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

目的： 观察程序性死亡受体1（PD-1）/程序性死亡受体配体1（PD-L1）免疫检查点抑制剂在临床抗肿瘤过程中患者免疫治疗前后的心电图改变，探讨免疫检查点抑制剂心脏不良反应的发生及影响因素。 方法： 筛选2019年10月1日至2020年9月30日于中国医学科学院肿瘤医院病理诊断确诊为局部晚期或转移性实体瘤患者93例，行PD-1/PD-L1抑制剂单药治疗，根据治疗剂量不同分组，A组（PD-1单抗，药物代号：609A）剂量1 mg/kg，21 d为1个周期（16例）；B组（PD-1单抗，药物代号：HX008）剂量200 mg，21 d为1个周期（23例）；C组（PD-1单抗，杰诺单抗）剂量3 mg/kg，14 d为1个周期（28例）；D组（PD-L1单抗，药物代号：LP002）剂量900 mg，14 d为1个周期（26例），各自按疗程进行，监测随访10个周期，分别记录各组患者心电图检查结果，分析心电图异常情况与心脏不良反应发生的相关性。 结果： 共有75例患者相继出现符合诊断标准的心电图异常情况，A组患者免疫治疗前后的心电图异常率差异无统计学意义（P＞0.05），而B组免疫治疗前后心电图异常率增加且差异有统计学意义（均P＜0.05），C组和D组免疫治疗后心电图异常率显著升高，自身免疫治疗前后差异有统计学意义（P＜0.001）。A组出现心电图异常的患者例数（8例，50.0%，8/16）低于和B组（20例，87.0%，20/23），差异有统计学意义（P＜0.05），C组出现心电图异常的患者例数（24例，85.7%，24/28）与D组（23例，88.4%，23/26）比较，差异无统计学意义（P＞0.05），但心电图异常率均高于A组。合并基础病的患者在免疫治疗过程中心电不良事件的发生率为无基础病患者的1.938倍。B组、C组和D组患者免疫治疗过程中心电不良事件的发生率分别是A组患者的6.667倍、6.000倍、7.667倍。 结论： 免疫检查点抑制剂引起的心电图早期改变敏感性较高，能够及早预测相关心脏不良反应，是否合并基础病和药物剂量是发生心电不良事件的相关因素，心电图早期的改变为临床治疗及预防提供依据。.

2023-09-01·Cancer Immunology, Immunotherapy

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

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

AbstractBackgroundPeripheral 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.MethodsWe 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.ResultsBetween 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.ConclusionsIn 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）

2024-11-19

·复宏汉霖

ESMO Asia 2024 | 复宏汉霖将携5项研究成果精彩亮相

2024年12月6日至8日，欧洲肿瘤学会亚洲分会（ESMO Asia）年会将于新加坡召开。复宏汉霖将在本次大会上分享抗PD-1单抗H药汉斯状®、抗EGFR单抗HLX07、达雷妥尤单抗生物类似药HLX15等3款产品的最新临床研究数据。 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，目前已在中国和多个东南亚国家获批上市，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，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4项适应症，惠及患者超过8.5万人。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。 HLX07是复宏汉霖自主研发的针对EGFR靶点的创新型生物药。基于公司成熟的抗体工程改造平台，复宏汉霖在西妥昔单抗的基础上，将HLX07的Fab区人源化，同时使该产品聚糖含量降至最低，以具备更低的免疫原性和良好的靶点亲和力。目前，公司围绕食管鳞癌、皮肤鳞癌、鼻咽癌等多个实体瘤适应症，正在积极开展HLX07单药或联合H药的II期临床探索。 HLX15是复宏汉霖自主开发的一款全人源抗CD38 IgG1κ单克隆抗体，有望用于治疗多发性骨髓瘤（Multiple myeloma，MM）。参照中国、欧盟和美国的生物类似药技术指导原则的要求，复宏汉霖采用逐步递进、比对及相似性评价原则，对HLX15与原研达雷妥尤单抗进行了头对头的药学分析和体内外药理学比对研究。2024年6月，HLX15的I期临床研究已成功完成，达到了所有预设的研究终点。以下为此次入选ESMO Asia的详细信息： ASTRUM-004R研究：斯鲁利单抗一线治疗局部晚期或转移性鳞状非小细胞肺癌的多中心、单臂、真实世界研究论文题目：First-Line Serplulimab for Advanced Squamous Non-Small Cell Lung Cancer: A Multicenter, Single-Arm, Real-World ASTRUM-004R Study 摘要编号：682P 主要研究者：沈波，江苏省肿瘤医院、江苏省肿瘤研究所、南京医科大学附属肿瘤医院展示时间：2024年12月7日下午17:50-18:45（新加坡时间）晚期非透明细胞肾细胞癌（nccRCC）一线治疗中，呋喹替尼联合斯鲁利单抗的疗效和安全性：单臂、多中心临床试验场次：Mini Oral session: Genitourinary tumours 论文题目：Efficacy and safety of fruquintinib combined with serplulimab as 1st line treatment in advanced non-clear cell renal cell carcinoma (nccRCC): A single-arm, multicentre clinical trial 摘要编号：274MO 报告人：黄吉玮，上海交通大学医学院附属仁济医院演讲时间：2024年12月8日上午9:42 – 9:47（新加坡时间） HLX07-NPC：HLX07联合斯鲁利单抗和化疗对比安慰剂联合斯鲁利单抗和化疗作为鼻咽癌一线治疗：一项随机、双盲、多中心II期研究场次：Mini Oral session: Head and neck cancers 论文题目：First-line HLX07 vs. Placebo Combined with Serplulimab and Chemotherapy for Nasopharyngeal Cancer: a Randomised, Double-blind, Multicentre Phase 2 study 摘要编号：LBA3 牵头主要研究者：张力，中山大学肿瘤防治中心演讲时间：2024年12月7日下午14:40-14:45（新加坡时间） HLX07-CSCC：HLX07单药治疗晚期皮肤鳞状细胞癌的有效性和安全性：一项开放标签、多中心II期研究论文题目：Efficacy and Safety of HLX07 Monotherapy in Advanced Cutaneous Squamous Cell Carcinoma: an Open-label, Multicentre Phase 2 Study 摘要编号：759P 牵头主要研究者：李常兴，南方医科大学南方医院展示时间：2024年12月7日下午17:50-18:45（新加坡时间） HLX15-001：一项在男性健康受试者中比较HLX15和达雷妥尤单抗注射液的药代动力学特征、安全性、耐受性和免疫原性的I期临床研究论文题目：A Randomised, Double-blind, Phase I Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of HLX15 and Daratumumab in Healthy Male Participants 摘要编号：63P 牵头主要研究者：苏钰文，南京医科大学附属逸夫医院展示时间：2024年12月7日下午17:50-18:45（新加坡时间）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，3款产品在国际获批上市，24项适应症获批，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）以及汉奈佳®（奈拉替尼），此外，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 Showcase Latest Results of 5 Clinical Trails at ESMO Asia 2024 From 6 to 8 December 2024, the European Society for Medical Oncology Asia (ESMO Asia) Congress will be held in Singapore. At this congress, Henlius will share the latest results of clinical trials of several products, including HANSIZHUANG (serplulimab), HLX07 (anti-EGFR mAb), and daratumumab biosimilar HLX15. 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. It has been approved in China and multiple countries in Southeastern Asia. 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 4 indications, benefiting more than 85,000 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. HLX07 is an innovative drug targeting EGFR independently developed by Henlius. Adopting the self-developed advanced antibody engineering platform, Henlius re-engineered cetuximab by humanising its Fab regions and minimizing its glycan contents to generate HLX07 to reduce immunogenicity and maintain a high binding affinity of the product. Currently, Henlius is conducting phase 2 clinical trials to explore HLX07 as monotherapy or in combination with HANSIZHUANG (serplulimab) for the treatment of solid tumours including esophageal squamous cell carcinoma (ESCC), cutaneous squamous cell carcinoma (CSCC), and nasopharyngeal carcinoma (NPC). HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius. The indication to be developed for HLX15 is multiple myeloma (MM). In accordance with the biosimilar guidelines of NMPA, EMA, and FDA, HLX15 has been developed strictly following the principles of stepwise development, comparability and similarity assessment and has been compared head-to-head with reference daratumumab via analytical studies and preclinical studies. In June 2024, the phase 1 clinical trial of HLX15 met its primary endpoint. Results to be presented at the ESMO Asia 2024 are as follows: ASTRUM-004R Study Title: First-Line Serplulimab for Advanced Squamous Non-Small Cell Lung Cancer: A Multicenter, Single-Arm, Real-World ASTRUM-004R Study Presentation Number: 682P Speaker: Bo Shen, Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital, Nanjing Medical University Time: December 7, 2024, 17:50-18:45 PM SGT Session: Mini Oral session: Genitourinary tumours Title: Efficacy and safety of fruquintinib combined with serplulimab as 1st line treatment in advanced non-clear cell renal cell carcinoma (nccRCC): A single-arm, multicentre clinical trial Presentation Number: 274MO Speaker: Jiwei Huang, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Time: December 8, 2024, 9:42 – 9:47 AM SGT HLX07-NPC Session: Mini Oral session: Head and neck cancers Title: First-line HLX07 vs. Placebo Combined with Serplulimab and Chemotherapy for Nasopharyngeal Cancer: a Randomised, Double-blind, Multicentre Phase 2 study Presentation Number: LBA3 Leading PI: Li Zhang, Sun Yat-sen University Cancer Center Time: December 7, 2024, 14:40-14:45 PM SGT HLX07-CSCC Title: Efficacy and Safety of HLX07 Monotherapy in Advanced Cutaneous Squamous Cell Carcinoma: an Open-label, Multicentre Phase 2 Study Presentation Number: 759P Leading PI: Changxin Li, Southern Medical University Nanfang Hospital Time: December 7, 2024, 17:50-18:45 PM SGT HLX15-001 Title: A Randomised, Double-blind, Phase I Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of HLX15 and Daratumumab in Healthy Male Participants Presentation Number: 63P Leading PI: Yu-wen Su, Sir Run Run Hospital, Nanjing Medical University Time: December 7, 2024, 17:50-18:45 PM SGT 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, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, 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 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), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and 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

生物类似药上市批准临床1期

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

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研发状态

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
宫颈癌	临床3期	-	嘉和生物药业有限公司	2023-07-05
肺泡软组织肉瘤	临床2期	中国	嘉和生物药业有限公司	2018-08-20
肉瘤	临床2期	-	浙江冠科美博生物科技有限公司	-
胸腺瘤	临床2期	-	浙江冠科美博生物科技有限公司	-
外周T细胞淋巴瘤	临床前	中国	嘉和生物药业有限公司	2020-07-21
肝细胞癌	药物发现	新西兰	Apollomics, Inc. (United States)	2018-09-05
肝细胞癌	药物发现	澳大利亚	Apollomics, Inc. (United States)	2018-09-05
肾细胞癌	药物发现	新西兰	Apollomics, Inc. (United States)	2018-09-05
肾细胞癌	药物发现	澳大利亚	Apollomics, Inc. (United States)	2018-09-05
复发性T细胞淋巴瘤	药物发现	中国	嘉和生物药业有限公司	2018-07-02

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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


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	(衊醖構鏇鬱觸襯鑰廠膚) = 鹽遞醖衊醖廠鏇觸簾製窪獵廠淵遞積糧繭壓遞 (顧憲顧鏇鑰觸簾製鬱餘, 11.03 ~ 26.95) 更多	积极	2023-05-31
NCT03977090 (ASCO2021) 人工标引	临床1期	转移性结直肠癌	15	geptanolimab+fruquintinib	(襯艱鏇積鬱艱觸鏇網糧) = geptanolimab (3mg/kg, every 2 weeks) and fruquintinib (4mg, once daily for 21 days on/7 days off) 顧鑰糧鹽蓋鏇壓廠鏇鏇 (窪艱壓製餘鬱構簾鹹窪 ) 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	(鹹齋積衊觸壓簾窪構膚) = 淵鹹艱廠獵鹽鏇膚積築糧製艱鏇衊簾獵鑰醖醖 (範製襯蓋願遞範鏇願廠 ) 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	(艱餘鹹鑰鬱襯繭廠顧廠) = 構獵選顧衊製顧鹹獵願觸遞鹹窪壓鬱膚製蓋淵 (鹹衊選範衊淵願繭獵願, 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)	(糧簾顧醖齋鏇願壓選鏇) = 9例(20.5%)发生与研究药物相关的严重不良事件(SAE) 鏇觸願鑰鬱範簾醖願製 (製襯鏇鑰選鏇鹹簾蓋窪 ) 更多	-	2020-09-19
NCT03502629 (AACR2020)	临床2期	复发性T细胞淋巴瘤	102	Geptanolimab (GB226)	(襯選艱糧範願鏇齋醖鹽) = 遞鑰鑰觸鬱範製憲遞鹹觸遞選獵襯簾簾鬱鬱製 (蓋醖壓簾願鏇願鑰鏇襯, 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	(憲積鹽網繭鏇齋繭憲鹹) = 觸餘餘選壓鑰觸構蓋膚壓蓋膚夢選鑰夢夢製膚 (憲鹹壓製積顧淵選糧糧 ) 更多	积极	2020-05-29