On February 25, the CDE website showed that AstraZeneca and Amgen jointly submitted the TSLP monoclonal antibody.Tezepelumab InjectionMarketing application for a new indication. Based on the progress of the drug's clinical research, it is speculated that the indication for this submission may beChronic Rhinosinusitis with Nasal Polyps。
Screenshot source: CDE official website
In November 2024, AstraZeneca announcedTezepelumab in Chronic Rhinosinusitis with Nasal Polyps（CRSwNP）Patient's Phase III WAYPOINT StudyAchieved Two Co-Primary Endpoints。WAYPOINT study is a randomized, double-blind trial designed to evaluateTezepelumabEfficacy and Safety of Subcutaneous Injection vs Placebo in Adult Patients with Severe CRSwNP.The primary endpoint of the study is the change from baseline at Week 52.The Effect of Tezepelumab on Nasal Polyp Score and Subject-Reported Nasal Congestion。The results showed,Compared with placebo, AstraZeneca and Amgen'sTezepelumabBoth statistically and clinicallySignificantly reduced the size of nasal polyps and alleviated nasal congestion.。In this trialTezepelumabThe safety and tolerability were consistent with the known characteristics of the drug.Tezepelumab was co-developed by AstraZeneca and Amgen, and isFirst-in-classA human monoclonal antibody that inhibits the action of TSLP.TSLP is a key epithelial cytokine located at the apex of multiple inflammatory cascades, closely related to allergic, eosinophilic, and other types of endothelial inflammation associated with severe asthma and other inflammatory diseases.In 2021, the drugFirst FDA Approval for Market Launch, used for patients with severeAsthmafor adult and pediatric patients 12 years of age and older as an add-on maintenance treatment. In November 2024, the drugFirst Launch in China, speculated to be used for asthma.
Screenshot source:Insight DatabaseIn addition to the two indications mentioned above,Tezelimab is also being developed forEosinophilic Esophagitis, Chronic Obstructive Pulmonary Disease,Atopic Dermatitis, Chronic Spontaneous Urticariaetc. Among themEosinophilic EsophagitisPhase III has been initiated in China.Phase clinical trials are currently ongoing.Insight database shows,TezepelumabIs currentlyThe world's only TSLP-targeted drug. Besides, the fastest progress comes fromBioShin（Bosakitug）, has entered Phase III clinical trials.
Source of screenshot:Insight Database
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