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 China, Macau China and Taiwan China. 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 China, and the United States in 2016, with phase I clinical trials currently being conducted in Taiwan China. 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 China. 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 China. 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.