Huahai Pharmaceutical HB0036 injection clinical trial was approved by the US FDA

On the evening of the 17th, Huahai Pharmaceutical announced that Shanghai Huaaotai Biopharmaceutical Co., Ltd. (hereinafter referred to as "Huaaotai"), a subsidiary of the company, recently received a notice of approval for the clinical trial application of HB0036 injection submitted to the US Food and Drug Administration (hereinafter referred to as "FDA").

In December 2021, the clinical trial of HB0036 injection submitted by Hua aotai to the FDA was accepted; at present, the FDA has completed the review and approved the clinical trial of the drug. Up to now, the company has invested a total of about 31.51 million yuan in research and development costs on the project.

It is reported that HB0036 is a bispecific antibody that targets programmed death receptor ligand 1 (PD-L1) and T cell immunoglobulin and ITIM domain (TIGIT), which can simultaneously bind to PD-L1 and TIGIT targets, block the two mediated immunosuppression, reactivate the immune system's killing of tumor cells, and ultimately achieve synergistic anti-tumor effect. Preclinical studies have shown that HB0036 is significantly more effective than the monotherapy group and comparable to the two-drug combination group.

At present, there is no similar drug marketing for the above two channels at home and abroad. Roche's development of Atezolizumab (PD-L1 monoclonal antibody) and Tiragolumab (TIGIT monoclonal antibody) combined first-line treatment of non-small cell lung cancer was awarded breakthrough therapy designation (BTD) by the FDA in January 2021. The latest data released by Roche in December 2021 shows that Atezolizumab combined with Tiragolumab can significantly reduce the risk of disease progression and death in patients with PD-L1 high-expression non-small cell lung cancer.

At home and abroad, Shanghai Henlius Biotechnology Co., Ltd., Pumis Biotechnology (Zhuhai) Co., Ltd., Nanjing Shenghe Pharmaceutical Co., Ltd., AstraZeneca and other enterprises have developed similar bispecific antibodies for PD-1/PD-L1 and TIGIT, which are in the clinical research or early research stage. (Xu Yu)