Xi'an Yangsen Ansen ® (Apatamine tablets) received accelerated approval from the State Drug Administration

Recently, Johnson and JohnsonCorporation(http://in ChinaPharmaceutical(http://subsidiary Xi'an Yangsen Pharmaceutical Co., Ltdannounced that its Ansen ® (Apatama tablets) has been approved by the NationalDrug(http://Regulatory Authority to treat adult patients with high-risk metastasis resistance to prostate cancer (NM-CRPC)In May this year, the Drug Review Center (CDE) of the National Drug Administration (CDE) granted the "priority review" of the ® of Ansen, and included the anineson ® in the second batch of clinically urgent ly
ing new drug(http://Non-metastatic prostate cancer refers to thedrug (http:// de-potential or surgical de-stome and the development of prostate-specific antigen (PSA) and no distant metastatic lesions were found through traditional imaging examination 　　Clinical studies have shown that the risk of distant metastasis or death with the treatment of Ansenaol ® is reduced by 72%, and the median non-metastasis (MFS) can be extended by more than two years (24.31 months) 　　About Ansen®
Ansenco ® is the first generation of androgen receptor inhibitors approved in China for non-metastatic prostate cancer patients 　　The Ansen® blocks androgen signaling pathways in prostate cancer cells and inhibits the growth of cancer cells in three ways: inhibits the binding of androgens to androgen receptors (AR), inhibits the nuclear transport of activated AR, and inhibits the binding of AR to cancer ousds (DNA) to block AR-mediated transcription 　　The approval of the SPARTAN Ansen® is based on Phase III data from a global multicenter, double-blind, randomized, placebo-controlled SPARTAN clinical trial (http:// , which assessed 1,207 patients with non-metastatic resistance prostate cancer randomized (2:1) to receive daily oral Ansencontoron ® (240 mg) (N-806) or a daily treatment for placebo.com (N-806) 　　PsA had risen rapidly in previous treatments for androgen deprivation All patients in the SPARTAN study had received GnRHa combination therapy or had had a double-sided testicular excision, and those patients needed to maintain ADT therapy 　　At the main end of the trial, the median non-metastatic survival of patients treated with the axon ® was statistically significantly improved to 40.51 months, more than two years (24.31 months) longer than 16.20 months (24.31 months) of patients receiving placebo treatment, and a 72% reduction in the risk of distant metastasis or death (HR - 0.28; P 0.0001 Other end points of efficacy include statistically significant improvements to transfer time (TTM), no progression (PFS), and progression time to symptoms , the progression-free survival in the Ansenyon ® group was 40.51 months and the placebo group was 14.72 months (HR-0.29;95% CI, 0.24-0.36; P 0.0001 anasensy® treatment group reduced the risk of PSA progression by 94% in patients compared to the placebo group (HR s 0.06; 95% CI, 0.05-0.08; P 0.0001), 93% of patients with PSA decreased by at least 50% compared to baseline, with a median to PSA decrease of 50% for 0.95 months in terms of safety
the most common adverse reactions in the Ansenson ® treatment group were fatigue, high blood pressure, rash, and diarrhea