Qilu Pharmaceutical Launches Novel ALK/ROS1 Inhibitor Iruplinalkib (Qixinke) for NSCLC at ¥23,800 per Box

On July 12, Qilu Pharmaceutical's first approved innovative drug, Iruplakib (brand name: Qixinke), was officially shipped to the market. The public retail price in some pharmacies (not considering benefits such as discounts or free drugs) is 23,800.00 yuan/box (specifications: 60mg*90 tablets, including 13% tax). It is used for treating ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who have experienced disease progression after previous treatment with crizotinib or are intolerant to crizotinib.

Iruak is a novel ALK/ROS1 inhibitor independently developed by Qilu Pharmaceutical. It can inhibit the ALK kinase activity of wild-type and ALK inhibitor-resistant mutations with different fusion types, and effectively inhibit the activity of ROS1 kinase with different fusion types.

Previously, Qilu Pharmaceutical publicly disclosed a single-arm, multi-center Phase II clinical study aimed at evaluating the efficacy and safety of Irulak in ALK mutation-positive advanced non-small cell lung cancer patients previously treated with crizotinib. The trial enrolled a total of 146 patients, with a median follow-up time of 9.3 months; 90 patients had brain metastases, of which 41 had measurable intracranial lesions, and 20 patients had previously received brain radiotherapy; 56 patients had previously undergone chemotherapy.

The primary endpoint of the trial is the objective response rate (ORR) assessed by an independent review committee according to RECIST v1.1; secondary endpoints include disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), time to progression (TTP), and safety.

The results showed that, as assessed by the IRC, the ORR of the Iruak treatment group was 67.8%, and the DCR was 96.6%. As assessed by the investigators, the ORR of the Iruak treatment group was 61.6%, the DCR was 94.5%, the median DoR was 13.1 months, the median PFS/TTP was 14.4 months, and the 18-month overall survival rate was 81.9%.

Notably, in early April this year, the new indication application for Iruak tablets for ROS1-positive NSCLC was also accepted by the pharmaceutical regulatory authority.

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