Xi'an Yangsen's Zei yu ® (Acetate Abitron tablets) new indications approved by the State Drug Administration

prostate cancer is the most common urogenital cancer in Chinese men, with a national incidence rate of 9.8 per 100,000 people and a high rate of 12.07 percent per yearyesterday (December 4), Johnson andCompany
(http://thesubsidiary ofPharmaceutical(http:// in China, Xi'an Yangsen Pharmaceutical Co., Ltd., announced that its Zeiyu ® (Abitron tablets) new indications by the NationalPharmaceutical(December 4) http://approved by the Supervisory Authority to treat newly diagnosed high-risk metastatic endocrine therapy-sensitive prostate cancer (mHSPC) with the combination of pernist or pernison, including mHSPC patients who have not received endocrine therapy or who have received endocrine therapy for up to 3 monthsZeayu ® has benefited significantly from clinical benefits and has previously been granted a "priority review" by the State Drug AdministrationThe approval of the new indications makes Zeju ® the first new endocrine therapydrug(http://in the field of mHSPC treatment in China that has been confirmed by large-scale international clinical studies to have significant survival benefitsZeyi ® was launched in China in January 2016 and has been approved in 108 countries and is widely used in more than 470,000 prostate cancer patients worldwide the approval of the relevant studies new indications are based on the results of an international multicenter, randomized, double-blind, controlled phase 3 clinical study LATITUDE the trial (http:// involved 1,199 newly diagnosed high-risk mHSPC patients, including 137 Chinese patients All patients were not treated with endocrinology before entering the group, or received endocrine therapy for no more than 3 months The patients were randomly divided into two groups, with the treatment group abitron being combined with pernitson and ADT (androgen deprivation therapy, ADT) (abitron group for short) and the control group being ADT plus placebo (ADT group) studies showed that Abiton combined with Pernisone reduced the risk of death by 38% compared to the ADT group (median total lifetime did not reach vs 34.7 months, HR s 0.62; p 0.0001) In addition, the median imaging non-progressive reinbeing (rPFS) in patients in the Abitron group was 33 months, 18.2 months lower than the aDT leader of rPFS 14.8 months, and the risk of imaging progression was reduced by 53% all minor study endpoints in the Abitron group improved significantly The median time to PSA progression (Time to PSA Progression, TTPP) was 33.2 months and the ADT group was 7.4 months, which means that about half of patients treated with zetadi® were protected from the effects of disease progression for nearly three years at the same time there was a statistically significant delay in the start time of subsequent treatment (e.g chemotherapy) (the median time to start chemotherapy did not reach vs 38.9 months, HR 0.44; p 0.0001) 　　In the LATITUDE trial, patients treated with abitron can significantly improve cancer pain, compared with the ADT group, can effectively delay pain progression for nearly 2.5 years, while abitron treatment can also effectively delay bone-related events, such as pathological fractures studies have shown that the overall safety of abitron is consistent with previous studies, and the most common adverse reactionises are fluid retention (peripheral edema)