创新单抗家族再添新成员 | 复宏汉霖与Galaxy正式签署许可协议

近日，上海复宏汉霖生物技术股份有限公司（以下简称“复宏汉霖”）与美国Galaxy Biotech, LLC（以下简称“Galaxy”）就一种作用于死亡受体路径的创新单抗（以下简称“该产品”）正式签署许可协议。基于协议条款，Galaxy 授权复宏汉霖于中国大陆、香港及澳门特别行政区以及台湾地区对该产品进行独家研发、使用、销售、要约出售、进出口及其他商业化行为。同时，未来复宏汉霖可根据约定行使选择权，将该产品的独家许可区域延伸至全球。

据悉，该产品系作用于死亡受体路径的创新单克隆抗体，其潜在适应症为多种实体瘤与血液恶性肿瘤。截至目前，全球尚未有针对死亡受体靶点的同类药物上市。

以单抗生物类似药为先导，复宏汉霖创新型单抗产品也快速跟进。通过本次合作，将进一步丰富复宏汉霖的创新单抗产品线。复宏汉霖已有三个创新单抗获得临床批件。HLX07（抗EGFR单抗）率先于2016年获得中国大陆、台湾和美国三地临床批准，I期临床试验现于台湾开展。HLX06（抗VEGFR2单抗）是复宏汉霖第二个实现三地临床申报的创新单抗药物。截至目前，HLX06已经在台湾启动临床I期研究。HLX10以当前市场上最受关注的PD-1为靶点，按照类似HLX06的研发布局开展申报工作，已于2017年正式获得美国、台湾食品药品监督管理局的临床试验许可，未来可广泛应用于癌症的免疫疗法。目前，复宏汉霖HLX10已在台湾启动临床I期研究。HLX20以PD-L1为靶点，当前已经获得国家食药监总局临床注册审评受理。此外，多种创新型单抗药物处于临床前研究阶段。

复宏汉霖创新型单抗产品线

Henlius and Galaxy signed a license agreement for new novel mAbs

Recently, Shanghai Henlius Biotech, Inc.（hereinafter referred to as ‘Henlius’）and Galaxy Biotech, LLC (an American company, hereinafter referred to as ‘Galaxy’) have formally signed a license agreement for novel monoclonal antibodies (mAbs) targeting the Death Receptor (DR) pathway (hereinafter referred to as ‘the Products’). Based on the terms of the agreement, Henlius is exclusively authorized to develop, use, sell, offer for sale, import and export,  and otherwise commercialize the Products in the licensed territory including mainland China, Hong Kong, Macau and Taiwan. Furthermore, Henlius can be granted an option to extend the licensed territory to the entire world  in the future.

The Products are novel mAbs targeting the DR pathway with a potential wide variery of indications including multiple solid tumors and hematological malignancies. Until now, there is no DR-targeted antibody therapeutics on the global market. 

With mAb biosimilars as leading products, Henlius has been devoting continuous efforts in developing innovative mAbs in a timely fashion. Through this cooperation, Henlius’ pipeline of novel products will be further expanded and enhanced. Henlius has already obtained IND approvals for three novel mAbs . HLX07 (anti-EGFR mAb) led the way by obtaining clinical trial approvals from Mainland China, Taiwan, and the United States in 2016, with phase I clinical trials currently being conducted in Taiwan. HLX06 (anti-VEGFR2 mAb), the second innovative product developed by Henlius also obtained regulatory approvals in the same three territories in 2017. HLX06 is currently in phase I clinical trials in Taiwan. Sharing the similar research and development (R&D) filing strategy as HLX06, HLX10, which targets PD-1,  has been officially approved by the Food and Drug Administration (FDA) and Taiwan Food and Drug Administration (TFDA) in 2017 for clinical trials and has a great potential to be widely applied in immunotherapies for cancers. Currently, the phase I clinical trials of HLX10 have also been initiated in Taiwan. HLX20, a mAb targeting PD-L1, has been recently filed to the China Food and Drug Administration (CFDA) for clinical trials. Additionally, multiple novel monoclonal antibodies for oncology indications are being developed by Henlius scientists, and they are currently in pre-clinical  R&D phases.

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