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12 Class 1 new drugs have been approved for clinical use, including anti-CD47 mAb, anti-LAG-3 mAb, SHP2 inhibitor, etc.!

 Last Update: 2022-01-26
 Source: Internet
 Author: User

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As of January 7, 2022, data from the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China shows that a total of 6,221 clinical trial applications have passed "implicit licenses"
.

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

Added 12 new class 1 drug candidates for neurosteroids, EGFR-targeting antibody-drug conjugates (ADCs), anti-CD47 monoclonal antibodies, anti-LAG-3 monoclonal antibodies, and SHP2 inhibitors

VistaGen Therapeutics: PH94B nasal spray

1.
VistaGen Therapeutics: PH94B nasal spray

Mechanism of Action: Neurosteroid Candidate

Indications: Anxiety symptoms in adults with social anxiety disorder (SAD)

The PH94B nasal spray declared by VistaGen Therapeutics was approved for clinical use in China for the first time, and the indication is the anxiety symptoms of adult SAD
.

According to public information, PH94B is a potential "first-in-class" fast-acting neurosteroid candidate under development by VistaGen, which has entered Phase 3 clinical studies for the treatment of SAD worldwide

A potential "first-in-class" fast-acting neurosteroid candidate for anxiety symptoms in adults with SAD has entered Phase 3 clinical studies globally for the treatment of SAD

Activates peripheral nasal chemosensory neurons, triggering neural circuits in the brain that suppress fear and anxiety Has a fast-acting pharmacological profile and a favorable safety profile, resulting in a fast-acting anxiolytic effect without systemic absorption and distribution

2.
Sidi Medicine: 3D-197 Injection

Mechanism of action: anti-CD47 monoclonal antibody

Indication: advanced malignant tumor

The 3D-197 injection declared by Sidi Medicine was approved for clinical use in China for the first time, and the indication is advanced malignant tumor
.

According to public information, 3D-197 is a new generation of anti-CD47 monoclonal antibody IMC-002 developed by ImmuneOncia Therapeutics

A new generation of anti-CD47 monoclonal antibodies for advanced malignant tumors

CD47 is a transmembrane protein expressed on tumor cells that transmits the "don't eat me" signal on phagocytes to its receptor signal-regulatory protein alpha (SIRPα)
.

After CD47 binds to SIRPα, it induces phosphorylation of immunoreceptor tyrosine inhibitory motif (ITIM) in the cytoplasmic domain of SIRPα, binds to Src homophosphatase 1 and 2 (SHP-1 and SHP-2) and inhibits Phagocytosis

IMC-002 is a fully human anti-CD47 IgG4 monoclonal antibody with potentially higher safety profile

Mechanism of action: ADCs targeting EGFR

Indications: solid tumors

MRG003 for injection, declared by Shanghai Meiyake Bio, a subsidiary of Lepu Bio, obtained an implied license for a clinical trial, and the indication is solid tumors
.

According to public information, MRG003 is an innovative ADC drug targeting EGFR in the pipeline of Lepu Biosciences .

Innovative ADCs targeting EGFR in solid tumors

According to a previous press release from Lepu Bio, MRG003 demonstrated a manageable safety profile and encouraging antitumor activity in patients with advanced solid tumors, including nasopharyngeal carcinoma and head and neck squamous cell carcinoma, after multiple lines of therapy
.

MRG003 demonstrated a manageable safety profile and encouraging antitumor activity in patients with advanced solid tumors, including nasopharyngeal carcinoma and head and neck squamous cell carcinoma, after multiple lines of therapy
.

4.
Innovent Bio: IBI110

Mechanism of Action: Anti-LAG-3 mAb

Indications: head and neck squamous cell carcinoma

Innovent's IBI110 received an implied license for a clinical trial for the neoadjuvant treatment of resectable locally advanced head and neck squamous cell carcinoma in combination
with sintilimab .

According to public information, IBI1101 is a new recombinant fully human anti-lymphocyte activation gene 3 (LAG-3) monoclonal antibody developed by Innovent
.
Previously, the product has been approved for clinical trials in China for indications such as small cell lung cancer and diffuse large B-cell lymphoma
.

Neoadjuvant therapy in combination with sintilimab for resectable locally advanced head and neck squamous cell carcinoma

LAG-3 is an immune checkpoint protein expressed on the surface of effector T cells and regulatory T cells (Tregs)
.
Studies have shown that inhibition of LAG-3 can allow T cells to regain cytotoxic activity and reduce the function of regulating T cells to suppress immune responses, while inhibition of PD-1 and LAG-3 at the same time can play a synergistic anti-tumor effect
.
At present, LAG-3 has become one of the hot targets in the field of cancer immunotherapy
.
Innovent announced the results of a Phase 1a/1b dose escalation study of IBI110 in patients with advanced solid tumors, demonstrating the synergistic anti-tumor effect of IBI110 in combination with sintilimab
.

5.
Dizhe Medicine: DZD8586 tablets

Mechanism of Action: Small Molecule Targeted Drugs

Indications: Relapsed and refractory B-cell non-Hodgkin lymphoma

The DZD8586 tablet of Dizhe Medicine was approved for clinical use in China for the first time, and the indication is relapsed and refractory B-cell non-Hodgkin's lymphoma
.
DZD8586 is an oral, highly selective, small molecule targeted drug that can penetrate the blood-brain barrier for the treatment of tumors and other important diseases
.
Preclinical studies have shown that DZD8586 has a good safety profile and the ability to penetrate the blood-brain barrier, and can effectively inhibit the growth of B-cell non-Hodgkin's lymphoma cells
.

Oral, highly selective, blood-brain barrier-penetrating small-molecule targeted drugs for relapsed and refractory B-cell non-Hodgkin's lymphoma

According to a recent press release from Dizhe Pharmaceuticals, after the clinical trial is approved, Dizhe Pharmaceuticals will start a Phase 1 clinical trial of DZD8586 for relapsed and refractory B-cell non-Hodgkin lymphoma in China as soon as possible
.
Previously, the product was approved by the FDA for clinical trials in October 2021, and clinical trials on healthy subjects are being carried out in the United States
.

6.
Navire Pharma: BBP-398 Capsules

Mechanism of action: SHP2 inhibitor

Indication: non-small cell lung cancer

BBP-398 capsules, declared by Navire Pharma, received two new implied licenses in China for clinical trials for the treatment of EGFR-mutated locally advanced or metastatic non-small cell lung cancer
in combination with osimertinib .
According to public information, BBP-398 is a SHP2 inhibitor developed by BridgeBio Pharma
.
In August 2020, LianBio entered into a cooperation with BridgeBio Pharma.
In mainland China and other major markets in Asia, LianBio will study the combination therapy of BBP-398 and other drugs in various solid tumors
.
It is reported that BBP-398 is undergoing clinical trials in the United States
.
In China, the drug candidate has previously obtained an implied license for clinical trials targeting solid tumors, and Liantuo Biosciences is conducting a Phase 1 clinical trial of the combination therapy
.

Combined with osimertinib in the treatment of EGFR-mutated locally advanced or metastatic non-small cell lung cancer

The full name of SHP2 is a Src homology 2 domain protein tyrosine phosphatase
.
This is a key signaling node and regulator that promotes cancer cell survival and growth through the RAS pathway and plays a key role in the way cancer cells develop resistance to targeted therapies
.
In the past, it has always been considered a "non-drugable" target, but with the research progress in recent years, SHP2 targeted drug research and development has gradually made breakthroughs, making it one of the frontier targets for new drug research and development, and is expected to be combined with immune testing.
Multiple drugs including point inhibitor drugs are used in combination to improve the effect of tumor treatment
.

In addition, the Class 1 new drugs that received the implied license for clinical trials this week also include: pan-AKT kinase inhibitor auresertib tablets declared by Lakai Pharmaceuticals , KL340399 injection declared by Kelun Biotech, and hydrochloric acid for injection declared by Dyne Pharmaceuticals Lycorine thioester, recombinant humanized anti-PD-1 monoclonal antibody injection declared by Hanzhong Bio , recombinant humanized anti-PD-1 monoclonal antibody injection declared by New Era Pharmaceuticals , Taize Huikang Biotechnology The declared TWP-103 injection will not be introduced here
.
It is hoped that the follow-up studies of these products under development will proceed smoothly and benefit patients as soon as possible
.

Kelun Botai Bio -Dyne Pharmaceutical Hanzhong Bio New Era Pharmaceutical Taize Huikang Bio

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