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23 new drugs are expected to be approved for marketing in China in 2023

 Last Update: 2023-02-02
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This paper combined with public information to screen 23 new drugs that are expected to be approved in China in 2023, including innovative small molecule targeted drugs, bispecific antibodies, antibody conjugates (ADCs), siRNA therapies, CAR-T products and other molecular types
.
Let's take a look at which patients they are expected to bring new hope and treatment options (in order of CDE acceptance date).

Small molecule targeted drugs, bispecific antibodies, antibody conjugates (ADCs), siRNA therapies, CAR-T products and other molecular types

Takeda: Mobocertinib Mode of Action: Tyrosine kinase inhibitor indications: Specific non-small cell lung cancer

Mobocertinib is a "first-in-class" potent oral small molecule tyrosine kinase inhibitor under development by Takeda, specifically designed
to selectively target EGFR exon 20 insertion.
It has been granted priority review status and breakthrough therapy designation by the US FDA, and accelerated approval in the US in September 2021 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR exon 20 insertion
mutations.
In July 2021, mobocertinib's new drug marketing application for the above indications was accepted by CDE and included in the priority review
.

Designed specifically for selective targeting of EGFR exon 20 insertion

Qilu Pharmaceutical: Mechanism of action of Iluok tablets: Indication for new ALK/ROS1 inhibitors: ALK-positive NSCLC

Eluoc is a novel ALK/ROS1 inhibitor developed by Qilu Pharmaceutical, which can not only inhibit the activity of ALK kinase in wild-type and ALK inhibitor resistance mutations of different fusion types, but also effectively inhibit the activity
of ROS1 kinase of different fusion types.
In July 2021, the new drug marketing application of eluococc tablets was accepted by CDE for patients with locally advanced or metastatic NSCLC who have progressed or are intolerant to crizotinib after disease progression or intolerance to crizotinib
.

It can not only inhibit the activity of ALK kinase in wild-type and ALK inhibitor-resistant mutations of different fusion types, but also effectively inhibit the activity of ROS1 kinase of different fusion types

Bristol-Myers Squibb: ozanimod capsule mechanism of action: S1P receptor modulator

Ozanimod is a novel orally selective sphingosine 1-phosphate (S1P) receptor modulator developed by Celgene, a subsidiary of Bristol-Myers Squibb (BMS), which has a selective high affinity for the two receptor subtypes of S1P1 and S1P5
.
In the United States, ozanimod has been approved by the FDA for the treatment of recurrent multiple sclerosis and moderately to severe active ulcerative colitis
in adults.
In July 2021, the new drug application of ozanimod capsules was accepted
by CDE.

It has a selective high affinity with the two receptor subtypes S1P1 and S1P5

Hansen Pharmaceutical: Pemosatide mechanism of action: EPO receptor agonist indications: patients with CKD anemia

Pemosatide injection is a class 1 new drug developed by Haosen Pharmaceutical, which is a long-acting new peptide erythropoietin (EPO) receptor agonist.

In September 2021, the new drug application of pemosatide injection was accepted by CDE, which is intended to be used in dialysis patients who are undergoing erythropoietin therapy due to anemia caused by chronic kidney disease (CKD), and only need to be administered once
every four weeks.
This is different from
the current clinical treatment of renal anemia drugs, which are mostly administered once a week.
In May 2022, the second marketing application of permosatide injection for the treatment of non-dialysis CKD anemia patients who did not receive EPO treatment was also accepted
by CDE.

Patients on dialysis who are receiving erythropoietin therapy for anemia due to chronic kidney disease (CKD) only need to be given one dose of non-dialysis CKD anemia every four weeks

Roche: Mechanism of action of vebotuzumab for injection: ADC targeting CD79b Indications: diffuse large B-cell lymphoma

Vebotuzumab is Roche's "first-in-class" antibody conjugate (ADC) targeting CD79b, which specifically binds to CD79b on tumor cells, delivers anti-cancer drugs to kill these B cells and reduce damage
to normal cells.
Previously, the product has been approved in several countries and regions around the world for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

In December 2021, the new drug application of vebotuzumab for DLBCL was accepted by CDE and included in the priority review
.

It kills tumor cells by specifically binding to CD79b on tumor cells, delivering anti-cancer drugs and reducing damage to normal cells

Janssen: Esketamine hydrochloride nasal spray mechanism of action: NMDA receptor antagonist indications: depression

Esketamine hydrochloride nasal spray is a non-selective, non-competitive NMDA receptor antagonist
developed by Janssen.
It can specifically modulate NMDA receptors, which may help repair neural connections
in brain cells in people with depression.
In March 2019, esketamine hydrochloride nasal spray was approved for marketing in the United States in combination with oral antidepressants for the treatment of adult patients with major depression who are resistant to existing therapies
.
According to a press release issued by Janssen at the time, this is the first drug
in 30 years to use a new mechanism of action to treat depression.
In January 2022, the marketing application of esketamine hydrochloride nasal spray was accepted
by CDE.

It can specifically modulate NMDA receptors, which may help repair neural connections in brain cells in people with depression

AstraZeneca/Dai-ichi Sankyō: Mechanism of action of dtrostuzumab for injection: ADC targeting HER2 indication: breast cancer

Injectable dremstuzumab (Enhertu) is used by AstraZeneca and Daiichi Sankyo) jointly developed ADC therapy consisting of
a humanized monoclonal antibody targeting HER2 linked to a topoisomerase 1 inhibitor payload via a tetrapeptide cleavage linker.
Previously, the drug has been approved by the FDA for multiple indications, including HER2-positive and HER2-low breast cancer, HER2-positive gastric cancer and gastroesophageal junction adenocarcinoma, and non-small cell lung cancer carrying HER2
mutations.
In March 2022, the marketing application of dremstuzumab for the treatment of HER2-positive breast cancer was accepted by CDE and included in the priority review.
In August 2022, the marketing application of the drug for the treatment of HER2-low expression adult breast cancer was accepted by CDE
.

Consists of a humanized monoclonal antibody targeting HER2 linked to a topoisomerase 1 inhibitor payload via a tetrapeptide cleavage linker

Newron/Zambon: Mechanism of action of safinamide tablets: inhibition of MAO-B and blocking sodium channels Indication: Parkinson's disease

Safinamide is a new Parkinson's disease treatment developed by Newron Pharmaceuticals, developed by Zambon and Meiji Companies such as Seika and Eisai are responsible for commercialization
.
The product has a unique mode of action, including selective and reversible monoamine oxidase B (MAO-B) inhibiting and blocking voltage-dependent sodium channels, thereby regulating abnormal glutamate release
.
Overseas, safinamide was approved by the FDA in 2017, becoming the first new chemical entity
approved in the United States for the treatment of Parkinson's disease in more than a decade.
In April 2022, Zambon's new drug application for safinamide was accepted
by CDE.

Has a unique mode of action, including selective and reversible monoamine oxidase B (MAO-B) inhibits and blocks voltage-dependent sodium channels, thereby regulating abnormal glutamate release

BMS company: Pomalidomide capsules mechanism of action: immunomodulator

Pomalidomide is an analogue of thalidomide developed by Celgene Corporation of BMS
.
It belongs to the class of immunomodulators and has multiple mechanisms of action, which can inhibit the proliferation of hematopoietic tumor cells and induce apoptosis
.
Overseas, pomalidomide has been approved by the FDA for the treatment of patients
with multiple myeloma and Kaposi sarcoma.
In June 2022, the new drug application of pomalidomide capsules was accepted
by CDE.

It belongs to the class of immunomodulators and has multiple mechanisms of action, which can inhibit the proliferation of hematopoietic tumor cells and induce apoptosis

Reindeer Biologics/Innovent Biologics: Mechanism of action of Iquilencel injection: CAR-T products targeting BCMA Indication: Multiple myeloma

Iquilencel injection is a BCMA-targeting CAR-T cell therapy candidate developed by Reindeer Biologics and Innovent Biologics
.
It uses lentiviral as a gene carrier to transfect autologous T cells, and CAR contains fully human scFv and CD8a Hinged and transmembrane, 4-1BB co-stimulation, and CD3ζ-activating domains
.
Previously, Iquilencel injection has been granted breakthrough therapy designation and orphan drug designation
by the FDA for the treatment of multiple myeloma.
In June 2022, the new drug application of Iquilencel injection for the treatment of relapsed/refractory multiple myeloma was accepted by CDE and included in the priority review
.

It uses lentiviral as a gene carrier to transfect autologous T cells, and CAR contains fully human scFv and CD8a Hinged and transmembrane, 4-1BB co-stimulation, and CD3ζ-activating domains

Innovent Biologics: Toleximab injection mechanism of action: PCSK9 monoclonal antibody indications: primary hypercholesterolemia and mixed dyslipidemia

Toleximab is a monoclonal antibody
targeting PCSK9 developed by Innovent Biologics.
It specifically binds to the PCSK9 molecule and increases LDLR levels by reducing PCSK9-mediated low-density lipoprotein receptor (LDLR) endocytosis, which in turn increases "bad" cholesterol LDL-C clearance and lowers LDL-C levels
.
In June 2022, the new drug application of toleximab injection for the treatment of primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia was accepted by CDE
.

It specifically binds to PCSK9 molecules, increasing LDLR levels by reducing PCSK9-mediated low-density lipoprotein receptor (LDLR) endocytosis

CSPC Group: Mechanism of action of nalsusumab injection: Anti-RANKL monoclonal antibody indications: giant cell tumor of bone

Nalsusumab injection (JMT103) is a class 1 new drug developed by Shanghai Jinmante Biotechnology, a subsidiary of CSPC Pharmaceutical Group, and is a fully human anti-RANKL monoclonal antibody
of IgG4 subtype.
The product adopts subcutaneous injection to inhibit the cell differentiation maturation and functional activity mediated by the RANKL-RANK signaling pathway by blocking the binding of RANKL to the onmembrane receptor RANK of cells, so as to achieve the role of
treating diseases.
In June 2022, the new drug application for nallosulab was accepted by CDE and included in the priority review for the treatment of unresectable or operationally difficult giant cell
tumors of bone.

By blocking the binding of RANKL to the onmembrane receptor RANK of cells, it inhibits the maturation and functional activity of cell differentiation mediated by the RANKL-RANK signaling pathway

Hengrui Pharmaceutical: SHR8554 injection mechanism of action: MOR agonist indications: moderate to severe pain after abdominal surgery

SHR8554 injection is a biased μ opioid receptor (MOR) agonist
developed by Hengrui Pharmaceutical.
Public information shows that opioids are one of the most commonly used drugs for the treatment of moderate to severe acute and chronic pain, and MOR agonists are a class
of opioids with strong analgesic effects.
Compared with classical MOR agonists, SHR8554 produces similar central analgesic effects while reducing the incidence of
common gastrointestinal adverse effects.
In July 2022, the new drug application of SHR8554 injection was accepted by CDE for the treatment of moderate to severe pain
after abdominal surgery.

SHR8554 produces similar central analgesia while reducing the incidence of common gastrointestinal adverse reactions

BMS company: Deuterium colesicitinib tablets mechanism of action: TYK2 allosteric inhibitor

Deuterium Colecoxitinib is an oral, selective tyrosine kinase 2 (TYK2) allosteric inhibitor
developed by BMS.
It binds to the regulatory domain of TYK2 to "lock" TYK2 in an inactivated state, thereby selectively inhibiting the activity of TYK2 and avoiding inhibition of JAK1-3
, other proteins of the JAK family.
In September 2022, deuterium colesitinib was approved in the United States for the treatment of adult patients
with moderate to severe psoriasis.
BMS's press release at the time noted that this was the first FDA-approved TYK2 inhibitor and the first innovation
in nearly 10 years of oral therapy for moderate to severe psoriasis.
In July 2022, the new drug application of deuterium colesitinib tablets was accepted
by CDE.

It binds to the regulatory domain of TYK2 to "lock" TYK2 in an inactivated state, thereby selectively inhibiting the activity of TYK2 and avoiding inhibition of JAK1-3, other proteins of the JAK family

Lilly: Galcanezumab injection mechanism of action: CGRP monoclonal antibody indications: migraine

Galcanezumab is the name of Eli Lilly and Company Company) is a humanized CGRP monoclonal antibody
under development.
CGRP (calcitonin gene-related peptide) is the "switch" that triggers migraine attacks, and galcanezumab blocks CGRP from binding to receptors by binding to CGRP, which can be expected to relieve and improve headache symptoms
.
Previously, the drug has been approved by the FDA for the preventive treatment of migraine in adults, as well as to reduce the frequency of paroxysmal cluster headache attacks in adults, and can be self-injected
subcutaneously by patients once a month.
In July 2022, the new drug marketing application of galcanezumab injection was accepted
by CDE.

Galcanezumab blocks CGRP binding to receptors by binding to CGRP, which can be expected to relieve and improve headache symptoms

Roche: Faricimab mechanism of action: Ang-2/VEGF-A biantibody

Faricimab injection is a bispecific antibody under development by Roche, which can simultaneously target and block two key pathogenic pathways, Ang-2 and VEGF-A
.
Both pathways destabilize blood vessels, causing them to leak and increase inflammation, driving many retinal diseases
that can lead to vision loss.
Previously, faricimab has been approved for marketing in dozens of countries and regions around the world for the treatment of wet or neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME).

In August 2022, the new drug marketing application of the product was accepted
by CDE.

A bispecific antibody that simultaneously targets and blocks two key pathogenic pathways, Ang-2 and VEGF-A

Roche: Corollimab mechanism of action: a new generation of C5 complement inhibitor indications: paroxysmal nocturnal hemoglobinuria

Corolimab is a new generation of C5 complement inhibitor under research by Roche, which can block the cleavage of complement C5 to C5a and C5b and inhibit complement activation
.
Previously, the indications of the drug for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) have been included in the breakthrough therapy variety and priority review
by CDE.
PNH is a life-threatening syndrome that causes sudden onset of hematuria, anemia, and thrombosis
.
Inhibition of complement C5 is the standard of care
for patients with PNH with significant clinical symptoms.
In August 2022, the new drug application for the treatment of PNH with corolimab was accepted
by CDE.

A new generation of C5 complement inhibitor that blocks the cleavage of complement C5 to C5a and C5b, inhibiting complement activation

Eli Lilly: Mechanism of action of telpotide injection: GIP/GLP-1 receptor double agonist

Ticpotide is a "first-in-class" drug developed by Eli Lilly that activates both GIP and GLP-1 receptors, which can improve blood sugar control
through a dual mechanism of action.
The drug is injected subcutaneously once a week, and the dose
can be adjusted according to tolerance.
In May, the drug was approved by the US FDA to improve blood sugar control
in adults with type 2 diabetes.
According to an earlier press release issued by Eli Lilly, the drug represents the first new diabetes drug type
in nearly 10 years.
In September 2022, the new drug marketing application of telpotide injection was accepted
by CDE.

A "first-in-class" drug that activates both GIP and GLP-1 receptors, it can improve glycemic control through a dual mechanism of action

Zejing Pharmaceutical: Mechanism of action of jacktinib: JAK inhibitor indications: myelofibrosis

Jacktinib is a novel JAK inhibitor
developed by Zejing Pharmaceutical.
It has significant inhibitory effects on all four subtypes of the Janus kinase family, with JAK2 and TYK2 being the strongest
.
In addition, the product can reduce hepcidin transcription by inhibiting the activity of ACVR1 protein, thereby improving iron metabolism imbalance, increasing hemoglobin, reducing the incidence of anemia in patients with myelofibrosis and reducing transfusion dependence
.
In October this year, the new drug application of jacktinib for the treatment of medium- and high-risk myelofibrosis was accepted
by CDE.

It has significant inhibitory effects on all four subtypes of the Janus kinase family, with JAK2 and TYK2 being the strongest

Keji Pharmaceutical: Zewauki orencel injection mechanism of action: CAR-T product targeting BCMA indication: multiple myeloma

Zewauki Olancel Injection (CT053) is a fully human anti-autologous BCMA developed by CARsgen Pharmaceutical CAR-T cell product
candidates.
It incorporates the CAR structure of fully human anti-BCMA-specific single-chain antibodies with low immunogenicity and high stability, which can reduce the automatic activation of CAR-T cells in the absence of tumor-related targets, which is expected to overcome the problem
of T cell depletion.
Previously, the product was granted FDA Advanced Therapies for Regenerative Medicine (RMAT) and orphan drug designation, as well as European Medicines Agency (EMA) priority drug designation and orphan drug designation, and was included in the breakthrough therapy variety and priority review
by CDE.
In October 2022, the marketing application of Zewauki orencel injection for the treatment of relapsed/refractory multiple myeloma was accepted
by CDE.

It incorporates the CAR structure of fully human anti-BCMA-specific single-chain antibodies with low immunogenicity and high stability, which can reduce the automatic activation of CAR-T cells in the absence of tumor-related targets, which is expected to overcome the problem of T cell depletion

Pfizer: Mechanism of action of riteritinib: JAK3 / TEC inhibitor indications: alopecia areata

Riterxitinib is a novel oral covalent dikinase inhibitor under research by Pfizer, which is highly selective for JAK3 kinase and tyrosine kinase in the TEC family, and can achieve the effect
of treating alopecia areata by inhibiting the intracellular information pathway of immune cells that cause hair loss.
Previously, riterxitinib was granted breakthrough therapy designation by the FDA for the treatment of alopecia areata
.
In November 2022, the new drug application of riteritinib capsules was accepted by CDE and included in the priority review, and is intended to be used in adolescents and adults aged 12 years and older with alopecia areata, including total and general alopecia
, who are suitable for systemic treatment.

It is highly selective for JAK3 kinase and tyrosine kinase in the TEC family, and can achieve the effect of treating alopecia areata by inhibiting the intracellular information pathway of immune cells that cause hair loss

Novartis: Mechanism of action of inclisiran injection: siRNA therapy targeting PCSK9

Inclisiran injection is a "first-in-class" siRNA therapy
targeting PCSK9 under development by Novartis.
It binds directly to the mRNA encoding the PCSK9 protein and reduces mRNA levels through RNA interference, thereby preventing the liver from producing the PCSK9 protein
.
According to Novartis' public information, the drug is the world's first siRNA drug to lower low-density lipoprotein cholesterol (LDL-C), and LDL-C
can be lowered by two injections per year.
Previously, it has been approved for listing in the European Union and the United States, and has landed in the Boao "Lecheng Pilot Zone" and the Guangdong-Hong Kong-Macao Greater Bay Area
in Hainan, China.
In November 2022, the new drug marketing application of inclisiran injection was accepted
by CDE.

It binds directly to the mRNA encoding the PCSK9 protein and reduces mRNA levels through RNA interference, thereby preventing the liver from producing the PCSK9 protein

Heyuan Biologics: Hergilencel injection mechanism of action: CAR-T product targeting CD19 Indication: B-cell acute lymphoblastic leukemia

Hergilencel injection is a CAR-T cell therapy product targeting CD19 under development by Heyuan Biologics, which has a unique CD19 scFv (HI19a) structure and manufacturing process
.
Previously, the drug has been included in the breakthrough therapy variety of CDE and has been granted orphan drug designation
by the FDA.
In December 2022, the marketing application of Hergilencel injection was accepted by CDE and included in the priority review for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (r/r) in adults B-ALL) patients
.

A CAR-T cell therapy product targeting CD19, which has a unique CD19 scFv (HI19a) structure and manufacturing process

In addition to the above 23 new drugs, many new drugs are also expected to be approved
in 2023.
Due to space limitations, this article will not introduce
them all.
It is hoped that these innovative therapies will be approved in China as soon as possible and bring new treatment options to patients!

Resources

[1] China Food and Drug Administration Center for Drug Evaluation (CDE) official website.
Retrieved Dec 29 , 2022.
From

[1] China Food and Drug Administration Center for Drug Evaluation (CDE) official website.
Retrieved Dec 29 , 2022.
From [2] Innovent Toleximab injection (PCSK-9 inhibitor) new drug application was officially accepted by the State Medical Products Administration.
Retrieved Jun 13 , 2022.
From https://mp.
weixin.
qq.
com/s/lkLbZo6RZgE1nTrM6tg7FA

[2] Innovent Toleximab injection (PCSK-9 inhibitor) new drug application was officially accepted by the State Medical Products Administration.
Retrieved Jun 13 , 2022.
From https://mp.
weixin.
qq.
com/s/lkLbZo6RZgE1nTrM6tg7FA

[3] The first one! CSPC RANKL monoclonal antibody new drug application for marketing! .
Retrieved Mar 2 2, 2022.
From https://mp.
weixin.
qq.
com/s/U1-dfAaYkWCnd6HmVemMCw

[4] Press releases, announcements and public materials of each company

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