Qilu Pharmaceutical Submits Prospectus for Iruplinalkib (Iruplinalkib, WX0593), a Novel ALK/ROS1 Inhibitor for Advanced NSCLC

Drug Namelruplinalkib Iruak

DrugCode:WX0593

CAS:1854943-32-0

Original Research Company: Qilu Pharmaceutical Co., Ltd.

Indications: Applicable to patients with disease progression after prior crizotinib treatment or intolerance to crizotinib, who have anaplastic lymphoma kinase (ALK)ALK) Positive locally advanced or metastatic non-small cell lung cancer (NSCLC) Treatment of patients.

Product Name:Qixinke

2013Year6In the month, Qilu Pharmaceutical Co., Ltd. conducted the design, synthesis, and screening evaluation of innovative compounds, identified candidate compounds, and subsequently carried out process development and early pharmaceutical research, preclinical pharmacological and toxicological evaluation, and sample stability studies.。

2016Year4Monthly clinical application declaration,2016Year12Approved for clinical use in the month.

2017At the beginning of the year, Qilu Pharmaceutical Co., Ltd. launched Irulast.ⅠPhase Clinical Study.

2019In the second quarter of the year, a scientific and reasonable clinical research strategy was quickly formulated based on the research results, and was carried out simultaneously.ⅡPeriod andⅢPhase Clinical Study.

2021Year7MonthlyⅡSubmit a new drug marketing application to the National Medical Products Administration based on the results of the clinical study.2023Year4Monthly CompletionIIIThe clinical trial application for production has been submitted and accepted.

2023Year6Month28The day when Iruak Tablets received marketing approval from the National Medical Products Administration (NMPA) in China.

2017Year9Month25Date2018Year10Month15Day, the incremental phase has enrolled a total of54ExampleALK/ROS1+ NSCLCPatient, extended phase total enrollment99ExampleALK/ROS1+ NSCLCPatients, totaling153The patient receivedIruplinalkib(Irak) treatment, of which only300 mgThree cases occurred in the dosage group of this study.DLTEvent, this study did not obtainMTD. The whole of the incremental phase and expansion phaseORRRespectively59.3% (32/54)And56.6% (56/99). Among them, those who have not receivedALKInhibitor TherapyALK+NSCLCAmong the patients, the two-stageORRRespectively81.0% (17/21) And76.3% (29/38); Previously treated with crizotinibALK+NSCLCAmong the patients, the two stagesORRRespectively38.1%(8/21)And45.7%(21/46). InROS1+NSCLCAmong the patients, the dose-escalation and expansion phasesORRRespectively30.0% (3/10)And44.4% (4/9)The above data shows,Iruplinalkib(Iruak) inALK/ROS1+ NSCLCIt demonstrated good safety, tolerability, and anti-tumor activity in patients.

2023Year2Month24Day,IruplinalkibIruac Treatment for Crizotinib ResistanceALKPositiveNSCLCPhase II Clinical Study of the Patient——INTELLECTResearch, full text published inBMC MedicineMagazine.IruplinalkibIruak Objective Response Rate (ORR) for69.9%`, the disease control rate was`96.6%, median progression-free survival (mPFS) for19.8months. Overall survival(OS)Under further observation, preliminary data shows,1YearOSRate is85.2%，2YearOSRate of57.9%. In baseline brain metastasis patients, usingIruplinalkibThe intracranial response rate treated by Iruak is64%。

References:WO2016000581(Compound9）