Qilu Pharma Submits NDA for Class 1 New Drug Iruplinalkib Targeting ROS1-Positive Non-Small Cell Lung Cancer

On April 4, the CDE website showed that Qilu Pharmaceutical's Irulastat tablet marketing application was accepted by the NMPA. It is speculated that the indication for this marketing application is ROS1-positive non-small cell lung cancer (NSCLC).

Iruac is a Class 1 new drug independently developed by Qilu Pharmaceutical. It is a highly selective ALK and ROS1 inhibitor. Multiple rounds of structural optimization were conducted on five structural series, and a novel spirocyclic compound with stronger anti-tumor activity and a lower incidence of adverse reactions was selected based on structure-activity relationships.

On November 5, 2022, Qilu Pharmaceutical Co., Ltd. presented the latest positive results of the Phase II clinical study of Iruac at the annual meeting of the Chinese Society of Clinical Oncology (CSCO) in an oral report. This study is an open-label, non-randomized, single-arm, multi-center Phase II clinical trial, enrolling 59 patients with ROS1-positive non-small cell lung cancer who had failed standard treatment, were unable to tolerate chemotherapy, or could not afford crizotinib treatment due to economic reasons.

The research results show that, in 50 patients who have not previously used crizotinib,The ORR of Iruak was 74% (37/50), and the disease control rate (DCR) was 96% (48/50).The median duration of response was 14.51 months. Iruac showed efficacy signals in patients resistant to crizotinib, with 2 out of 9 patients achieving partial response and a 6-month response rate of 100%.

Clinical Results of Iruak (Source: Qilu Pharmaceutical Co., Ltd. Official WeChat Account)

Notably, this is the second indication submitted by Qilu Pharmaceutical for Irulac. Previously, on July 28, 2021, the drug regulatory authority accepted the marketing application of Irulac for treating patients with locally advanced or metastatic NSCLC who are positive for ALK fusion genes and had disease progression after prior Crizotinib treatment or were intolerant to Crizotinib.

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