In October, these more than 10 new drugs were submitted for listing in China, from Roche, Hengrui Pharmaceuticals, Novartis, etc.

According to the announcement of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (CDE) and the press releases of various companies, more than a dozen new drugs were submitted for marketing in China in October (including new indications)
.

Among them, some have been accepted by the CDE, or are planned to be included in the priority review

1.
Roche: Entritinib Capsule Mechanism of Action: Specific Tyrosine Kinase Inhibitor

1.
Roche: Entritinib Capsule Mechanism of Action: Specific Tyrosine Kinase Inhibitor

Entratinib is a specific tyrosine kinase inhibitor designed for NTRK and ROS1 gene fusion.
It can inhibit TRK A/B/C and ROS1 kinase activity
.

Previously, the drug has received accelerated FDA approval in the United States for the treatment of adult and adolescent cancer patients carrying NTRK gene fusions, and non-small cell lung cancer patients carrying ROS1 gene mutations

Entratinib is a specific tyrosine kinase inhibitor designed for NTRK and ROS1 gene fusion, it can inhibit TRK A/B/C and ROS1 kinase activity

This time the drug submitted a new drug marketing application in China and was accepted.
The proposed indications are: NTRK fusion-positive locally advanced or metastatic solid tumors
.

At the same time, the drug will be included in the priority review by the CDE on the grounds of "a drug that meets the conditions for approval

NTRK fusion-positive locally advanced or metastatic solid tumors

2.
Hengrui Medicine: SHR3680 Tablets Mechanism of Action: Second-generation AR inhibitor

2.
Hengrui Medicine: SHR3680 Tablets Mechanism of Action: Second-generation AR inhibitor

SHR3680 is the second-generation anti-androgen receptor (AR) antagonist, which achieves the purpose of treating prostate cancer by blocking the normal activation of the AR signaling pathway
.

According to an earlier press release of Hengrui Medicine , SHR3680 has a stronger AR inhibitory effect than the first generation AR inhibitor, and has no agonistic effect

Compared with the first generation of AR inhibitors, SHR3680 has a stronger AR inhibitory effect and no agonistic effect

This time, the marketing application of SHR3680 has been accepted by CDE, and it is planned to be included in the priority review on the grounds of "drugs included in the breakthrough therapeutic drug program".
The proposed development indication is: treatment of metastatic hormone-sensitive prostate cancer with high tumor burden (mHSPC) ) Patients
.

Previously, SHR3680 has reached the primary endpoint in a phase 3 clinical trial for this indication, which can significantly reduce the risk of disease progression or death in mHSPC patients with high tumor burden

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

3.
Li's Pharmaceutical Factory: First gram Lizumab injection Mechanism of action: anti-PD-L1 monoclonal antibody

3.
Li's Pharmaceutical Factory: First gram Lizumab injection Mechanism of action: anti-PD-L1 monoclonal antibody

Socazolimab injection (socazolimab, formerly known as ZKAB001) is a fully human anti-PD-L1 monoclonal antibody against tumor PD-L1 protein that is being developed by Lee's Pharmaceutical Factory.
The submission is for the treatment of recurrence.
New drug marketing application for sexual or metastatic cervical cancer
.

Previously, the drug was included in the breakthrough treatment category by CDE.

This submission is for the marketing application of a new drug for the treatment of recurrent or metastatic cervical cancer

Public information shows that the antibody cell line of socazolimab was introduced from Sorrento Therapeutics by Lee's Pharmaceutical Factory
.

It can not only bind to the PD-L1 protein, block the interaction between the PD-L1 protein and its receptor PD-1, thereby releasing the inhibition of the PD-1 or PD-L1 signaling pathway on T cells, and enhancing the T cell’s effect on tumors.

4.
Lepu Bio: Pratlizumab injection Mechanism of action: anti-PD-1 monoclonal antibody

4.
Lepu Bio: Pratlizumab injection Mechanism of action: anti-PD-1 monoclonal antibody

Putlimumab (pucotenlimab, HX008) is a humanized monoclonal antibody targeting human PD-1 by using human IgG4 subtype
.

It is the core product of Lepu Bio
.
The indication submitted this time is: for the treatment of satellite instability (MSI-H)/mismatch repair function defect (dMMR) solid tumors .
Prior to this, the drug had submitted a marketing application for the second-line treatment of melanoma in July this year
.

For the treatment of satellite instability (MSI-H)/mismatch repair defect (dMMR) solid tumors

Public information shows that Pratizumab can antagonize PD-1 signaling to restore the ability of immune cells to kill cancer cells by blocking the binding of PD-1 to its ligands PD-L1 and PD-L2
.
At the same time, it innovatively uses antibody engineering technology to introduce mutations in the Fc region to increase the binding affinity of FcRn, thereby greatly extending its half-life , in order to improve the clinical efficacy and drug compliance of patients
.
Prior to this, Pratizumab has achieved a 46.
0% overall clinical response rate (ORR) and a disease control rate (DCR) of 70.
0% in a pivotal phase 2 clinical study conducted in MSI-H/dMMR advanced solid tumors.
)
.

It innovatively uses antibody engineering technology to introduce mutations in the Fc region to increase the binding affinity of FcRn, thereby greatly extending its half-life

5.
Boehringer Ingelheim: spesolimab mechanism of action: IL-36R targeting monoclonal antibody

5.
Boehringer Ingelheim: spesolimab mechanism of action: IL-36R targeting monoclonal antibody

Spesolimab is a monoclonal antibody that targets the interleukin-36 receptor (IL-36R).
It can block the effects of IL-36R.
It can treat skin diseases, palmoplantar pustulosis, ulcerative colitis and other inflammations.
The potential of sexual diseases
.
Previously, spesolimab has been included in the breakthrough treatment category by CDE and is intended to be used to treat the onset of generalized pustular psoriasis (GPP)
.
This time the drug submitted a marketing application in China, and the indication is also GPP
.

A monoclonal antibody targeting the interleukin-36 receptor (IL-36R), which can block the effects of IL-36R

The drug's current marketing application in China is based on its pivotal phase 2 clinical study in the world
.
The key results of the study showed that: 54.
3% of patients had no visible pustules in the skin after 1 week of spesolimab treatment; 42.
9% of patients had clear or almost clear skin symptoms after 1 week of spesolimab treatment ; at the same time, the safety of spesolimab throughout the study Sexual data is acceptable
.

54.
3% of the patients had no visible pustules in the skin after 1 week of spesolimab treatment; 42.
9% of the patients had clear or almost clear skin symptoms after 1 week of spesolimab treatment

6.
Maibo Pharmaceutical: CMAB007 for injection .
Mechanism of action: anti-IgE antibody

6.
Maibo Pharmaceutical: CMAB007 for injection .
Mechanism of action: anti-IgE antibody

CMAB007 is a biosimilar of omalizumab, and it is the second drug submitted by Maibo Pharmaceutical to apply for marketing
.
Omalizumab is an antibody therapeutic drug that specifically targets and blocks anti-immunoglobulin E (IgE).
The original product is Xolair (omalizumab), which is jointly developed by Novartis and Roche
.
In terms of the mechanism of action, omalizumab can minimize the release of multiple mediators in the allergic inflammatory cascade by reducing the level of free IgE, down-regulating high-affinity IgE receptors and limiting the degranulation of mast cells
.

Omalizumab is an antibody therapeutic drug that specifically targets and blocks anti-immunoglobulin E (IgE).

CMAB007 submitted a marketing application in China this time and is intended to be developed for the treatment of asthma patients who are still not fully controlled after the treatment of medium/high-dose inhaled corticosteroids and long-acting β-adrenergic receptor agonists
.
Clinical trials have shown that CMAB007 can improve the condition of asthma patients and reduce the incidence of acute asthma with lower doses of inhaled corticosteroids
.
According to Maibo Pharmaceuticals announcement, CMAB007 is expected to become the first monoclonal antibody (mAb) asthma therapy developed by a Chinese company and marketed in China
.

Treatment of asthma patients who are still not adequately controlled after medium/high-dose inhaled corticosteroids plus long-acting β-adrenergic receptor agonists

7.
Novartis: Libexili Succinate Tablets Mechanism of Action: CDK 4/6 Inhibitor

7.
Novartis: Libexili Succinate Tablets Mechanism of Action: CDK 4/6 Inhibitor

Ribociclib (Kisqali) is a selective cyclin-dependent kinase (CDK) inhibitor, which can inhibit CDK 4/6 with higher specificity and prevent the uncontrolled proliferation of cancer cells
.
Prior to this, the product has been approved for marketing in dozens of countries and regions including the United States and the European Union for a variety of breast cancer indications
.

A selective cyclin-dependent kinase (CDK) inhibitor, which can inhibit CDK 4/6 with higher specificity

In a phase 3 clinical study in the treatment of HR-positive and HER2-negative postmenopausal advanced or metastatic breast cancer patients, the median overall survival (OS) of patients receiving ribociclib and letrozole combination therapy was significantly better than that of the control Group (63.
9 months vs 51.
4 months)
.
The results of another phase 3 study MONALEESA-7 in premenopausal women with HR-positive/HER2-negative metastatic breast cancer showed that: at a median follow-up time of 53.
5 months, ribociclib combined with endocrine therapy group and placebo combined with endocrine The treatment group still had OS benefit compared with the median OS period of 58.
7 months and 48.
0 months, respectively
.

Postmenopausal before menopause

8.
Xuanzhu Biology: Anaprazole sodium enteric-coated tablets .
Mechanism of action: a new generation of PPI inhibitors

8.
Xuanzhu Biology: Anaprazole sodium enteric-coated tablets .
Mechanism of action: a new generation of PPI inhibitors

Anaprazole sodium developed by Xuanzhu Biological is a new generation of proton pump inhibitor (PPI) inhibitor, which can inhibit gastric acid secretion and is used to treat duodenal ulcer
.
According to Xuanzhu Bio’s press release, the company’s submission of a new drug listing application for Anaprazole sodium enteric-coated tablets is the first drug to submit a new drug listing application, marking Xuanzhu Bio’s new drug development from research and development to commercial development.
Mileage
.

A new generation of proton pump inhibitor (PPI) inhibitors that can inhibit gastric acid secretion and are used to treat duodenal ulcers

Public information shows that Anaprazole sodium is metabolized by multiple enzymes and non-enzymes, and the risk of drug interactions is low
.
The results of the Phase 2 trial in the treatment of duodenal ulcer showed that the new drug can effectively treat duodenal ulcer, promote ulcer healing, and relieve ulcer-related symptoms.
The duodenal ulcer healing rate under gastroscopy is better, and it is safe.
, Good tolerance
.

9.
Zejing Pharmaceutical: Donafenib Tosylate Tablets Mechanism of Action: Multikinase Inhibitor

9.
Zejing Pharmaceutical: Donafenib Tosylate Tablets Mechanism of Action: Multikinase Inhibitor

Donafinil is an oral multi-target, multi-kinase inhibitor small molecule anti-tumor drug developed by Zejing Pharmaceutical
.
In June of this year, the drug was approved for marketing in China through the priority review and approval process for the treatment of patients with unresectable hepatocellular carcinoma who had not received systemic treatment in the past
.
This time, we submitted a new indication marketing application for Donafenib, which is aimed at the treatment of locally advanced/metastatic radioiodine refractory differentiated thyroid cancer (RAIR-DTC)
.

For the treatment of locally advanced/metastatic radioiodine refractory differentiated thyroid cancer (RAIR-DTC)

The marketing application for this new indication is mainly based on the results of a phase 3 clinical trial code-named ZGDD3
.
According to the press release of Zejing Pharmaceuticals, the study plans to enroll 204 patients, which is one of the largest sample studies conducted among Chinese patients with thyroid cancer
.
The results of the study show that Donafenib treatment has an excellent anti-tumor effect, and while significantly prolonging the progression-free survival (PFS) of patients with RAIR-DTC, it also shows good safety and tolerability
.

While significantly prolonging the progression-free survival (PFS) of RAIR-DTC patients, it also shows good safety and tolerability

10.
Jinsai Pharmaceutical: Recombinant Human Growth Hormone Injection Mechanism of Action: Peptide Hormone

10.
Jinsai Pharmaceutical: Recombinant Human Growth Hormone Injection Mechanism of Action: Peptide Hormone

Growth hormone (GH) is a peptide hormone secreted by the anterior pituitary gland of the human body, which can promote the growth of bones, internal organs and the whole body
.
According to information on the official website of Jinsai Pharmaceutical, the recombinant human growth hormone injection developed by the company has been approved in China for 8 indications , including growth disorder in girls caused by gonadal hypoplasia (Turner syndrome), which was just approved at the end of September this year.

.

8 indications have been approved in China

This time, it submitted a new indication market application for recombinant human growth hormone injection for Jinsai Pharmaceutical.
It is planned to be developed for the treatment of children with slow growth and short stature in children
.
It is worth mentioning that in October this year, the product was also included in the proposed priority review as "new varieties, dosage forms and specifications of children’s drugs that meet the physiological characteristics of children".

Intended to be developed for the treatment of children with slow growth, children with short stature and many other indications

11.
Kangzhe Pharmaceutical/Sun Pharma: Tiralizumab Injection Mechanism of Action: IL-23 Targeted Therapy

11.
Kangzhe Pharmaceutical/Sun Pharma: Tiralizumab Injection Mechanism of Action: IL-23 Targeted Therapy

Tirazizumab is an innovative therapy introduced by CMS from Sun Pharma.
It can selectively bind to the p19 subunit of IL-23 and inhibit its interaction with IL-23 receptors, thereby inhibiting pro-inflammatory Release of cytokines and chemokines
.
In March 2018, Tiralizumab was approved for marketing in the United States for the treatment of adult patients with moderate to severe plaque psoriasis who are suitable for systemic therapy or phototherapy
.

It can selectively bind to the p19 subunit of IL-23 and inhibit its interaction with IL-23 receptor, thereby inhibiting the release of pro-inflammatory cytokines and chemokines

Previously, tiralizumab has reached the primary efficacy endpoint in two multicenter, randomized, double-blind, placebo-controlled trials (reSURFACE 1 and reSURFACE 2), demonstrating the use of tiralizumab compared with placebo 100mg can achieve significant clinical improvement .
This improvement is achieved by at least 75% skin clearance (psoriasis area sensitivity index or PASI 75) and a physician’s comprehensive assessment (PGA) score of "clearance" at the 12th week after two administrations.
Or "minimum" to measure
.

Significant clinical improvement can be achieved with tilapizumab 100mg

12.
Boan Biology: Disumab Injection Mechanism of Action: RANKL Targeted Therapy

12.
Boan Biology: Disumab Injection Mechanism of Action: RANKL Targeted Therapy

Recently, the biosimilar drug (LY06006/BA6101) of Disumab developed by Boan Biologics, a subsidiary of Luye Pharmaceuticals, submitted a listing application in China
.
LY06006 is an IgG2 fully human monoclonal antibody, a biological analogue of Prolia, which inhibits the binding of RANKL to its receptor RANK, reduces the formation, function and survival of osteoclasts, thereby reducing bone resorption and increasing bone mass , Improve the strength of cortical bone or cancellous bone
.
Globally, the original research product Prolia has been approved for multiple indications
.
In June 2020, Prolia was also approved for listing in China
.

By inhibiting the binding of RANKL and its receptor RANK, the formation, function and survival of osteoclasts are reduced, thereby reducing bone resorption, increasing bone mass, and improving cortical bone or cancellous bone strength
.

According to a press release issued by Luye Pharma, LY06006 is intended to be developed to: 1) treat osteoporosis in postmenopausal women with a high risk of fracture; 2) increase bone mass in men with osteoporosis at a high risk of fracture ; 3) Treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture; 4) Increase in bone mass in patients at high risk of fracture due to androgen deprivation treatment for non-metastatic prostate cancer; 5) and increase Bone mass in patients at high risk of fracture due to breast cancer receiving aromatase inhibitor therapy
.

Osteoporosis in postmenopausal women and osteoporosis in men

13.
Saisheng Pharmaceutical/Theravance Company: Tilavacin Hydrochloride for Injection Mechanism of action: lipoglycopeptide antibiotics

13.
Saisheng Pharmaceutical/Theravance Company: Tilavacin Hydrochloride for Injection Mechanism of action: lipoglycopeptide antibiotics

Tilavancin (Vibativ) is a lipoglycopeptide antibiotic.
Through cooperation with Theravance company, Saisheng Pharmaceutical has obtained the exclusive right to develop, commercialize and manufacture telavancin in Greater China
.
Previously, the drug has been approved for marketing in the United States and Canada for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible strains of Staphylococcus aureus
.

For the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible strains of Staphylococcus aureus

Public information shows that Tilavancin has a dual mechanism of action, which not only inhibits bacterial cell wall synthesis, but also destroys bacterial cell membrane function
.
It is active against a series of clinically relevant Gram-positive pathogens, and can be used for drug-sensitive isolation of Staphylococcus aureus (including methicillin-sensitive and drug-resistant isolation), and complex skin and skin structure infections (CSSSI).
Infection or ventilator-associated bacterial pneumonia
.

Tilavancin has a dual mechanism of action, which not only inhibits bacterial cell wall synthesis, but also destroys bacterial cell membrane function
.

In addition, in October, other new drugs submitted marketing applications and received CDE acceptance, such as Bristol-Myers Squibb (BMS) Nivolumab injection, UCB (UCB) lacosamide tablets, Servier (Les Laboratoires) Servier) atorvastatin Ting Pei perindopril capsule, Tasly biological injection of recombinant human prourokinase and so on
.

Due to limited space, this article will not introduce them one by one
.
It is hoped that these new drugs will be approved in China as soon as possible, bringing new treatment options to patients
.

[1] Drug Evaluation Center of China National Medical Products Administration.
Retrieved Nov 1, 2021, from https://

[1] Drug Evaluation Center of China National Medical Products Administration.
Retrieved Nov 1, 2021, from https:// [2] Blockbuster I Zejing Pharmaceuticals announced that the application for the new indication of Zeprosen® has been accepted by the National Medical Products Administration.
Retrieved