▎Edited by the WuXi AppTec content team

Today (January 16), the official website of China's National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical Co., Ltd. has submittedIruakNew Indication Marketing Application Officially ApprovedAccording to the press release previously issued by Qilu Pharmaceutical,Iruak is a novel oral anaplastic lymphoma kinase (ALK)/ROS1 inhibitor, which has been approved for the first-line treatment of ALK-positive non-small cell lung cancer (NSCLC).。

Screenshot source:NMPA Official Website

ALK is a major driver of lung cancer, with approximately 5% of NSCLC patients havingALKGene Rearrangement.ROS1Gene Rearrangement &ALKGene rearrangement is also a common genetic variation in NSCLC patients. For lung cancer patients with ALK fusion positivity, marketed ALK tyrosine kinase inhibitors (ALK-TKIs) have shown significant efficacy, but there are still some unresolved clinical issues, such asDrug resistance, unsatisfactory efficacy for patients with brain metastases, high incidence of adverse reactionsetc.

Public information shows that, inIruak'sIn the research and development, Qilu Pharmaceutical has formulated a series of standards to address existing challenges in the ALK-TKI field.Iruac can inhibit the ALK kinase activity of wild-type and ALK inhibitor-resistant mutations with different fusion types; simultaneously, it effectively inhibits the activity of ROS1 kinase with different fusion types, featuring a low starting dose, rapid onset, and wide safety window.Clinical studies have confirmed that the product is carriedALKOrROS1In patients with rearranged advanced NSCLC, it demonstrated good safety and promising anti-tumor activity. In June 2023, Iruak tablets received approval from the NMPA.Marketing Approval, for the treatment of patients with ALK-positive locally advanced or metastatic NSCLC who have previously received crizotinib but still show disease progression or are intolerant to crizotinib.

This approval of a new indication for Yiluak covers ALK-positive NSCLC patients.First-line treatment. Public data shows that the product had previously achieved positive results in the phase 3 INSPIRE study. This is a randomized, open-label, multi-center phase 3 clinical study aimed at...ALK-positive NSCLC patients who have not received ALK-TKI treatmentEvaluation of the Efficacy and Safety of Irualk versus Crizotinib.The primary endpoint was progression-free survival (PFS) assessed by the IRC., the principal investigator of this study is from the Cancer Hospital of the Chinese Academy of Medical Sciences.Professor Shi Yuankai。