Xi'an Yangsen Zhaoxuan ® (Daretoyu mono-anti-injection) approved by the State Drug Administration

recently, Johnson and JohnsonCompany(http://in ChinaPharmaceutical(http://subsidiary Xi'an Yangsen Pharmaceutical Co., Ltdannounced that its mega-® (Daretoyu mono-resistant injection) has been approved by the NationalDrug(http://Regulatory Authority for single-drug treatment of recurrent and refractory multiple myeloma patients, who have received previous treatments including protease inhibitors and immunosuppressive immunosuppressive agentsThe approval of mega-®
mega-® is based on data from two international clinical studies (MMY2002 and GEN501) and one Chinese clinical study (MMY1003)Studies have shown that in patients with recurrent and refractory multiple myeloma, the ® monotherapy can significantly improve efficacy and be safe and controllableThe results of two international clinical studies, which have been combinedanalysis (http:// , show that patients with multiple myeloma who have received multiple-line treatment have used 16 mg/kg of Daretou mono-drug therapy, the median total survival is extended to 20 months, and 83% of patients have the best efficacy assessed as stable or better, with a total remission rate of 31% In addition, no adverse events during treatment associated with the ® of megashavetic sedatives have resulted in interruption of treatment 　　The results of the open, non-randomized Phase I study MMY1003 conducted in China show that the clinical efficacy and safety of mega-® single-drug use in Chinese patients who have received at least 2 lines of treatment in China are generally consistent with global clinical research in terms of safety
the most common adverse reaction in clinical studies of mega-® treatment was infusion-related reactions (46%) Other common adverse reactions ( s20%) include fatigue, anemia, neutropenomic granulocytic reduced, nausea, back pain, cough, fever, upper respiratory tract infections, and thrombocythotic reduced disease8 　　To date, the ® has been approved in more than 80 countries and regions, and is widely used in more than 80,000 patients worldwide the approval of the mega-® is xian Yangsen's approval of the Wanyi ® in 2005 for the field of multiple myeloma treatment of another global cutting-edge
target drug (http://