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In 2022, these approved Class 1 new drugs are worth paying attention to!

 Last Update: 2022-12-30
 Source: Internet
 Author: User

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According to the GBI SOURCE Global Drug Database, as of December 19, 2022 A total of 14 Class 1 new drugs have been approved for marketing in China (see Table 1 for details), including 4 imported new drugs and 10 domestic new drugs
.
In terms of drug categories, there are 5 therapeutic biological products, namely North China Pharmaceutical Omutivirumab, Henlius Serplulimab, Akeso Cardunilimab, Lepu Bioputelimab and Boehringer Ingelheim Pesolimab
.
In terms of treatment areas, it mainly involves anti-tumor, cardiovascular, antidepressant, etc
.

GBI SOURCE

Table 1.
Class 1 new drugs approved in 2022 (as of December 19)

*Source: GBI SOURCE Global Drug Database

GBI SOURCE

*Screening criteria: 2020 version of registered classification chemistry class 1, therapeutic biology class 1; 2016 Edition Registration Classification Chemistry Class 1; The 2007 edition is registered as chemistry class 1.
1 and therapeutic biology class 1

01 North China Pharmaceutical

Omotivimab

Approval time: 2022-01-25

Approval time:

Indications: Passive immunity in adults exposed to rabies virus

Indications:

On January 25, North China Pharmaceutical's therapeutic biology class 1 drug omitivimab (trade name: Xunke) injection was approved by the State Food and Drug Administration for passive immunity
in adult rabies virus exposed patients.
The drug was submitted for marketing in July 2020 and was included in the priority review process
.
Omutivimab injection contains high-efficiency anti-rabies monoclonal antibody NM57 (IgG1 subtype), which can specifically neutralize the linear neutralization epitope at rabies virus glycoprotein conserved antigen site I, thereby preventing rabies virus from infecting tissue cells and playing a role in
preventing rabies.

Omotivimab

02 Henlius

Serplulimab

Approval time: 2022-03-22

Approval time:

Indications: Treatment of standard-of-standard, unresectable or metastatic microsatellite highly unstable (MSI-H) solid tumors

Indications:

In March 2022, Henlius' self-developed PD-1 monoclonal antibody serplulimab (trade name: Hans-like) was approved for marketing in China for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) solid tumors
that have failed standard therapy.
In October 2022, Hans-like was approved in China for a new indication for the first-line treatment of inoperably advanced or metastatic squamous non-small cell lung cancer (sqNSCLC).

At present, Hans-like has been granted orphan drug certification
by the European Commission (EC) and the US Food and Drug Administration (FDA).

Serplulimab

03 Pfizer

Albuxitinib

Approval time: 2022-04-08

Approval time:

Indications: Treatment of moderate to severe atopic dermatitis in adults

Indications:

In April 2022, Pfizer's innovative pico-drug albuxitinib tablets (trade name: Xibico) was approved for marketing in China for the treatment of moderate to severe atopic dermatitis
in adults.
As a breakthrough therapy for the treatment of atopic dermatitis, Xibike is a highly selective JAK1 inhibitor that only needs to be taken orally once a day, which will provide new treatment options
for Chinese patients.
The only JAK1 inhibitor previously approved in China for the treatment of atopic dermatitis is Ebviu patinib (trade name: Furui).

Since September 2021, Cyptic has obtained marketing authorization
in the United Kingdom, Japan, the European Union, the United States and other countries and regions.

Albuxitinib tablets

04 Luoxin Pharmaceutical

Tegolaxen

Approval time: 2022-04-08

Approval time:

Indications: Reflux esophagitis

Indications:

In April 2022, Luoxin Pharmaceutical's innovative drug tegolaxen tablets (trade name: Taixinzan) was approved for marketing for reflux esophagitis
.
Tegolaxen tablets are potassium competitive acid blocker drugs (P-CAB), October 2015, Luoxin Pharmaceutical's subsidiary Shandong Luoxin and South Korea HK inno.
N The Corporation reached an agreement to acquire exclusive rights
to develop, manufacture and commercialize tegolasan tablets in China.
At present, there are two new indications for tegolaxen tablets in clinical trials, of which phase III.
clinical trial for duodenal ulcer is underway, and clinical trials in combination with appropriate antibacterial therapy for eradication of Helicobacter pylori infection in adults have been approved
.
The first P-CAB marketed in China is Takeda Pharmaceutical's vonoraxen tablets, which were approved in China in May 2020 for adult reflux esophagitis
.

Tegolasan tablets

05 Bayer

Velisiga

Approval time: 2022-05-18

Approval time:

Indications: Adult patients with symptomatic chronic heart failure with stable reduced ejection fraction (ejection fraction <45%) after decompensated heart failure after intravenous therapy

Indications:

In May 2022, the innovative therapy jointly developed by Bayer and Merck Veliciga (trade name: Only the same) was approved for marketing through the priority review and is suitable for adult patients with symptomatic chronic heart failure with a stable ejection fraction (ejection fraction <45%) after recent heart failure decompensation and intravenous therapy
.
In May 2014, Bayer and Merck reached an agreement to jointly develop and promote the same
thing.
In January 2021, the drug was approved for marketing in the United States for the treatment of patients with symptomatic chronic heart failure with ejection fraction less than 45% after a heart failure exacerbation event
.
In August 2020, Bayer's application for the marketing of Vicotong was accepted by China CDE and included in the priority review
.

Velisiga

06 Akeso

Cardunilimab

Approval time: 2022-06-28

Approval time:

Indications: Treatment of patients with relapsed or metastatic cervical cancer who have previously failed to receive platinum-containing chemotherapy

Indications:

In June 2022, the NMPA conditionally approved the marketing of Akeso's cardunilimab injection (trade name: ketanib) through the priority review and approval process, which is suitable for the treatment
of patients with relapsed or metastatic cervical cancer who have previously failed platinum-containing chemotherapy 。 Cardunilimab is a new and pioneering PD-1/CTLA-4 bispecific antibody independently developed by Akeso, which can block the interaction of PD-1 and CTLA-4 with their ligands PD-L1/PD-L2 and B7.
1/B7.
2, thereby blocking the immunosuppressive response of PD-1 and CTLA-4 signaling pathways, promoting tumor-specific T cell immune activation, and then exerting anti-tumor effects
.

Cardunilimab

07 Bayer

Phenerone

Approval time: 2022-06-28

Approval time:

Indications: Suitable for adult patients with chronic kidney disease associated with type 2 diabetes

Indications:

In June 2022, Bayer's Class 1 innovative drug phenirenal tablets (trade name: Kerendia) were approved for marketing in China, which is suitable for adult patients with chronic kidney disease associated with type 2 diabetes, which can reduce the risk of
continuous decline in eGFR and end-stage renal disease.
Phenerrone is a nonsteroidal, selective mineralocorticoid receptor (MR) antagonist
.
MR is expressed in the kidneys, heart, and blood vessels, and fenerone reduces inflammation and fibrosis
mediated by MR overactivation.
The launch of this drug provides new treatment options
for adult patients with type 2 diabetes-related chronic kidney disease.

Phenerone tablets

08 Hengrui Pharmaceutical

Revirumide

Approval time: 2022-06-28

Approval time:

Indications: Treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden

Indications:

In June 2022, Hengrui Pharmaceutical's Class 1 innovative drug Revilumide Tablets (trade name: Erien) was approved for marketing in China, which is suitable for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden
.
Reverutamide is a second-generation androgen receptor (AR) inhibitor with stronger AR inhibitors and no agonist effect than first-generation AR inhibitors
.
At present, 6 non-steroidal AR inhibitors such as bicalutamide and enzalutamide have been marketed in the world, and bicalutamide, enzalutamide, apatamide and darolutamide have been approved for marketing
in China.

Revirutamide tablets

09 Lepu Bio

Putelimumab

Approval time: 2022-07-19

Approval time:

Indications: Indicated for patients with advanced solid tumors with unresectable or metastatic highly microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).

Indications:

In July 2022, LepuBio's PD-1 antibody putelimab (trade name: Puyouheng) was conditionally approved by the State Food and Drug Administration for patients with advanced solid tumors
with unresectable or metastatic highly microsatellite instability (MSI-H) or mismatch repair defect (dMMR).
On September 29, 2022, Puyouheng was approved by the State Food and Drug Administration for a new indication for unresectable or metastatic melanoma
that had previously failed systemic therapy.
At present, 8 domestic PD-1 drugs have been approved in China, in addition to putelimab, Hengrui Pharmaceutical's carrelizumab, Innovent Biologics' intellulimab, BeiGene's tirelizumab, Junshi Biologics' teripulimab, Akeso's paipelilimab, Yuheng's sepalimab and Henlius' serulimab
.

Putelimumab

10 Hua Medicine

Docagliatin

Approval time: 2022-09-30

Approval time:

Indications: Indicated for improving glycemic control in adults with type 2 diabetes

Indications:

In September 2022, Hua Medicine's Class 1 innovative drug Docagliatin Tablets (trade name: Hua Tangning) was approved for marketing, which is suitable for improving blood sugar control
in adult patients with type 2 diabetes.
This hypoglycemic drug is the world's first oral hypoglycemic drug with a new mechanism, which will provide innovative treatment options
for patients with type 2 diabetes in China.
Prior to the approval of Hua Tangning, Hua Medicine had made full preparations
for its commercialization.
In August 2020, Bayer invested CNY 4.
5 billion to reach a strategic cooperation with Hua Medicine, which is responsible for clinical research, drug registration, drug supply and distribution.
Bayer is responsible for the marketing, promotion and medical education activities
of Docgliptin in China.
In September 2021, Hua Medicine and Sinopharm reached a supply chain cooperation agreement, and the two sides carried out in-depth cooperation
in logistics and warehousing, supply chain management and channel informatization.
In February 2022, Hua Medicine and Heyall Pharma signed a commercial production cooperation agreement for docagliatin, which will facilitate the commercial supply
of Huatang Ning in China after its launch.
On October 28, 2022, Hua Tangning's first prescription landed in Shanghai, and it was simultaneously
sold in pharmacies across the country.
It is reported that the price of Huatang Ning is 420 yuan / box
.

Docgliatin tablets

11 Luye Pharmaceutical

Toludi venlafaxine hydrochloride

Approval time: 2022-11-01

Approval time:

Indications: Depression

Indications:

In November 2022, Shandong Luye Pharmaceutical's Class 1 innovative drug Toludi venlafaxine hydrochloride sustained-release tablets (LY03005, trade name: Ruoxinlin) was launched, which is suitable for the treatment
of depression.
LY03005 is a new molecular entity therapy with a novel mechanism of action, and its marketing application was accepted
by CDE in June 2021.
In addition to China, LY03005 is also in the marketing review stage in the United States and has completed phase I clinical trials in Japan for the treatment of depression
.
In addition, the phase III clinical trial of the drug for the treatment of generalized anxiety disorder has also been approved in
China.

Toludi venlafaxine hydrochloride sustained-release tablets

12 Yingli Pharmaceutical

Limplisse

Approval time: 2022-11-08

Approval time:

Indications: Treatment of relapsed/refractory (R/R) follicular lymphoma (FL)

Indications:

In November 2022, Yingli Pharmaceutical's self-developed anti-cancer class 1 new drug Linplisept (trade name: Intarui) was conditionally approved by the State Food and Drug Administration for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL).

After the approval for marketing, Yingli Pharmaceutical will jointly promote the commercialization
of Intari in China with Hengrui Pharmaceutical.
In 2020, Linplisset was awarded by the State Food and Drug Administration for the treatment of R/R Breakthrough therapy designation
for FL.
Previously, Linplisset has received three orphan drug designations from the US FDA for the indications of FL, chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and T-cell lymphoma
.

Limplisse

13 Red Sun Pharmaceutical

Toluenesulfonamide

Approval time: 2022-11-15

Approval time:

Indications: Alleviation of severe airway obstruction in adults with central non-small cell lung cancer

Indications:

In November 2022, the tosylamide injection of Tianjin Hongri Jiandakang Pharmaceutical Technology Co.
, Ltd.
, a shareholding subsidiary of Red Sun Pharmaceutical, was approved for marketing
.
Toluenesulfonamide injection is an innovative chemical drug for the treatment of solid tumors, highly selective for tumor cells, and is the first chemical ablation drug approved by fiber bronchoscopic intratumors in China, and the first drug indicated to alleviate severe airway obstruction in adult patients with central non-small cell lung cancer, filling the gap
of respiratory interventional drug treatment.
According to statistics from the World Agency for Research on Cancer (IARC), there were about 816,000 new cases of lung cancer and about 715,000 deaths in China in 2020
.
Non-small cell lung cancer accounts for more than 80% of lung cancers, of which about 70% are central.

14 Boehringer Ingelheim

Pesolimab

Approval time: 2022-12-13

Approval time:

Indications: Treatment of generalized pustular psoriasis (GPP) episodes in adults

Indications:

In December 2022, Boehringer Ingelheim's innovative drug pesolimab injection (trade name: San Ligzo) was approved by the State Food and Drug Administration for the treatment of adult generalized pustular psoriasis (GPP
).
It is worth mentioning that San Lizhuo has been qualified for breakthrough therapy drug recognition and priority review and approval by the State Food and Drug Administration, which is only three months
away from the approval time in the United States.
Currently, San Reidre is also being developed for the maintenance treatment of GPP and for the treatment of other neutrophilic skin diseases
.
It is reported that San Lizhuo has been recommended by the 2022 edition of the "Chinese Expert Consensus on the Diagnosis and Treatment of Pustular Psoriasis
".

Pesolimab

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