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Annual Inventory In 2022, these 14 Class 1 new drugs were approved in China

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

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2022 is coming to an end
.
According to the official website of China's National Medical Products Administration (NMPA), as of December 18, more than 50 new drugs have been approved in China this year, including 14 Class 1 new drugs
.

14 Class 1 new drugs
.

Sorting through these Class 1 new drugs (according to the registration classification at the time of drug application, excluding vaccines and traditional Chinese medicines), we found that the vast majority of them (9/14) were approved expedited through priority review
.
From the perspective of therapeutic fields, these products are mostly anti-tumor new drugs, and also involve endocrinology and metabolism, immune system, cardiovascular and other disease fields
.
Among them, many products belong to the "first" new drugs, which have certain clinical significance, such as the world's first PD-1/CTLA-4 bispecific antibody, the world's first glucokinase activator (GKA) drug.
.
.

The vast majority (9/14) were approved by priority review, mostly new anti-tumor drugs, the world's first PD-1/CTLA-4 bispecific antibody, the world's first glucokinase activator (GKA) class of drugs.
.
.

North China Pharmaceutical: Omutivimab

Mode of action: recombinant human anti-rabies monoclonal antibody

Indications: Passive immunity of rabies virus exposed patients

In January this year, North China Pharmaceutical's class 1 new drug omintavirumab injection was approved by NMPA for passive immunity
in adult rabies virus exposed patients.
According to public information, this is a recombinant human anti-rabies virus monoclonal antibody injection, which can directly neutralize the rabies virus in the body and is used for passive immunity
of patients bitten and scratched by rabies or other rabies virus-susceptible animals.

A recombinant human anti-rabies virus monoclonal antibody injection that can directly neutralize rabies virus in vivo

Olmutivimab has achieved good safety and efficacy data in a randomized controlled phase 3 clinical trial in combination with human rabies vaccine for post-exposure prophylaxis in people exposed to suspected class III rabies virus to achieve primary efficacy and secondary efficacy endpoints
.
Previously, the product was also included in the priority review
by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China on the grounds of "urgently needed clinical shortage drugs, innovative drugs for the prevention and treatment of major infectious diseases and rare diseases, and improved new drugs".

Primary and secondary efficacy endpoints were met

Henlius: Serplulimab

Mode of action: anti-PD-1 monoclonal antibody

Indications: MSI-H solid tumor, non-small cell lung cancer

In March this year, Henlius announced the approval of the PD-1 inhibitor serplulimab in China for the treatment of adult patients with advanced solid tumors with unresectable or metastatic microsatellite high instability (MSI-H
).
Data from the Phase 2 clinical trial of serplulimab in MSI-H/mismatch repair-deficient (dMMR) solid tumors showed that in primary efficacy analysis populations, the Independent Imaging Evaluation Committee (IRRC) based on RECIST The objective response rate (ORR) assessed by v1.
1 criteria was 39.
7%, including 3 complete responses and 24 partial responses
.

The objective response rate (ORR) of adult advanced solid tumors treated for unresectable or metastatic microsatellite highly unstable (MSI-H) was 39.
7%, including 3 complete responses and 24 partial responses

In October this year, serplulimab was approved for a second indication in China, in combination with carboplatin and albumin paclitaxel, for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (NSCLC).

The data showed that the combination of chemotherapy significantly prolonged PFS in patients, and had a higher ORR and longer duration of response (DoR) than the control group, and had a good
safety profile.
In addition, the marketing application for the new indication of serplulimab for the treatment of extensive-stage small cell lung cancer and esophageal squamous cell carcinoma has also been accepted by CDE
.

First-line treatment of inoperably advanced or metastatic squamous non-small cell lung cancer (NSCLC) significantly prolongs PFS in patients with higher ORR and longer duration of response (DoR)

Pfizer: Albuxitinib

Mode of action: JAK1 inhibitor

Indications: atopic dermatitis

In April this year, Pfizer's oral JAK1 inhibitor albuxitinib tablets were approved for marketing in China for the treatment of moderate to severe atopic dermatitis
in adults.
Albuxitinib is a once-daily oral Janus kinase 1 (JAK1) inhibitor
.
According to the Pfizer press release, the product has been recognized as a breakthrough therapy by the US FDA, and has also been prioritized for review in China, and has achieved global synchronous research and development and synchronous registration
.

Janus kinase 1 (JAK1) inhibitors, which require only once-daily oral administration, have been developed and registered globally

Previously, abaxitinib tablets have achieved positive results in multiple phase 3 clinical trials in patients with moderate to severe atopic dermatitis, and it has shown significant improvements in skin symptom clearance, disease severity, and rapid improvement of pruritus symptoms
compared with placebo.

It showed significant improvement in skin symptom clearance and disease severity, and rapidly improved the pruritus symptoms of patients

Luoxin Pharmaceutical: Tegolaxen tablets

Mode of action: potassium competitive acid blocker

Indications: Reflux esophagitis

In April this year, Luoxin Pharmaceutical announced that its innovative drug tegolaxen tablets were approved in China for the treatment of reflux esophagitis
.
According to public information, this is a potassium competitive acid blocker (P-CAB), which can block the potassium channel of H+/K+-ATPase, competitively block the binding of potassium ions to the enzyme, stay in the stomach parietal cells for a long time, thereby rapidly inhibiting the secretion
of gastric acid.
Relevant clinical studies have shown that compared with other acid-suppressing drugs, it generally takes 1.
5~4 hours to take effect, and tegolaxen has the characteristics
of rapid onset of action in 30 minutes, strong and long-lasting acid suppression, and easy to take.

A potassium competitive acid blocker (P-CAB) has the characteristics of rapid onset of action in 30 minutes, strong and long-lasting acid suppression, and easy to take

Bayer/Merck: Velisi tablets

Mode of action: sGC agonist

Indications: chronic heart failure

In May this year, the innovative therapy Vericigua, jointly developed by Bayer and Merck (MSD), was approved in China for adults with symptomatic chronic heart failure with reduced ejection fraction who have recently been decompensated for heart failure and stabilized after intravenous therapy, to reduce the risk of
heart failure hospitalization or emergency intravenous diuretic therapy.
Vericiguer is a direct, water-soluble guanylate cyclase (sGC) agonist taken orally once daily to restore the function of key signaling pathways by activating sGC, which is important for vascular and cardiac function
.

Symptomatic chronic heart failure is a direct water-soluble guanylate cyclase (sGC) agonist taken orally once daily

According to the Bayer press release, the approval of VELISIGUER is based on the positive results
of the VICTORIA study.
The data showed that at a median follow-up of 10.
8 months, the absolute risk of primary endpoint events (ARR) was reduced by 4.
2% in the velicigua group for the primary endpoint, which was clinically significant, and the number of people needing treatment (NNT) was 24, which corresponds to one less primary endpoint event
per 24 patients treated.

The absolute risk (ARR) reduction of 4.
2% was clinically significant

Hengrui Pharmaceutical: Revilumide tablets

Mode of action: AR inhibitors

Indications: Prostate cancer

In June this year, the NMPA announced the conditional approval of Hengrui Pharmaceutical's new androgen receptor (AR) inhibitor revilumide tablets for metastatic hormone-sensitive prostate cancer (mHSPC)
with high tumor burden.
According to the public information of Hengrui Pharmaceutical, reverutamide tablets are a second-generation AR inhibitor, which has a stronger AR inhibitor effect than the first-generation AR inhibitor and has no agonistic effect
.

Second-generation AR inhibitors

The approval is based primarily on the results of a Phase 3 clinical study
called CHART.
The data showed that as of May 16, 2021, the 24-month radiographic progression-free survival (rPFS) rate assessed by the independent review committee (IRC) of the revilumide group was 72.
3% (vs 50.
0%), which was significantly longer than that of the control group, and the risk of imaging progression or death was reduced by 56%.

The 24-month overall survival (OS) rates were 81.
6% and 70.
3%, respectively, and the patients in the revilumide group had significantly longer OS and reduced the risk of death by 42%.

In addition, patients in the revilumide group also showed significant benefit
on secondary and exploratory efficacy endpoints.

The 24-month radiographic progression-free survival (rPFS) rate was 72.
3% (vs 50.
0%), 24-month overall survival (OS) rates were 81.
6% and 70.
3%, respectively

Bayer: Phenelidone tablets

Mode of action: nonsteroidal selective mineralocorticoid receptor antagonist

Indications: Chronic kidney disease associated with type 2 diabetes mellitus

In June, Bayer announced that its candidate, Fenelidone tablets, was approved in China for adults with chronic kidney disease (CKD) associated with type 2 diabetes to reduce the risk of
end-stage renal disease with declining glomerular filtration rate (eGFR) estimates.
According to the Bayer press release, phenirenal tablets are the first non-steroidal selective mineralocorticoid receptor antagonists approved for chronic kidney disease associated with type 2 diabetes, acting on key factors
in disease progression that existing standard therapies have not addressed.

Estimates of glomerular filtration rate were the first non-steroidal selective mineralocorticoid receptor antagonists for chronic kidney disease associated with type 2 diabetes

The FIDELIO-DKD study, a pivotal Phase 3 clinical trial, showed that in patients with type 2 diabetes with CKD, fenelidone slowed kidney disease progression by 18% and reduced cardiovascular risk by 14%
compared with current standard of care 。 Another Phase 3 clinical trial, FIGARO-DKD, showed that the use of fenerone reduced the risk of first cardiovascular death or non-fatal cardiovascular event in patients with type 2 diabetes with CKD by 13%
when already receiving the maximum tolerated dose of angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs).

slowed kidney disease progression by 18%, reduced cardiovascular risk by 14%, and reduced the risk of first cardiovascular death or non-fatal cardiovascular event by 13%;

Akeso: Cardonilimab

Mode of action: PD-1/CTLA-4 bispecific antibody

Indications: Cervical cancer

In June this year, Akeso announced that its cardunilimab injection was approved in China for the treatment
of patients with relapsed or metastatic cervical cancer who had previously failed platinum-containing chemotherapy.
According to public information, cardunilimab is the world's first approved PD-1/CTLA-4 bispecific antibody
.
It realizes the activation of immune cells through "double debraking", that is, by simultaneously inhibiting the two immune signal checkpoint pathways of PD-1 and CTLA-4, it indirectly liberates and activates immune cells, enhances immune activity, and strengthens anti-tumor effects
.

The world's first approved PD-1/CTLA-4 bispecific antibody

The approval is based on the results of a pivotal clinical study
.
The data showed that for relapsed or metastatic cervical cancer that failed platinum-containing chemotherapy with cardunilimab monotherapy, the ORR of cardunilimab single-agent 2/3 line therapy reached 33.
0%, and the partial response (CR) rate reached 12%, regardless of the patient's PD-L1 status; The ORR of PD-L1+ patients (CPS≥1) was as high as 43.
8%.

At the same time, the progression-free survival of the treatment group was also significantly improved, and the survival was also significantly prolonged
.

Regardless of the patient's PD-L1 status, the ORR of 2/3 line of cardunelli monotherapy reached 33.
0%, and the partial response (CR) rate reached 12%; The ORR of PD-L1+ patients (CPS≥1) was as high as 43.
8%

Lepu Bio: Putelimab

Mode of action: anti-PD-1 antibody

Indications: MSI-H or dMMR solid tumor, melanoma

In July this year, Lepu Biotech announced that the anti-PD-1 antibody putelimab injection was approved for marketing in China, which is suitable for patients
with advanced solid tumors with unresectable or metastatic MSI-H or dMMR.
The approval is primarily based on the results of a multicenter Phase 2 clinical study in the ITT population with an ORR of 49.
0% as assessed by the IRC according to RECIST1.
1, including 9 complete responses and 40 partial responses; In the subgroup of colorectal cancer who had failed previous three-drug therapy, the ORR was 50.
0%.

The ORR was 49.
0%, including 9 complete responses and 40 partial responses

In September this year, putelimab was approved in China for a new indication for unresectable or metastatic melanoma
that had previously failed systemic therapy.
The approval is primarily based on the results of a single-arm pivotal Phase 2 clinical study, developed by IRC under RECIST The ORR assessed by 1.
1 criteria was 20.
2%, including 1 complete response and 23 partial responses
.
In addition, Lepu Biologics also explores the therapeutic effect of putelimab in other indications, such as second-line treatment of gastric cancer or gastroesophageal junction cancer, NSCLC, triple-negative breast cancer, hepatocellular carcinoma, etc
.

The ORR was 20.
2%, including 1 complete response and 23 partial responses

Hua Medicine: Docgliatin tablets

Mode of action: glucokinase activator

Indications: Type 2 diabetes mellitus

In October this year, the NMPA announced that it had approved the marketing of Hua Medicine's Class 1 new drug Docagliatin tablets to improve blood sugar control
in adult patients with type 2 diabetes.
According to public information, doggliatin is a "first-in-class" GKA diabetes treatment drug
.
The approval of this drug not only marks the first approved product of Hua Medicine, but also marks the first approved GKA drug
in the world.

A "first-in-class" GKA diabetes treatment

Docagliatin has previously met primary efficacy and safety endpoints
in two Phase 3 registered clinical studies (SEED and DAWN).
Both studies showed that dotagliatin can act quickly during the treatment period, continuously and effectively reduce glycated hemoglobin, significantly reduce blood glucose levels two hours after meals in patients with type 2 diabetes, and continuously improve β cell function and insulin resistance
.
Moreover, the incidence of hypoglycemia in patients is very low, there are no side effects such as gastrointestinal tract, and it has good safety and tolerability
.

Fast-acting, sustained and effective reduction of glycated hemoglobin, significantly reducing blood glucose levels two hours after meals in patients with type 2 diabetes, and continuously improving β cell function and insulin resistance

Luye Pharmaceutical: Toludi venlafaxine hydrochloride sustained-release tablets

Mode of action: inhibition of multiple reuptake

Indications: depression

In November this year, the NMPA announced that it had approved the marketing of Toludi venlafaxine hydrochloride sustained-release tablets, a Class 1 innovative drug declared by Luye Pharmaceutical, which is suitable for the treatment
of depression.
According to the NMPA announcement, the antidepressant effect of this product may be related to
the enhancement of the 5-HT and NE effects of the central nervous system by inhibiting the reuptake of serotonin (5-HT) and norepinephrine (NE).

By inhibiting the reuptake of serotonin (5-HT) and norepinephrine (NE).

This approval is based on the results of 6 clinical studies
completed in China by toludi venlafaxine hydrochloride sustained-release tablets.
The results of the phase 3 clinical trial showed that the candidate was significantly better than placebo in many indicators at the end of 8 weeks, especially in improving anhedonia, cognitive impairment, blockade, fatigue and so on
.
In addition, the drug candidate is well tolerated and safe, does not cause drowsiness, and does not affect weight, lipid metabolism, and sexual function
.

The candidate was significantly better than placebo in several indicators at the end of 8 weeks, especially in improving anhedonia, cognitive impairment, blockade, fatigue, etc

Yingli Pharmaceutical: Linplisset tablets

Mode of action: PI3Kδ inhibitor

Indications: Follicular lymphoma

In November this year, the NMPA announced that it had conditionally approved the marketing of Linplisset tablets declared by Yingli Pharmaceutical for adult patients
with relapsed or refractory follicular lymphoma who have received at least two previous systemic treatments.
This is a new generation PI3K delta (phosphoesteryl inositol 3-kinase isotype δ) highly selective inhibitor, through which Hengrui Pharmaceutical obtained its joint development rights in Greater China and exclusive exclusive commercialization rights
.

A new generation of highly selective inhibitors of PI3K delta (phosphoesterinositol 3-kinase isotype δ).

Results from a Phase 2 registration clinical trial showed that Linplisset demonstrated significant efficacy in patients with relapsed/refractory follicular lymphoma, achieving an overall response rate of 79.
8%, a disease control rate (DCR) of 96.
6%, and a 12-month overall survival rate of 91.
4
%.
In addition, oral administration of Linplisept is safe, controllable, well tolerated, and patients only need to take oral administration once a day, which is convenient
to use.

An overall response rate of 79.
8%, a disease control rate (DCR) of 96.
6%, and a 12-month overall survival rate of 91.
4% were achieved

Red Sun Pharmaceutical: Tosylamamide injection

Mode of action: chemical ablation drugs

Indications: Alleviation of airway obstruction in specific lung cancers

In November this year, Red Sun Pharmaceutical issued an announcement that the marketing application of class 1 new drug toluenesulfonamide injection has been officially approved to alleviate severe airway obstruction
in adult patients with central non-small cell lung cancer.
This is a transfiberobronchoscopic local injection of chemical ablation drug, the mechanism of action is: after entering tumor cells, by promoting lysosomal rupture, improving intracytoplasmic hydrogen peroxide activity, inhibiting the activity of mitochondrial ATP synthetase, and then promoting coagulation necrosis
of tumor cells.
The product is highly selective for tumor cells, but has relatively little damage to normal cells, and has the characteristics
of wide application, safety and easy operation.

A chemical ablation drug injected locally within a fiberoptic bronchoscopic tumor

Boehringer Ingelheim: pesolimab

Mode of action: IL-36R monoclonal antibody

Indications: Generalized pustular psoriasis (GPP)

In December, the NMPA announced that it had approved the marketing of a rare skin disease-targeted biologic, pesolimab, for the treatment of
GPP episodes in adults through a priority review and approval process.
Pesolimab is Boehringer Ingelheim) developed a humanized antagonistic monoclonal IgG1 antibody that binds to the interleukin-36 receptor (IL-36R) and blocks IL-36R-36R activation induced by human IL-36α, IL-36β and IL-36γ, thereby inhibiting pro-inflammatory and pro-fibrotic pathways
in inflammatory skin diseases.

It binds to the interleukin-36 receptor (IL-36R) and blocks IL-36α, IL-36β, and IL-36γ-induced IL-36R activation in humans

Boehringer Ingelheim said in the press release that pesolimab is an innovative product that is simultaneously developed and registered worldwide, and it is also the first therapeutic drug
approved in China specifically for the treatment of adult GPP attacks.
The approval is based on the global key EffisayilTM 1 Study Phase 2 clinical results
.
The data showed that 54.
3% of patients achieved no visible pustules in the skin after 1 week of pesolimab treatment, and 42.
9%
of patients achieved clearance or almost clearance of skin symptoms within 1 week of treatment.
Data on the safety profile of pesolimab were acceptable in studies, and common adverse events included fever and mild to moderate infection
.

54.
3% of patients achieved no visible pustules on the skin within 1 week of treatment, and 42.
9% achieved clearance or almost clearance of skin symptoms within 1 week of treatment

Congratulations on the approval of these innovative drugs in China, and look forward to the arrival of more innovative drugs in the future, so that patients have more treatment options
.

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