The 4th R & D daily! Evaluation of escitalopram oxalate tablets in Huahai pharmaceutical

Fourth! Huahai Pharmaceutical Co., Ltd has passed the evaluation of escitalopram oxalate tablets; AstraZeneca has been active in the phase 3 trial of innovative therapy for lupus erythematosus; orsacom's "super antibiotic" has been included in the priority review; Kelun pharmaceutical's apixaban tablets have passed the consistency evaluation We focus on the latest development of pharmaceutical research and development, and provide timely and accurate information reference for R & D personnel On November 12, aliscan announced that its in-process monoclonal antibody, anifrolumab, for the treatment of moderate and severe systemic lupus erythematosus (SLE), had achieved positive results such as significantly reducing disease activity in key phase 3 experiment tulip 2 On November 12, Roche announced that its oral SMN2 gene splicing regulator risdiplam significantly improved the motor function of patients in the critical phase 3 trial of sunfish in the treatment of type 2 or type 3 spinal muscular atrophy (SMA), reaching the main end point of the trial Recently, Gilead announced the new data of clinical research on gs-9688 (selgantolimod) Gs-9688 is an oral, selective toll like receptor 8 (tlr8) small molecule agonist In a multicenter, randomized, double-blind phase II study of 48 patients with chronic HBV infection who have achieved virologic inhibition, gs-9688 (once a week) combined with oral antiviral drugs has good tolerance during the extended administration period, and shows dose-dependent pharmacodynamic activity On November 11, ervebo (V920) of MSD passed the approval of European regulators, becoming the first approved Ebola vaccine in the world Ervebo is composed of modified vesicular stomatitis virus (VSV) and important glycoprotein on the surface of Ebola virus VSV can sicken some domestic animals, but it is harmless to human beings The virus activates the immune system by producing a mild infection that causes the latter to produce antibodies against the Ebola protein On November 11, Bristol Myers Squibb announced that the US FDA has accepted a supplementary biological product license application (SBLA) submitted by it, and granted the breakthrough drug qualification of opdivo and yevoy immunotherapy (the "oy" combination) for the treatment of advanced liver cancer patients who have been previously treated with sorafenib FDA has granted the SBLA priority review, with PDUFA target date of March 10, 2020 Recently, according to the nmpa website, the listing application of three generic drugs esketamine hydrochloride declared by Hengrui has been in the "approval" state, and is expected to be approved for listing this month The drug is used in the treatment of surgical analgesia, sedation and severe depression On November 12, aosaikang announced that the polymyxin e-mesylate sodium for injection of Jiangsu aosaikang Pharmaceutical Co., Ltd., a wholly-owned subsidiary of the company, was included in the list of priority evaluation varieties by the drug evaluation center of the State Drug Administration On November 12, Huahai pharmaceutical announced that it had recently received the approval document for drug registration approved and issued by the State Food and drug administration The product was declared according to four categories of new registration classification, and it was deemed to have passed the consistency evaluation after being approved On November 11, Kelun pharmaceutical announced that its subsidiary Hunan Kelun Pharmaceutical Co., Ltd had recently obtained the drug registration approval document for the chemical "heparin sodium sealed injection" approved and issued by the State Drug Administration Heparin sodium tube sealing injection is used to keep the lumen of the intravenous injection device (such as indwelling needle and catheter) unblocked It can be used after the injection device is placed in the vein, after each application and after each blood collection On November 11, Kelun pharmaceutical announced that the company recently obtained the approval document for drug registration of the chemical "apixaban tablets" approved and issued by the State Food and drug administration, which is deemed to have passed the consistency evaluation Apixaban, originally developed as Bristol Myers Squibb and Pfizer, is mainly used in adult patients undergoing selective hip or knee replacement to prevent venous thromboembolism On November 11, Hehuang pharmaceutical announced that the State Food and Drug Administration had accepted the application for the listing of a new drug suufatinib for the treatment of advanced non pancreatic neuroendocrine tumors The new drug application is based on the successful sanet EP clinical research data Sanet EP is a phase III critical study of suofantinib's indications for advanced non pancreatic neuroendocrine tumors, and there is no effective treatment for these patients.