shanghai synergy pharmaceutical sciences co.,ltd.(hereinafter referred to as "shanghai synergy") recently received approval from the National Medical Products Administration (hereinafter referred to as "NMPA") for its clinical trial application for HHT120 capsules. The relevant information is hereby announced as follows:
I. Basic information of the drug Drug
Name: HHT120 capsules
Indication: This product is intended for the prevention of venous thromboembolism after major orthopedic surgery
Acceptance number: CXHL2200037/8
Dosage form: Capsules
Application: Clinical trial
Applicant:shanghai synergy pharmaceutical sciences co.,ltd.
Conclusion: Approval for clinical trial
II. Other relevant information about the drug
HHT120 is an inhibitor targeting thrombin, with a novel chemical structure with independent intellectual property rights. It can block the activation of fibrinogen in the blood coagulation cascade, thereby blocking the formation of thrombus. In addition to participating in the coagulation process, thrombin also participates in a variety of physiological and pathological processes in the body, such as the occurrence of inflammation, tissue repair, axonal growth, atherosclerosis, and tumor cell metastasis. The first clinical trial indication is intended for oral use in the prevention of venous thromboembolism (VTE) after major orthopedic surgery.
Preclinical studies have shown that HHT120 dose-dependently inhibits thrombus formation, inhibits blood flow reduction, and prolongs coagulation indicators. Compared with dabigatran, a marketable drugs with the same target, HHT120 has basically the same effect on inhibiting thrombosis as dabigatran at the same dose, but the time to increase bleeding is only 50% of that of dabigatran. Therefore, it is predicted that the bleeding risk of HHT120 in clinical practice may be lower.
At present, the only oral direct thrombin inhibitor on the market is dabigatran etexilate, which was developed by Boehringer Ingelheim Pharmaceuticals of Germany. In April 2008, it was first marketed in Germany and the United Kingdom for the primary prevention of VTE after total hip or knee replacement surgery. On October 20, 2010, the US FDA approved dabigatran for the prevention of stroke and systemic thromboembolism associated with atrial fibrillation, and in June 2014, it was approved for the treatment of deep vein thrombosis and pulmonary embolism. The patent for this drug has expired, and several generic drugs have been marketed in China. At present, there are no other drugs with the same target under clinical research.