The first class 1 new drug!

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 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 reported for clinical application in May 2016 at the earliest, 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

Currently, 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).
The first three have been negotiated to enter the medical insurance category B list
.
In addition, Pfizer's lauratinib and Takeda's brigatinib are also in the process of listing applications
.

In addition, many domestic companies also have clinical-stage ALK inhibitor innovative drug projects.
In addition to the approved Betta and Qilu, which have been approved for production, Chia Tai Tianqing and First Pharmaceutical Holdings are making the fastest progress and have started phase 3 clinical trials
.

Qilu Pharmaceutical: 19 innovative drugs under development

According to the Insight database, Qilu has now established a research and development pipeline with 19 innovative drugs.
Except for two new hepatitis B drugs and an anti-infective drug, the rest are all anti-tumor drugs; the focus is on biological drugs and is in the pipeline.
Biological drugs accounted for more than 70%
.

The most advanced three  models of new drugs has been entered  3  clinical, respectively ALK / ROS1  inhibitor WX-0593, PD-1 monoclonal antibody  QL1604 and  EpCAM  the ADC  Moao beads monoclonal antibody
.

WX-0593 may be the Yiluok tablet declared for the market this time.
As Qilu's first innovative drug declared for marketing, Yiluok has a milestone significance
.
P D -1 single anti-  QL1604  currently has started  five clinical for liver cancer, stomach cancer, the MSI -H / d MMR  solid tumors such as multiple types of cancer , in breast cancer, Hodgkin's lymphoma and other types of cancer have also been approved Clinical
.
Moao natalizumab is Qilu in July 2020 for $ 35 million a self Sessen Bio introduction of antibody-drug conjugates for non-muscle invasive bladder cancer
.

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
.
In terms of monoclonal antibodies, PD-1, TIGIT, 4-1BB, and Claudin18.
2 targets are laid out, and the field of double antibodies includes PD-1/CTLA-4, PD-L1/TGFβ, PD-L1/4-1BB, etc.
Target combination
.