Pfizer tontib submits a new listing application in China six phase 3 clinical synchronization!

Pfizer's JAK inhibitor, tofacitinib, submitted a new listing application in China and was accepted on May 26, according to a new publication on the website of the Drug Review Center (CDE) of the State Drug AdministrationTofatib has been approved overseas for a number of indications, and is currently only approved for treatment of adult patients with rheumatoid arthritis in ChinaIt is one of Pfizer's core products in the field of autoimmune disease treatment, and a Phase 3 clinical trial for plaque psoriasis has been completed, and six Phase 3 clinical trials are under way, involving a variety of indications such as active psoriasis arthritis and juvenile iapathic arthritispicture Source: CDE Screenshot
JAK belongs to the cytoplasmic tyrosine kinase family, a total of four JAK subtypes, including JAK1, JAK2, JAK3 and TYK2, subtypes between overlapping binding objectsJAK kinases are thought to play an important role in inflammation because they involve signaling of more than 50 cytokines and growth factors, many of which are involved in driving immune mediated responsesJAK inhibitors have shown efficacy in treating certain inflammatory and autoimmune diseasestofatib is a new oral JAK inhibitor developed by Pfizer that can ultimately improve the condition by inhibiting the JAK pathway and thus inhibiting cell signaling and related gene expression and activationIn the United States, Pfizer's tofatib has been approved to treat rheumatoid arthritis, psoriasis arthritis, ulcerative colitis and other indicationsin China, tofatib was first approved in March 2017 (product named Shangjie) for the treatment of adult patients with moderate to severe active rheumatoid arthritis whoaret methotrexate is not effective or cannot be tolerated, and can be used in combination with methotrexate or other abioticlyimproved anti-rheumatoid drugs (DMARD)Pfizer has registered 10 clinical trials of tofatib in China, including six international multi-center Phase 3 clinical trials and a Phase 3 clinical trial conducted only in Chinese patients, involving plaque-like psoriasis, active psoriasis and other indications, according to the China Drug Clinical Trial Registration and Information Disclosure PlatformDetails:a randomized, double-blind, international multicenter 3 clinical study to assess the efficacy and safety of oral tofatibs in patients with moderate to severe chronic plaque confetti in Asiaa randomized, double-blind phase 3 clinical study in China to evaluate the efficacy and safety of tofata tablets for active psoriasis arthritistwo single-arm, open, non-randomized international multi-center 3 clinical, the main purpose is to determine the long-term safety and tolerance of tofatib/tofatib oral fluid treatment of juvenile isoarthritis (JIA), the secondary purpose is to assess the efficacy of tofatibtablets/ tofatib oral fluid therapy JIA continuityThe study is under way and recruitment has not yet beguntwo randomized, double-blind international multicenter 3 clinical studies to evaluate the efficacy, safety, tolerance and pharmacokinetics of tofatib/tofatib oral fluid for the treatment of systemic childhood isopathic arthritis (sJIA) respectively The study is under way and recruitment has not yet begun a randomized, double-blind, international multicenter 3 clinical study to evaluate the efficacy and safety of patients with active spinal itisen (AS) treatment of tofata tablets, and the data will be used to support clinical registration The study is under way and recruitment has not yet begun congratulatepfing inc inc to submit a new listing application in China for the tablets, hoping that the drug will be approved soon and benefit more patients Reference the Drug Review Center of the State Drug Administration of China Retrieved May 26, 2020, from http:// May 26, 2020, http:// (original title: Pfizer-Fatib submits a new listing application in China, six 3-stage clinical synchronization synchronicising!) )