Recently, HLX20, a recombinant fully human anti-PD-L1 monoclonal antibody developed by Shanghai Henlius Biotech, Inc., received a notice from Therapeutic Goods Administration (TGA)，Australia，about the approval of Phase I clinical trial for the treatment of advanced solid tumors in Australia.
In December 2017, HLX20 has filed the IND to the Chinese Food and Drug Administration (CFDA). The initiation of this Phase I Clinical trial of HLX20 make an important milestone for Henlius as its first clinical trial in Australia. It is also a reflection of Henlius’ ability to execute international strategy to carry out global multi-center clinical studies.
HLX20 and HLX10 (a PD-1 inhibitor) are both strategic programs of Henlius novel pipeline, with a large potential to be applied widely in cancer immunotherapy in the future. At present, the developing of cancer immunotherapy is to treat patients combined anti-PD-1/L1 mAbs and other 1-2 mAbs, which could improve the response rate when the monotherapy of PD-1/L1 inhibitor is not effective enough. However the cost of antibody research, development and production is very high in some pharmaceutical companies in Europe and the United States, resulting in a single course of combination treatment costs up to about 100,000 US dollars. It’s quite difficult to afford even for the patients in developed countries. With the innovative strategy of “combination therapy”, Henlius also manage to reduce manufacturing costs to make all of its products more cost-effective. Henlius believe that its combination therapy which contains 2 to 3 mAbs will be no more expensive than a single imported mAb. In this way, it can significantly increase the accessibility of combination treatment, making the vision of affordable combination therapy probably achievable soon.
About PD-1/PD-L1 Inhibitors
PD-1/PD-L1 inhibitors are a novel group of checkpoint inhibitors being developed for the immunotherapy of cancer. HLX10 (PD-1 inhibitor) and HLX20 (PD-L1 inhibitor) act to inhibit the association of the programmed death-ligand 1 (PD-L1) with its receptor, programmed cell death protein 1 (PD-1), thus activating the immune system to attack the tumor. Since first PD-1 inhibitor approved by the US Food and Drug Administration in 2014 for the treatment of melanoma, the indications were extended to non-small cell lung cancer, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma carcinoma, Hodgkin's lymphoma, microsatellite instability-high cancer, and Merkel cell carcinoma.
About Henlius
Shanghai Henlius Biotech, Inc., a joint venture company founded by Fosun Pharma and a team of overseas scientists in December 2009, specializes in the discovery, development, manufacturing and commercialization of high-quality biological therapeutics to treat a range of chronic and often life-threatening diseases.
As of now, Henlius has completed IND filings of 11 products with 16 indications, and 4 biosimilar mAbs of these are in late-stage development currently. Apart from biosimilars, Henlius has been devoting continuous efforts in developing novel monoclonal antibodies in a timely fashion. Phase I clinical trials of the first 3 novel products were conducted successfully.
In October 2017, Henlius submitted its first New Drug Application (NDA) of HLX01 (Rituximab Injection) to CFDA, which soon assigned HLX01 into its priority evaluation list in early 2018, making HLX01 potentially the first approved biosimilar in China. Recently, Henlius has completed its first Phase III study of HLX01 investigating its efficacy.