Hengrui’s “annual sales of 1.7 billion yuan” apatinib’s second indication applies for listing

Chinese Cabbage On February 19, the CDE official website showed that the second indication of apatinib, a new class 1 drug of Hengrui, was declared for market with the acceptance number of cxhs2000004, and the second indication was second-line treatment of liver cancer Apatinib is the second approved class 1 new drug of Hengrui, with a sales volume of about 1.7 billion yuan in 18 years It is definitely the King brand product of Hengrui On February 14, Hengrui announced that it had recently completed the phase III clinical trial of apatinib mesylate for patients with advanced liver cancer who had failed or could not tolerate at least first-line systemic treatment, and the drug registration application had been accepted by CDE According to the announcement, in the phase III clinical trial for patients with advanced HCC who have failed or could not tolerate at least first-line systemic treatment, compared with the placebo group, the total survival time (OS) of apatinib mesylate group was significantly longer and the risk of death was reduced Similarly, apatinib mesylate significantly prolonged the progression free survival (PFS) and disease progression time, and also significantly improved the objective response rate (ORR) and disease control rate (DCR) At the same time, apatinib mesylate was well tolerated At present, the clinical results of apatinib in the second-line treatment of stage III liver cancer have not been published, but the stage II clinical results are excellent The median TTP of the primary end point was 3.3 months The median OS was 9.8 months, Orr was 2% and 0% in the second and third cycles, and DCR was 64.7% and 37.3% respectively Apatinib mesylate (trade name: itane) is an oral small molecule anti angiogenesis inhibitor independently developed by Hengrui, which can inhibit the activity of VEGF-2 tyrosine kinase and tumor angiogenesis with high specificity At present, in 2014, it was approved to be listed for the treatment of advanced gastric adenocarcinoma or gastric esophageal junction adenocarcinoma patients who had undergone at least two kinds of systemic chemotherapy, and only one indication has been approved to be listed, with a sales volume of about 1.7 billion yuan in 18 years In addition to the second-line treatment of liver cancer, clinical trials for other indications of apatinib are also under way.