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Since 2022, Qilu Pharma's innovative drugs have ushered in new progress: Today, the official website of the Center for Drug Evaluation (CDE) of China's State Drug Administration shows that Qilu Pharma's pan-RAF inhibitor has been approved for clinical use for the first time; May 16 , Qilu Pharmaceutical announced that its self-developed DLL3/CD3 bispecific antibody was approved for clinical use in China; on May 10, the clinical trial application for hepatitis B RNAi therapy introduced by Qilu Pharmaceutical was accepted by CDE; At the annual meeting of the Association for Research (AACR), Qilu Pharmaceutical has selected 8 research abstracts of new anti-tumor drugs
These successive developments have once again attracted the attention of Qilu Pharmaceutical's innovative drug product pipeli.
According to public information, the research scope of Qilu Pharmaceutical covers tumor, cardiovascular and cerebrovascular, anti-infection, mental system, nervous system, ophthalmology and other disease fiel.
In recent years, the company has established a rich innovative drug research and development pipeline through a combination of independent research and development and introducti.
This article will combine public information to sort out some of the Class 1 innovative drugs (excluding biosimilars) that Qilu Pharmaceutical has made progress in the past year, for readers' reference on.
QLH11906 mechanism of action: pan-RAF inhibitor
QLH11906 mechanism of action: pan-RAF inhibitor According to public information, QLH11906 is a pan-RAF inhibitor
developed by Qilu Pharmaceutica.
On May 24, CDE's official website showed that QLH11906 tablets have obtained two implied licenses for clinical trials and are intended to be developed for the treatment of advanced solid tumors with abnormal MAPK signaling pathway
According to the preclinical study results presented by the researchers at this year's AACR annual meeting, QLH11906 is a highly selective pan-RAF inhibitor with good antitumor activity and is expected to be a therapeutic drug for patients with BRAF and KRAS mutant tumors
A pan-RAF inhibitor is proposed to be developed for the treatment of advanced solid tumors with abnormal MAPK signaling pathway A highly selective pan-RAF inhibitor with good anti-tumor activity is expected to be a therapeutic drug for patients with BRAF and KRAS mutant tumors
QL1706 Mechanism of Action: Anti-PD-1/CTLA-4 Combination Antibody
QL1706 Mechanism of Action: Anti-PD-1/CTLA-4 Combination Antibody QL1706 is an anti-PD-1/CTLA-4 combination antibody
developed by Qilu Pharma based on its combination antibody technology platfor.
According to Qilu Pharmaceutical's press release, QL1706 uses innovative technology to transform the heavy chain of CTLA-4 antibody, which reduces the toxic and side effects of CTLA-4 antibody, while maintaining the characteristics of high expression, easy purification, high activity and high stabili.
Previously, the drug has been approved for a number of clinical trials in China, involving indications including recurrent or metastatic cervical cancer, advanced liver cancer
, e.
According to the latest announcement from the CDE, QL1706 has obtained an implied license for a new clinical trial targeting extensive-stage small cell lung cancer
In April this year, the abstract of the Phase 1 clinical study of QL1706 has been selected for the 2022 AACR Annual Meeti.
Recurrent or metastatic cervical cancer, advanced liver cancer, extensive-stage small cell lung cancer
QLS31904 Mechanism of Action: DLL3/CD3 Bispecific Antibody
QLS31904 Mechanism of Action: DLL3/CD3 Bispecific AntibodyQLS31904 is a bispecific antibody targeting DLL3/CD3independently developed by Qilu Phar.
A bispecific antibody targeting DLL3/CD3
A few days ago, the drug has just been approved for clinical research in advanced solid tumors in Chi.
Intended to develop QLS31904 for the treatment of advanced solid tumors such as small cell lung cancer
AB-729 Injection Mechanism of Action: RNAi Therapy
AB-729 Injection Mechanism of Action: RNAi TherapyAB-729 is an RNAi drug developed by Arbutus for the treatment or prevention of hepatitis
An RNAi drug for the treatment or prevention of hepatitis B
According to public information, AB-729 is an RNAi drug targeting hepatocyte.
AB-729 is an RNAi drug targeting hepatocytes
Mechanism of Action of Iruac : A Novel ALK/ROS1 Inhibitor
Mechanism of Action of Iruac : A Novel ALK/ROS1 InhibitorIluac (WX-0593, formerly known as Iluac) is a novel ALK/ROS1 inhibitor independently developed by Qilu Pharma , which can inhibit wild-type and anaplastic lymphoma kinase (ALK) inhibition of different fusion typ.
A novel ALK/ROS1 inhibitor for patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)
In February 2022, Iruak's Phase 1 clinical study data was published in Signal Transduction and Targeted Thera.
Iluac has favorable safety, tolerability and antitumor activity in patients with ALK/ROS1+ NSCLC
QLF31911 Drug Type: Innovative Biomacromolecules
QLF31911 Drug Type: Innovative BiomacromoleculesQLF31911 injection is an innovative biomacromolecule developed by Qilu Pharmaceutical, and it is also one of the key varieties in Qilu Pharmaceutical's tumor immunity product li.
Intended to be developed for the treatment of various malignancies including hematological and solid tumors
QLF32004Drug Type: Innovative Biomacromolecules
QLF32004Drug Type: Innovative BiomacromoleculesAccording to the public information of Qilu Pharmaceutical, QLF32004 is an innovative biological macromolecule drug developed by the compa.
The drug is in a Phase 1 clinical trial in Chinese patients with advanced malignancies
QLS31905 mechanism of action: Claudin12/CD3 double antibody
QLS31905 mechanism of action: Claudin12/CD3 double antibodyQLS31905 is a bispecific antibody that targets Claudin12 and CD3independently developed by Qilu Pharmaceutica.
A bispecific antibody targeting Claudin12 and CD3 in patients with advanced malignant solid tumors positive for Claudin12
QLC12102 (CEND-1 for Injection) Mechanism of Action: Tumor Penetrating Peptide
QLC12102 (CEND-1 for Injection) Mechanism of Action: Tumor Penetrating PeptideQLC12102 is a tumor penetrating peptide (also known as iRGD)introduced by Qilu Pharmaceutical from Cend , which can bind to neuropil protein, one of the proteins highly expressed on pancreatic cancer cells
A tumor-penetrating peptide (also known as iRGD) that binds to neuropilin, one of the proteins highly expressed on pancreatic cancer cells, to treat patients with advanced metastatic pancreatic cancer
QLF31907 mechanism of action: PD-L1/4-1BB double antibody
QLF31907 mechanism of action: PD-L1/4-1BB double antibodyQLF31907 is a bispecific antibody that targets PD-L1 and 4-1BBindependently developed by Qilu Pharmaceutica.
A bispecific antibody targeting PD-L1 and 4-1BB
In preclinical studies, QLF31907 has shown good safety and efficacy, and has obvious synergistic effect compared with PD-L1 mAb and 4-1BB m.
The drug is in a phase 1 clinical study in patients with advanced malignancies
QLS31901 mechanism of action: PD-L1/TGFβ bifunctional fusion protein
QLS31901 mechanism of action: PD-L1/TGFβ bifunctional fusion protein QLS31901 is a PD-L1/TGF-β bifunctional antibody-ligand capture fusion protein
developed by Qilu Pharmaceutica.
According to public information, one end of QLS31901 is an antibody that can recognize and bind PD-L1, and the other end is a receptor for TGF-β, which can antagonize both TGF-β and PD-L1 at the same ti.
By blocking the PD-L1 pathway and TGF-β pathway at the same time, QLS31901 can improve the tumor suppressive microenvironment, enhance the effector function of cytotoxic T lymphocytes, promote the killing of tumor cells by immune cells, and overcome tumor cells' resistance to PD-1/.
-L1 therapy resistance, thereby increasing the effectiveness of anti-tumor dru.
Currently, Qilu Pharma is evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of QLS31901 in patients with advanced malignant tumors in
Phase 1 clinical trials, and determining the recommended dose (RP2D) for Phase 2 clinical trial.
In April this year, the basic research results of QLS31901 were presented at the AACR annual meeti.
Mechanism of action of VB4-845 injection : a new generation ADC
Mechanism of action of VB4-845 injection : a new generation ADC VB4-845 is a next-generation antibody-drug conjugate (ADC) developed by Sesen Bio for the treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) that has failed Bacille Calmette-Guerin (BCG)
In July 2020, Qilu Pharma entered into an exclusive licensing agreement with Sesen Bio to acquire the exclusive rights to develop, manufacture and commercialize VB4-845 in Greater Chi.
Published data show that VB4-845 will target the antibody fragment of epithelial cell adhesion molecule (EpCAM) on the surface of tumor cells, and the cytotoxic Pseudomonas exotoxin A (ETA), through a stable genetically engineered polypepti.
connected togeth.
EpCAM is highly expressed on the surface of non-muscle-invasive bladder cancer cells, but is expressed at low or no levels in normal cel.
As an ADC therapy, the advantage of VB4-845 is that its smaller molecular weight can facilitate tumor penetration and drug delive.
In the United States, VB4-845 was granted Fast Track designation by the F.
In China, Qilu Pharma is conducting a Phase 3 clinical trial of VB4-845 in patients with non-muscle invasive bladder cancer
In addition to the above-mentioned new drugs, there are many other developments in Qilu Pharmaceutical's innovative drug pipeli.
Due to space limitations, this article will not introduce them one by o.
It is hoped that the follow-up clinical research of these innovative drugs of Qilu Pharmaceutical will proceed smoothly and benefit the majority of patients as soon as possib.
References:
[1] The official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of Chi.
Retrieved May 24, 2022, From https:// [2] Qilu Pharmaceutical's public press release
