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

[+2]

CTR20244703

/ Active, not recruitingN/A

马来酸奈拉替尼片（40mg）在中国健康受试者中餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

主要研究目的：按有关生物等效性试验的规定，选择Excella GmbH & Co.KG生产的马来酸奈拉替尼片（商品名：贺俪安®，规格：40mg）为参比制剂，对湖南科伦制药有限公司生产并提供的受试制剂马来酸奈拉替尼片（规格：40mg）进行餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂马来酸奈拉替尼片（规格：40mg）和参比制剂马来酸奈拉替尼片（商品名：贺俪安®，规格：40mg）的安全性。

开始日期2025-01-07

申办/合作机构

湖南科伦制药有限公司

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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1,018

项与马来酸奈拉替尼相关的文献（医药）

2025-03-01·BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

Neratinib derivative 7A induces apoptosis in colon cancer cells via the p53 pathway

Article

作者: Ji, Jing ; Zhou, Ying ; Wang, Xiu-Jun ; Zhang, Xing-Yu ; Sun, Qian ; Liu, Ruo-Tong ; Ye, Xiao-Qing ; Cheng, Wen-Hao ; Liu, Zhi-Yu ; Zhou, Chun-Yun ; Zhang, Bo-Yu

Colorectal cancer remains a significant health threat, with its incidence continuously rising, underscoring the urgent need for the development of new therapeutic agents. In our previous research, we identified 7A, a derivative of Neratinib, as having pronounced antitumor activity. However, its specific effects and mechanisms in colorectal cancer have not been thoroughly investigated. Therefore, this study employed in vivo and in vitro experiments, utilizing techniques such as RNA sequencing, Western blotting, and PCR, to provide a comprehensive analysis of 7A's mechanism of action in colorectal cancer. The results indicate that 7A induces DNA damage and activates the P53 pathway, thereby promoting apoptosis in colorectal cancer cells. Additionally, 7A treatment significantly reduced angiogenesis and tumor weight. Our findings suggest that 7A, a Neratinib derivative, holds promise as a novel candidate for colorectal cancer therapy.

2025-01-01·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Corrigendum to “Genipin-crosslinked albumin nanoparticles containing neratinib and silibinin: A dual-death therapy for triple negative breast cancer” [Int. J. Pharm. 648 (2023) 123570]

作者: Jain, Sanyog ; Ghadi, Rohan ; Wadikar, Aaradhya ; Date, Tushar ; Gabhale, Akash ; Pandey, Pawan Kumar ; Dharshini, M ; Kuche, Kaushik

2025-01-01·Cancer Reports

Neratinib and the Role of Anti‐HER2 Therapy in Salivary Duct Carcinoma

Article

作者: Martinelli, Enrica ; Santini, Chiara ; Bertolini, Federica ; Napolitano, Martina ; Dominici, Massimo ; Trudu, Lucia

ABSTRACT:

Backgroud:

Salivary duct carcinoma (SDC) is a rare and aggressive malignancy with a generally dismal prognosis and no standard of care established, despite a known association with epidermal growth factor receptor 2 (HER2) and androgen receptor (AR) over‐expression.

Case:

We report the case of a 64‐year‐old female with extra‐ and intracranial metastases of SDC with evidence of AR and HER2 overexpression. After progression on first line chemotherapy, was administered neratinib, a pan‐Erb2 receptor tyrosine kinase inhibitor.Even with central nervous system involvement at diagnosis, a durable clinical response was obtained with a PFS of 11 months and no significant toxicities to manage. Best response observed during tratment was partial response.

Conclusions:

This case confirms the potential efficacy of neratinib in HER2‐positive SDC and underlines the need to define the best therapeutic sequence and potential biomarkers for these rare patients.

294

项与马来酸奈拉替尼相关的新闻（医药）

2025-02-13

·复星医药

2025 ORS | 复星医药子公司复宏汉霖地舒单抗生物类似药HLX14国际多中心III期临床研究数据首次发表

美国时间2025年2月11日，复星医药子公司复宏汉霖自主开发的地舒单抗生物类似药候选药物HLX14（重组抗RANKL 全人单克隆抗体注射液）国际多中心III期临床研究（NCT05352516）数据于2025年美国骨科研究学会（ORS）年会发布，并由徐州医科大学附属医院辛立教授进行口头报告。 HLX14为复宏汉霖按照中国、欧盟和美国等生物类似药相关法规自主开发的地舒单抗生物类似药。复宏汉霖已于2022年与Organon达成授权许可和供应合作，授予其对包括HLX14在内的两款候选生物类似药在除中国以外的全球区域进行独家商业化的权益，协议覆盖美国、欧盟、加拿大等市场。2024年4月，HLX14用于治疗骨折高风险的绝经后妇女的骨质疏松症的国际多中心临床III期对照研究达到主要研究终点。基于一系列的头对头比对研究，HLX14的上市申请于2024年相继获得美国食品药品监督管理局（FDA）、欧洲药品管理局（EMA）和加拿大卫生部（Health Canda）受理。以下为此次发布的详细信息：试验设计本研究为一项随机、双盲、国际、平行对照的III期研究。受试者为年龄在60至90岁之间、确认已绝经且腰椎或全髋骨矿物质密度（BMD）T评分通过中心双能X线吸收法扫描为−4.0 < T评分 ≤ −2.5的女性。合格的受试者按1:1分配分别接受两剂HLX14或欧盟市售原研地舒单抗（PROLIA）。在第52周，接受PROLIA的受试者再次按1:1随机分配接受第三剂HLX14或PROLIA。本研究的共同主要终点为第52周腰椎BMD（LS-BMD）从基线变化的百分比（由中心影像评估）及基线至第26周的血清胶原蛋白C端肽（s-CTX）较基线改变百分比-时间曲线下面积（AUEC0-26W）。次要终点包括腰椎BMD基线变化百分比（由研究者评估），股骨颈及全髋部BMD的百分比变化（由中心影像及研究者评估），骨折率，s-CTX及血清N-末端I型前胶原肽（s-P1NP）的相对变化百分比，安全性，药代动力学（PK），和免疫原性。结果在2022年6月17日至2024年6月5日期间，共有514例受试者被随机分配到HLX14组（256名）或欧盟市售原研地舒单抗（PROLIA）组（258名）。在第52周，来自PROLIA组的220例受试者再次随机分配，接收最后一剂HLX14（PROLIA/HLX14组，110名）或PROLIA（PROLIA/PROLIA组，110名）；HLX14组的220例受试者继续接受最后一剂HLX14（HLX14/HLX14组）。在基线到第52周期间，HLX14组和PROLIA组的腰椎骨密度（LS-BMD）均有所增加。通过中央影像评估，从基线到第52周的平均（标准偏差）百分比变化分别为HLX14组6.10%（3.95%），PROLIA组5.90%（3.83%）。两组之间的调整平均差异为0.23%（90%置信区间[CI]：−0.36%，0.83%；95% CI：−0.48%，0.95%）。90%置信区间和95%置信区间均落在预设的等效性界限−1.45%到1.45%之间, 证明了两组疗效等效性。对于主要药效动力学（PD）终点，HLX14组和PROLIA组的AUEC0-26W几何均值（CVb%）分别为14075.1253（17.3%）day*%inhibition，13883.3613（17.9%）day*%inhibition。HLX14组和PROLIA组AUEC0-26W的几何均值比为1.01（90% CI：0.99, 1.04；95% CI：0.98, 1.05）。几何均值比的90%和95%置信区间均落在预设的等效性界限0.8到1.25之间，证明两组PD等效性。因此，本研究的共同主要终点已达到。所有敏感性、补充性和亚组分析结果也与主要分析一致。所有次要疗效终点的结果进一步支持了HLX14和欧盟市售原研地舒单抗（PROLIA）等效。在基线到第52周期间，两组的安全性结果相当；HLX14组出现了69例（27.0%）与治疗相关的不良事件（TRAEs），而PROLIA组出现了82例（31.8%）。从第52周到第78周，PROLIA/HLX14、PROLIA/PROLIA、HLX14/HLX14各组之间的安全性特征仍相似；PROLIA/HLX14组报告了14例（12.7%）TRAEs，PROLIA/ PROLIA组报告了15例（13.6%），HLX14/HLX14组报告了25例（11.4%）。总体而言，安全性评估未发现HLX14和PROLIA之间存在显著差异，即使在单次治疗药物转换之后也是如此。各组在单次药物转换前后的抗药抗体和中和抗体的发生率也相当。结论综上所述，HLX14与欧盟市售原研地舒单抗在疗效上具有等效性，并且二者的安全性特征相似。本研究的结果支持 HLX14 作为地舒单抗的生物类似药，在获批上市后，将可以提高骨折风险的绝经后女性对抗骨质疏松症和骨质流失的有效治疗方法的可及性。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，4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50多个分子，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，欧盟商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就16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。 Phase 3 MRCT Results of Denosumab Biosimilar HLX14 Released at ORS 2025 On February 11, 2025, the results of the international multicenter phase 3 study (NCT05352516) of denosumab biosimilar candidate HLX14 were released at the 2025 Orthopaedic Research Society (ORS) Annual Meeting. The results were orally presented by Professor Li Xin from The Affiliated Hospital of Xuzhou Medical University, the leading principal investigator of NCT05352516. Henlius independently developed denosumab biosimilar candidate HLX14 in accordance with the NMPA, EMA, FDA, and other international biosimilar guidelines. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception from the agreement is China. In April 2024, NCT05352516 met the primary endpoints. Based on a series of head-to-head comparison studies, the marketing applications of HLX14 have been accepted by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada in 2024. The detailed results of the study released at ORS 2025 Annual Meeting are as follows: Study design In this randomized, double-blind, international multicenter, parallel-controlled phase 3 study, female subjects aged 60 to 90 years with confirmed postmenopausal status and lumbar spine or total hip bone mineral density (BMD) T-score of −4.0 < T-score ≤ −2.5 as assessed by central dual-energy X-ray absorptiometry scans were initially randomized 1:1 to receive two doses of HLX14 or EU-denosumab. At Week 52, the subjects receiving EU-denosumab were re-randomized 1:1 to receive either a third dose of HLX14 or EU-denosumab, subjects receiving HLX14 will be continue with a third dose of HLX14. The co-primary endpoints were the percent change from baseline at lumbar spine BMD (LS-BMD) at week 52 as assessed by the central imaging, and the area under the effect-time curve for percent change of serum type I collagen C-telopeptide (s-CTX) from baseline to Week 26 (AUEC0-26W). Secondary endpoints included efficacy endpoints of the percent change from baseline in BMD at lumbar spine (assessed by the investigator), at femoral neck and total hip (as assessed by central imaging and investigator), fracture rate, relative percent change in s-CTX and serum procollagen type I N propeptide, safety, PK, and immunogenicity. Results Between 17 June, 2022 to 05 June, 2024, a total of 514 subjects were randomized to the HLX14 (n= 256) or EU-denosumab (n=258) group. At Week 52, 220 subjects from the EU-denosumab group were re-randomized to receive a final dose of HLX14 (EU-denosumab/HLX14 group, n=110) or EU-denosumab (EU-denosumab/EU-denosumab group, n=110); 220 subjects in the HLX14 group continued to receive the final dose of HLX14 (HLX14/HLX14 group). From baseline to week 52, an increase in LS-BMD was evident in both the HLX14 and EU-denosumab groups; the mean (standard deviation) percent change from baseline to Week 52 as assessed by central imaging were 6.10% (3.95%), and 5.90% (3.83%) for the HLX14, and EU-denosumab group, respectively. The adjusted mean difference between the two groups was 0.23% (90% confidence interval [CI]: −0.36%, 0.83%; 95% CI: −0.48%, 0.95%). The 90% CI and 95% CI for the difference both fell within the pre-specified equivalence margins of −1.45% to 1.45%, demonstrating the efficacy equivalence between the two groups. As for the primary PD endpoint, the geomean (CVb%) of AUEC0‑26W for subjects in the HLX14, and EU-denosumab group were 14075.1253 (17.3%) day*%inhibition, and 13883.3613 (17.9%) day*%inhibition, respectively. The geometric mean ratio of AUEC0‑26W for the HLX14 and EU-denosumab groups was 1.01 (90% CI: 0.99, 1.04; 95% CI: 0.98, 1.05). The 90% CI and 95% CI for the geometric mean ratio of AUEC0‑26W both fell within the pre-specified equivalence margins of 0.8 to 1.25, demonstrating the PD equivalence between the two groups. Henceforth, the co-primary endpoints in this study were met. All sensitivity, supplementary and subgroup analysis were also consistent with the primary analysis. The results of all secondary endpoints support the efficacy equivalence between HLX14 and EU-denosumab. The safety findings were comparable between the two groups from baseline to week 52; treatment-related adverse events (TRAEs) were reported in 69 (27.0%) subjects in the HLX14 group and 82 (31.8%) in the EU-denosumab group. Importantly, the safety profiles of the EU-denosumab/HLX14, EU-denosumab/EU-denosumab, and HLX14/HLX14 groups remained comparable from week 52 to week 78; TRAEs were observed in 14 (12.7%) in the EU-denosumab/HLX14 group, 15 (13.6%) in the EU-denosumab/EU-denosumab group, and 25 (11.4%) subjects in the HLX14/HLX14 group. Overall, the safety evaluation did not indicate notable differences between HLX14 and EU-denosumab, even after the single transition between the treatment drugs. Lastly, the incidence of anti-drug antibodies and neutralizing antibodies were also comparable between the groups prior to and after the single transition. Conclusion The efficacy equivalence of HLX14 and EU-denosumab was demonstrated along with comparable safety profiles for HLX14 and EU-denosumab. Taken together, the findings from this study add to the totality of evidence supporting HLX14 as a proposed biosimilar to reference denosumab that, if approved by regulatory agencies, may improve access to effective therapies for osteoporosis and bone loss in postmenopausal women at high risk of fracture. About Henlius Henlius (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 4 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 over 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 the EU), 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 16 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

临床3期临床结果生物类似药

2025-02-12

·复宏汉霖

2025 ORS | 复宏汉霖地舒单抗生物类似药HLX14国际多中心III期临床研究数据首次发表

美国时间2025年2月11日，复宏汉霖自主开发的地舒单抗生物类似药候选药物HLX14（重组抗RANKL 全人单克隆抗体注射液）国际多中心III期临床研究（NCT05352516）数据于2025年美国骨科研究学会（ORS）年会发布，并由徐州医科大学附属医院辛立教授进行口头报告。 HLX14为复宏汉霖按照中国、欧盟和美国等生物类似药相关法规自主开发的地舒单抗生物类似药。复宏汉霖已于2022年与Organon达成授权许可和供应合作，授予其对包括HLX14在内的两款候选生物类似药在除中国以外的全球区域进行独家商业化的权益，协议覆盖美国、欧盟、加拿大等市场。2024年4月，HLX14用于治疗骨折高风险的绝经后妇女的骨质疏松症的国际多中心临床III期对照研究达到主要研究终点。基于一系列的头对头比对研究，HLX14的上市申请于2024年相继获得美国食品药品监督管理局（FDA）、欧洲药品管理局（EMA）和加拿大卫生部（Health Canda）受理。以下为此次发布的详细信息：试验设计本研究为一项随机、双盲、国际、平行对照的III期研究。受试者为年龄在60至90岁之间、确认已绝经且腰椎或全髋骨矿物质密度（BMD）T评分通过中心双能X线吸收法扫描为−4.0 < T评分 ≤ −2.5的女性。合格的受试者按1:1分配分别接受两剂HLX14或欧盟市售原研地舒单抗（PROLIA）。在第52周，接受PROLIA的受试者再次按1:1随机分配接受第三剂HLX14或PROLIA。本研究的共同主要终点为第52周腰椎BMD（LS-BMD）从基线变化的百分比（由中心影像评估）及基线至第26周的血清胶原蛋白C端肽（s-CTX）较基线改变百分比-时间曲线下面积（AUEC0-26W）。次要终点包括腰椎BMD基线变化百分比（由研究者评估），股骨颈及全髋部BMD的百分比变化（由中心影像及研究者评估），骨折率，s-CTX及血清N-末端I型前胶原肽（s-P1NP）的相对变化百分比，安全性，药代动力学（PK），和免疫原性。结果在2022年6月17日至2024年6月5日期间，共有514例受试者被随机分配到HLX14组（256名）或欧盟市售原研地舒单抗（PROLIA）组（258名）。在第52周，来自PROLIA组的220例受试者再次随机分配，接收最后一剂HLX14（PROLIA/HLX14组，110名）或PROLIA（PROLIA/PROLIA组，110名）；HLX14组的220例受试者继续接受最后一剂HLX14（HLX14/HLX14组）。在基线到第52周期间，HLX14组和PROLIA组的腰椎骨密度（LS-BMD）均有所增加。通过中央影像评估，从基线到第52周的平均（标准偏差）百分比变化分别为HLX14组6.10%（3.95%），PROLIA组5.90%（3.83%）。两组之间的调整平均差异为0.23%（90%置信区间[CI]：−0.36%，0.83%；95% CI：−0.48%，0.95%）。90%置信区间和95%置信区间均落在预设的等效性界限−1.45%到1.45%之间, 证明了两组疗效等效性。对于主要药效动力学（PD）终点，HLX14组和PROLIA组的AUEC0-26W几何均值（CVb%）分别为14075.1253（17.3%）day*%inhibition，13883.3613（17.9%）day*%inhibition。HLX14组和PROLIA组AUEC0-26W的几何均值比为1.01（90% CI：0.99, 1.04；95% CI：0.98, 1.05）。几何均值比的90%和95%置信区间均落在预设的等效性界限0.8到1.25之间，证明两组PD等效性。因此，本研究的共同主要终点已达到。所有敏感性、补充性和亚组分析结果也与主要分析一致。所有次要疗效终点的结果进一步支持了HLX14和欧盟市售原研地舒单抗（PROLIA）等效。在基线到第52周期间，两组的安全性结果相当；HLX14组出现了69例（27.0%）与治疗相关的不良事件（TRAEs），而PROLIA组出现了82例（31.8%）。从第52周到第78周，PROLIA/HLX14、PROLIA/PROLIA、HLX14/HLX14各组之间的安全性特征仍相似；PROLIA/HLX14组报告了14例（12.7%）TRAEs，PROLIA/ PROLIA组报告了15例（13.6%），HLX14/HLX14组报告了25例（11.4%）。总体而言，安全性评估未发现HLX14和PROLIA之间存在显著差异，即使在单次治疗药物转换之后也是如此。各组在单次药物转换前后的抗药抗体和中和抗体的发生率也相当。结论综上所述，HLX14与欧盟市售原研地舒单抗在疗效上具有等效性，并且二者的安全性特征相似。本研究的结果支持 HLX14 作为地舒单抗的生物类似药，在获批上市后，将可以提高骨折风险的绝经后女性对抗骨质疏松症和骨质流失的有效治疗方法的可及性。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，4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50多个分子，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，欧盟商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就16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。 Phase 3 MRCT Results of Denosumab Biosimilar HLX14 Released at ORS 2025 On February 11, 2025, the results of the international multicenter phase 3 study (NCT05352516) of denosumab biosimilar candidate HLX14 were released at the 2025 Orthopaedic Research Society (ORS) Annual Meeting. The results were orally presented by Professor Li Xin from The Affiliated Hospital of Xuzhou Medical University, the leading principal investigator of NCT05352516. Henlius independently developed denosumab biosimilar candidate HLX14 in accordance with the NMPA, EMA, FDA, and other international biosimilar guidelines. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception from the agreement is China. In April 2024, NCT05352516 met the primary endpoints. Based on a series of head-to-head comparison studies, the marketing applications of HLX14 have been accepted by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada in 2024. The detailed results of the study released at ORS 2025 Annual Meeting are as follows: Study design In this randomized, double-blind, international multicenter, parallel-controlled phase 3 study, female subjects aged 60 to 90 years with confirmed postmenopausal status and lumbar spine or total hip bone mineral density (BMD) T-score of −4.0 < T-score ≤ −2.5 as assessed by central dual-energy X-ray absorptiometry scans were initially randomized 1:1 to receive two doses of HLX14 or EU-denosumab. At Week 52, the subjects receiving EU-denosumab were re-randomized 1:1 to receive either a third dose of HLX14 or EU-denosumab, subjects receiving HLX14 will be continue with a third dose of HLX14. The co-primary endpoints were the percent change from baseline at lumbar spine BMD (LS-BMD) at week 52 as assessed by the central imaging, and the area under the effect-time curve for percent change of serum type I collagen C-telopeptide (s-CTX) from baseline to Week 26 (AUEC0-26W). Secondary endpoints included efficacy endpoints of the percent change from baseline in BMD at lumbar spine (assessed by the investigator), at femoral neck and total hip (as assessed by central imaging and investigator), fracture rate, relative percent change in s-CTX and serum procollagen type I N propeptide, safety, PK, and immunogenicity. Results Between 17 June, 2022 to 05 June, 2024, a total of 514 subjects were randomized to the HLX14 (n= 256) or EU-denosumab (n=258) group. At Week 52, 220 subjects from the EU-denosumab group were re-randomized to receive a final dose of HLX14 (EU-denosumab/HLX14 group, n=110) or EU-denosumab (EU-denosumab/EU-denosumab group, n=110); 220 subjects in the HLX14 group continued to receive the final dose of HLX14 (HLX14/HLX14 group). From baseline to week 52, an increase in LS-BMD was evident in both the HLX14 and EU-denosumab groups; the mean (standard deviation) percent change from baseline to Week 52 as assessed by central imaging were 6.10% (3.95%), and 5.90% (3.83%) for the HLX14, and EU-denosumab group, respectively. The adjusted mean difference between the two groups was 0.23% (90% confidence interval [CI]: −0.36%, 0.83%; 95% CI: −0.48%, 0.95%). The 90% CI and 95% CI for the difference both fell within the pre-specified equivalence margins of −1.45% to 1.45%, demonstrating the efficacy equivalence between the two groups. As for the primary PD endpoint, the geomean (CVb%) of AUEC0‑26W for subjects in the HLX14, and EU-denosumab group were 14075.1253 (17.3%) day*%inhibition, and 13883.3613 (17.9%) day*%inhibition, respectively. The geometric mean ratio of AUEC0‑26W for the HLX14 and EU-denosumab groups was 1.01 (90% CI: 0.99, 1.04; 95% CI: 0.98, 1.05). The 90% CI and 95% CI for the geometric mean ratio of AUEC0‑26W both fell within the pre-specified equivalence margins of 0.8 to 1.25, demonstrating the PD equivalence between the two groups. Henceforth, the co-primary endpoints in this study were met. All sensitivity, supplementary and subgroup analysis were also consistent with the primary analysis. The results of all secondary endpoints support the efficacy equivalence between HLX14 and EU-denosumab. The safety findings were comparable between the two groups from baseline to week 52; treatment-related adverse events (TRAEs) were reported in 69 (27.0%) subjects in the HLX14 group and 82 (31.8%) in the EU-denosumab group. Importantly, the safety profiles of the EU-denosumab/HLX14, EU-denosumab/EU-denosumab, and HLX14/HLX14 groups remained comparable from week 52 to week 78; TRAEs were observed in 14 (12.7%) in the EU-denosumab/HLX14 group, 15 (13.6%) in the EU-denosumab/EU-denosumab group, and 25 (11.4%) subjects in the HLX14/HLX14 group. Overall, the safety evaluation did not indicate notable differences between HLX14 and EU-denosumab, even after the single transition between the treatment drugs. Lastly, the incidence of anti-drug antibodies and neutralizing antibodies were also comparable between the groups prior to and after the single transition. Conclusion The efficacy equivalence of HLX14 and EU-denosumab was demonstrated along with comparable safety profiles for HLX14 and EU-denosumab. Taken together, the findings from this study add to the totality of evidence supporting HLX14 as a proposed biosimilar to reference denosumab that, if approved by regulatory agencies, may improve access to effective therapies for osteoporosis and bone loss in postmenopausal women at high risk of fracture. About Henlius Henlius (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 4 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 over 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 the EU), 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 16 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

临床3期生物类似药临床结果

2025-02-11

·PRNewswire

New Breast Cancer Therapy to Reduce Risk of Recurrence and Improve Disease-Free Survival Now Approved in Thailand

NERLYNX® (neratinib) has been approved as a single agent for the treatment of early-stage HER2+ breast cancer, and in combination with capecitabine for the treatment of advanced or metastatic HER2+ breast cancer[1] Approval coincides with the first appointment of field force employees, signifying the growth of Specialised Therapeutics in Thailand SINGAPORE, Feb. 11, 2025 /PRNewswire/ -- A NEW breast cancer therapy shown to significantly reduce the risk of cancer recurrence and improve disease-free survival in women is now approved for use in Thailand.[1,2,3] NERLYNX® (neratinib), an oral medication, has been approved by the Thailand Food and Drug Administration (Thailand FDA) as a single agent "for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago."[1] Additionally, NERLYNX has been approved in combination with capecitabine"for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting."[1] In early breast cancer, NERLYNX has been shown to significantly reduce the ongoing risk of recurrence in women positive for human epidermal growth factor receptor 2 (HER2+), with the greatest benefit seen in women who are also hormone-receptor positive (HR+) and who commence therapy within 12 months of completing trastuzumab-based therapy.[2,3] For these women, the five-year risk of recurrence is reduced by up to 42%.[4] In women with advanced or metastatic HER2+ breast cancer, NERLYNX in combination with capecitabine (N+C) was found to significantly improve mean progression free survival (PFS) by 2.2 months over treatment with lapatinib plus capecitabine (L+C).[5] The duration of treatment response was longer for patients administered N+C (8.5 months) versus L+C (5.6 months), while the risk of disease progression or death was reduced by up to 24% among those treated with N+C at a median follow-up of 30 months.[5,6] NERLYNX is being made available in Thailand by independent pharmaceutical company, Specialised Therapeutics (ST), under exclusive license from Puma Biotechnology, Inc. ST Chief Executive Officer, Mr Carlo Montagner, said the approval of NERLYNX in Thailand was an important milestone for the company. "We are proud to have obtained approval of NERLYNX in Thailand for adults with HER2 positive breast cancer. This is a significant milestone for Specialised Therapeutics, but importantly also for women diagnosed with breast cancer in Thailand who will be presented with an opportunity to access a treatment that will help reduce the risk of disease recurrence and improve outcomes, in either the early or advanced stages of their disease." Breast cancer is the most common cancer diagnosed in Thai women, and the second leading cause of cancer mortality in females, behind liver cancer.[7] The incidence of breast cancer in Thailand has been rising at an alarming rate, with the annual age-standardised incidence rate doubling over the past 20 years (from 17.8/100,000 in 1998, to 35.7/100,000 in 2020).[8,9] In 2022, 21,628 Thai women were newly diagnosed with breast cancer, accounting for almost a quarter (23.2%) of all new cancer diagnoses in females.[7] Coinciding with the NERLYNX approval, ST is also pleased to announce the growth of its Thailand office, with new field force members due to join the company in March 2025. "We are extremely excited about the new journey we are undertaking in Thailand," said Mr Montagner. "Hiring our first field force employees, who have an extensive understanding of the local healthcare landscape, enables us to connect with oncologists around the country at the earliest opportunity, ahead of launching NERLYNX and making it available for eligible breast cancer patients as soon as possible. "As we continue to seek approvals for our strong pipeline of specialised medicines and technologies, we remain committed to meeting the needs of patients with rare diseases across Thailand, and making a difference to their lives. We look forward to working with the Thailand FDA and local specialists as we endeavour to provide timely access to these new treatments for the patients that need them." Ends. About NERLYNX NERLYNX (neratinib) is an irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4.[10] It is an oral tablet and works by binding to multiple receptors inside the cancer cell, blocking signals that tell cancer cells to grow and multiply.[11,12] NERLYNX has received approval for the treatment of certain patients with extended adjuvant and/or metastatic HER2-positive breast cancer in more than 40 countries outside the United States (US), including the European Union (EU), China, Latin America, Australia, Canada, and Hong Kong. About HER2-Positive (HER2+) Breast Cancer Approximately 20-25% of breast cancer tumours over-express the HER2 protein. HER2-positive (HER2+) breast cancer is a highly heterogeneous tumour that is often more aggressive than other types of breast cancer and has a poor prognosis, increasing the risk of disease progression and death.[10,13,14] While trastuzumab has helped to improve the survival and prognosis of patients with HER2+ breast cancer, around 20-30% of patients will experience recurrence and metastases after trastuzumab targeted therapy.[14] About the ExteNET Study[2-4,15] The ExteNET trial was a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in patients with early-stage HER2-positive breast cancer. The ExteNET trial randomised 2,840 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomised to receive neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of five years after randomisation. The primary endpoint of the trial was invasive disease-free survival (iDFS). The trial demonstrated that after a median follow up of 5.2 years, treatment with neratinib resulted in a 27% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.73, p = 0.008). The 5-year iDFS rate for the neratinib arm was 90.2%, versus 87.7% for the placebo arm. An additional five-year sub-group analysis demonstrated a 42% reduction in risk of recurrence and 59% reduction in risk of CNS recurrence or death of any cause in women who were HR+ and who had commenced neratinib therapy within 12 months of completing treatment with trastuzumab. The most common adverse reactions (≥ 5%) were diarrhoea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection. About the NALA Study[5,6] The NALA trial was a randomised, active-controlled, Phase III trial investigating the efficacy of neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), plus capecitabine (N+C) against lapatinib, a reversible dual TKI, plus capecitabine (L+C) in patients with centrally confirmed HER2+ metastatic breast cancer who had received two or more prior anti-HER2 based regimens in the metastatic setting. 621 patients were enrolled at 203 sites in 28 countries across Europe, North and South America, Asia, and Australia. The primary outcome measures for the trial were progression-free survival (PFS), and overall survival (OS). Median PFS was 5.6 months for patients who received N+C and 5.5 months for those receiving L+C (hazard ratio = 0.76, p = 0.0059). The PFS rate at 12 months was 29% versus 15%, respectively. Median OS was 21 months for patients receiving N+C, compared to 18.7 months for those receiving L+C (hazard ratio = 0.88, p = 0.2086). The most common adverse reactions of any grade (>5%) in the N+C arm were diarrhoea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, decreased weight, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms. About Specialised Therapeutics Founded in 2007, Specialised Therapeutics is the region's largest independent specialty pharmaceutical company, providing new therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions. The ST mission is to provide specialty therapies where there is an unmet need. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas. ST is a member of the World Orphan Drug Alliance (WODA). Additional information can be found at . References: SOURCE Specialised Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床3期上市批准孤儿药

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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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, ESMO2024) 人工标引	N/A	HER2阳性乳腺癌辅助 HER2 Positive	250	Neratinib <240 mg	選淵鹽鹽鹽積憲鬱製醖(範醖襯顧衊蓋窪齋餘遞) = 壓鬱製餘憲顧積壓膚網襯鬱膚廠襯齋鏇艱壓廠 (構壓壓襯壓獵鹹鹹蓋窪 ) 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	艱窪窪遞鏇蓋淵壓鹽鏇(願窪鬱製艱遞憲構觸繭) = 醖膚顧觸鑰壓艱鏇觸鹹遞餘鹹蓋築憲鏇餘繭夢 (廠艱憲鬱憲艱壓鹽艱願 ) 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%)	艱窪窪遞鏇蓋淵壓鹽鏇(願窪鬱製艱遞憲構觸繭) = 簾簾遞衊鹽觸鏇壓衊簾遞餘鹹蓋築憲鏇餘繭夢 (廠艱憲鬱憲艱壓鹽艱願 ) 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	築鹹齋選製膚艱蓋鏇選(餘艱鹹糧窪艱積範願願) = 衊觸淵觸糧範醖簾鏇夢蓋糧蓋鹽簾鑰膚觸艱鑰 (蓋窪醖鏇製鑰積醖選醖 ) 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	衊鑰醖獵鏇鏇蓋鹹遞憲(築遞廠鬱簾顧襯衊遞鹹) = 醖網廠襯廠觸鑰鑰蓋觸範窪鹽憲簾淵齋壓積顧 (壓糧鹽窪壓鏇醖製廠壓, 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)	窪憲築顧窪鑰範獵獵夢(積願鬱蓋衊鏇憲願願廠) = 鬱鑰鹹鏇繭簾築簾鏇願積廠願觸衊窪網蓋襯淵 (憲顧鑰顧壓觸齋艱觸願 ) 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)	窪憲築顧窪鑰範獵獵夢(積願鬱蓋衊鏇憲願願廠) = 餘選鏇襯窪夢鹽醖製積積廠願觸衊窪網蓋襯淵 (憲顧鑰顧壓觸齋艱觸願 ) 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)	糧艱積構鹽簾膚鏇鏇築(繭窪廠獵積襯艱鏇積淵) = 醖獵範鑰鹽齋觸積簾鹹憲鑰選蓋願顧簾襯願顧 (簾鏇鬱糧簾窪鹹窪獵鏇, 構糧鏇膚膚膚製蓋膚構 ~ 醖膚廠衊鏇衊鑰齋顧餘) 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)	鑰構觸壓醖窪鏇鏇窪夢(糧築齋範膚鏇鏇蓋壓簾) = 鑰製構積鹽積壓鬱鑰鏇憲獵餘積鹽糧襯淵鏇繭 (窪構膚鹽築鹹範衊齋遞, 獵製顧鏇積構網糧築糧 ~ 範膚選襯築網壓壓獵鹹) 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	繭鏇鏇夢顧廠艱憲夢顧(衊築衊築築鏇襯鬱獵壓) = most common adverse events of any grade in >10% pts were diarrhoea, nausea and fatigue with 81.3%, 22.2%, 19.8% respectively. 鹹網鬱築選鬱艱膚糧鏇 (鬱繭鬱膚觸繭築獵鑰製 )	积极	2024-05-15
NCT05491057 (NER-Tree, ESMO_BC2024)	N/A	HER2阳性乳腺癌辅助 HER2+	250	Neratinib	廠糧鑰襯構艱遞網獵顧(蓋齋蓋膚齋顧鹹壓簾壓) = 憲遞鏇餘築衊壓選遞蓋鹽鹽範網願製蓋廠襯簾 (鬱獵齋網鏇糧鹹構淵鏇 )	积极	2024-05-14
NCT05491057 (NER-Tree, ESMO_BC2024)	N/A	HER2阳性乳腺癌辅助 HER2+	250	Trastuzumab plus pertuzumab	構網遞蓋觸選蓋艱衊選(選構壓膚艱繭壓壓襯積) = 積願餘製艱鑰觸糧願顧簾鑰顧醖鬱蓋獵顧鑰醖 (網壓廠選獵壓醖窪憲艱 )	积极	2024-05-14
NCT02236000 (NSABP FB-10, Pubmed) 人工标引	临床1/2期	HER2阳性乳腺癌二线 HER2 Positive	49	T-DM1 + neratinib	鹹製窪襯積繭糧蓋夢醖(網膚鹹願選窪網築範艱) = 壓顧繭鬱製壓襯觸夢鬱廠鬱築築積齋襯選夢糧 (衊憲積鹹醖遞窪窪製獵 ) 更多	积极	2024-04-22
NCT01953926 (SUMMIT, Pubmed) 人工标引	临床2期	子宫颈转移癌 HER2 mutations	22	Neratinib 240mg/day	築窪範淵廠醖糧獵醖製(壓構廠蓋鏇醖淵獵遞齋) = 糧齋積壓積廠夢憲願鹽窪糧淵選選築壓選築餘 (構蓋範壓廠齋醖夢糧製, 5.2 ~ 40.3) 更多	积极	2024-02-01