On the evening of the 17th, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) announced that the company’s subsidiary Shanghai Hangzhou Alltest Biotech Co.Ltd(688606) Pharmaceutical Co., Ltd. (hereinafter referred to as “huaaotai”) recently received a notice of approval of the application for clinical trial of hb0036 injection submitted to the U.S. Food and Drug Administration (hereinafter referred to as “FDA”).
In December 2021, the clinical trial of hb0036 injection submitted by huaaotai to FDA was accepted; At present, FDA has completed the review and approved the drug to carry out clinical trials. Up to now, the company has invested about 31.51 million yuan in R & D expenses in this project.
It is reported that hb0036 is a bispecific antibody targeting programmed death receptor ligand 1 (PD-L1) and T cell immunoglobulin and ITIM domain (tigit). It can combine with PD-L1 and tigit with high specificity at the same time, block their mediated immunosuppression, reactivate the killing of tumor cells by the immune system, and finally achieve synergistic antitumor effect. Preclinical studies showed that the curative effect of hb0036 was significantly better than that of the single drug treatment group and equivalent to that of the two single drug combination group.
At present, no similar drugs targeting the above two pathways have been listed outside China. The combination of atezolizumab (PD-L1 monoclonal antibody) and tiragolumab (tigit monoclonal antibody) developed by Roche for the first-line treatment of non-small cell lung cancer was granted breakthrough therapy recognition (BTD) by FDA in January 2021. The latest data published by Roche in December 2021 showed that atezolizumab combined with tiragolumab could significantly reduce the risk of disease progression and death in patients with non-small cell lung cancer with high PD-L1 expression.
At home and abroad, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., pumis Biotechnology (Zhuhai) Co., Ltd., Nanjing Shenghe Pharmaceutical Co., Ltd., AstraZeneca and other enterprises have developed similar bispecific antibodies against PD-1 / PD-L1 and tigit, which are in the stage of clinical research or early research respectively.
