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复宏汉霖创新型抗HER2单抗1期临床研究完成首例患者给药

2019-08-01 来源: 复宏汉霖 作者: 复宏汉霖
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近日,复宏汉霖创新型抗HER2单抗HLX22 1期临床研究在中国完成首例患者给药。该新药的临床1期试验在HER2过表达晚期实体瘤患者中开展,以评价其安全性、耐受性、药代动力学及药效学特性。

据悉,HLX22是复宏汉霖从AbClon, Inc.受让、并后续自主研发的创新型治疗用生物制品,是一款针对HER2靶点开发的人源化lgG1单克隆抗体注射液。目前,复宏汉霖已获得HLX22单抗注射液全球范围内的开发与商业化权利。

未来,HLX22不仅将作为单药产品在乳腺癌和胃癌的治疗中发挥重要作用,更有机会协同同靶点产品HLX02(复宏汉霖自主研发的注射用曲妥珠单抗),成为HER2阳性胃癌国际First-in-class的联合治疗方案,进一步推动复宏汉霖全球化战略的落地,以质高价优的生物药,造福全球更多病患。

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个联合治疗致力于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 Innovative Anti-HER2 Monoclonal Antibody HLX22 Have Dosed First Patient for Its Phase 1 Study

Recently, the first patient was dosed in a phase 1 study of HLX22, an innovative humanized lgG1 monoclonal antibody injection targeting human epidermal growth factor receptor-2 (HER2). The study is conducted to evaluate safety, tolerability and pharmacokinetics of HLX22 in patients with advanced solid tumors with over-expressed HER2.

Henlius introduced HLX22 from AbClon, Inc. (AbClon), researched and developed it independently as follows. As of now, Henlius has been granted exclusive rights to develop and commercialize HLX22 globally.

With the good performance in pre-clinical stage, HLX22 is expected not only to be used as mono-therapy in the treatment of GC and BC, but also in combination with HLX02 (a trastuzumab biosimilar developed by Henlius), making it a potentially first-in-class combination therapy in GC in the world. Looking forward, Henlius will continue to promote the implementation of the globalization strategy to achieve the vision of providing all patients with high-quality and affordable protein therapeutics.

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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