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复宏汉霖HLX10新增乙肝适应症获中国台湾临床许可

2019-07-15 来源: 复宏汉霖 作者: 复宏汉霖
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关于慢性乙型肝炎

乙型肝炎病毒(HBV)是一种双链DNA病毒,属于肝炎病毒家族。据统计,全球有超过2.5亿乙肝病毒携带者,每年约有60万人死于与乙肝病毒相关的肝病。慢性HBV感染的特点是T细胞对HBV抗原反应不足,阻断程序性死亡蛋白(PD-1)可恢复HBV特异性T细胞应答,以治疗慢性乙型肝炎。

关于复宏汉霖

复宏汉霖是一家中国领先的生物制药公司,致力于为全球患者提供质高价优的创新生物药。自2010年成立以来,公司在中国上海、台北和美国加州均设有研发中心,已经建立并持续拓展全面的生物类似药及生物创新药产品管线,产品覆盖肿瘤、自身免疫性疾病等领域。

 

截至目前,复宏汉霖已有1个产品成功上市,2个产品获得新药上市申请受理,13个产品、6个联合治疗方案在全球范围内开展20多项临床试验。其中,公司首款重磅产品汉利康®(利妥昔单抗注射液)于2019年2月获国家药监局新药上市注册批准,成为中国首个获批上市的生物类似药。HLX03(阿达木单抗注射液)与HLX02(注射用曲妥珠单抗)已获国家药监局新药上市申请受理,现已纳入优先审评程序。HLX02相继在中国大陆、乌克兰、欧盟波兰和菲律宾全面启动国际多中心3期临床试验,成为国内首个开展国际多中心3期临床研究的生物类似药,并于2019年6月获欧洲药品管理局上市申请受理。

Henlius Novel Anti-PD-1 Antibody HLX10 Received Clinical Trial Approval in Taiwan for the Treatment of Hepatitis B

Henlius has recently received a clinical approval from the Taiwan Food and Drug Administration (TFDA) for its HLX10, a recombinant humanized anti-programmed death-1 (PD-1) monoclonal antibody, for the treatment of chronic hepatitis B infection.

HLX10, an innovative monoclonal antibody independently developed by Henlius, can be used with other therapies as combination immunotherapy for the treatment of various tumors. As of today, HLX10 has been approved to initiate clinical trials in the United States, Taiwan and mainland China. For the combination immunotherapy, the first patient was dosed in a phase 3 study of HLX10 in combination with chemotherapy as first-line treatment in subjects with local advanced or metastatic esophageal squamous cell carcinoma (ESCC). The clinical trial application of HLX10 in combination with HLX07, a fully humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody, has been submitted to the National Medical Product Administration (NMPA) for review. Its HLX10 in combination with HLX04, a bevacizumab biosimilar, has already been approved to initiate clinical trials by the NMPA in China. The HLX10+HLX04 study in patients with advanced solid tumors is the first combination immunotherapy clinical trial being approved to initiate in China.

Henlius actively diversifies its combination immunotherapies of its core HLX10 (anti-PD-1) and HLX20 (anti-programmed death ligand-1, anti-PD-L1) with other therapies. Currently, Henlius is actively exploring and developing, in collaboration with partners, opportunity of cancer immunotherapy to provide patients with efficacious and affordable therapeutic treatments.

About chronic hepatitis B

Hepatitis B virus (HBV) is a double-stranded DNA virus belonging to the family of hepadnaviruses. It is estimated that there are more than 250 million HBV carriers in the world, of whom approximately 600,000 die annually from HBV-related liver disease. Insufficient T cell response to HBV antigen is characteristic of chronic HBV infection. Blockade of program cell death protein (PD-1) can rescue HBV specific T cell response and could cure chronic HBV.

About Henlius

Henlius is a leading biopharmaceutical company in China that offers high-quality, affordable and innovative drugs to patients worldwide. Founded in 2010 and headquartered in Shanghai with two R&D centers in Taipei and California, Henlius has established and continues to expand its comprehensive product pipeline of biosimilars and bio-innovative drugs to treat tumors and autoimmune diseases.

Until now, in addition to one product launched commercially and two products under NDA/MAA review, Henlius has conducted over 20 clinical studies for 13 products and 6 combination therapies worldwide. HLX01 (rituximab injection), the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China. Moreover, HLX03 (adalimumab injection) and HLX02 (trastuzumab for injection) have their New Drug Applications under primary review by the NMPA. HLX02 is the first biosimilar developed in China to enter a global multi-center phase 3 clinical trial in China, Poland, Ukraine and the Philippines. In June 2019, the Marketing Authorization Application for HLX02 was accepted to review by EMA.

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