A Randomized, Double-blind, Multi-center, Phase II Study to Evaluate the Anti-tumor Efficacy, Safety and Tolerability of HLX53 (an Anti-TIGIT Fc Fusion Protein) Combined with Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) Compared to Placebo + Serplulimab + HLX04, in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

开始日期2024-08-05

申办/合作机构

上海复宏汉霖生物技术股份有限公司

CTR20241634

/ Recruiting临床2期

一项评估HLX53（抗TIGIT 的Fc 融合蛋白）联合斯鲁利单抗注射液（HLX10，重组抗 PD-1 抗体）及HLX04（贝伐珠单抗生物类似药），对比安慰剂+斯鲁利单抗+HLX04，在未经治疗的局晚期或转移性肝癌患者的有效性、安全性和耐受性的随机、双盲、多中心II 期临床研究

PART A：主要目的：评估HLX53+HLX10 +HLX04 一线治疗晚期HCC中的安全性和耐受性次要目的：初步评估HLX53+HLX10+HLX04一线治疗晚期HCC中的临床疗效 PART B：主要目的：评估HLX53+HLX10+HLX04对比安慰剂+HLX10+HLX04一线治疗晚期HCC中的临床疗效次要目的：初步评估HLX53+HLX10+HLX04对比安慰剂+HLX10+HLX04一线治疗晚期HCC中的安全性和耐受性评估HLX53+HLX10+HLX04对比安慰剂+HLX10+HLX04治疗晚期HCC的潜在预测性生物标志物及耐药生物标志物

开始日期2024-08-05

申办/合作机构

上海复宏汉霖生物技术股份有限公司

NCT06491355

/ Not yet recruiting临床2期IIT

Efficacy and Safety of First-Line Treatment Induced With mFOLFOX6 and HLX04 Regimen, Following Combined With Serplulimab in MSS Initially Unresectable Metastatic Colorectal Cancer: A Prospective, Multicenter, Randomized, Controlled Trial (ASTRUM-IUmCRC)

This is a prospective, multi-center, randomized controlled clinical intervention study, aiming to explore the effectiveness and safety of mfolfox6 and hlx04 regimens combined with slulimumab as first-line treatment for MSS-type initial unresectable metastatic colorectal cancer after induction therapy. This study plans to include a total of 72 patients with untreated MSS-type initial unresectable metastatic colorectal cancer.
This study randomly allocated groups through a randomization system, and entered the following treatment groups at a ratio of 1:1: (1) Experimental group: mfolfox6 and hlx04 regimen induction therapy followed by slulimab treatment (36 cases); (2) Control group Group: mfolfox6 and hlx04 regimen treatment (36 cases).

开始日期2024-07-01

申办/合作机构

Sir Run Run Shaw Hospital

100 项与贝伐珠单抗生物类似药 (上海复宏汉霖) 相关的临床结果

登录后查看更多信息

100 项与贝伐珠单抗生物类似药 (上海复宏汉霖) 相关的转化医学

登录后查看更多信息

100 项与贝伐珠单抗生物类似药 (上海复宏汉霖) 相关的专利（医药）

登录后查看更多信息

项与贝伐珠单抗生物类似药 (上海复宏汉霖) 相关的文献（医药）

2024-09-01·Med

Adding first-line PD-1 inhibition to anti-VEGF and XELOX in pMMR metastatic colorectal cancer: Steppingstones, stumbling blocks, and next phase

Article

作者: Søreide, Kjetil ; Veen, Torhild

In the randomized, double-blind, multicenter study by Wang et al.,¹ the addition of serplulimab (a PD-1 antibody) to anti-VEGF (HLX04; a bevacizumab biosimilar) together with chemotherapy (XELOX) was deemed to be tolerable and safe and may improve progression-free survival. However, even if adverse events were comparable, oncological endpoints including survival need to be confirmed in the next phase 3 study.

2024-09-01·Med

First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial

Article

作者: Wang, Feng ; Ke, Ying ; Cao, Bangwei ; Sun, Meili ; Luo, Suxia ; Yang, Liu ; Liang, Xinjun ; Zhang, Mingjun ; Jin, Yongdong ; Li, Jing ; Xu, Rui-Hua ; Wang, Qingyu ; Chen, Kehe ; Wang, Wei ; Deng, Yanhong ; Lin, Yuan ; Zhu, Jun ; Cheng, Ying ; Wang, Zi-Xian ; Peng, Junjie ; Li, Zhen ; Zhang, Jingdong ; Yu, Haoyu

BACKGROUND:

Whether or not the addition of immunotherapy to current standard-of-care treatments can improve efficacy in proficient mismatch repair (pMMR)/microsatellite-stable (MSS) metastatic colorectal cancer (mCRC), the predominant type of mCRC, is unclear.

METHODS:

This randomized, double-blind, phase 2 part of a phase 2/3 trial was conducted at 23 hospitals across China (ClinicalTrials.gov: NCT04547166). Patients with unresectable metastatic/recurrent colorectal adenocarcinoma and no prior systemic therapy were randomly assigned 1:1 to receive every-3-weeks intravenous serplulimab (300 mg) plus HLX04 (7.5 mg/kg) and XELOX (serplulimab group) or placebo (300 mg) plus bevacizumab (7.5 mg/kg) and XELOX (placebo group). The primary endpoint was independent radiology review committee (IRRC)-assessed progression-free survival (PFS). Secondary endpoints included other efficacy endpoints and safety.

FINDINGS:

Between July 16, 2021, and January 20, 2022, 114 patients were enrolled and randomly assigned to the serplulimab (n = 57) or placebo (n = 57) group. All patients had stage IV CRC, and 95.7% of the patients with available microsatellite instability (MSI) status were MSS. With a median follow-up duration of 17.7 months, median PFS was prolonged in the serplulimab group (17.2 vs. 10.7 months; hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.31-1.14). Although the median overall survival (OS) was not reached for either group, a trend of an OS benefit was observed for the serplulimab group (HR, 0.77; 95% CI, 0.41-1.45). 36 (65.5%) and 32 (56.1%) patients in the serplulimab and placebo groups had grade ≥3 treatment-related adverse events, respectively.

CONCLUSIONS:

Serplulimab plus HLX04 and XELOX exhibits promising efficacy and is safe and tolerable in patients with treatment-naive mCRC.

FUNDING:

This work was funded by Shanghai Henlius Biotech, Inc.

2023-07-01·Analytical and Bioanalytical Chemistry

Demonstrating analytical similarity of a biosimilar HLX04 to bevacizumab with a panel of state-of-the-art methods and tiering of quality attributes.

Article

作者: Fei, Mengdan ; Cao, Yanjing ; Wang, Hongya ; Yu, Lu ; Qin, Peilan ; Shen, Pengcheng ; Lu, Lihong ; Xu, Yanpeng ; Gao, Wenyuan ; Zhang, Lei ; Liu, Kemeng ; Zhang, Zhongli

Therapeutical monoclonal antibodies are structurally and functionally complex, whereas the innovator's manufacturing processes are proprietary. With respect to the similarity assessment, a proposed biosimilar product needs to demonstrate a side-by-side comparison between the reference product (RP) and candidate product in terms of physicochemical properties and biological activities, as well as nonclinical and clinical outcomes. Here, a comprehensive analytical similarity assessment was performed for in-depth comparison of HLX04, China-sourced Avastin^® (CN-Avastin^®), and Europe-sourced Avastin^® (EU-Avastin^®) following a tier-based quality attribute (QA) evaluation. A series of orthogonal and state-of-the-art analytical techniques were developed for the assessment. Ten lots of HLX04 were compared with 29 lots bevacizumab RP. Referred to the characterization results, HLX04 is highly similar to the RPs with respect to physicochemical properties and biological functions. In addition, HLX04 was found with similar stability and degradation behaviors upon multiple stressed conditions to bevacizumab. Minor differences were observed in glycosylation, aggregates, FcγRIIIa(F), and FcγRIIIa(V) binding activities; nevertheless, they were evaluated and demonstrated not to impact clinical outcomes. According to the reported clinical results, the totality of evidence, including the pharmacokinetic, efficacy, safety, and immunogenicity, further shows that HLX04 is similar to CN-/EU-Avastin^®.

246

项与贝伐珠单抗生物类似药 (上海复宏汉霖) 相关的新闻（医药）

2025-02-20

·复星医药

汉贝泰®首次海外获批，复星医药子公司复宏汉霖加速拓展拉美市场

汉贝泰®首次海外获批，获得玻利维亚AGEMED批准上市复宏汉霖第四款海外获批自研产品，持续拓展新兴市场携手Eurofarma，三款合作产品均实现合作区域获批上市近期，复星医药子公司复宏汉霖自主开发和生产的汉贝泰®（贝伐珠单抗注射液）正式获得玻利维亚国家药品与卫生技术局（Agencia Estatal de Medicamentos y Tecnologías en Salud，AGEMED）批准上市，商品名为LONGIVA。这一里程碑标志着汉贝泰®成为继汉曲优®（曲妥珠单抗）、H药汉斯状®（斯鲁利单抗）、汉利康®（利妥昔单抗）后，复宏汉霖第四款在海外获批上市的自主研发和生产的产品，进一步推动了公司的全球化进程。未来，复宏汉霖将始终坚守“可负担的创新，值得信赖的品质”这一初心，持续推动更多产品在全球获批上市，以惠及更广泛的患者群体。 Henlius Bevacizumab Secures First Overseas Approval, Accelerating Henlius' Expansion into Latin American Market • HANBEITAI (bevacizumab) receives first overseas approval from Bolivia's AGEMED • The 4th self-developed product of Henlius approved overseas, continuing to expand into emerging markets • In collaboration with Eurofarma, all three partnered products have been approved for marketing in the partnered regions Recently, HANBEITAI (bevacizumab), independently developed and produced by Henlius, has been officially approved by Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) for marketing in Bolivia under the trade name LONGIVA. This milestone marks HANBEITAI as the fourth self-developed and -manufactured product of Henlius to be approved for overseas marketing, following HANQUYOU (trastuzumab), HANSIZHUANG (serplulimab), and HANLIKANG (rituximab). This further propels the company's globalization process. The approval is based on the exclusive commercial cooperation between Henlius and Eurofarma, a leading pharmaceutical company in Brazil and Latin America. In 2022, Henlius entered into a license agreement with Eurofarma for the development, manufacturing and commercialization in 16 Latin American countries of Henlius' independently developed HANLIKANG, HANQUYOU, and HANBEITAI. Leveraging Henlius' leading product quality and Eurofarma's strong local capabilities, HANQUYOU and HANLIKANG have already been approved for marketing in Latin American countries including Bolivia. The approval of HANBEITAI by AGEMED signifies that all three partnered products have been successfully approved in the partnered territories, highlighting the fruitful outcomes of the close collaboration. HANBEITAI’s development, manufacturing and the quality management system are in line with global standards. The approval of HANBEITAI by AGEMED in Bolivia is mainly based on the review of a series of data. The application dossier is mainly based on the information submitted to China’s National Medical Products Administration (NMPA) in the New Drug Application (NDA). Henlius has conducted a set of head-to-head comparisons between HANBEITAI and the reference bevacizumab, including analytical similarity studies, non-clinical studies and clinical studies. The results showed that HANBEITAI and the reference product are highly similar in terms of quality, safety and efficacy. Henlius’ three production sites – Xuhui Facility, Songjiang First Plant and Songjiang Second Plant – along with their quality management systems, have successfully passed approximately 100 inspections and audits conducted by NMPA, the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), PIC/S members Indonesia Food and Drug Administration (BPOM) and Brazilian National Health Surveillance Agency (ANVISA), and the EU qualified person, as well as multiple international business partners. Moving forward, Henlius remains committed to its mission of "Affordable innovation, Reliable Quality", continuing to drive the global approval and marketing of more products to benefit a broader patient population.

上市批准引进/卖出

2025-02-19

·氨基观察

首款国产ROR1 ADC出海；晶泰科技配股融资20.88亿港币

氨基观察-创新药组原创出品作者 | 黄凯国产ROR1 ADC拉开出海序幕。 2月19日，石药集团公告，子公司巨石生物与Radiance Biopharma达成协议，后者将获得巨石生物自主研发的重组抗人类受体酪氨酸激酶样孤儿受体1(ROR1)抗体偶联药物SYS6005项目在一定区域范围内的开发和商业化等权利。晶泰科技持续获得资本市场认可。 2月19日，晶泰科技公告表示，拟配股融资20.88亿港币，每股价格为6.1港币。新冠口服药明星企业真实生物二战IPO。 2月18日，据港交所官网，真实生物递交港交所上市申请。真实生物致力于探索并解决抗病毒和抗肿瘤领域现有治疗方案中的耐药性问题，目前的核心产品为1.1类原创新药阿兹夫定。在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。 / 01 / 市场速递 1）德琪医药宣布计划接入DeepSeek以加速后续管线研发 2月19日，德琪医药宣布，公司计划加大投入，整合资源成立专门的AI部门。这一举措包括本地部署DeepSeek以加速具有空间位阻遮蔽效应的T细胞衔接器（TCE）平台后续管线研发。 2）石药集团ROR1 ADC出海 2月19日，石药集团公告，子公司巨石生物与Radiance Biopharma达成协议，后者将获得巨石生物自主研发的重组抗人类受体酪氨酸激酶样孤儿受体1(ROR1)抗体偶联药物SYS6005项目在一定区域范围内的开发和商业化等权利。 3）康龙化成完成对海心智惠控股 2月19日，康龙化成宣布，其子公司康龙化成临床已完成对浙江海心智惠科技有限公司的控股交易。 4）石牧出任武田中国肿瘤负责人日前，武田中国抗肿瘤事业部有了新的人事任命，从2025年 2月17日起，石牧正式加入武田中国，担任抗肿瘤事业部负责人，直接向武田中国高层汇报。 / 02 / 资本信息 1）晶泰科技配股融资20.88亿港币 2月19日，晶泰科技公告表示，拟配股融资20.88亿港币，每股价格为6.1港币。 2）真实生物申请港交所上市 2月18日，据港交所官网，真实生物递交港交所上市申请。真实生物致力于探索并解决抗病毒和抗肿瘤领域现有治疗方案中的耐药性问题，目前的核心产品为1.1类原创新药阿兹夫定。 / 03 / 医药动态 1）蒽恺赛生物NKC007细胞注射液获临床许可 2月19日，据CDE官网，蒽恺赛生物NKC007细胞注射液获临床许可，拟用于复发/难治性急性髓系白血病。 2）科兴中维冻干呼吸道合胞病毒mRNA疫苗获临床许可 2月19日，据CDE官网，科兴中维冻干呼吸道合胞病毒mRNA疫苗获临床许可，用于预防呼吸道合胞病毒感染所致的下呼吸道疾病。 3）中盛溯源NCR101注射液获临床许可 2月19日，据CDE官网，中盛溯源NCR101注射液获临床许可，拟开展治疗间质性肺病的研究。 4）维泰瑞隆SIR2501片获临床许可 2月19日，据CDE官网，维泰瑞隆SIR2501片获临床许可，拟开展治疗肌萎缩侧索硬化的研究。 5）复宏汉霖第四款产品在海外获批 2 月 19 日，复宏汉霖宣布，其自主开发和生产的汉贝泰®（贝伐珠单抗注射液）正式获得玻利维亚国家药品与卫生技术局批准上市，商品名为 LONGIVA。这是复宏汉霖第四款在海外获批上市的自主研发和生产的产品。 / 04 / 器械跟踪 1）科心医疗半自动体外除颤仪不予注册 2月19日，据NMPA官网，科心医疗半自动体外除颤仪不予注册。 2）键嘉医疗科技骨科手术导航定位系统获注册许可 2月19日，据NMPA官网，键嘉医疗科技骨科手术导航定位系统获注册许可。 / 05 / 数字医疗日报 1）讯飞医疗与一脉阳光达成战略合作 2月19日，讯飞医疗科技宣布，与一脉阳光于近日订立战略合作协议，双方拟在业务市场开发、优势产品和业务模式的深度合作、创新的智慧医疗业务投资模式设计、医疗垂类认知大模型及医学影像AI诊断大模型的合作研发及共同探索智能化的健康管理等领域开展合作。 2）复星健康云HIS上线DeepSeek AI助手日前，复星健康云HIS（新一代智慧医疗云平台）通过集成DeepSeek-R1满血版，在云HIS平台上推出了一款全新的AI助手，并在复星健康大湾区四家医院同步上线。这款助手能高效地辅助剖析患者病历，为医生提供极具针对性的诊断建议，并基于患者的个体差异，深度融合海量临床病例数据与前沿医学研究成果，为医生推荐高度个性化的治疗方案。 3）轻松健康集团全面融合DeepSeek 日前，轻松健康集团宣布，完成与DeepSeek的技术整合。 / 06 / 海外药闻 1）诺和诺德申请冻结亨利医药资产 2月14日，诺和诺德向新加坡国际商事法院申请了冻结令，要求冻结亨利医药及Huang Zhenhua在新加坡的资产。诺和声称，KBP在出售高血压和肾病治疗药物Ocedurenone的时，故意隐瞒了该药物临床试验中的不利数据，从而误导其进行收购。诺和计划启动仲裁，索赔8.3亿美元。 2）拜耳帕金森病基因疗法获FDA再生医学先进疗法认定 2月19日，拜耳全资拥有并独立运营的基因治疗子公司AskBio宣布：其用于治疗帕金森病的基因治疗药物AB-1005已获得美国FDA授予的再生医学先进疗法认定。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

抗体药物偶联物IPO信使RNA疫苗孤儿药

2025-02-19

·复宏汉霖

产品速递 | 汉贝泰®首次海外获批，复宏汉霖加速拓展拉美市场

汉贝泰®首次海外获批，获得玻利维亚AGEMED批准上市复宏汉霖第四款海外获批自研产品，持续拓展新兴市场携手Eurofarma，三款合作产品均实现合作区域获批上市近期，复宏汉霖自主开发和生产的汉贝泰®（贝伐珠单抗注射液）正式获得玻利维亚国家药品与卫生技术局（Agencia Estatal de Medicamentos y Tecnologías en Salud，AGEMED）批准上市，商品名为LONGIVA。这一里程碑标志着汉贝泰®成为继汉曲优®（曲妥珠单抗）、H药汉斯状®（斯鲁利单抗）、汉利康®（利妥昔单抗）后，复宏汉霖第四款在海外获批上市的自主研发和生产的产品，进一步推动了公司的全球化进程。此次获批是基于复宏汉霖与巴西及拉美地区领先的制药公司Eurofarma的独家商业化合作。2022年，复宏汉霖与Eurofarma达成合作，授权其在16个拉美地区国家对公司自主开发的利妥昔单抗汉利康®、曲妥珠单抗汉曲优®、贝伐珠单抗汉贝泰®三款产品进行开发、生产和商业化权益。依托复宏汉霖领先的产品品质和Eurofarma强大的本地化能力，汉曲优®和汉利康®已在玻利维亚等拉美国家获批上市。此次汉贝泰®获AGEMED批准上市，标志着双方合作的三款产品在合作区域均已实现获批，充分体现了双方紧密合作的丰硕成果。汉贝泰®的研发、生产和质量控制环节遵循国际最高标准。此次汉贝泰®在玻利维亚获批主要基于AGEMED对一系列研究数据的审查，相关申报资料主要基于该产品递交中国国家药品监督管理局（NMPA）上市许可申请（NDA）的资料。复宏汉霖针对汉贝泰®开展了一系列与原研贝伐珠单抗的头对头比对研究，包括药学比对研究、非临床比对研究和临床比对研究，研究结果证明汉贝泰®在质量、安全性和有效性等方面与原研药高度相似。公司生产基地及配套的质量管理体系已通过约百项由NMPA、欧洲药品管理局（EMA）、美国食品药品监督管理局（FDA）、PIC/S成员印尼食品药品监督管理局（BPOM）和巴西国家卫生监督管理局（ANVISA）、欧盟质量受权人（QP）及公司国际商业合作伙伴进行的多项实地核查及审计。未来，复宏汉霖将始终坚守“可负担的创新，值得信赖的品质”这一初心，持续推动更多产品在全球获批上市，以惠及更广泛的患者群体。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。 Henlius Bevacizumab Secures First Overseas Approval, Accelerating Henlius' Expansion into Latin American Market • HANBEITAI (bevacizumab) receives first overseas approval from Bolivia's AGEMED • The 4th self-developed product of Henlius approved overseas, continuing to expand into emerging markets • In collaboration with Eurofarma, all three partnered products have been approved for marketing in the partnered regions Recently, HANBEITAI (bevacizumab), independently developed and produced by Henlius, has been officially approved by Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) for marketing in Bolivia under the trade name LONGIVA. This milestone marks HANBEITAI as the fourth self-developed and -manufactured product of Henlius to be approved for overseas marketing, following HANQUYOU (trastuzumab), HANSIZHUANG (serplulimab), and HANLIKANG (rituximab). This further propels the company's globalization process. The approval is based on the exclusive commercial cooperation between Henlius and Eurofarma, a leading pharmaceutical company in Brazil and Latin America. In 2022, Henlius entered into a license agreement with Eurofarma for the development, manufacturing and commercialization in 16 Latin American countries of Henlius' independently developed HANLIKANG, HANQUYOU, and HANBEITAI. Leveraging Henlius' leading product quality and Eurofarma's strong local capabilities, HANQUYOU and HANLIKANG have already been approved for marketing in Latin American countries including Bolivia. The approval of HANBEITAI by AGEMED signifies that all three partnered products have been successfully approved in the partnered territories, highlighting the fruitful outcomes of the close collaboration. HANBEITAI’s development, manufacturing and the quality management system are in line with global standards. The approval of HANBEITAI by AGEMED in Bolivia is mainly based on the review of a series of data. The application dossier is mainly based on the information submitted to China’s National Medical Products Administration (NMPA) in the New Drug Application (NDA). Henlius has conducted a set of head-to-head comparisons between HANBEITAI and the reference bevacizumab, including analytical similarity studies, non-clinical studies and clinical studies. The results showed that HANBEITAI and the reference product are highly similar in terms of quality, safety and efficacy. Henlius’ three production sites – Xuhui Facility, Songjiang First Plant and Songjiang Second Plant – along with their quality management systems, have successfully passed approximately 100 inspections and audits conducted by NMPA, the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), PIC/S members Indonesia Food and Drug Administration (BPOM) and Brazilian National Health Surveillance Agency (ANVISA), and the EU qualified person, as well as multiple international business partners. Moving forward, Henlius remains committed to its mission of "Affordable innovation, Reliable Quality", continuing to drive the global approval and marketing of more products to benefit a broader patient population. 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

上市批准

100 项与贝伐珠单抗生物类似药 (上海复宏汉霖) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC07	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
输卵管癌	中国	上海复宏汉霖生物制药有限公司	2023-01-03
卵巢上皮癌	中国	上海复宏汉霖生物制药有限公司	2023-01-03
原发性腹膜癌	中国	上海复宏汉霖生物制药有限公司	2023-01-03
宫颈癌	中国	上海复宏汉霖生物制药有限公司	2023-01-03
结直肠癌	中国	上海复宏汉霖生物制药有限公司	2021-11-30
非小细胞肺癌	中国	上海复宏汉霖生物制药有限公司	2021-11-30

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
非鳞状非小细胞肺癌	临床3期	中国	上海复星医药产业发展有限公司	2023-01-30
肝细胞癌	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2022-11-15
湿性年龄相关性黄斑变性	临床3期	俄罗斯	上海复宏汉霖生物技术股份有限公司	2021-04-06
转移性结直肠癌	临床3期	日本	上海复宏汉霖生物技术股份有限公司	2021-03-10
晚期肺非鳞状非小细胞癌	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2019-12-12
恶性上皮肿瘤	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2019-12-02
鳞状非小细胞肺癌	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2019-12-02
门静脉血栓形成	临床2期	-	上海复宏汉霖生物技术股份有限公司	2021-08-01
晚期肝细胞癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2019-09-24
晚期恶性实体瘤	临床1期	中国	上海复宏汉霖生物技术股份有限公司	2018-11-27

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03973112 (Phase 2 study of serplulimab with the bevacizumab biosimilar HLX04, Pubmed \| Cancer Immunol Immunother)	临床2期	晚期肝细胞癌一线	61	Serplulimab 3 mg/kg + HLX04 5 mg/kg	艱築窪簾遞齋鬱鏇糧廠(窪顧廠窪憲顧齋醖廠觸) = One patient died from adverse events that were considered related to study treatment 糧繭範淵選衊齋壓餘鑰 (鏇鹹遞襯築範範構膚壓 )	积极	2025-01-03
NCT04547166 (ASCO_GI2024) 人工标引	临床2/3期	转移性结直肠癌一线 Deficient DNA Mismatch Repair (dMMR) \| MSI-High \| Microsatellite Stable (MSS) \| ... 更多	114	Serplulimab+HLX04+XELOX	遞顧願蓋觸膚簾夢膚構(廠蓋簾齋製艱築齋齋鬱) = 顧獵憲糧築製淵窪襯淵窪獵繭獵鹽艱醖簾夢鑰 (憲鏇鹹積鹹簾製築構網 ) 更多	积极	2024-01-18
				Placebo+ bevacizumab+ XELOX	遞顧願蓋觸膚簾夢膚構(廠蓋簾齋製艱築齋齋鬱) = 繭觸廠鏇積鹹鏇構夢糧窪獵繭獵鹽艱醖簾夢鑰 (憲鏇鹹積鹹簾製築構網 ) 更多
NCT03973112 (ESMO_ASIA2023)	临床2期	晚期肝细胞癌	-	Serplulimab 3 mg/kg + HLX04 5 mg/kg	構積製膚築糧齋憲製壓(夢艱範淵衊蓋選遞構構) = 10 (47.6%) patients in group C and 29 (47.5%) in group D reported grade ≥3 treatment-emergent adverse events 糧獵範艱選衊簾鏇餘膚 (鏇膚鹽鬱淵鬱製淵鏇網 ) 更多	-	2023-12-02
				Serplulimab 3 mg/kg + HLX04 10 mg/kg
NCT04993352 (Pubmed) 人工标引	临床1/2期	湿性年龄相关性黄斑变性	1	HLX04-O	觸膚觸網窪構簾膚選製(觸遞醖鹹繭醖簾顧壓範) = 醖鏇憲願選蓋餘觸壓構壓鏇築憲觸繭艱網觸淵 (廠襯顧夢壓鏇築觸蓋構 ) 更多	积极	2022-09-18
NCT03973112 (Corporate Publications) 人工标引	临床2期	晚期肝细胞癌	41	Serplulimab 3 mg/kg+HLX04 5 mg/kg	簾鬱餘蓋構壓願獵襯鏇(艱艱積觸膚網遞醖鑰構) = 淵簾構鬱醖餘鑰選齋憲衊膚鹽夢衊壓繭範獵範 (艱襯醖鹹獵顧願構選築 ) 更多	积极	2022-08-30
				Serplulimab 3 mg/kg+HLX04 10 mg/kg	簾鬱餘蓋構壓願獵襯鏇(艱艱積觸膚網遞醖鑰構) = 選衊窪鬱夢築鹹選鏇簾衊膚鹽夢衊壓繭範獵範 (艱襯醖鹹獵顧願構選築 ) 更多
NCT03511963 (HLX04-mCRC03, Corporate Publications) 人工标引	临床3期	结直肠癌一线	675	Chemotherapy+HLX04	襯艱構範遞遞窪範窪壓(憲襯願襯鬱醖鹽膚鹹憲) = 鑰選積範製衊積餘醖觸鑰積蓋製醖鹽選顧鹹憲 (壓襯鏇壓築憲餘夢廠衊 ) 更多	相似	2021-09-26
				Chemotherapy+bevacizumab	襯艱構範遞遞窪範窪壓(憲襯願襯鬱醖鹽膚鹹憲) = 鹹願遞鏇窪構餘廠範壓鑰積蓋製醖鹽選顧鹹憲 (壓襯鏇壓築憲餘夢廠衊 ) 更多
NCT03511963 (HLX04-mCRC03, CSCO2021)	临床3期	转移性结直肠癌一线	677	HLX04	積窪窪鹹醖淵壓窪網網(夢鏇鹽醖觸壓醖衊選繭) = 醖齋淵糧繭積齋選夢遞願願簾獵築願網夢衊夢 (簾鏇淵淵齋顧遞範顧繭 ) 更多	积极	2021-09-25
				Reference bevacizumab	積窪窪鹹醖淵壓窪網網(夢鏇鹽醖觸壓醖衊選繭) = 膚廠醖獵餘製齋築繭選願願簾獵築願網夢衊夢 (簾鏇淵淵齋顧遞範顧繭 ) 更多
NCT03511963 (HLX04-mCRC03, Pubmed) 人工标引	临床3期	转移性结直肠癌一线	677	XELOX or mFOLFOX6+HLX04	網製糧築鬱窪鏇構齋糧(鑰網構繭鏇壓艱憲糧積) = 遞顧齋願襯壓壓構齋壓鹽願膚膚廠積繭鬱網鏇 (淵鏇範衊糧蓋廠糧獵鹹, 41.1 ~ 51.8)	相似	2021-07-01
				XELOX or mFOLFOX6+Bevacizumab	網製糧築鬱窪鏇構齋糧(鑰網構繭鏇壓艱憲糧積) = 鹹網齋鑰繭鬱遞窪構鑰鹽願膚膚廠積繭鬱網鏇 (淵鏇範衊糧蓋廠糧獵鹹, 45.4 ~ 56.1)
NCT03511963 (HLX04-mCRC03, ESMO_ASIA2020)	临床3期	转移性结直肠癌一线 KRAS/BARF mutation	-	HLX04	鹹糧壓遞憲鑰顧鹽糧獵(艱膚齋鹽願鏇鹽簾鹹艱) = 鹹鹹鑰廠積獵窪網網繭築構繭壓鏇鑰憲齋製醖 (醖淵範積構膚鑰鬱糧鏇 )	积极	2020-11-22
				Bevacizumab	鹹糧壓遞憲鑰顧鹽糧獵(艱膚齋鹽願鏇鹽簾鹹艱) = 鏇艱艱廠網衊繭構築膚築構繭壓鏇鑰憲齋製醖 (醖淵範積構膚鑰鬱糧鏇 )
NCT03511963 (HLX04-mCRC03, ESMO_ASIA2018)	临床3期	转移性结直肠癌一线	640	HLX04	積簾獵選築築鹽艱壓網(淵鹹範憲壓鬱艱簾觸積) = 鏇範選顧廠遞鏇願襯鹹鹹鑰構鑰築膚獵鏇憲獵 (築網鹽蓋蓋製願衊衊範 )	积极	2018-11-24
				Avastin® sourced from US, EU or CN	積簾獵選築築鹽艱壓網(淵鹹範憲壓鬱艱簾觸積) = 鹹憲繭範構網顧觸憲餘鹹鑰構鑰築膚獵鏇憲獵 (築網鹽蓋蓋製願衊衊範 )