Xi'an Yangsen-type ® (injection with Invrisi monoantigen) approved by the State Drug Administration

Today, Xi'an YangsenPharmaceutical(http://LimitedCompany
(http://announced that the NationalDrug(http://Supervisory Authority has approved the ® (REMICADE®), i.einjected with infritis, for adult patients receiving traditional treatment is not effective, intolerant or have medical contraindications, can be used to relieve symptoms and symptoms and symptomsThe approval of the Class ® is based primarily on the results of two Global Phase III ClinicalTrial(http://and one Phase III clinical trial for patients in ChinaACT 1 and ACT 2 are two international multicenter, randomized, double-blind, placebo-controlled clinical trials of patients with moderate lysinactive active ative colitis who received poor traditional treatmentin the ACT 1 study, at week 54, 44.9% of patients in the combined Invlixi monoantigen treatment group received clinical results, compared with 19.8% in the placebo group (p 0.001); 16.5%, p 0.001 and 46.1% vs 18.2%, p 0.001; the proportion of patients with sustained efficacy and continuous remission in the combined Inversimono treatment group was higher than in the placebo treatment group (37.9% vs 14.0%, p 0.001; and 20.2% vs 6.6%, p 0.001) 　　Week 30 (22.3% vs 7.2%, p 0.001, aggregate ACT 1 and ACT 2 data) and Week 54 (21.0% vs 8.9%, p.022, ACT 1 data), when the proportion of patients in the combined Inveritia monotherapy group who was able to maintain clinical remission while taking glucocorticoids was higher than the placebo therapy group 　　Phase III clinical studies conducted in China have also shown that invliative monosyformis is safe and effective in the treatment of patients with moderate to severe ulcerative colitis in China Compared to the placebo group (n s 49), the clinical response rate in the 8th week of the Invlixi monoantigen group (n s 50) was (n s 32 (64%) vs n s 16 (33%); P-0.0021 and mucous membrane healing rate ( n - 17 (34%) vs n s 8 (16%); P is higher, and the clinical remission rate in week 26 is higher n s 14 (28%) vs.n 5 (10%) and P 0.0281 No serious adverse events related to drug (http:// occurred during the study period 　　Since its approval in China in May 2006, ® has been approved for use in patients with moderate to severe active rheumatoid arthritis, moderate to severe active Crohn's disease, fistula crohn's disease, patients with active hyperthyroidism, and patients with active hyperthyroidism, as well as patients in patients with systemic treatment and ineffective, contraindication or intolerance of chronic severe plaque disease patients such as cyclosporine, methotrexate or photochemical therapy Ulcerative colitis is its seventh indication approved in China to date, class has been approved in more than 100 countries and is widely used in more than 3 million patients worldwide