近日迪士尼彩乐园代理网址，复星医药子公司复宏汉霖H药 汉斯状（斯鲁利单抗）纠合汉贝泰（贝伐珠单抗，HLX04）在晚期肝细胞癌（HCC）患者中开展的II期临床有计划（NCT）最新数据发表于Cancer Immunology, Immunotherapy（IF 4.6）。有计划成果袒露，H药纠合汉贝泰在先前未经调理的晚期肝细胞癌患者中具有可控的安全性，并展现出剖释的抗肿瘤活性。
Liver Cancer
这次在Cancer Immunology, Immunotherapy发表的最新数据聚焦既往未禁受系统抗肿瘤调理的患者（n=61）的数据，患者每2周静脉输注一次斯鲁利单抗3 mg/kg纠合HLX04 10 mg/kg。主要至极为安全性，次要至极包括客不雅缓解率（ORR）、总糊口期（OS）、无发达糊口期（PFS）、合手续缓解时辰（DoR）等。遗弃2023年2月7日，斯鲁利单抗纠合HLX04展现出考究的安全性和耐受性。在可评估灵验性分析集（EES）东说念主群中（n=58），经寥落影像评估委员会评估的ORR为29.3%（95%置信区间[CI]：18.1–42.7），中位PFS为7.3个月（95% CI：2.8–11.0），中位DoR为12.7 个月 (95% CI: 4.5–不行评估)。在17名有缓解的患者中，12名（70.6%）DoR达到或逾越6个月。该有计划成果袒露，斯鲁利单抗、HLX04相等纠合疗法在既往未经调理的晚期HCC患者中的安全性特征，与既往报说念的抗PD-1单抗单药、贝伐珠单抗单药以及阿替利珠单抗纠合贝伐珠单抗的调理决议均一致。此外，相较于现存同类抗PD-(L)1居品，斯鲁利单抗和HLX04纠合疗法在中国东说念主群中展现出同样或更大糊口获益。该有计划数据有望为斯鲁利单抗纠合抗血管生成药物在HCC一线的临床实验提供依据。
张开剩余89%畴前，复宏汉霖将合手续加码立异，以临床需求为先导，陆续高效地为环球患者提供更多可职守、疗效更好的调理决议。
对于复宏汉霖
复宏汉霖（2696.HK）是一家外西化的立异生物制药公司，勤勉于为环球患者提供可职守的高品性生物药，迪士尼彩乐园官方网址居品掩饰肿瘤、自己免疫疾病、眼科疾病等规模，已有6款居品在中国获批上市，3款居品在外洋获批上市，4个上市恳求分辩获中国药监局、好意思国FDA和欧盟EMA受理。自2010年树立以来，复宏汉霖已建成一体化生物制药平台，高效及立异的自主中枢智商说合研发、分娩及交易运营全产业链。公司已树立完善高效的环球立异中心，按照外洋药品分娩质地贬责程序（GMP）程序进行分娩和质地管控，不休夯实一体化抽象分娩平台，其中，公司交易化分娩基地已接踵取得中国、欧盟和好意思国GMP认证。
复宏汉霖前瞻性布局了一个多元化、高质地的居品管线，涵盖50多个分子，并全面激动基于自有抗PD-1单抗H药汉斯状的肿瘤免疫纠合疗法。遗弃现在，公司已获批上市居品包括国内首个生物雷同药汉利康（利妥昔单抗）、自主研发的中好意思欧三地获批单抗生物雷同药汉曲优（曲妥珠单抗，好意思国商品名：HERCESSI，欧洲商品名：Zercepac）、汉达远（阿达木单抗）、汉贝泰（贝伐珠单抗）、环球首个获批一线调理小细胞肺癌的抗PD-1单抗汉斯状（斯鲁利单抗）以及汉奈佳（奈拉替尼）。公司亦同步就16个居品在环球边界内开展30多项临床磨练，对外授权全面掩饰西洋主流生物药阛阓和稠密新兴阛阓。
Serplulimab plus HLX04 for HCC: Phase 2 Results Published in Cancer Immunology, Immunotherapy
Recently, the latest data from Henlius' Phase II clinical study (NCT) of serplulimab (HANSIZHUANG) in combination with HLX04 (bevacizumab) for the treatment of advanced hepatocellular carcinoma (HCC) were published in Cancer Immunology, Immunotherapy. The study demonstrated that the combination therapy of serplulimab with HLX04 showed a manageable safety profile and promising anti-tumor efficacy in previously untreated patients with advanced HCC.
The NCT study is an open-label, multicenter, single-arm, phase 2 clinical trial aimed to evaluate the safety and efficacy of serplulimab as monotherapy or in combination with HLX04 in patients with advanced hepatocellular carcinoma (HCC). Data from this study were first published in the renowned hepatology journal Liver Cancer in 2022, presenting the results of the combination therapy in patients who had received prior systemic therapy. Patients received intravenous infusions of serplulimab at 3 mg/kg every two weeks in combination with different doses of HLX04 (5 mg/kg or 10 mg/kg). The study results demonstrated that the combination of serplulimab and HANBEITAI showed a manageable safety profile and favorable anti-tumor activity in patients with previously treated advanced HCC.
The latest data published in Cancer Immunology, Immunotherapy focus on the subgroup of patients (n=61) who had not previously received systemic treatment. These patients received intravenous infusions of serplulimab (3 mg/kg) combined with HLX04 (10 mg/kg) every two weeks. The primary endpoint was safety, while secondary endpoints included objective response rate (ORR), overall survival (OS), progression-free survival (PFS), and duration of response (DoR), among others. As of February 7, 2023, the combination therapy of serplulimab and HLX04 was well tolerated in patients with aHCC in the first-line setting. In the efficacy evaluable set (EES) of patients (n=58), the ORR was 29.3% (95% CI: 18.1–42.7) as assessed by an independent radiological review committee (IRRC) per RECIST v1.1. The median PFS was 7.3 months (95% CI: 2.8–11.0), and the median DoR was 12.7 months (95% CI: 4.5–not evaluable [NE]). Notably, among the 17 patients who achieved a response, 12 (70.6%) had a DoR of at least 6 months.
The study results showed that the safety profile of serplulimab, HLX04, and their combination therapy in patients with previously untreated advanced HCC was consistent with those reported for monotherapy with anti-PD-1 inhibitors, bevacizumab, and the combination of atezolizumab plus bevacizumab. Moreover, compared to other PD-(L)1 inhibitors, the combination therapy of serplulimab and HLX04 conferred similar or greater survival benefit in the Chinese population. These findings may provide a basis for the clinical application of serplulimab in combination with anti-angiogenic agents as a first-line treatment for HCC.
HANSIZHUANG, the world's first anti-PD-1 mAb approved for the first-line treatment of SCLC developed by Henlius, has been approved in China and several Southeast Asian countries, benefiting over 90,000 patients to date. Focusing on gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. This includes extensive clinical development in high-incidence cancers such as colorectal cancer, gastric cancer, liver cancer, and esophageal cancer. In September 2023, the combination of HANSIZHUANG and chemotherapy for the first-line treatment of unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC) was approved by the National Medical Products Administration (NMPA), offering a new immunotherapy option for patients with ESCC. Additionally, HANSIZHUANG has led the way with a phase 3 clinical study on neoadjuvant/adjuvant therapies for gastric cancer, striving to benefit gastric cancer patients from the early line of immunotherapy. Furthermore, the international multicenter clinical study (ASTRUM-015) of HANSIZHUANG in combination with bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer (mCRC) has launched its phase 3 stage and completed the first patient dosing in China, Japan, and Indonesia. With the accelerated progress, HANSIZHUANG is expected to become the world's first anti-PD-1 mAb for previously untreated mCRC and fill the clinical gap in first-line immunotherapy in these patients.
Looking forward, Henlius will actively improve efficiency through innovations, focusing on unmet medical needs to bring more high-quality and affordable therapies to patients worldwide.
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, 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, 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.
(复星医药)
发布于：北京市不同于传统障碍赛迪士尼彩乐园代理网址，飓风赛不设置头带、计时芯片或排名，更多关注个人突破与团队协作。本次赛事的赛道设计巧妙融入了山峰、湖泊、峡谷与城堡等元素，极具挑战性和观赏性，夜间任务的加入更为赛事增添了神秘感与刺激感。
