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On July 24, the CDE official website showed that Qilu Pharmaceutical submitted and accepted a listing application for a new class 1 drug "Yiluok Tablets"
WX-0593: Or the second domestic ALK inhibitor reported for market
WX-0593: Or the second domestic ALK inhibitor reported for marketWX-0593 is a new type of ALK/ROS1 inhibitor independently developed by Qilu Pharmaceutical, which can inhibit the activity of different fusion types of wild-type and ALK inhibitor-resistant mutations of ALK kinase, and can effectively inhibit the activity of different fusion types of ROS1 kinase
According to the Insight database, WX-0593 was first applied for clinical application in May 2016, and the clinical trial was first announced in October 2017.
In October 2019, Qilu initiated a phase III clinical study (CTR20191231) comparing WX-0593 tablets and crizotinib in the treatment of ALK-positive non-small cell lung cancer.
At the 2019 ESMO conference, Qilu announced the Phase 1 clinical data of WX-0593
The results show that WX-0593 has a significant anti-tumor effect at the initial dose of 30 mg, and the efficacy of 120 mg and 180 mg is the most significant
Objective response rate (ORR) results
At present, 4 ALK inhibitors have been approved for marketing in China, including 3 imported drugs crizotinib (Pfizer, January 2013), ceritinib (Novartis, May 2018) and aletinib ( Roche, August 2018), and a domestic innovative drug Ensatinib (Beida Pharmaceuticals, October 2020).
In addition, many domestic companies also have clinical-stage ALK inhibitor innovative drug projects.
Qilu Pharmaceutical: 19 innovative drugs under development
Qilu Pharmaceutical: 19 innovative drugs under developmentAccording to the Insight database, Qilu has now established a research and development pipeline with 19 innovative drugs.
The three fastest-growing new drugs have entered phase 3 clinical trials, namely ALK/ROS1 inhibitor WX-0593, PD-1 mAb QL1604 and EpCAM ADC moozizumab
WX-0593 may be the Yiluok tablet declared for the market this time.
In terms of biological drugs, ziluzumab, double antibodies, and ADCs all have corresponding layouts, and there are many potential targets in the field of tumor immunity
