Henlius, which is a subsidiary of the China-based Fosun Pharma Group, is developing the novel monoclonal antibody HLX10, which binds to and inhibits PD-1 and its downstream signalling pathways, potentially restoring immune function through activation of T cells and T-cell mediated immune responses against tumour cells.

The single-centre, phase I clinical study will evaluate the safety, tolerability and pharmacokinetics of the anti-PD-1 antibody (HLX10) in combination with the company’s candididate bevacizumab copy biological (HLX04) in patients with advanced solid tumours.

The trial will be carried out in 30 patients with histologically or cytologically confirmed advanced malignant solid tumours who have failed standard of care, or have no standard-of-care therapy or are not suitable for standard of care at the present stage.

Patients will receive intravenous injections of HLX10, at three dose levels (1 mg/kg, 3 mg/kg, 10 mg/kg) once every two weeks. In addition, HLX04, will be intravenously injected at a fixed dose of 5 mg/kg once every two weeks. The study drugs will be given in combination for up to two years or until the disease gets worse, whichever comes first.

The trial will be carried out in China and is expected to be completed in December 2020.

Henlius already completed a phase I pharmacokinetics, safety and immunogenicity trial with its candidate bevacizumab copy biological HLX04 in healthy male subjects in October 2017. The company is also currently recruiting for a phase II study in patients with advanced hepatocellular carcinoma and for a phase III study in patients with metastatic colorectal cancer (mCRC), which are expected to be completed in October 2021 and April 2020, respectively.

Henlius had its rituximab copy biological, Hanlikon, approved by China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration in February 2019 [1]. Then in June 2019, the company had the regulatory submission for its proposed trastuzumab biosimilar (HLX02) accepted by the European Medicines Agency [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. China approves rituximab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 18]. Available from: www.gabionline.net/Biosimilars/News/China-approves-rituximab-copy-biological
2. GaBI Online - Generics and Biosimilars Initiative. EMA accepts first application for Chinese-made biosimilar HLX02 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 18]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-first-application-for-Chinese-made-biosimilar-HLX02

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