Efficacy and Safety of Neratinib as Extended Adjuvant Therapy in HER2-Positive Early Breast Cancer Patients Who Achieved pCR After Neoadjuvant Therapy But Have High-Risk Factors: A Multi-Center, Real-World Study From Hebei, China

Neratinib is an oral, irreversible pan-HER tyrosine kinase inhibitor. Current treatment guidelines recommend neratinib as an extended adjuvant therapy for HER2-positive breast cancer patients to further reduce the risk of recurrence.
Even when HER2-positive breast cancer patients achieve pathological complete response (pCR) after neoadjuvant therapy, those with high-risk factors (such as large tumors [cT3/T4] or lymph node-positive disease) still face a risk of cancer returning. However, there is limited data on the effectiveness and safety of neratinib in these patients.
This study aims to provide real-world evidence on how well neratinib works in high-risk HER2-positive breast cancer patients who achieved pCR, helping to improve treatment strategies for Chinese patients.

开始日期2025-06-30

申办/合作机构

河北医科大学第四医院

NCT06813079

/ Not yet recruiting临床2期IIT

ADOPT: Adaptive Organoid-Based Precision Therapy Study in Pancreatic Cancer - A Prospective Single-Arm Phase II Trial

The purpose of this study is to see if using Patient Derived Organoids (PDO) to choose a drug for the treatment of pancreatic cancer individually for each patient is useful. The study will look at the number of participants who have a response to their assigned drug.

开始日期2025-02-17

申办/合作机构

University Health Network

NCT05919108

/ Recruiting临床2期IIT

Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers

This phase II trial tests how well neratinib prior to the primary treatment (neoadjuvant) works in treating patients with stage I-III HER2 mutated lobular breast cancers. Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving neratinib in addition to normal therapy may work better in treating cancer than the endocrine therapy patients would normally receive.

开始日期2025-01-31

申办/合作机构

The Vanderbilt-Ingram Cancer Center

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100 项与马来酸奈拉替尼相关的临床结果

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100 项与马来酸奈拉替尼相关的转化医学

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100 项与马来酸奈拉替尼相关的专利（医药）

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1,059

项与马来酸奈拉替尼相关的文献（医药）

2025-07-01·PHARMACOLOGICAL RESEARCH

Orally effective FDA-approved protein kinase targeted covalent inhibitors (TCIs): A 2025 update

Review

作者: Roskoski, Robert

Because aberrations of protein kinase activity play causal roles in several human diseases, this family of enzymes is one of the most important drug targets of the 21st century. Of the 88 protein kinase antagonists that are approved by the FDA, eleven of them form irreversible covalent complexes with their target enzymes. The clinical efficacy of ibrutinib, a Bruton tyrosine kinase blocker, in the treatment of mantle cell lymphoma following its 2013 approval helped to overcome a general bias against the development of irreversible drug inhibitors. Other approved targeted covalent inhibitors include acalabrutinib and zanubrutinib, which also block Bruton tyrosine kinase. Afatinib, dacomitinib, lazertinib, mobocertinib, and osimertinib inhibit members of the epidermal growth factor receptor family (ErbB1/2/3/4) and are used in the treatment of non-small cell lung cancers. Neratinib inhibits ErbB2 and is used in the management of ErbB2/HER2-positive breast cancer. Futibatinib blocks the fibroblast growth factor receptor family and is prescribed for the treatment of cholangiocarcinoma while ritlecitinib, which inhibits JAK3, is used in the management of alopecia areata. The eleven drugs considered in this review have a common mechanism of action involving the addition of a protein cysteine thiolate anion (proteinS:) to an acrylamide or an acrylamide-like derivative producing a thioether. The development of targeted covalent inhibitors is gaining acceptance as a valuable component of the medicinal chemist's toolbox and has made a significant impact on the development of protein kinase antagonists and receptor modulators.

2025-06-01·BIOMEDICINE & PHARMACOTHERAPY

Neratinib and metformin: A novel therapeutic approach against HER2-Positive Breast Cancer

Article

作者: Hassan, Arij Fouzat ; Al-Thawadi, Hamda ; Saeed, Sumayyah ; Merhi, Maysaloun ; Moustafa, Ala-Eddin Al ; Ulamec, Monika ; Peric-Balja, Melita ; Mateo, Jericha Miles ; Kheraldine, Hadeel ; Vranic, Semir

BACKGROUND:

HER2-positive breast cancer (BC) is highly aggressive with a poor prognosis. It is driven by HER2 oncoprotein activation/crosstalk with other receptors like EGFR/(HER1), HER3, and HER4, in addition to IGF-1R, making these receptors ideal therapeutic targets as they are expressed/overexpressed in this subtype. We postulated that targeting HER2 and IGF-1R together is a promising therapy for HER2-positive BC. Thus, we explored the outcome of a novel combination treatment using neratinib, a pan-HER inhibitor, and metformin, an IGF-1R inhibitor, on HER2-positive BC cells.

METHODS:

In this investigation, we used cellular and molecular biology techniques in addition to an angiogenesis model and tissue microarray analysis.

RESULTS:

Our data revealed that this combination therapy significantly reduced cell viability compared to individual treatments and exhibited a synergistic effect in HER2-positive BC cells. Moreover, the combination disrupted cell cycle progression and inhibited colony formation, and invasion of HER2-positive BC cells; this is accompanied by the deregulation of HER1-3 and IGF-1R expression patterns, in addition to Caspase-3, BCL2, Fascin, and Vimentin. Moreover, key regulator molecular pathways, including, ERK1/2, AKT, p38 MAPK, and mTOR, were significantly downregulated upon treatment with neratinib and metformin combination. Additionally, our data pointed out that neratinib and metformin combination inhibited angiogenesis, in-ovo, an important biological event in cancer progression. Finally, using a cohort of 55 HER2-positive BC samples, we revealed that HER2 and IGF-1R are co-expressed in most of the cases.

CONCLUSIONS:

These findings suggest that neratinib and metformin combination can present a promising strategy for targeting multiple pathways in HER2-positive BC.

2025-05-01·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Targeted delivery of neratinib/xanthan gum-capped calcium carbonate nanoparticles induces apoptosis through PI3K/AKT pathway in breast cancer mice model

Article

作者: Wu, Yilin ; Liu, Yanxi ; Zhang, Yawen ; Wang, Xuekui ; Wang, Wan

Breast cancer (BC) continues to be the most common malignancy among women, presenting therapeutic challenges including drug resistance. This study examines the effectiveness of neratinib-loaded xanthan gum-capped calcium carbonate nanoparticles (NB/XG@CaCO₃NPs) for targeted breast cancer treatment. The nanoparticles were synthesized using the co-precipitation method, characterized, and assessed against MCF7 and MDA-MB231 breast cancer cell lines. In vitro, NB/XG@CaCO₃NPs demonstrated considerable cytotoxicity at approximately 50 μg/mL, whereas non-cancerous HMEC cells retained high viability. Flow cytometry demonstrated an 85.2 % apoptosis rate, signifying effective cancer cell mortality. Mechanistic investigations validated that the downregulation of the PI3K/AKT pathway facilitated the anti-tumor effects. In vivo, NB/XG@CaCO₃NPs administered intravenously to cadmium chloride-induced breast cancer mice significantly diminished tumor volume and enhanced histomorphology without causing major organ toxicity. qRT-PCR and western blot analysis further confirmed tumor suppression at the molecular level. These results indicate that NB/XG@CaCO₃NPs present a viable targeted treatment for BC, efficiently suppressing tumor proliferation while maintaining biocompatibility.

396

项与马来酸奈拉替尼相关的新闻（医药）

2025-06-25

·复宏汉霖

从全球首个到本土可及，H药汉斯状®日本小细胞肺癌桥接试验完成首例患者入组

2025年6月25日，复宏汉霖（2696.HK）宣布，公司自主研发的H药汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）在日本开展的桥接临床试验（NCT06812260）完成首例患者入组。 H药汉斯状®是全球首个获批用于一线治疗小细胞肺癌（SCLC）的抗PD-1单抗，已在中国、英国、德国、新加坡、印度等近40个国家和地区获批上市，惠及逾11万患者。NCT06812260研究由关西医科大学附属医院Takayasu Kurata教授担任牵头主要研究者，此次桥接试验旨在评估该产品联合化疗一线治疗广泛期小细胞肺癌（ES-SCLC）在日本患者中的疗效及安全性，为后续H药在日本市场的注册申报奠定基础。肺癌是全球发病率和死亡率最高的癌症，据GLOBOCAN最新数据显示，肺癌是日本发病率第二大高发癌种，2022年日本肺癌新发病例13.6万余例，肺癌死亡病例逾8.3万例，位居该国癌症死亡人数第一[1]。SCLC占肺癌总数的15%-20%，具有恶性程度高、转移早、疾病进展迅速等特点，预后极差。SCLC分为局限期和广泛期，在被确诊为SCLC的日本患者中，约40-50%为ES-SCLC，而其中在确诊后存活5年的患者不足4%[2,3]。此前，复宏汉霖已针对H药汉斯状®用于一线治疗ES-SCLC开展一项随机、双盲、安慰剂对照的国际多中心III期临床研究（ASTRUM-005）。该研究结果于2022年美国临床肿瘤学会（ASCO）年会以口头报告方式首次发布，并于全球四大顶级医学期刊之一的《美国医学会杂志》（JAMA）在线发表，成为全球首个登上JAMA主刊的小细胞肺癌免疫治疗临床研究。2025年美国临床肿瘤学会（ASCO）年会上，ASTRUM-005研究公布研究结束分析结果，截至2024年12月31日（中位随访时间42.4个月），斯鲁利单抗组的4年总生存期（OS）率达21.9%，对照组为7.2%，且安全性可控，进一步夯实了H药能为ES-SCLC患者带来显著的长期生存获益。基于ASTRUM-005研究的优异结果，H药用于治疗ES-SCLC陆续在中国、东南亚多国、欧洲、英国和印度获批用于一线治疗ES-SCLC。复宏汉霖在全球范围内积极推进H药在获批上市进程，目前，公司正在美国开展一项H药对比一线标准治疗阿替利珠单抗用于ES-SCLC的头对头桥接试验，以进一步支持H药在美国的上市申报。复宏汉霖将持续以科学证据为核心，通过本土化开发，推动精准治疗策略的落地，为日本乃至全球患者提供更贴合临床需求的治疗选择。参考文献[1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834[2] Sawabata N, Asamura H, Goya T, et al; Japanese Joint Committee for Lung Cancer Registry. Japanese Lung Cancer Registry Study: first prospective enrollment of a large number of surgical and nonsurgical cases in 2002. J Thorac Oncol. 2010 Sep;5(9):1369-75.[3] Oze I, Ito H, Nishino Y, et al. Trends in Small-Cell Lung Cancer Survival in 1993-2006 Based on Population-Based Cancer Registry Data in Japan. J Epidemiol. 2019 Sep 5;29(9):347-353.关于日本桥接研究（NCT06812260）本研究为一项在日本初治广泛期小细胞肺癌（ES-SCLC）患者中进行的单臂、开放、II期的桥接研究。合格的患者将每三周接受一次HLX10（重组人源化抗PD-1单克隆抗体注射液）联合化疗（卡铂-依托泊苷）治疗。主要研究目的为评价HLX10联合化疗在日本初治ES-SCLC患者中的疗效，次要目的为评估HLX10联合化疗的安全性、药代动力学（PK）和免疫原性。主要研究终点为第24周缓解（完全缓解[CR]或部分缓解[PR]）率。次要研究终点包括总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）、缓解持续时间（DOR）、生活质量、安全性、PK和免疫原性指标。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，4款产品在国际获批上市，5个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。Henlius Doses First Patient in Japanese Bridging Study of Serplulimab for Extensive-Stage Small Cell Lung Cancer Shanghai, China, June 25, 2025 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in its Japanese bridging study (NCT06812260) of its self-developed innovative anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly®). Serplulimab is the world’s first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer. It has been approved in nearly 40 countries and regions, including China, the UK, Germany, Singapore, and India, benefiting over 110,000 patients to date. The Japanese bridging studyis, led by Professor Takayasu Kurata of Kansai Medical University Hospital, aims to evaluate the efficacy and safety of serplulimab in combination with chemotherapy for the first-line treatment of extensive-stage SCLC (ES-SCLC) in Japanese patients. This milestone lays a foundation for future regulatory submissions in Japan. Lung cancer is the leading cause of cancer-related deaths worldwide. According to the latest GLOBOCAN data, it is the second most commonly diagnosed cancer in Japan, with over 136,000 new cases and more than 83,000 deaths reported in 2022, making it the country’s top cause of cancer-related mortality[1]. SCLC accounts for 15%–20% of all lung cancers and is characterized by high malignancy, early metastasis, and rapid disease progression, with a dismal prognosis. ES-SCLC accounts for 40%–50% of SCLC cases in Japan, and fewer than 4% of these patients survive five years post-diagnosis[2,3]. Henlius previously conducted ASTRUM-005, a randomized, double-blind, placebo-controlled, global phase 3 study evaluating serplulimab in combination with chemotherapy as a first-line treatment for ES-SCLC. The results were first presented as an oral presentation at the 2022 ASCO Annual Meeting and subsequently published in JAMA, one of the world's top four medical journals—marking the first SCLC immunotherapy study to be published in the journal's main issue. At the 2025 ASCO Annual Meeting, final analysis results of the study were presented: as of December 31, 2024 (median follow-up: 42.4 months), the 4-year overall survival (OS) rate was 21.9% in the serplulimab group versus 7.2% in the control group, with a manageable safety profile, further underscoring the long-term survival benefit of serplulimab for ES-SCLC patients. Driven by the strong clinical data from ASTRUM-005, serplulimab has been approved for first-line treatment of ES-SCLC in China, Europe, UK, India and multiple Southeast Asian countries. In parallel, Henlius is conducting a head-to-head bridging study in the U.S. comparing serplulimab to the current standard-of-care, atezolizumab, to support its potential U.S. regulatory submission. Henlius remains committed to science-based development and will continue advancing localized strategies to enable precision treatment, aiming to deliver clinically relevant therapeutic options for patients in Japan and around the world. About NCT06812260 This is a single-arm, open-label, phase 2 bridging trial conducted in Japanese patients with previously untreated extensive-stage small-cell lung cancer (ES-SCLC). Eligible patients will be administrated once every three weeks with HANSIZHUANG in combination with chemotherapy (carboplatin-etoposide). The primary objective of the study is to evaluate the efficacy of HANSIZHUANG in combination with chemotherapy in Japanese patients with previously untreated ES-SCLC. The secondary objectives are to evaluate the safety, pharmacokinetics, and immunogenicity of HANSIZHUANG in combination with chemotherapy. The primary endpoint is the response (complete response (CR) or partial response (PR)) rate at week 24. Secondary endpoints include overall survival (OS), progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), quality of life, safety, pharmacokinetics, and immunogenicity parameters.About HenliusHenlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.联系方式媒体：PR@Henlius.com投资者：IR@Henlius.com喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

ASCO会议临床结果临床3期上市批准免疫疗法

2025-06-24

·复宏汉霖

复宏汉霖H药在英国和印度获批，用于广泛期小细胞肺癌一线治疗

- H药汉斯状®是全球首个获批一线治疗ES-SCLC的抗PD-1单抗，迄今惠及逾110,000位患者- H药汉斯状®目前已在近40个国家和地区获批上市，包括中国、欧洲、印度和东南亚多个国家- 欧洲和印度的商业化由Intas及其子公司Accord Healthcare负责复宏汉霖（2696.HK）宣布，公司自主研发的抗PD-1单抗 H药汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）已于近期相继获英国药品和保健品监管局（MHRA）和印度中央药品标准控制组织（CDSCO）批准，用于广泛期小细胞肺癌（ES-SCLC）的一线治疗，由合作伙伴Intas及子公司Accord Healthcare负责该产品在当地的推广，商品名为Hetronifly®。此次获批主要基于ASTRUM-005研究，该研究在全球开设了128个试验中心，入组585例受试者，在2025年美国临床肿瘤学会（ASCO）年会上，ASTRUM-005研究公布了研究结束分析结果，数据显示中位随访达42.4个月，斯鲁利单抗联合化疗组的4年总生存率（OS）为21.9%（95% CI：17.6–26.6%），证实了该免疫治疗方案对ES-SCLC患者的长期生存获益。肺癌是全球癌症相关死亡的首要原因之一[1]。小细胞肺癌（SCLC）约占肺癌总数的15%，是肺癌中侵袭性最强的亚型，治疗选择有限。H药汉斯状®为全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗。英国医药和健康产品管理局（MHRA）医疗质量与准入执行署署长Julian Beach表示：“斯鲁利单抗是英国首个且唯一获批用于小细胞肺癌治疗的抗PD-1单抗，为这一恶性肺癌类型的患者提供了新的治疗选择。这类患者当前治疗手段有限，预后较差，该药物的获批具有重要意义。”[2]在印度，肺癌在癌症发病率和死亡率中均位列第4位，2022年新发病例超过81,000例，死亡人数逾75,000人[1]。根据联合国人口基金发布的《2025年世界人口状况报告》，印度人口预计将达到14.6亿，仍为全球人口第一大国[3]。庞大的人口基数与日益增长的医疗需求也进一步突显了提升创新药可及性的紧迫性。此次H药双国获批，同步进入主流成熟市场英国与新兴市场印度，借助Intas及Accord Healthcare在当地成熟的市场准入能力和销售网络，有望加快H药在当地的覆盖进程，缓解该领域的迫切临床需求，为更多患者带来实质性的治疗获益，进一步拓展这款创新免疫治疗方案的全球可及性。Accord欧洲中东和北非地区执行副总裁Paul Tredwell表示在 Accord，我们始终致力于支持癌症患者。MHRA批准Hetronifly®上市，为对抗广泛期小细胞肺癌这一最具侵袭性的肺癌类型之一提供了新的治疗选择。这一里程碑反映了我们持续推动为难治疾病提供创新特药的承诺。复宏汉霖首席商务发展官兼高级副总裁曹平表示Hetronifly®在英国和印度的获批，不仅代表公司全球化战略的持续推进，更是我们‘以患者为中心’承诺的切实践行。我们正持续拓展H药在全球市场的覆盖，致力于让高质量的创新药惠及更多患者作为复宏汉霖全球化战略的重要支点，H药正持续加速其全球布局。截至目前，H药已在中国、印度尼西亚、新加坡、德国等近40个国家和地区获批上市，累计惠及患者超过11万人。其在小细胞肺癌治疗方面的潜力已获得国际广泛认可，包括获得美国FDA、欧盟委员会和瑞士Swissmedic授予的小细胞肺癌（SCLC）孤儿药资格，英国创新许可与准入通道合作组织授予的创新通行证资格认定，以及韩国MFDS授予的广泛期小细胞肺癌（ES-SCLC）孤儿药资格。目前，公司正在美国和日本开展头对头桥接研究，对比H药与当前广泛期小细胞肺癌一线标准治疗方案阿替利珠单抗，以进一步支持其全球注册申报。未来，公司将持续践行“以患者为中心”的使命，携手全球合作伙伴，共同推进创新药物的可及性，让更多患者共享生命质量的提升。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，4款产品在国际获批上市，5个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。Serplulimab Approved in the UK and India for the First-Line Treatment of Extensive-Stage Small Cell Lung Cancer- Serplulimab is the world’s first anti-PD-1 mAb approved for the first-line treatment of ES-SCLC and has reached over 110,000 patients- It has been approved in nearly 40 countries including China, Europe, India and multiple Southeast Asian countries- Commercialisation in Europe and India is led by Intas and its subsidiary Accord Healthcare Henlius (2696.HK) announced that its self-developed anti-PD-1 monoclonal antibody (mAb) serplulimab (trade name in Europe: Hetronifly®) has been approved in both the United Kingdom and India for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Commercialisation in the UK and India will be led by Henlius’ partner Intas and its subsidiary Accord Healthcare. The approvals were primarily based on the results of the global phase 3 clinical study ASTRUM-005, which enrolled 585 patients across 128 trial sites worldwide. At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the results from the final analysis of ASTRUM-005 were presented, showing a median follow-up of 42.4 months and a 4-year overall survival (OS) rate of 21.9% (95% CI: 17.6–26.6%) for the serplulimab plus chemotherapy group. These results further confirm the long-term survival benefit of this immunotherapy-based regimen for patients with ES-SCLC. Lung cancer remains the leading cause of cancer-related death globally[1]. Small cell lung cancer (SCLC), one of the most aggressive subtypes, accounts for approximately 15% of all lung cancer cases and is associated with limited treatment options. Hetronifly® is the world’s first anti-PD-1 monoclonal antibody approved for the first-line treatment of SCLC. Julian Beach, Interim Executive Director of Healthcare Quality and Access at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), commented: “As the first and only anti-PD-1 monoclonal antibody approved in the UK for small cell lung cancer, this marks an important new treatment option for patients with this aggressive type of lung cancer who currently have limited choices and face a poor prognosis.” [2] In India, lung cancer ranks fourth in both incidence and mortality among cancers. In 2022, over 81,000 new cases and more than 75,000 deaths were reported[1]. According to the State of World Population 2025 report by the United Nations Population Fund (UNFPA), India’s population is projected to reach 1.46 billion, reaffirming its position as the most populous country in the world[3]. The growing demand for healthcare resources highlights the urgent need to improve access to innovative therapies. The approvals of Hetronifly® in the UK and India—representing a mature, mainstream biologics market and emerging market, respectively—underscore a significant milestone in expanding the therapy’s global reach. Leveraging the local expertise and commercial networks of Intas and Accord Healthcare, Hetronifly® is expected to accelerate market penetration and address unmet medical needs in both regions, bringing tangible clinical benefits to more patients. Regarding the UK approval, Paul Tredwell, Executive Vice-President, EMENA, Accord Healthcare said: “At Accord, we are dedicated to supporting patients with cancer. The MHRA’s approval of Hetronifly® provides a new treatment option in the fight against extensive-stage small cell lung cancer — one of the most aggressive forms of lung cancer. This milestone reflects our ongoing commitment to providing novel specialty medicines for difficult-to-treat conditions.” Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, said: “The approvals of serplulimab in the UK and India not only represent continued progress in our globalisation strategy, but also reflect our concrete commitment to putting patients first. We are steadily expanding the global reach of the product, aiming to bring high-quality innovative therapies to more patients around the world.” As a core product of Henlius’ globalisation strategy, serplulimab has now been approved in nearly 40 countries and regions including China, Indonesia, Singapore, Germany, the UK and India, reaching over 110,000 patients worldwide. Its potential in SCLC has been widely recognised, with orphan drug designations granted by the US FDA, the European Commission, and Swissmedic for SCLC; Innovation Passport Designation from the U.K. Innovative Licensing and Access Pathway Steering Group (ILAP); and orphan drug designation from South Korea’s MFDS for ES-SCLC. Henlius is currently conducting head-to-head bridging trials in the US and Japan comparing serplulimab with atezolizumab—the current standard of care for ES-SCLC—to further support global regulatory filings. Looking ahead, the company will continue to collaborate with global partners to enhance accessibility and bring more life-changing therapies to patients worldwide.About HenliusHenlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.联系方式媒体：PR@Henlius.com投资者：IR@Henlius.com喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

ASCO会议上市批准申请上市临床结果免疫疗法

2025-06-20

·复宏汉霖

复宏汉霖亮相BIO 2025：创新成果引关注

美国时间6月16 - 19日，2025美国生物技术大会暨展览会（2025 BIO International Convention, “BIO 2025”）在美国麻省波士顿会展中心（Boston Convention & Exhibition Center）举行。复宏汉霖连续第七年再次亮相此次大会，在1885展台为参会嘉宾带来精彩展示，吸引了众多参会者及组织机构前来参观交流。展会期间，复宏汉霖高效开展了约130场会面，聚焦创新产品、前沿技术平台及肿瘤免疫疗法等领域的合作机遇与潜在合作伙伴展开深入交流。左右滑动查看更多复宏汉霖高级副总裁兼首席商务发展官曹平女士在BIO主题演讲中强调：公司成立以来始终践行为患者提供高质量且可负担的创新药物的使命，全球累计惠及患者超80万例，实现从研发到商业化的价值闭环。复宏汉霖首席技术官、高级副总裁许圣昌博士聚焦复宏汉霖在AI辅助药物开发领域的突破性进展进行了介绍，印证了公司"创新-可及"双引擎发展路径的国际竞争力。此外，在公司协办的“BlOCHINA Global Forum 2025@Boston”中国生物药国际化论坛上，曹平女士与公司总裁黄玮女士携手全球合作伙伴Accord、Dr.Reddy's、Palleon、Organon、Sermonix，分享与中国生物制药企业合作的核心驱动力和战略考量，全面展示了公司的国际化合作布局，引发业界的高度聚焦与广泛赞誉，进一步增强了公司在全球生物医药市场的影响。左右滑动查看更多复宏汉霖以患者需求为根基，以创新为引擎，以全球化为驱动，依托前沿的生产与质量体系和卓越的商业化运营能力，致力于为全球患者提供可负担的高品质生物药。公司就汉曲优®（美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、H药汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）、汉利康®、HLX11、HLX14、HLX15等多个产品，携手Accord、Abbott、Dr.Reddy’s、Eurofarma、KGbio、Sandoz和Organon等国际一流的生物制药企业拓展全球市场，授权区域全面覆盖欧美主流生物药市场和众多新兴市场。汉曲优®是在中美欧三地皆获批的“中国籍”单抗生物类似药，现已在超过50个国家和地区获批上市，其商业化供货网络已覆盖中国、东南亚、北美、欧洲、中东及拉丁美洲等地区，惠及超过25万名患者。公司另一款抗肿瘤核心产品H药汉斯状®是全球首个获批用于一线治疗小细胞肺癌（SCLC）的抗PD-1单抗，已在中国、欧洲及东南亚等30余个国家和地区获批上市。同时，H药治疗SCLC也已获得美国FDA、欧盟EC、瑞士Swissmedic的孤儿药资格认定，并获韩国MFDS授予ES-SCLC孤儿药资格，有望惠及全球更广泛的肿瘤患者群体。与此同时，公司高效推进创新管线产品的临床进展，创新型抗HER2单抗HLX22的国际多中心III期研究同步于中国、澳大利亚、欧盟、日本、美国、南美洲等国家和地区开展。潜在同类首创/最优产品HLX43（PD-L1 ADC）的国际多中心II期临床研究于中国完成首例受试者给药，是全球首个进入临床II期的靶向PD-L1的ADC产品。未来，复宏汉霖将继续携手全球合作伙伴，通过创新与合作，为全球患者带来更多优质、可负担的治疗选择。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，4款产品在国际获批上市，5个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。Henlius Shines at 2025 BIO International Convention, Showcasing Its Innovative AchievementsFrom June 16-19, 2025, the 2025 BIO International Convention (“BIO 2025”) was held at the Boston Convention & Exhibition Center in Boston, Massachusetts, USA. Marking its seventh consecutive year at the conference, Henlius showcased a wide range of innovative research and development accomplishments, attracting significant attention from numerous attendees and organizations. During the conference, Henlius held around 130 in-depth meetings, driving exchanges on collaboration opportunities for in-licensing, research collaboration, or commercial right out-licensing. Ping Cao, Henlius SVP and Chief Business Development Officer, emphasized in her BIO keynote: Henlius has delivered on its mission to provide high-quality and affordable biologics since inception, benefiting over 800,000 patients globally while achieving end-to-end value integration from R&D to commercialization. Simon Hsu, CTO and SVP of Henlius, highlighted breakthroughs in AI-driven drug development, demonstrating how Henlius' double engines of innovation and accessibility fuel its global competitiveness. Additionally, at the 'BIO CHINA Global Forum 2025@Boston' co-hosted by Henlius, the company's executives engaged in in-depth discussions with global partners Accord, Dr. Reddy's, Palleon, Organon, and Sermonix on strategic drivers for global partnerships with Chinese biopharma, showcasing our international footprint. The dialogue sparked significant industry attention and further amplified the company's global influence in the biologics market. Henlius anchors its strategy in unmet patient needs, powers progress through continuous innovation and advances its global presence with manufacturing and quality systems, as well as commercialization capabilities, delievering the goals of providing innovative and affordable biologics for global patients. The company has expanded its global market presence with several products, including HANQUYOU, HANSIZHUANG, HANLIKANG, HLX11, HLX14, and HLX15, in collaboration with renowned international biopharmaceutical companies such as Accord, Abbott, Dr.Reddy’s, Eurofarma, KGbio, Sandoz and Organon. It has achieved comprehensive coverage in the mainstream biopharmaceutical markets of Europe, the United States, and numerous emerging markets, contributing to the global development of China's biopharmaceutical innovation. Henlius’ self-developed and manufactured trastuzumab biosimilar HANQUYOU (trade name: HERCESSI™ in U.S. and Zercepac® in Europe) is a China-developed mAb biosimilar approved in China, Europe, and U.S. It has been approved in over 50 countries and regions, covering China, Southeast Asia, North America, the EU, Middle East, and Latin America, benefiting over 250,000 patients. Additionally, the company prides itself on its HANSIZHUANG (serplulimab, trade name: Hetronifly ® in Europe), the world's first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC), and it has been approved in more than 30 countries and regions, including China, the EU, and Southeast Asia. To date, Orphan Drug Designation (ODD) granted to HANSIZHUANG for the treatment of SCLC by U.S. FDA, EC, and Swissmedic, and for Extensive-Stage SCLC (ES-SCLC) by Korea MFDS. Meanwhile, the company is efficiently advancing the clinical progress of its innovative product portfolio. The phase 3 international multicentre clinical trails of Henlius' novel anti-HER2 mAb, HLX22, is being conducted simultaneously across China, Australia, the European Union, Japan, the United States, South America, and other countries and regions. Recently, the first subject has been dosed for a phase 2 international muticenter clinical trial of HLX43（PD-L1 ADC）, another company’s potential first/best-in-class products. At present, HLX43 is the first PD-L1 ADC progressed to phase 2 clinical trial development globally. Looking forward, Henlius will continue to collaborate closely with global partners, leveraging innovation and cooperation, to deliver more high-quality, affordable treatment options to patients worldwide.About HenliusHenlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.联系方式媒体：PR@Henlius.com投资者：IR@Henlius.com喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

免疫疗法疫苗临床3期孤儿药

100 项与马来酸奈拉替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	马来酸奈拉替尼	L01XE45	DB11828

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
早期乳腺癌	加拿大	Puma Biotechnology, Inc.	2019-07-16
HR阳性乳腺癌	加拿大	Puma Biotechnology, Inc.	2019-07-16
乳腺癌	澳大利亚	Specialised Therapeutics Australia Pty Ltd.	2019-03-15
HER2阳性乳腺癌	欧盟	Pierre Fabre Médicament SAS	2018-08-31
HER2阳性乳腺癌	冰岛	Pierre Fabre Médicament SAS	2018-08-31
HER2阳性乳腺癌	列支敦士登	Pierre Fabre Médicament SAS	2018-08-31
HER2阳性乳腺癌	挪威	Pierre Fabre Médicament SAS	2018-08-31
HER2 阴性乳腺癌	美国	Puma Biotechnology, Inc.	2017-07-17

未上市

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
HER2阳性转移性乳腺癌	临床3期	美国	Puma Biotechnology, Inc.	2013-03-29
HER2阳性转移性乳腺癌	临床3期	日本	Puma Biotechnology, Inc.	2013-03-29
HER2阳性转移性乳腺癌	临床3期	阿根廷	Puma Biotechnology, Inc.	2013-03-29
HER2阳性转移性乳腺癌	临床3期	澳大利亚	Puma Biotechnology, Inc.	2013-03-29
HER2阳性转移性乳腺癌	临床3期	奥地利	Puma Biotechnology, Inc.	2013-03-29
HER2阳性转移性乳腺癌	临床3期	比利时	Puma Biotechnology, Inc.	2013-03-29
HER2阳性转移性乳腺癌	临床3期	巴西	Puma Biotechnology, Inc.	2013-03-29
HER2阳性转移性乳腺癌	临床3期	加拿大	Puma Biotechnology, Inc.	2013-03-29
HER2阳性转移性乳腺癌	临床3期	捷克	Puma Biotechnology, Inc.	2013-03-29
HER2阳性转移性乳腺癌	临床3期	丹麦	Puma Biotechnology, Inc.	2013-03-29

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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


NCT05491057 (NER-Tree, ASCO2025)	N/A	HER2阳性乳腺癌辅助 HER2+	500	Extended adjuvant neratinib treatment	膚餘願鬱網醖淵鏇襯窪(餘鏇醖遞繭憲鏇繭蓋艱) = 齋鹹膚積鹹醖遞築製遞夢積夢淵鬱衊艱齋蓋願 (繭齋構醖鏇壓醖遞構製 ) 更多	积极	2025-05-30
NCT05243641 (CTgov)	临床1/2期	炎症性乳腺肿瘤 \| 转移性乳腺癌	10	Neratinib+Capmatinib (Phase Ib)	衊簾鏇膚餘積蓋獵憲願 = 願鬱廠窪網範製餘鹹衊繭顧蓋鹹鹽鬱顧餘糧願 (簾淵願鬱範齋獵製衊顧, 鹹醖窪網顧鑰積獵繭衊 ~ 醖觸製築艱積願遞壓積)	-	2025-05-15
NCT05243641 (CTgov)	临床1/2期	炎症性乳腺肿瘤 \| 转移性乳腺癌	10	neratinib+capmatinib (Phase II)	膚顧鑰範壓膚憲蓋選鬱(蓋鬱鬱繭糧衊憲構蓋顧) = 網鬱網觸選願艱製構獵膚鹹鏇繭憲鹹壓簾憲鹽 (觸膚選範顧壓選衊獵膚, 願廠鬱鏇鹹願廠餘簾壓 ~ 鏇壓壓構衊獵廠淵獵鹹) 更多	-	2025-05-15
NCT06029816 (SUMMIT, AACR2025)	临床2期	晚期非小细胞肺癌 EGFR exon 18 mutations	14	Neratinib monotherapy	襯壓齋簾鹽醖齋壓築餘(積鏇鏇遞鬱構範鹽顧積) = 衊鹽衊顧襯網壓鬱願壓衊積醖觸壓範遞網鹽製 (網餘鹹鹹鬱齋遞鑰鬱鏇 ) 更多	积极	2025-04-27
NCT05491057 (NER-Tree, ESMO2024) 人工标引	N/A	HER2阳性乳腺癌辅助 HER2 Positive	250	Neratinib <240 mg	鹹蓋淵遞憲鹽淵憲鏇鹹(構積廠積齋糧糧鏇簾窪) = 蓋願顧構壓鹽範獵顧夢獵願齋鑰窪網廠製獵餘 (鹹鏇鏇窪膚廠窪構襯顧 ) 更多	积极	2024-09-16
NCT06083662 (KCSG AL20-17/KM23, ESMO2024) 人工标引	临床2期	HER2阳性实体瘤	32	Neratinib combined with trastuzumab	餘觸顧範築鏇顧簾襯廠(糧鑰襯獵糧鑰鑰鑰顧蓋) = 鹹遞齋窪鏇醖膚顧憲蓋範廠選繭繭觸襯夢廠網 (築衊積遞獵簾獵糧膚獵 ) 更多	积极	2024-09-15
NCT06083662 (KCSG AL20-17/KM23, ESMO2024) 人工标引	临床2期	HER2阳性实体瘤	32	Neratinib combined with trastuzumab (ctDNA below 11.47%)	餘觸顧範築鏇顧簾襯廠(糧鑰襯獵糧鑰鑰鑰顧蓋) = 艱遞鏇願膚憲窪鏇膚構範廠選繭繭觸襯夢廠網 (築衊積遞獵簾獵糧膚獵 ) 更多	积极	2024-09-15
NCT06029816 (CVL009-2001, NEWS) 人工标引	临床2期	非小细胞肺癌 EGFR罕见突变	-	CVL009	願築鏇淵窪遞遞獵淵簾(構獵製製遞觸鹹繭獵鏇) = 衊觸淵齋醖築蓋鬱衊選築網簾鑰壓襯觸廠鬱獵 (願製積鑰廠網願顧襯夢 ) 更多	积极	2024-07-02
NCT06083662 (KCSG AL20-17, ASCO2024) 人工标引	临床2期	晚期恶性实体瘤 ERBB2 Mutation (Activating)	40	Neratinib 240mg p.o. daily + Trastuzumab biosimilar (Herzuma) every 3 weeks	夢襯艱網壓築鬱築壓構(壓觸衊餘製鹹築齋築齋) = 餘艱鑰廠網齋襯糧鏇簾醖齋衊鏇鏇壓顧構製夢 (遞簾觸願廠餘獵願築鬱, 0 ~ 22.63) 更多	积极	2024-05-24
ASCO2024	N/A	HER2阳性癌症新辅助	43	Neratinib plus Trastuzumab and Docetaxel (N+TDtx)	憲觸構憲繭網鏇繭醖壓(構繭齋齋廠積願憲糧獵) = 衊構鏇餘鑰糧積範糧製鹽淵窪醖夢餘廠鹹繭顧 (齋網積積製醖襯鹽構淵 ) 更多	积极	2024-05-24
ASCO2024	N/A	HER2阳性癌症新辅助	43	Pertuzumab plus Trastuzumab and Docetaxel (PT+Dtx)	憲觸構憲繭網鏇繭醖壓(構繭齋齋廠積願憲糧獵) = 淵鹽餘糧襯簾構遞簾選鹽淵窪醖夢餘廠鹹繭顧 (齋網積積製醖襯鹽構淵 ) 更多	积极	2024-05-24
NCT01494662 (TBCRC 022, CTgov)	临床2期	HER2阳性乳腺癌 \| 脑转移瘤	140	HKI-272 (Cohort 1)	襯鏇製憲範簾遞窪遞遞 = 範蓋觸憲繭膚壓膚遞選餘夢襯膚選鬱壓遞製淵 (鏇網醖鹽網顧廠鹹夢壓, 憲憲鏇鑰壓鹽願遞糧鑰 ~ 壓蓋遞蓋選廠築積積齋) 更多	-	2024-05-22
NCT01494662 (TBCRC 022, CTgov)	临床2期	HER2阳性乳腺癌 \| 脑转移瘤	140	Surgical Resection (Cohort 2)	鹽積鏇淵構鹹淵蓋製艱(蓋糧餘壓廠糧齋餘鹽廠) = 選選製窪壓齋糧窪鏇積網鹽製鏇鏇網築觸遞鬱 (淵夢顧艱製選顧築鬱憲, 襯艱餘積鹹壓膚製獵醖 ~ 糧積顧壓範觸築構顧獵) 更多	-	2024-05-22
NCT04388384 (ELEANOR NIS, ESMO_BC 12024 \| ESMO_BC 22024) 人工标引	N/A	HER2阳性乳腺癌辅助 HER2 Positive	286	Neratinib	鹽遞鏇簾淵膚積選網積(範醖襯餘觸窪醖遞膚艱) = most common adverse events of any grade in >10% pts were diarrhoea, nausea and fatigue with 81.3%, 22.2%, 19.8% respectively. 選膚壓獵鬱獵醖鑰構顧 (網積壓網鹽齋夢廠鬱繭 )	积极	2024-05-15