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This week, 11 new class 1 drugs were approved for clinical use!

 Last Update: 2022-03-09
 Source: Internet
 Author: User

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Source: Pharmaceutical Guanlan

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"
.

This week, 12 new category 1 drugs (excluding supplementary applications) were added

1.
Fudan Zhangjiang: FZJ-003 Capsule

Mechanism of action: JAK1 inhibitor

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

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

2.
Bangshun Pharmaceutical: OB756 tablets

Mechanism of action: JAK2 inhibitor

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

3.
Jiakesi Pharmaceutical: JAB-21822 tablets, JAB-3312 capsules

Mechanism of action: KARS G12C inhibitor, SHP2 inhibitor

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
.

According to JAB-21822, a potent and irreversible KRAS G12C inhibitor, JAB-21822 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.

According to public information, 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

Mechanism of action: multi-targeted kinase inhibitor

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.

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

Mechanism of action: monoclonal antibody targeting Claudin 18.
2

Indication: Claudin 18.
2 positive advanced solid tumor

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.

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 was 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

Mechanism of action: PD-L1/VEGF dual-target biological drug

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 and angiogenesis of vascular endothelial cells, 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

Mechanism of action: BCMA/CD3 double antibody

Indication: multiple myeloma

Pfizer's elranatamab has been granted an implied license for a clinical trial and is intended for the following indications: monotherapy 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

Mechanism of action: Triazaacenaphthene class II topoisomerase inhibitor

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, it can selectively bind and inhibit DNA gyrase and DNA topoisomerase IV (type II topoisomerase), thereby inducing single-strand breaks in DNA during replication, and then killing the purpose of pathogens
.
Early research shows 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

Mechanism of action: agonists targeting the IL-2 signaling pathway

Indication: head and neck squamous cell carcinoma

The bempegaldesleukin for injection declared by Nektar Therapeutics (development codenamed NKTR-214) 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
.

10.
Junjing Bio: WJ01075 tablets

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

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
.

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