A Phase Ib Clinical Study With Extension Phase to Evaluate Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib in the Treatment of Relapsed or Metastatic NSCLC Patients

This study is a multi-center, open-label, dose-finding phase Ib clinical study with extension phase, which is aimed at evaluating the efficacy and safety of GB226 combined with fruquintinib in treatment of relapsed or metastatic NSCLC patients with EGFR-sensitive mutations who have failed to respond to EGFR-TKI treatment,evaluating the pharmacokinetic characteristics of GB226 and fruquintinib, and the immunogenicity of GB226, and preliminarily evaluating the antitumor activity of GB226 and fruquintinib.

开始日期2019-07-23

申办/合作机构

嘉和生物药业有限公司

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100 项与杰诺单抗相关的临床结果

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100 项与杰诺单抗相关的转化医学

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100 项与杰诺单抗相关的专利（医药）

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项与杰诺单抗相关的文献（医药）

2024-10-23·Zhonghua zhong liu za zhi [Chinese journal of oncology]

[Clinical predictive value of PD-1/PD-L1-induced electrocardiogram changes for cardiotoxicity].

Article

作者: Xue, N ; Li, X J ; Wu, D W ; Peng, L L

Objective: To observe the electrocardiogram (ECG) changes of programmed death receptor 1 (PD-1)/programmed death receptor-ligand 1 (PD-L1) immune checkpoint inhibitors before and after immunotherapy of patients during clinical antitumor process, and to explore the occurrence and influencing factors of cardiotoxicity of immune checkpoint inhibitors. Methods: A total of 93 patients with locally advanced or metastatic solid tumors confirmed by pathological diagnosis in Cancer Hospital of Chinese Academy of Medical Sciences from October 1, 2019 to September 30, 2020 were selected and treated with PD-1/PD-L1 inhibitor monotherapy. Groups were divided according to immunotherapy regimen: Group A (drug code: 609A), 16 patients were given 1 mg/kg of the drug for 21 days; Group B (drug code: HX008), 23 patients were treated with 200mg for 21 days; Group C (drug code: GB226), 28 patients were treated with 3mg/kg for 14 days; Group D (drug code: LP002), 26 patients were treated with 900mg for 14 days. The patients were monitored and followed up for 10 cycles. The ECG results of each group were recorded, and the correlation between ECG abnormality and cardiotoxicity was analyzed. Results: A total of 75 patients showed abnormal ECG that met the diagnostic criteria. There was no significant difference in abnormal ECG rate after immunotherapy in group A (P＞0.05), while the incidence of adverse cardiac events increased after immunotherapy in group B (P＜0.05), and the abnormal ECG rate increased significantly after chemotherapy in group C and group D. There was statistical difference before and after immunotherapy (P＜0.001). The number of abnormal cases in group A (8 cases, 50.0%, 8/16) was significantly lower than that of group B (20 cases, 87.0%, 20/23). The number of abnormal cases in group C and group D was 24 (85.7%) and 23 (88.4%), respectively, without statistical difference (P＞0.05), but their abnormal rates of ECG were higher than that in group A. The incidence of electrical adverse events in immunotherapy center of patients with underlying diseases was 1.93 times higher than that of patients without underlying diseases. The incidence of central electrical adverse events during immunotherapy in group B, C and D was 6.667, 6.000 and 7.667 times higher than that in group A, respectively. Conclusions: The high sensitivity of early ECG changes induced by immune checkpoint inhibitors enables early prediction of related cardiotoxicity. The presence or absence of comorbid underlying disease and drug dosage are correlated with the occurrence of adverse cardiac events, and these early changes provide a evidence for clinical treatment and prevention.

2023-09-01·Cancer immunology, immunotherapy : CII

Efficacy and safety of geptanolimab (GB226) for relapsed/refractory primary mediastinal large B-cell lymphoma: an open-label phase II study (Gxplore-003)

Article

作者: Shi, Yuankai ; Xie, Liping ; Zhou, Hui ; Zhang, Hongyu ; Cui, Jie ; Liu, Hui ; Guo, Genny ; He, Wenduo ; Zou, Liqun ; Cao, Junning ; Zhou, Fang ; Peng, Zhigang ; Gao, Yuhuan ; Zhang, Xiaohong ; Li, Xiaoling ; Zhang, Huilai ; Zhong, Liye ; Jin, Chuan ; Zhang, Weihua

BACKGROUND:

This study aimed to assess the efficacy and safety of geptanolimab (GB226), a fully humanized, recombinant anti-programmed cell death-1 monoclonal antibody, in Chinese patients with refractory or relapsed (r/r) primary mediastinal large B-cell lymphoma (PMBCL).

METHODS:

This was a multicenter, open-label, single-arm phase II study (Gxplore-003), conducted at 43 hospitals in China (NCT03639181). Patients received geptanolimab intravenously at a dose of 3 mg/kg every 2 weeks until documented confirmed disease progression, intolerable toxicity, or any other cessation criteria was met. The primary endpoint was objective response rate (ORR) in the full analysis set assessed by the independent review committee (IRC) according to the Lugano Classification 2014.

RESULTS:

This study was prematurely terminated due to the slow rate of patient accrual. Between Oct 15th, 2018 and Oct 7th, 2020, 25 patients were enrolled and treated. By the data cutoff date on Dec 23rd, 2020, the IRC-assessed ORR was 68.0% (17/25; 95% confidence interval [CI] 46.5-85.1%), with the complete response rate of 24%. The disease control rate was 88% (22/25; 95%CI 68.8-97.5%). Median duration of response was not reached (NR) (95%CI, 5.62 months to NR), with 79.5% of patients having response durations of more than 12 months. Median progression-free survival was NR (95%CI, 6.83 months to NR). Treatment-related adverse events (TRAEs) were reported in 20 of 25 (80.0%) patients, and grade 3 or higher TRAEs occurred in 11 of 25 (44%) patients. No treatment-related deaths occurred. The immune-related adverse events (irAEs) of any grade were observed in 6 (24.0%) patients, and no grade 4 or grade 5 irAEs were reported.

CONCLUSION:

Geptanolimab (GB226) demonstrated promising efficacy and a manageable safety profile in Chinese patients with r/r PMBCL.

2021-12-01·Journal of hematology & oncology1区 · 医学

Efficacy and safety of geptanolimab (GB226) for relapsed or refractory peripheral T cell lymphoma: an open-label phase 2 study (Gxplore-002)

1区 · 医学

ArticleOA

作者: Ge, Zheng ; Xi, Yaming ; Xie, Liping ; Fan, Lei ; Shi, Yuankai ; Jin, Chuan ; Ke, Xiaoyan ; Zhang, Hongyu ; Zhou, Shengyu ; Cui, Jie ; Wu, Jianqiu ; Jiang, Ming ; Gao, Yuhuan ; Zhou, Hui ; Wang, Qian ; Guo, Ye ; Wang, Zhao ; Zhang, Yang ; Zhang, Weihua ; Zhang, Huilai ; Cen, Hong ; Zhang, Liling ; Li, Yufu ; Liu, Li ; Du, Xin ; Xie, Fan ; Peng, Zhigang ; Su, Hang ; Yang, Haiyan ; Shuang, Yuerong ; Feng, Ru ; Wang, Lin ; Wang, Zhen ; Zhang, Mingzhi ; Ma, Liping

Abstract:

Background:

Peripheral T cell lymphoma (PTCL) is a rare disease and recent approved drugs for relapsed/refractory (r/r) PTCL provided limited clinical benefit. We conducted this study to evaluate the efficacy and safety of geptanolimab (GB226), an anti-PD-1 antibody, in r/r PTCL patients.

Methods:

We did this single-arm, multicenter phase 2 study across 41 sites in China. Eligible patients with r/r PTCL received geptanolimab 3 mg/kg intravenously every 2 weeks until disease progression or intolerable toxicity. All patients who received at least one dose of geptanolimab and histological confirmed PTCL entered full analysis set (FAS). The primary endpoint was objective response rate (ORR) in FAS assessed by the independent radiological review committee (IRRC) per Lugano 2014 criteria.

Results:

Between July 12, 2018, and August 15, 2019, 102 patients were enrolled and received at least one dose of geptanolimab. At the data cutoff date (August 15, 2020), the median follow-up was 4.06 (range 0.30–22.9) months. For 89 patients in FAS, 36 achieved objective response (40.4%, 95% CI 30.2–51.4), of which 13 (14.6%) were complete response and 23 (25.8%) had partial response assessed by IRRC. The median duration of response (DOR) was 11.4 (95% CI 4.8 to not reached) months per IRRC. Patients with PD-L1 expression ≥ 50% derived more benefit from geptanolimab treatment compared to < 50% ones (ORR, 53.3% vs. 25.0%, p = 0.013; median PFS 6.2 vs. 1.5 months, p = 0.002). Grade ≥ 3 treatment-related adverse events occurred in 26 (25.5%) patients, and the most commonly observed were lymphocyte count decreased (n = 4) and platelet count decreased (n = 3). Serious adverse events were observed in 45 (44.1%) patients and 19 (18.6%) were treatment related.

Conclusions:

In this study, geptanolimab showed promising activity and manageable safety profile in patients with r/r PTCL. Anti-PD-1 antibody could be a new treatment approach for this patient population.Trial registration: This clinical trial was registered at the ClinicalTrials.gov (NCT03502629) on April 18, 2018.

项与杰诺单抗相关的新闻（医药）

2024-10-08

·药渡

嘉和生物与亿腾医药宣布合并

10月7日，嘉和生物发布公告，宣布与亿腾医药订立合并协议，嘉和生物将通过合并方式收购亿腾医药，合并后的新公司名称预计将改为亿腾嘉和。该交易以换股形式进行，该建议合并构成嘉和生物的反向收购，在合并后的新公司中原亿腾医药股东占比77.43%，原嘉和生物股东占比22.57%，亿腾医药实际控制人将成为合并公司的控股股东，同时，合并后新公司股东将包括高瓴、淡马锡、奥博资本、红杉资本等医药行业知名投资机构。合并资料显示，嘉和生物成立于2007年，主要从事肿瘤及自体免疫药物的开发及商业化，其于2020年10月于港交所上市，股东队伍包括高瓴、康恩贝、沃森生物，淡马锡、高盛、黑石、泰格医药旗下的观由资本等，其IPO获得了约1247倍的超额认购。刚上市时，嘉和生物手握十多款在研靶向药物，其中曲妥珠单抗类似药GB221、英夫利昔单抗类似药GB242、利妥昔单抗类似药GB241均已进入临床III期，PD-1药物GB226获得NDA优先审评。但上市之后，嘉和生物的产品商业化进展并不顺利。 2022年3月，其GB242（英夫利西单抗）获国家药品监督管理局批准，用于治疗类风湿性关节炎、强直性脊柱炎、银屑病、成人溃疡性结肠炎、成人及6岁以上儿童克罗恩病、瘘管性克罗恩病，该药也成为国产第3款英夫利西单抗生物类似药。不过基于激烈的竞争以及本身市场规模不大，2022年该药销售额为1190万元，之后其销售情况并未有具体披露。 2023年3月，嘉和生物用于治疗复发、难治性外周T细胞淋巴瘤（PTCL）的PD-1药物GB226的新药上市申请未获国家药监局批准，这也成为第一款被国家药监局拒绝批准上市的PD-1产品。据彼时嘉和生物方面向媒体表示，外周T细胞淋巴瘤包括有超过20种亚型，各亚型发病机制非常复杂，部分亚型发病机制尚不明确。目前全球没有PD-1产品被批准用于PTCL的治疗，所以国家药监局对于相关适应证产品的审评就更为谨慎。同时，GB242也早已不是公司的核心产品，从2022年开始，嘉和生物的核心产品就转为了GB491、GB261和GB263T三个双多抗产品。今年3月，嘉和生物口服CDK4/6抑制剂GB491（盐酸来罗西利片）联合来曲唑治疗既往未经过系统性抗肿瘤治疗的激素受体(HR)阳性、人表皮生长因子受体2(HER2) 阴性(HR+╱HER2-)晚期乳腺癌患者的新药上市许可申请获国家药监局受理，GB491也成为目前嘉和生物最受关注的产品。财务方面，2021年至2023年，嘉和生物的营收分别为0元、0.159亿元（主要通过GB242的药品销售及按服务收费合约向客户提供研究及制造服务产生的收益）、0元。截止2023年底，嘉和生物的员工数从264人缩减至104人，减员比例达到60.61%。不过，今年8月，嘉和生物宣布与TRC 2004达成许可及股权协议，将CD20/CD3双特异性抗体GB261除大中华区（中国大陆、香港、澳门及台湾）外全球权益授权给TRC 2004。根据协议条款，嘉和生物将获得数量可观的股权、数千万美元的首付款、高达4.43亿美元的里程碑付款以及净销售额个位数到双位数百分比的分层特许权使用费。这也使得其2024年收益增长，嘉和生物2024年上半年报显示，其总收益约为1450万元，主要归因于为付费服务合约项下的客户提供研究及制造服务；研发开支约为1.1亿元，同比减少51.2%，主要由于员工福利及新药研发费及临床试验开支减少；全面亏损总额约为1.32亿元，同比减少52.1%。截至2024年6月底，结余10.27亿元现金，足够支持公司未来5年的稳定运营。嘉和生物在此次的公告中称，其GB491商业化在即，公司的发展到了一个重要的阶段，需要有强大的商业能力来把握著一切可能的市场机遇。经评估多家潜在标的公司后，嘉和生物董事会认为亿腾医药符合上述标准，且与亿腾医药进行合并符合嘉和生物及股东的整体利益，亿腾医药拥有领先的具有巨大市场潜力的创新专利药物和具有竞争市场优势的原研产品的多元化组合，具备完善的商业化平台支持稳健的财务业绩，拥有行业领先的销售及营销网络支援协同管线的未来商业化，具有先进制造平台及全球供应链管理体系。 “借壳上市” 值得一提的是，此次嘉和生物与亿腾医药合并，对于亿腾医药而言，或也是一次“借壳上市”。早在2021年4月，亿腾医药就向港交所递交招股书，已先后四次递交招股书，但始终无法实现上市，此次与嘉和生物合并，也意味着其上市之路迎来新的转机。资料显示，亿腾医药成立于2001年，是一家拥有研发、制造、销售完整价值链能力的中国综合生物制药公司，聚焦于心血管、呼吸、抗感染等领域。产品管线方面，亿腾医药目前拥有3款核心商业化产品，分别是稳可信（注射用万古霉素）、希刻劳（头孢克洛胶囊）、亿瑞平（丙酸氟替卡松雾化吸入用混悬液），以及3款创新产品唯思沛（二十碳五烯酸乙酯）、稳可达（芦曲泊帕片）、景助达（恩替司他片）。据嘉和生物的公告称，亿腾医药的景助达（HDAC抑制剂，用于治疗HR+╱HER2－乳腺癌）预计将与嘉和生物的GB491在商业化方面及治疗HR+╱HER2－晚期乳腺癌方面产生有非常强的协同效应。财务方面，亿腾医药2021年至2023年的收入分别为20.73亿元、20.74亿元和23.03亿元，其中税后净利润分别约为1.57亿元、3.063亿元和3.08亿元。截至2023年底，亿腾医药三大主要商业化原研产品的总收入合共为21.92亿元，占该年度总收入的88.3%。截至2022年底，亿腾医药拥有超过300个区域分销商，覆盖中国30个省份的16000多家医院和13000多家药店。文 | 医谷药渡媒体商务合作媒体公关 | 新闻&会议发稿张经理：18600036371（微信同号）点击下方“药渡“，关注更多精彩内容免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！👇👇👇

并购临床3期生物类似药财报免疫疗法

2024-08-07

·复宏汉霖

ESMO 2024 | 复宏汉霖H药汉斯状及汉曲优多项最新研究结果入选

2024年欧洲肿瘤内科学会（ESMO）大会将于9月13日到17日在西班牙马德里盛大召开。复宏汉霖首个创新型单抗 H药汉斯状®（斯鲁利单抗）、中美欧三地获批的曲妥珠单抗生物类似药汉曲优®的多项最新研究结果入选本次大会。其中，由吉林省肿瘤医院程颖教授担任主要研究者牵头开展的H药针对广泛期小细胞肺癌（ES-SCLC）III期临床研究（ASTRUM-005）小细胞肺癌患者中吸烟相关突变的探索性研究，以及由同济大学附属东方医院周彩存教授牵头开展的H药针对鳞状非小细胞肺癌（sqNSCLC）的III期临床研究（ASTRUM-004）的探索性生物标志物分析结果将在大会上首次发布。 H药为复宏汉霖自主研发的重组人源化抗PD-1单抗注射液，也是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。以临床需求为导向，公司围绕H药进行了差异化、多维度的适应症布局，广泛覆盖肺癌、消化道肿瘤等高发大癌种。目前，H药已在中国获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）和食管鳞状细胞癌（ESCC），惠及患者超过7万人。此外，探索H药在多项差异化适应症中疗效的创新联合疗法正在进行中，如H药联合贝伐珠单抗及化疗一线治疗转移性结直肠癌（mCRC），联合化疗用于胃癌的新辅助/辅助治疗，联合化疗同步放疗治疗局限期小细胞肺癌等。汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）是复宏汉霖按照中国、欧盟和美国等生物类似药法规自主研发的曲妥珠单抗，也是公司首个通过FDA批准在美国开展商业化的产品，可用于治疗HER2阳性早期乳腺癌、转移性乳腺癌和转移性胃癌，涵盖原研已获批准的所有适应症。目前，汉曲优®已在全球47个国家和地区获批上市，累计惠及200,000+患者，为全球乳腺癌和胃癌患者带来可负担、高品质的治疗选择。以下为此次发布的详细信息： ASTRUM-005研究场次：SCLC 论文题目：Smoking-related genomic mutation patterns in patients with small cell lung cancer treated in ASTRUM-005 study（ASTRUM-005小细胞肺癌患者中吸烟相关突变的探索性研究）摘要编号：1796P 牵头主要研究者：程颖展示时间：2024年9月14日（中欧夏令时） ASTRUM-004研究场次：Biomarkers & translational research (agnostic) 论文题目：Exploratory biomarker analysis of phase 3 ASTRUM-004 study: serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer（斯鲁利单抗联合化疗一线治疗鳞状非小细胞肺癌的关键III期临床研究ASTRUM-004的探索性生物标志物分析）摘要编号：152P 牵头主要研究者：周彩存展示时间：2024年9月15日（中欧夏令时）场次：SCLC 论文题目：Consolidation Serplulimab Following Concurrent Hypofractionated Chemoradiotherapy for Limited-stage SCLC: Preliminary Analysis of Phase II ASTRUM-LC01 Study（ASTRUM-LC01 II 期临床试验：局限期小细胞肺癌低剂量放化疗后斯鲁利单抗巩固治疗的初步分析）摘要编号：1795P 主要研究者：毕楠展示时间：2024年9月14日（中欧夏令时）场次：NSCLC, early stage 论文题目：Perioperative serplulimab and chemotherapy in patients with resectable squamous non-small cell lung cancer: an open-label, single-arm, phase 2 trial（斯鲁利单抗联合化疗围术期治疗可切除鳞状非小细胞肺癌患者：一项开放标签的单臂II期临床试验）摘要编号：1225P 主要研究者：陈海泉展示时间：2024年9月14日（中欧夏令时）场次：SCLC 论文题目：Efficacy and Safety of Integrating Consolidative Thoracic Radiotherapy with Immunochemotherapy in ES-SCLC: A Real-world Retrospective Analysis（广泛期小细胞肺癌患者胸部放疗联合免疫疗法巩固治疗：一项真实世界研究的回顾性分析）摘要编号：1799P 主要研究者：刘成新展示时间：2024年9月14日（中欧夏令时）场次：Breast cancer, early stage 论文题目：Phase II study of pyrotinib plus albumin-bound paclitaxel and Trastuzumab (HLX02) as neoadjuvant treatment in HER2-positive, stage II-III breast cancer（吡咯替尼联合白蛋白紫杉醇及曲妥珠单抗HLX02用于HER2 阳性 II-III 期乳腺癌新辅助治疗的 II 期研究）摘要编号：275P 主要研究者：罗婷展示时间：2024年9月16日（中欧夏令时）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，已在中国上市5款产品，在国际获批上市3款产品，23项适应症获批，3个上市申请分别获中国药监局和欧盟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。继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）和汉贝泰®（贝伐珠单抗）相继获批上市，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。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。 Henlius to Release Latest Results of HANSIZHUANG and HANQUYOU at ESMO Congress 2024 2024 European Society of Medical Oncology (ESMO) Congress will take place from September 13-17 in Madrid, Spain. During the conference, Henlius will release multiple results on its first innovative product HANSIZHUANG (serplulimab) as well as its trastuzumab biosimilar approved in China, Europe and U.S., HANQUYOU. The results to be displayed include the smoking-related genomic mutation patterns in patients with small cell lung cancer treated in ASTRUM-005 study, a pivotal phase 3 clinical study of serplulimab for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) led by Professor Ying Cheng from Jilin Cancer Hospital, and the exploratory biomarker analysis of ASTRUM-004 study, a pivotal phase 3 clinical study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (sqNSCLC) led by Professor Caicun Zhou from Shanghai East Hospital, School of Medicine, Tongji University. HANSIZHUANG (serplulimab) is a recombinant humanised anti-PD-1 monoclonal antibody（mAb）injection independently developed by Henlius, and the world's first anti-PD-1 mAb approved for the first-line treatment of SCLC. Underpinned by the patient-centric strategy, Henlius has carried out a differentiated and multi-dimensional layout in the field of gastrointestinal cancer and lung cancer, covering a wide variety of indications. Up to date, HANSIZHUANG has been approved by the National Medical Products Administration (NMPA) for the treatment of MSI-H solid tumours, sqNSCLC, ES-SCLC, and esophageal squamous cell carcinoma (ESCC), benefiting more than 70,000 patients. Moreover, a wide variety of clinical trials on immuno-oncology combination therapies in differentiated indications has been initiated by the company to further explore the efficacy of the product, such as HANSIZHUANG plus bevacizumab and chemotherapy as first-line treatment for patients with metastatic colorectal cancer (mCRC) , HANSIZHUANG plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer (GC), and HANSIZHUANG plus chemotherapy and concurrent radiotherapy in patients with limited-stage small cell lung cancer (LS-SCLC),etc. HANQUYOU is the trastuzumab biosimilar independently developed by Henlius in accordance with the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and other international biosimilar guidelines. It is Henlius’ first FDA-approved product. HANQUYOU is indicated for the treatment of HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer, which corresponds to all the approved indications of the trastuzumab originator. Up to date, HANQUYOU has been approved in 47 countries and regions, benefiting 200,000+ patients, bringing affordable and high-quality treatment options to breast cancer and gastric cancer patients worldwide. Details of the presentation are as follows: ASTRUM-005 Study Session: SCLC Title: Smoking-related genomic mutation patterns in patients with small cell lung cancer treated in ASTRUM-005 study Presentation Number: 1796P Leading PI: Ying Cheng Onsite Poster display date: Saturday, 14 September 2024 ASTRUM-004 Study Session: Biomarkers & translational research (agnostic) Title: Exploratory biomarker analysis of phase 3 ASTRUM-004 study: serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer Presentation Number: 152P Leading PI: Caicun Zhou Onsite Poster display date: Sunday, 15 September 2024 Session: SCLC Title: Consolidation Serplulimab Following Concurrent Hypofractionated Chemoradiotherapy for Limited-stage SCLC: Preliminary Analysis of Phase II ASTRUM-LC01 Study Presentation Number: 1795P PI: Nan Bi Onsite Poster display date: Saturday, 14 September 2024 Session: NSCLC, early stage Title: Perioperative serplulimab and chemotherapy in patients with resectable squamous non-small cell lung cancer: an open-label, single-arm, phase 2 trial Presentation Number: 1225P PI: Haiquan Chen Onsite Poster display date: Saturday, 14 September 2024 Session: SCLC Title: Efficacy and Safety of Integrating Consolidative Thoracic Radiotherapy with Immunochemotherapy in ES-SCLC: A Real-world Retrospective Analysis Presentation Number: 1799P PI: Chengxin Liu Onsite Poster display date: Saturday, 14 September 2024 Session: Breast cancer, early stage Title: Phase II study of pyrotinib plus albumin-bound paclitaxel and Trastuzumab (HLX02) as neoadjuvant treatment in HER2-positive, stage II-III breast cancer Presentation Number：275P PI：Ting Luo Onsite Poster display date: Monday, 16 September 2024 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, 5 products have been launched in China, 3 have been approved for marketing in overseas markets, 23 indications are approved worldwide, and 3 marketing applications have been accepted for review in China 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 backbone. Apart from the launched products 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) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. 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期上市批准生物类似药临床结果

2024-06-19

·药渡

全球First-in-class！迪哲医药戈利昔替尼重磅获批

6月19日，迪哲医药的JAK抑制剂戈利昔替尼正式获得国家药品监督管理局（NMPA）批准，适应症为复发/难治外周Ｔ细胞淋巴瘤（r/r PTCL），成为全球首个且唯一治疗PTCL的高选择性JAK1抑制剂。这也意味着迪哲医药在一年的时间内获批了两款全球FIC/BIC的药物，这在本土Biotech中可谓“前无古人”。 1 全球首个且唯一针对T细胞淋巴瘤的JAK抑制剂戈利昔替尼是一款新一代口服、高选择性JAK1抑制剂。迪哲通过针对r/r PTCL的差异化适应症布局，获得全球首发优势，开启了一条难有竞争者的赛道。从数量上看，JAK抑制剂赛道已经十分拥挤，全球进入临床研究阶段的JAK抑制剂已超过100项，但这些药物关注的适应症多集中于自免领域，如类风湿关节炎、重症斑秃等。迪哲医药的戈利昔替尼是其中唯一一款专注于T细胞淋巴瘤的JAK抑制剂。就临床结果看，戈利昔替尼全面突破治疗瓶颈，为r/r PTCL患者带来更深缓解、全面获益、更长生存。此次获批，是基于全球关键性注册临床（JACKPOT8 B部分）研究成果，经IRC评估，戈利昔替尼单药显示出强效持久的抗肿瘤活性，客观缓解率（ORR）达44.3%，完全缓解（CR）率达23.9%，均是既往靶向治疗方案的近2倍，且在多种PTCL常见亚型中均观察到肿瘤缓解。同时，中位缓解持续时间（mDoR）长达20.7个月，远超现有疗法（小于12个月），可为患者带来更为持久的临床获益，该成果发表于国际知名顶刊《柳叶刀·肿瘤学》。 2022年2月，戈利昔替尼治疗r/r PTCL患者获得FDA授予快速通道认定。该认定将有助于公司大幅提高与FDA的沟通效率，加快戈利昔替尼在美国、欧盟注册的进程。 2 全新作用机制和独特分子设计改写PTCL十年无好药的窘境外周T细胞淋巴瘤（PTCL）通常泛指起源于胸腺后的成熟T/NK细胞淋巴瘤，是一组恶性程度高、异质性极强的恶性淋巴细胞增殖性疾病。 PTCL在所有非霍奇金淋巴瘤中生存率最低，大部分PTCL病理亚型的初诊患者会采取的治疗方案是以CHOP为基础的四联化疗。然而，患者初治缓解后仍存在极高的复发风险，生存预后极差，3年生存率仅有23%，中位OS仅5.8个月。图. 复发难治性PTCL中位OS情况然而，棘手的是，r/r PTCL发病机制复杂，这个领域要做成药很难，而现有药物又均不够理想。既往获批新药单药治疗整体ORR不及30%，CR率不到15%，且无法对各亚型PTCL均有效。流行病学调查显示，PTCL在亚洲人群中的发病率约是西方人群的两倍。在中国，PTCL发病率占非霍奇金淋巴瘤（NHL）的24.4%，而西方人群这一比例仅为5~10%。根据GLOBOCAN统计数据，中国2020年新发NHL患者人数约为9万，其中PTCL新发患者人数约2万例。疾病难治且发病率较低的情况下，欧美国家药企缺乏研发动力。可以说，假如中国企业不积极开发，此领域要诞生有效治疗药物可能遥遥无期。跨国药企曾几度尝试突破r/r PTCL，研究都以失败告终。而国内企业最近的尝试，比如嘉禾生物的PD-1杰诺单抗及恒瑞的PI3K林普利塞，也纷纷折戟。在戈利昔替尼诞生以前的过去十年里，全球范围内没有全面治疗PTCL的创新药成功上市。迪哲医药从源头开创了靶向JAK/STAT通路治疗PTCL的全新作用机制，填补了既往药物多个亚型的治疗空白。根据2022年WHO分类标准，PTCL包含39种亚型，我国占比较多的亚型有ENKTCL、PTCL-NOS、AITL，不同亚型具有不同的病理学特征和临床表现，对药物治疗的反应也不尽相同。针对r/r PTCL患者，指南推荐首选临床试验，目前推荐级别最高、临床应用较为广泛的治疗药物是2014年在中国获批上市的西达本胺。然而，西达本胺单药治疗r/r PTCL患者ORR为28%，仅对AITL亚型有效，整体疗效有限。与之相比，戈利昔替单药治疗r/r PTCL带来全面获益，针对多种亚型均表现出显著更高的缓解，填补了既往药物在多个亚型治疗上的空白。此外，戈利昔替尼独特的创新分子结构，实现对JAK1的极高选择性（选择性相对JAK家族其它成员高200~400倍）和长半衰期(戈利昔替尼在人体内的半衰期可长达近50个小时)。因此，戈利昔替尼能在对肿瘤进行持续抑制的同时，大幅提高治疗安全性和耐受性。事实上，戈利昔替尼的优秀，已获得重磅指南的认可。在今年4月举办的2024年CSCO指南大会上，戈利昔替尼凭借优异临床研究数据，提前获得最新发布的《CSCO淋巴瘤诊疗指南（2024版）》Ⅱ级推荐，用于治疗r/r PTCL患者。对于未获批上市的药品，II级推荐已为最高推荐级别，表明血液领域权威专家对戈利昔替尼临床研究质量及疗效的高度认可。 3 持续高效输出源头创新的能力迪哲医药曾对媒体表示，公司成立伊始就把快速形成自我造血机制作为公司发展的关键一步，公司的研发团队从自身优势领域入手，以最快速度把最有把握的产品推向市场。 PTCL领域里，戈利昔替尼是多个同期开展II期单臂关键性临床研究的产品中首个获批上市的国创新药。迪哲的高效创新能力从舒沃替尼的研发便开始展现，该药物从国内首例临床研究受试者入组到正式获批上市，仅用时不到4年，超越第三代EGFR-TKI药王奥希替尼在国内的效率（4.5年），树立了源头创新药临床推进速度新标准。 4 差异化FIC/BIC管线助力公司从中国走向全球一直以来，迪哲医药通过聚焦源头创新，打造富含FIC/BIC潜力，且极具差异化的管线布局。公司的首个上市新药舒沃替尼于2023年8月获批，为首款针对EGFR 20号外显子插入突变（exon20ins）晚期非小细胞肺癌（NSCLC）的国创新药。在短短7个月的时间内，舒沃替尼在自费市场就实现销售收入近2亿元，月均销售额更是已逼近同样针对“罕见靶点”且市场规模相当的MET抑制剂——赛沃替尼医保放量后的水平。眼见着肿瘤治疗药物市场的又一国产“爆款”即将登场。本次戈利昔替尼的获批又成为公司差异化道路的第二块试金石，它不仅为PTCL患者提供了全新治疗选择，更标志着迪哲医药在肿瘤领域的创新研发能力再获认可。后续管线中，迪哲医药针对B细胞非霍奇金淋巴瘤（B-NHL）的DZD8586也备受关注。BTK抑制剂对部分B-NHL疗效显著，但耐药问题仍是全球性挑战；同时，伴中枢神经系统淋巴瘤（CNSL）的患者预后很差，已上市BTK抑制剂血脑屏障穿透能力有限。作为全球首创可完全穿透血脑屏障的非共价LYN/BTK双靶点抑制剂，DZD8586可有效抑制多种B-NHL亚型细胞的生长，有望克服以上临床难点。 2023年ASH年会上，迪哲公布了DZD8586 针对多种B-NHL的临床数据。研究结果显示，50mg剂量下DZD8586针对多线治疗失败的B-NHL患者ORR达71.4%，其中在（弥漫大B细胞淋巴瘤）DLBCL患者中，ORR高达83.3%。针对DLBCL，目前全球尚无BTK抑制剂获批。DZD8586极具FIC/BIC潜力，这或是迪哲又一次“不走寻常路”策略的胜利。着眼未来，迪哲医药正加速其国际化步伐，推进产品海外上市，为全球病患带来更多治疗选择与希望。结语戈利昔替尼的获批，不仅仅只是为r/r PTCL患者带来更多生的希望，也在一定程度上承载了我国创新药研发历史上里程碑意义。同时，也给了国内Biotech更多的启示，与其在同质化靶点的“内卷”里打滚，不如提起勇气差异化布局，做前人所不能做之事，成功或许来得更快。参考资料： 1、迪哲医药官网、年报、公告等 2、《2024 CSCO指南更新|“新机制”与“新结构”双管齐下，全球首个高选择性JAK1抑3、制剂全面突破PTCL治疗瓶颈》，药事网，2024-05-08 4、《精准医学时代治疗外周T细胞淋巴瘤的新型药物研究进展》，山东第一医科大学（山东省医学科学院）学报[J],2023,44(1):1-9 5、《迪哲医药顺利摘U已不远?》，药渡数据，2023-12-20 点击下方“药渡“，关注更多精彩内容一文盘点2023年全国销售TOP10药品格局 2024年上半年FDA批准药物或新适应症（上） 2024年上半年FDA批准药物或新适应症（下）

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16417

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
外周T细胞淋巴瘤	申请上市	中国	嘉和生物药业有限公司	2020-07-21
宫颈癌	临床3期	-	嘉和生物药业有限公司	2023-07-05
纵隔大b细胞淋巴瘤	临床2期	-	嘉和生物药业有限公司	2023-07-05
子宫颈转移癌	临床2期	中国	嘉和生物药业有限公司	2019-05-23
复发性宫颈癌	临床2期	中国	嘉和生物药业有限公司	2019-05-23
PD-L1阳性宫颈癌	临床2期	中国	嘉和生物药业有限公司	2019-03-07
胸腺癌	临床2期	中国	嘉和生物药业有限公司	2018-12-18
B细胞淋巴瘤	临床2期	中国	嘉和生物药业有限公司	2018-10-15
肝细胞癌	临床2期	澳大利亚	Apollomics, Inc. (United States)	2018-09-05
肝细胞癌	临床2期	新西兰	Apollomics, Inc. (United States)	2018-09-05

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临床结果

适应症

分期

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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


NCT03808857 (ASCO2023) 人工标引	临床2期	PD-L1阳性宫颈癌二线 PD-L1 Expression	100	geptanolimab 3 mg/kg	鹹餘顧鹹選選憲選憲夢(範範鹽製廠遞醖鑰繭鏇) = 憲壓積顧築糧鹽襯選窪製廠製醖顧構鑰淵壓網 (構廠簾襯網膚壓糧蓋遞, 11.03 ~ 26.95) 更多	积极	2023-05-31
NCT03639181 (ESMO2021) 人工标引	临床2期	复发性原发性纵隔大B细胞淋巴瘤	25	Geptanolimab	築窪顧壓鬱繭顧齋衊衊(襯願蓋壓願構憲艱網糧) = 網糧築膚窪廠顧製積範憲艱壓廠構廠衊餘艱鹹 (積鑰願壓繭淵築襯繭顧, 42.52 ~ 82.03) 更多	积极	2021-09-19
NCT03977090 (ASCO2021) 人工标引	临床1期	转移性结直肠癌	15	geptanolimab+fruquintinib	鏇壓夢夢齋醖壓餘顧廠(網窪繭襯襯淵廠鏇窪艱) = geptanolimab (3mg/kg, every 2 weeks) and fruquintinib (4mg, once daily for 21 days on/7 days off) 淵窪繭繭構艱窪鬱淵壓 (餘醖範觸簾憲淵廠蓋繭 ) 更多	积极	2021-05-28
NCT03977090 (ASCO2021) 人工标引	临床1期	转移性结直肠癌	15	geptanolimab+fruquintinib (MSS)		积极	2021-05-28
NCT03502629 (Gxplore-002, Pubmed \| J Hematol Oncol) 人工标引	临床2期	外周T细胞淋巴瘤	102	geptanolimab	餘鏇範鹹顧鏇鬱壓醖積(艱製鹽鹽壓餘憲襯餘鹽) = 願製鑰壓膚醖餘繭齋廠餘艱淵窪壓憲鬱獵鑰遞 (憲鬱鹽製壓獵艱廠齋艱 ) 更多	积极	2021-01-12
NCT03623581 (Pubmed \| Clin Cancer Res) 人工标引	临床2期	肺泡软组织肉瘤	37	geptanolimab	選廠齋網繭窪蓋鑰築鬱(蓋醖製醖廠製鹽襯膚範) = 製範鹹窪餘願壓積餘蓋壓鹽淵鏇獵窪觸築壓鏇 (遞襯齋繭顧夢襯衊襯範, 22.5 ~ 55.2) 更多	积极	2020-12-15
CSCO2020	临床2期	复发性宫颈癌 \| PD-L1阳性宫颈癌 \| 转移性宫颈癌	46	杰诺单抗注射液(GB226)	醖顧憲蓋夢鏇廠簾壓壓(衊顧網範齋鹽艱膚築齋) = 9例(20.5%)发生与研究药物相关的严重不良事件(SAE) 齋衊鏇選憲蓋蓋衊壓蓋 (網餘廠齋顧遞齋顧襯鹹 ) 更多	-	2020-09-19
NCT03502629 (AACR2020)	临床2期	复发性T细胞淋巴瘤	102	Geptanolimab (GB226)	膚鏇鬱鏇鑰窪積鬱淵鏇(築齋夢糧製餘憲觸壓範) = 繭範糧製製鬱範餘範衊鏇積製鏇醖獵繭積餘醖 (製艱選夢觸艱艱膚鹹衊, 26.98% ~ 46.39%) 更多	积极	2020-08-15
NCT03053466 (ASCO2020) 人工标引	临床1期	复发性实体肿瘤	22	APL-501	襯鹹顧遞醖鏇築壓衊齋(衊網齋選齋鏇憲憲膚夢) = 鑰憲選壓餘繭醖醖鹹憲範糧艱糧襯鏇夢餘觸繭 (窪艱糧製網觸衊簾築製 ) 更多	积极	2020-05-29