Qilu Pharmaceuticals "橼 acid tote cloth slow release tablets" the first imitation application for the market.

On August 27, CDE's official website showed that Qilu 3 generic drug Sium acid tofatab slow release tablets" listing application was accepted (receiving number CYHS2000583), the dosage form is the first declaration in China.
from: CDE official website acid tofatib is a class of oral Janus kinase (JAK) inhibitors originally developed by Pfizer prescription drugs (commodity name Xeljanz), selective inhibition of JAK kinase, blocking JAK/STAT path, thereby inhibiting cell signal transducation and related gene expression and activation, used to treat rheumatoid arthritis, psoriasis arthritis, ulcerative colitis and other immune diseases.
the drug, which includes tablets, slow-release tablets, and oral solutions, was first approved by the FDA in 2012, and the reprieve was approved by the FDA in February 2016, the first JAK inhibitor to be used once a day to treat rheumatoid arthritis.
December 2019, a new adaptation of the release agent was approved for moderate to severe active ulcerative colitis (UC).
In addition, phase 3 clinical trials for plaque-like psoriasis have been completed, and six phase 3 clinical trials are under way involving a variety of adaptations such as active psoriasis arthritis and early idrenic arthritis.
long-term effect of slow-release tablets, only need to take once a day advantage is conducive to the control of the patient's disease.
year-on-year growth since its launch, reaching $2,242 million in 2019.
, tablets were approved for sale in March 2017 and negotiated into The Health Care Category B list in 2019, with the latest winning bid of $26.79.
, due to the high technical barriers to slow release preparations, there is no domestic market for this dosage form.
from: Insight database Insight database shows that the current domestic tofatic cloth tablet type in addition to the original research has been Zhengda Qing, Qilu, Koren, Yangzijiang, Nanjing Zhengda Tianqing 5 generic drugs approved for listing.
, however, only Pfizer filed a listing application on May 26 for a reprieve tablet.
qilu is the first in China to submit a listing application for the dosage form.
addition, the stone drug Eusin is in the BE trial phase.
JAK kinase plays an important role in inflammation, and inhibitors have been shown to treat certain inflammatory and autoimmune diseases.
to date, seven JAK inhibitors have been approved worldwide, including Delgocitinib of Leo Pharmaceuticals, Fedratinib of New Base Pharmaceuticals, Upatini of AbbVie, Pfeitini of Astellas, Barrettini of Lilly and Reed of Novartic.
, however, only Tofatib, barrettinib and reedtinib were approved domestically.
look forward to Qilu'"s tolu acid tofatab slow release tablets" to be approved as soon as possible, benefiting more patients.
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