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According to the data on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration, since 2022, 118 clinical trial applications have passed the "implicit license"
.
Added 12 new category 1 drugs (excluding supplementary applications)
118 12 class 1 new drugs JAK1 inhibitors, JAK2 inhibitors, KARS G12C inhibitors, SHP2 inhibitors, multi-targeted kinase inhibitors, Claudin 18.
1.
Mechanism of action: JAK1 inhibitor
Indications: atopic dermatitis
Indications: atopic dermatitis The FZJ-003 capsule declared by Fudan Zhangjiang has obtained an implied license for clinical trials, and the indication is atopic dermatitis
.
According to public information, FZJ-003 is an oral selective inhibitor of JAK1 and is currently conducting a phase 1 clinical trial for rheumatoid arthritis in China
Oral selective inhibitor of JAK1, currently in phase 1 clinical trial for rheumatoid arthritis in China
The JAK kinase family has become an important target for the treatment of various blood diseases and autoimmune diseases, among which JAK1 inhibitors have been proved in clinical studies to control the disease by regulating a variety of cytokines related to atopic dermatitis pathology
.
According to an earlier announcement by Fudan Zhangjiang, FZJ-003 was approved for a Phase 2 clinical trial for the treatment of moderate to severe atopic dermatitis
Phase 2 clinical trial in the treatment of moderate to severe atopic dermatitis
2.
Mechanism of action: JAK2 inhibitor
Indications: Systemic lupus erythematosus
Indications: Systemic lupus erythematosus The OB756 tablet declared by Bangshun Pharmaceutical has obtained an implied license for a clinical trial, and the indication is systemic lupus erythematosus
.
According to an earlier press release from Bangshun Pharmaceuticals, OB756 is an oral selective JAK2 inhibitor independently developed by the company, which can exert therapeutic effects by targeting the kinase activity of JAK2 V617F and blocking the JAK/STAT signaling pathway
By targeting the kinase activity of JAK2 V617F and blocking the JAK/STAT signaling pathway, it can play a therapeutic role in myelofibrosis
3.
Jiakesi Pharmaceutical: JAB-21822 tablets, JAB-3312 capsules
Jiakesi Pharmaceutical: JAB-21822 tablets, JAB-3312 capsules
Mechanism of action: KARS G12C inhibitor, SHP2 inhibitor
Mechanism of action: KARS G12C inhibitor, SHP2 inhibitorIndications: Advanced solid tumors
Indications: Advanced solid tumors JAB-21822 Tablets and JAB-3312 Capsules combination therapy received an implied approval from a clinical trial for the combination of the two in KRAS G12C-mutated advanced solid tumors
.
JAB-21822 is a potent and irreversible KRAS G12C inhibitor, which is currently undergoing phase 1 clinical trials of monotherapy in China and the United States; JAB-3312 is a SHP2 target It is a small-molecule inhibitor with high selectivity for SHP2.
Combination of the two for KRAS G12C-mutated advanced solid tumors JAB-21822 JAB-3312
Public information shows that after KRAS G12C inhibitor treatment develops resistance, the combination of SHP2 inhibitor is expected to effectively overcome and reverse the resistance problem of KRAS inhibitor, and the synergistic anti-cancer effect of the combination therapy has been proved in many clinical trials.
.
4.
Taili Bio: TSN084 tablets
Taili Bio: TSN084 tablets
Mechanism of action: multi-targeted kinase inhibitor
Mechanism of action: multi-targeted kinase inhibitorIndications: Advanced or metastatic malignant tumors
Indications: Advanced or metastatic malignant tumors The TSN084 tablet filed by Teled Bio has obtained an implied license for a clinical trial for the indication of advanced or metastatic malignancies
.
Tyleris focuses on exploring the development of innovative therapies for drug-resistant tumors.
Potential "first-in-class" novel multi-kinase inhibitors that act by targeting CDK8/19 and several other kinases closely related to tumorigenesis and immune escape
Taili Bio said that TSN084 tablet is the company's first Sino-US dual reporting project, and it has obtained the US FDA's clinical trial license in October 2021
.
The company expects to conduct simultaneous dose escalation studies of the product in China and the United States
.
5.
Doer Bio: DR30303 for injection
Doer Bio: DR30303 for injection
Mechanism of action: monoclonal antibody targeting Claudin 18.
2
2
Indication: Claudin 18.
2 positive advanced solid tumor
2 positive advanced solid tumor Claudin 18.
2 positive
DR30303 for injection declared by Doer Bio, a subsidiary of Huadong Medicine, was approved for clinical use in China and is indicated for advanced solid tumors positive for Claudin 18.
2
.
Claudin18.
2 is highly expressed in many gastric cancer, pancreatic cancer, ductal adenocarcinoma, colorectal adenocarcinoma and other tumors, and is not expressed in other normal tissues other than differentiated gastric mucosal epithelial cells.
ideal target for the development of immunotherapy for solid tumors
.
2-positive advanced solid tumors
According to the recent announcement of Huadong Medicine, DR30303 is a humanized monoclonal antibody targeting Claudin18.
2 under development.
Action (ADCC) and complement-dependent cytotoxicity (CDC) induce tumor cell death
.
This time, the product has been approved for a Phase 1 clinical trial, which will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of DR30303 in the treatment of advanced solid tumors
.
6.
Pumis Bio: PM8002 Injection
Pumis Bio: PM8002 Injection
Mechanism of action: PD-L1/VEGF dual-target biological drug
Mechanism of action: PD-L1/VEGF dual-target biological drugIndication: triple negative breast cancer
Indication: triple negative breast cancer The class 1 biological new drug PM8002 injection declared by Pumis Bio has obtained an implied license for a clinical trial, and the indication is triple-negative breast cancer
.
According to the official website of Pumis Bio, PM8002 is a biological drug targeting PD-L1/VEGF
.
Previously, the product has been granted an implied license for clinical trials in China and is conducting a Phase 1/2a clinical trial for advanced solid tumors
.
Blockade of vascular endothelial growth factor (VEGF) can not only inhibit the proliferation of vascular endothelial cells and angiogenesis, but also improve the tumor microenvironment and increase the infiltration of cytotoxic T lymphocytes in the tumor microenvironment
.
Blocking the VEGF and PD-L1 pathways at the same time can form a synergistic anticancer effect
.
According to public information, there are currently a number of dual-antibody or dual-specific fusion protein products targeting PD-1/VEGF or PD-L1/VEGF in the world that have entered the clinical research stage
.
.
7.
Pfizer: elranatamab
Pfizer: elranatamab
Mechanism of action: BCMA/CD3 double antibody
Mechanism of action: BCMA/CD3 double antibodyIndication: multiple myeloma
Indication: multiple myeloma Pfizer's elranatamab received an implied license for a clinical trial, intended for the following indications: single agent or in combination with daratumumab, for at least 1 line of anti-multiple myeloma therapy (including lenadulum) amines and proteasome inhibitors) in patients with multiple myeloma
.
According to public information, the product is a bispecific antibody drug targeting BCMA and CD3, which has entered the phase 3 clinical research stage globally
.
In addition, the product was granted Fast Track designation by the FDA for the treatment of relapsed/refractory multiple myeloma
.
8.
GlaxoSmithKline (GSK): gepotidacin tablets
GlaxoSmithKline (GSK): gepotidacin tablets
Mechanism of action: Triazaacenaphthene class II topoisomerase inhibitor
Mechanism of action: Triazaacenaphthene class II topoisomerase inhibitorIndications: Simple urinary tract infection
Indications: Simple urinary tract infection GlaxoSmithKline's gepotidacin tablet has been granted an implied license for a clinical trial for the treatment of uncomplicated urinary tract infection (acute cystitis) in adults and adolescents over 12 years of age
.
According to public information, the product is a potential "first-in-class" antibiotic with a new mechanism of action.
It is a triazaacenaphthylene type II topoisomerase inhibitor and is in phase 3 clinical research worldwide
.
Gepotidacin has a dual mechanism that selectively binds and inhibits DNA gyrase and DNA topoisomerase IV (type II topoisomerase), thereby inducing single-strand breaks in DNA during replication, thereby killing the purpose of pathogens
.
Early studies have shown that it is active against most strains of Escherichia coli and Staphylococcus saprophytes, including those resistant to existing antibiotics
.
Uncomplicated urinary tract infections are mainly caused by Escherichia coli and Staphylococcus saprophyticus infections.
Patients have resistance to first-line drugs, and new antibiotics need to be developed to combat the increasingly widespread drug-resistant infections
.
9.
Nektar Therapeutics: bempegaldesleukin for injection
Nektar Therapeutics: bempegaldesleukin for injection
Mechanism of action: agonists targeting the IL-2 signaling pathway
Mechanism of action: agonists targeting the IL-2 signaling pathwayIndication: head and neck squamous cell carcinoma
Indication: head and neck squamous cell carcinoma The bempegaldesleukin for injection (development code name NKTR-214) filed by Nektar Therapeutics has obtained an implied license for clinical trials, and the indication is squamous cell carcinoma of the head and neck
.
According to public information, this is an agonist targeting the IL-2 signaling pathway, which has been granted a breakthrough therapy designation by the FDA
.
As a cytokine, IL-2 has the ability to activate CD8 positive T cells, natural killer cells and promote their proliferation
.
A current R&D focus in the IL-2 field is the development of activators that selectively activate the IL-2 receptor signaling pathway in CD8-positive T cells
.
NKTR-214 is such an agonist, which is expected to stimulate the proliferation of CD8+ effector T cells, natural killer cells and CD4+ helper T cells by selectively activating the IL-2 signaling pathway
.
Globally, NKTR-214 has entered Phase 2/3 or registration clinical trials, and is being used in combination with various immune checkpoint inhibitors, including Opdivo, to explore the therapeutic effect on various cancers
.
It is expected to stimulate the proliferation of CD8+ effector T cells, natural killer cells and CD4+ helper T cells by selectively activating the IL-2 signaling pathway
.
10.
Junjing Bio: WJ01075 tablets
Junjing Bio: WJ01075 tablets
Indication: advanced malignant tumor
Indication: advanced malignant tumor The WJ01075 tablet declared by Junjing Bio has been approved for clinical use in China, and the indication is advanced malignant tumor
.
According to public information, Junjing Biology was jointly invested and established by Junshi Biology and Weijing Biology
.
11.
Shenghe Bio: IAE0972 for injection
Shenghe Bio: IAE0972 for injection
Indications: Advanced malignant solid tumors
Indications: Advanced malignant solid tumors The IAE0972 for injection declared by Shenghe Bio has obtained an implied license for a clinical trial, and the indication is advanced malignant solid tumors
.
According to information on CDE's official website, this product is the first to obtain an implied license for clinical trials in China
.
It is hoped that the follow-up research of these class 1 new drugs under development will proceed smoothly and benefit patients as soon as possible
.
References:
[1] China National Medical Products Administration Center for Drug Evaluation (CDE).
Retrieved Jan 14, 2022, From https:// [2] Official websites and public information of each company
