Shunitini set Qi Tianqing, Howson, Shimedicine three listing applications

the original title: "Schonitini" set Qi Tianqing, Howson, Shimedicine three listing applications
IThe purpose
of this test is to take the cider sconeini capsule provided by Zhengda Tianqing Pharmaceutical Group Co., Ltdas the subject preparation, and conduct human bioavailability and bioequivalence test with the reference agent Sotan in accordance with the provisions of the bioequicity test, while observing the safety of the test preparation schonotinib capsule and the ginseng preparation Sotan in the health of the subjectsIIHowson's BE(Sconetini is a once-a-day administration, not affected by food)Schodon's BE
4Original Research:1.Scone for an oral small molecule multi-target receptor tyrosinekase inhibitor (receptorrosinekinase, rTKI), has multiple effects that inhibit tumor angiogenesis and anti-tumor cell growthThe targets of theare: PDGfR alpha (PDGFR alpha and PDGFR beta), VEGFR (VEGFR1, VEGFR2, VEGFR3), FLT-3, CSF-1R, kit and retindications: progressive or intolerant gastrointestinal intersothelis (GIST) for meadausulfonate imatomy; advanced renal cell carcinoma (RCC); complementary treatment in adults at high risk of recurrence after renal cell carcinoma (RCC) renal nedecilliation; unable to remove topical advanced or metastatic pancreatic neuroendocrine tumors (pNET)2.This product was discovered by SUGEN and was launched in the United States in June 2006 and produced by PfizerLabs, named Sutent®, which is listed as 12.5mg, 25mg, 37.5mg, 50mg size capsule(Sugenwasvestedby Pharmacia and Upjohnin 1999inastockswapvaluedat $650million, and runinalargelyadiarhasiarhasiarinearandtsatatedia Pharmaciawassandby Pfizerin 2002-3)
.Pfizer's first half 2018 results were $537 million, and global results for 2017 was $1,081 million, compared with $1,095 million in 2016 Compound patent WO-00160814, due in China in 2021 V Domestic situation: 1 This product was listed in China in 2007, according to the latest sample hospital data, in 2018 the size of the apple acid sconeini capsule (Sotan) (Sunitinib) market size reached 600 million yuan In October 2018, the National Medical Security Administration issued a notice explicitly including 17 anti-cancer drugs in the medical reimbursement list Pfizer's original drug, the Sunitinib capsule, is among them after negotiation price: (28 capsules / 12.5 mg / box) 12268 yuan down to 4030 yuan, indications: renal cell carcinoma 3 At present, Phase III clinical trials of late-stage RCC targeted drugs are mainly conducted in Western populations Previous studies have shown racial disparities in targeted drug-related adverse events (AE) On May 2, 2018, the first multicenter phase IV prospective study to assess the efficacy and safety of Schonitinib for the first-line treatment of patients with metastatic kidney cancer in China (mRCC) was published online in the journal Future Oncology (QinSK, JinJ, GuoJetal.Efficacy and safetyof-lineinibin.com.co.uk.com.-e-cons.com.uk.com.uk.co.uk the study from 11 centers in China between July 2008 and August 2011, 105 patients with non-recetic metastatic renal transparent cell carcinoma aged 18 were treated daily with first-line scantine 50mg (4/2 programme) until the disease progressed or had an intolerant toxic reaction The main study endpoint mPFS 14.2 months, mOS for 30.7 months, 1 year survival rate of 72.0% Of the 103 patients, ORR was 31.1%, of which 1 (1%) CR, 31 (30.1%) PR, 47 (45.6%) were stable, and 18 (17.5%) of the disease progressed Drug melting ring reference: NMPA/CDE; Pharmacosomydata, Pharnex Datamonitor; FDA/EMA ;