On March 17, the ClinicalTrials.gov website showed that Qilu Pharmaceutical Co., Ltd. initiated a Phase III clinical trial.EvaluationQLM3003 Ointment(Improved New Drug of Tofacitinib)Treatment of patients with mild to moderate atopic dermatitisThe effect.Insight database shows,This is the first tofacitinib product to initiate a Phase III clinical trial for atopic dermatitis in China.。
Source: ClinicalTrials.govThe main ingredient of QLM3003 Ointment is Tofacitinib, a small-molecule pan-JAK inhibitor. According to the information on the CDE official website, the registration classification of QLM3003 Ointment is "2.1; 2.2; 2.4", and it is an improved new drug.Tofacitinib Original Research Drug(Product name: Xeljanz)Developed by Pfizer, it was first approved in the United States in 2012 for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis and other indications.TofacitinibIt is a blockbuster drug under Pfizer,The highest annual sales revenue once reached 2.455 billion US dollars.However, with the expiration of the patent, the sales of tofacitinib have started to decline year by year.The latest sales in 2024 have reached only $1.168 billion.。
Source: Insight DatabaseIn China, Pfizer's Xeljanz has been approved for the treatment of ankylosing spondylitis, psoriatic arthritis, juvenile idiopathic arthritis, ulcerative colitis, rheumatoid arthritis and other indications. Meanwhile, there are 41TofacitinibGeneric drugs have been approved, including tablets and extended-release tablets.In the case that the track is already a red ocean,, and three other companies are in the process of development.Modified New Drug of Tofacitinib, respectively from Qilu, Triastek Pharmaceuticals, and Transoceanic Biopharma, have not yet been approved.Among them, Qilu Pharmaceutical's QLM3003 ointment is the furthest along, having already entered Phase III.It is worth mentioning that,Qilu has made a differentiation in the selection of indications, choosingThe relatively unexplored direction of atopic dermatitis, becauseThe original Pfizer drug and other generic drugs have not yet been approved in China.Indications。Cover Source:Corporate Logo
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