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Monoclonal Antibody HLX10 in Patients with Metastatic MSI-H/dMMR Solid Tumors


Recently, a Phase 2 study of HLX10, a recombinant humanized anti-programmed cell death protein 1 (PD-1) monoclonal antibody (mAb) injection developed by Henlius, has dosed the first patient. The study was conducted to evaluate the clinical efficacy, safety and tolerability of HLX10 as monotherapy in patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors who failed to respond to standard therapy.

HLX10, a noval mAb developed by Henlius independently, can be widely used in the treatment of solid tumors with other products as combination immunotherapy. Currently, HLX10 is also further developed for the treatment of chronic hepatitis b infection. HLX10 has been approved to initiate clinical trials in the United States, Taiwan China, and mainland China successively. For the combination immunotherapy, two Phase 3 trials of HLX10,  which were conducted to evaluate clinical efficacy and safety of HLX10 plus chemotherapy as first line treatment for patients with ESCC and sqNSCLC, have recently dosed their first patients. The investigational new drug (IND) of HLX10 in combination with HLX07, an innovative anti-EGFR mAb, has been accepted to review by NMPA. Moreover, HLX10 in combination with HLX04, a bevacizumab biosimilar, has been approved to initiate clinical trials for patients with advanced solid tumors as the first combination therapy study approved in China.

Henlius actively diversifies its combination immunotherapies of its core HLX10 (anti-PD-1 mAb) and HLX20 (anti-programmed death ligand-1, anti-PD-L1 mAb) with other therapies. Looking forward, the company will continue implementing the product development strategy to capture future immuno-oncology opportunities with the aim of providing more affordable and better therapeutic options for patients.

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.