率92.3%！YK-029A为初治EGFR20ins患者带来全新选择 药物名称： YK-029A 药物靶点： EGFR 研发公司： 海南越康生物 药物介绍： YK-029A 是由国家级科研团队研发的第三代 EGFR 酪氨酸激酶抑制剂（TKI）。2022年9月，纳入突破性治疗药物，用于未经系统治疗的 EGFR 20外显子插入突变（EGFR ex20ins）晚期非小细胞肺癌 (NSCLC) 患者。 2024年初，YK-029A一线治疗EGFR Exon20ins肺癌患者的临床1期研究（CTR20180350）数据更新。 结果显示： 在 26 例可评估患者中，客观缓解率（ORR）高达 73.1%，疾病控制率（DCR）高达 92.3%。 四、BEBT-109 药物名称： BEBT-109 药物靶点： EGFR 研发公司： 必贝特 药物介绍： BEBT109 是一种有效、广谱、选择性 EGFR 酪氨酸激酶抑制剂 (TKI) ( 95 )。临床前试验结果表明，BEBT109在体内吸收和清除迅速，显著降低了药物蓄积和相关毒性的可能性。与奥希替尼相比，BEBT109 对 EGFR ex20ins 突变的抑制效力显著提高，约强 4.1 倍。目前，正在计划进行一项 II 期研究，该研究涉及使用 BEBT109 治疗患有 EGFR ex20ins 和其他罕见 EGFR 突变的非小细胞肺癌 (NSCLC) 患者。 我们期待未来，肺癌将有更多的新靶点，新药物，新选择，让肺癌真正成为慢性病，让更多的患者活过一个又一个五年。

Advancements in targeted therapies have transformed the treatment landscape for NSCLC, enabling precision medicine approaches that improve outcomes. These therapies focus on specific genetic mutations or molecular drivers, such as EGFR, ALK, ROS1, BRAF, and MET, which are commonly implicated in NSCLC. Drugs targeting these mutations, such as tyrosine kinase inhibitors (TKIs), offer significant benefits, including higher response rates, improved progression-free survival, and fewer off-target effects compared to traditional chemotherapy. Additionally, continuous innovation has led to the development of next-generation inhibitors that overcome resistance to earlier therapies, further enhancing their efficacy. LAS VEGAS, Jan. 14, 2025 /PRNewswire/ -- DelveInsight's ' Non-Small Cell Lung Cancer Pipeline Insight 2025 ' report provides comprehensive global coverage of pipeline NSCLC therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the NSCLC pipeline domain. Key Takeaways from the Non-Small Cell Lung Cancer Pipeline Report DelveInsight's NSCLC pipeline report depicts a robust space with 100+ active players working to develop 120+ pipeline therapies for NSCLC treatment. Key NSCLC companies such as Merck Sharp & Dohme LLC, AbbVie, Qilu Pharmaceutical Co., Ltd., Suzhou Puhe Pharmaceutical Technology Co., LTD, Exelixis, Genmab, OncoResponse, Inc., Next Point Therapeutics, Inc., Light Chain Bioscience - Novimmune SA, Immunitas Therapeutics, Hansoh BioMedical R&D Company, Mythic Therapeutics, Shanghai Henlius Biotech, and others are evaluating new NSCLC drugs to improve the treatment landscape. Promising NSCLC pipeline therapies such as V940, Telisotuzumab Vedotin, QL1706, YK-029A, XL092, PRO1184, OR2805, NPX267, NI-1801, IMT-009, HS-20117, MYTX-011, HLX301, and others are under different phases of NSCLC clinical trials. In December 2024, the FDA granted breakthrough therapy designation to sacituzumab tirumotecan (MK-2870/SKB264/) for the treatment of patients with advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC). In September 2024, AbbVie announced that it had submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for accelerated approval of elotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression. In August 2024, the FDA granted Fast track designation to Deltacel (KB-GDT-01) with low-dose radiation therapy to potentially treat patients with metastatic non–small cell lung cancer (NSCLC) whose disease progressed on 2 or more prior lines of standard-of-care therapy, including immune checkpoint inhibitors, platinum-based chemotherapy, and targeted therapy. In July 2024, Nuvalent announced the first patient dosed in HEROEX-1 Phase Ia/Ib clinical trial of NVL-330, its novel HER2-selective Inhibitor. In April 2024, ABVC BioPharma announced that the Company and its affiliate Rgene Corporation entered into a comprehensive licensing agreement with OncoX for the drug ABV-1501. Under the terms of the agreement, ABVC grants OncoX exclusive rights for one of ABVC's four products in its Oncology pipeline to develop, manufacture, and commercialize BLEX 404. In April 2024, Hansoh Pharma announced that the Class 1 new drug " HS-10504 tablet" independently developed by its subsidiary Jiangsu Hansoh Pharmaceutical Group Co., Ltd. and Shanghai Hansoh Biomedical Technology Co., Ltd. had obtained the clinical trial notification letter issued by the National Medical Products Administration of the People's Republic of China. It is intended for the treatment of advanced non-small cell lung cancer, with specific indications to be determined after clinical trials. In February 2024, the FDA granted breakthrough therapy designation to NVL-520 as a treatment for patients with ROS1-positive metastatic non–small cell lung cancer (NSCLC) who received prior treatment with at least 2 ROS1 tyrosine kinase inhibitors (TKIs). Request a sample and discover the recent advances in NSCLC treatment drugs @ Non-Small Cell Lung Cancer Pipeline Report The NSCLC pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage NSCLC drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the NSCLC clinical trial landscape. Non-Small Cell Lung Cancer Overview Non-small cell lung cancer (NSCLC) is the most prevalent form of lung cancer, originating in the tissues of the lungs. Unlike small cell lung cancer, which grows rapidly, NSCLC typically develops more slowly but often spreads to other parts of the body by the time it is diagnosed, emphasizing the need for early detection and treatment. Small-cell lung cancer derives its name from the small, round appearance of its cells under a microscope, while the cells in NSCLC are larger. Despite its slower growth, NSCLC is frequently diagnosed at an advanced stage, further underscoring the importance of early intervention. In the United States, approximately 230,000 people are diagnosed with lung cancer annually, and it accounts for an estimated 135,000 deaths each year. Lung cancer causes more deaths than prostate, breast, brain, and colorectal cancers combined. It is the leading cause of cancer deaths in men and the second most common in women. However, these figures are declining, largely due to anti-smoking initiatives and reduced tobacco use. The classification of lung tumors is based on the 2015 World Health Organization (WHO) guidelines, which utilize immunohistochemistry and light microscopy to guide treatment decisions and predict outcomes. NSCLC encompasses several subtypes, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. Adenocarcinoma, the most common subtype, accounts for nearly half of all lung cancer cases. Squamous cell carcinoma, once the most prevalent, typically originates in the tracheobronchial tree but is now more frequently found in peripheral lung areas. Large cell carcinoma is a diagnosis of exclusion, characterized by poor differentiation and lack of specific classification through immunohistochemistry or electron microscopy. The causes of NSCLC can be divided into avoidable and unavoidable risk factors. Tobacco use remains the most significant preventable risk factor, while other causes include alcohol consumption, exposure to secondhand smoke, asbestos, radon, arsenic, chromium, nickel, ionizing radiation, and polycyclic aromatic hydrocarbons. Diagnosis involves a comprehensive blood count (CBC), a complete metabolic panel (CMP), and imaging studies. Hypercalcemia or elevated alkaline phosphatase may indicate metastasis to bones. Initial imaging with a chest X-ray can help identify nonspecific signs, followed by computed tomography (CT) for detailed characterization. A tissue biopsy is essential for confirming the diagnosis through histopathologic and immunohistochemistry evaluation. Treatment options for NSCLC include standard therapies like surgery, radiation, chemotherapy, targeted therapy, and immunotherapy, as well as newer approaches like laser therapy, photodynamic therapy (PDT), and cryosurgery. The choice of treatment depends on the cancer's stage, the patient's functional status, comorbidities, and the molecular characteristics of the tumor. Surgery is often required for localized cases, while advanced stages may call for a combination of therapies. Participation in clinical trials can also offer access to emerging treatments. Managing NSCLC requires a collaborative, interprofessional approach, beginning with prevention. Primary care providers play a critical role in smoking cessation counseling and early detection through lung cancer screening, which can improve prognosis by identifying the disease before it progresses to advanced stages. Find out more about NSCLC treatment drugs @ Drugs for Non-Small Cell Lung Cancer Treatment A snapshot of the Non-Small Cell Lung Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging NSCLC pipeline therapies @ Non-Small Cell Lung Cancer Clinical Trials Non-Small Cell Lung Cancer Therapeutics Assessment The NSCLC pipeline report proffers an integral view of the NSCLC emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Non-Small Cell Lung Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Immunostimulants, Antibody-dependent cell cytotoxicity, Cytotoxic T-lymphocyte antigen 4 inhibitors, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Apoptosis stimulants, Mitosis inhibitors, Tubulin inhibitors, Tubulin polymerization inhibitors, Epidermal growth factor receptor antagonists, Proto-oncogene protein c-met inhibitors Key Non-Small Cell Lung Cancer Companies: Merck Sharp & Dohme LLC, AbbVie, Qilu Pharmaceutical Co., Ltd., Suzhou Puhe Pharmaceutical Technology Co., LTD, Exelixis, Genmab, OncoResponse, Inc., Next Point Therapeutics, Inc., Light Chain Bioscience - Novimmune SA, Immunitas Therapeutics, Hansoh BioMedical R&D Company, Mythic Therapeutics, Shanghai Henlius Biotech, and others Key Non-Small Cell Lung Cancer Pipeline Therapies: V940, Telisotuzumab Vedotin, QL1706, YK-029A, XL092, PRO1184, OR2805, NPX267, NI-1801, IMT-009, HS-20117, MYTX-011, HLX301, and others Dive deep into rich insights for new drugs for NSCLC treatment, visit @ Non-Small Cell Lung Cancer Drugs Table of Contents For further information on the NSCLC pipeline therapeutics, reach out @ Non-Small Cell Lung Cancer Treatment Drugs 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, market share of the individual therapies, and key NSCLC companies including EMD Serono, Merck, Cellular Biomedicine Group, Inc., Celgene, CellSight Technologies, Inc., BeyondSpring Pharmaceuticals Inc., J Ints Bio, Forward Pharmaceuticals Co., Ltd., AstraZeneca, Bristol-Myers Squibb, Teligene US, Rain Oncology Inc, ReHeva Biosciences, Inc., Amgen, Novartis, RedCloud Bio, Parexel, Vitrac Therapeutics, LLC, Mythic Therapeutics, Instil Bio, Mirati Therapeutics Inc., Daiichi Sankyo, Inc., AstraZeneca, Precision Biologics, Inc, Promontory Therapeutics Inc., Palobiofarma SL, Regeneron Pharmaceuticals, Revolution Medicines, Inc., Cullinan Oncology, LLC, Iovance Biotherapeutics, Inc., Innate Pharma, among others. HER2-mutant Non-Small Cell Lung Cancer Pipeline HER2-mutant 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 HER2-mutant non-small cell lung cancer companies, including Dizal Pharmaceuticals, Puma Biotechnology, AstraZeneca, Jiangsu Hengrui Medicine, among others. Small Cell Lung Cancer Market Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2032 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 advanced small cell lung cancer companies, including Ascentage Pharma, Merck & Co, AstraZeneca, Advenchen Laboratories, Advanced Accelerator Applications, Trillium Therapeutics, Wigen Biomedicine, Linton Pharm, Carrick Therapeutics, among others. Small-cell Lung Cancer Pipeline 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 small-cell lung cancer companies, including Ascentage Pharma, Merck & Co, AstraZeneca, Advenchen Laboratories, GlaxoSmithKline, Advanced Accelerator Applications, Trillium Therapeutics, Vernalis, Oncoceutics, NewBio Therapeutics, Wigen Biomedicine, Linton Pharm, Carrick Therapeutics, Xencor, Jiangsu HengRui Medicine, Aileron Therapeutics, Roche, Ipsen, Celgene, Lee's Pharmaceutical Limited, AbbVie, G1 Therapeutics, Chipscreen Biosciences, Luye Pharma Group, Shanghai Henlius Biotech, CSPC ZhongQi Pharmaceutical Technology, Impact Therapeutics, 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED