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13 innovative drugs approved by the State Drug Administration in 2020
Release time: 2021-04-21 & nbsp & nbsp & nbsp Source: Anonymous

It is understood,Since 2018,China ’s local innovative drugs enter the booming period,Domestic innovative drug review and approval continuously speed up。

2020Early Year,Sudden new crown pneumonia epidemic spreads globally。Under the epidemic,Press the pause key。The pharmaceutical industry is the industry with the most close prevention of the epidemic,It also ushered in new opportunities for development。Here,Xiaobian collected and sorted out 13 types of 1 new medicine approved in China in 2020,For the industry for reference。

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Application Company: Beijing Nuochengjianhua Pharmaceutical Technology Co., Ltd.

Target/action mechanism: BTK inhibitor

The State Drug Administration approves the first type of innovative drugs (commodity name: Yi Nuokai) listing by the National Pharmaceutical Supervision and Administration Bureau to approve the approval procedure of the review and approval procedure attached to the review and approval procedure.,Suitable for treatment: (1) Patients with lymphoma (MCL) patients who have received at least one treatment in the past。(2) Patients with chronic lymphocyte leukemia (CLL)/small lymphocyte lymphoma (SLL) patients who have received at least one treatment in the past。

Obntinib is a selective Bruton tyrosine kinase inhibitor。This variety is listed as an adult cells lymphoma、Adult chronic lymphocyte leukemia、Patients with small lymphocyte lymphoma provides new treatment options。The State Drug Administration requires that the species of the listing license holder will continue to complete the research work after the relevant conditions and requirements。

02.

Application Company: Yichang Dongguang Yangtze Yangtze Pharmaceutical Co., Ltd.

Target/action mechanism: NS5A inhibitor

Recently,The State Drug Administration approves the first type of innovative drug phosphate (product name: Dong Weien), which is approved by Yichang Dongguang Changjiang Pharmaceutical Co., Ltd.。This medicine is an innovative medicine for my country's independent research and development and own independent intellectual property,phosphate Imiwei Capsule needs to be combined with Sododbrow tablets,Used to treat adult genes type 1 non -liver sclerosis chronic hepatitis C。

phosphate Yimetow is a non -structural protein (NS) 5A inhibitor,Can inhibit virus RNA replication and virus particle assembly。This variety is better to meet Stake Sports Bettingstake online sports bettingthe clinical needs of patients。

03.

Declaration Company: Liaoning Haicco Pharmaceutical Co., Ltd.

Target/action mechanism: short -acting GABAA receptor regulator

Recently,The State Drug Administration approves the approval of the approval procedure of the priority review and approval of the 1 type of innovative drug ring phenol injection (commodity name: Schushanin) listing。This medicine is an innovative medicine for my country's independent research and owning independent intellectual property,The sedation in the digestive tract endoscopic inspection。

Circle Phenol is a GABAA receptor agonist,For anesthesia sedative medicine。This variety provides new treatment options for patients。

 

04, the State Drug Administration approved the listing of Flipo Pali capsules

Application Company: Jiangsu Hengrui Pharmaceutical Co., Ltd.

Target/action mechanism: PARP inhibitor

Recently,The State Drug Administration approves the first type of innovative medicine Flippari capsule (product name: Iri), which is approved by Jiangsu Hengrui Pharmaceutical Co., Ltd.。This medicine is an innovative medicine for my country's independent research and development and own independent intellectual property,Platinum -sensitive recurrence ovarian cancer used in the embryo -based BRCA mutation (GBRCAM) that used to pass the second line and above chemotherapy、Treatment of patients with fallopian tube cancer or primary peritoneal cancer。

Flippali is a small molecular PARP inhibitor,It can inhibit the DNA repair process in BRCA1/2 function abnormal cells,induced cell cycle block,Then inhibit the proliferation of tumor cells。This variety provides new treatment options for patients。

05, Lanali Ulitab injection is approved for listing

Manufacturer: Catalent Indiana,LLC (United States)

Target/action mechanism: targeted inhibitory plasma lush peptide release enzyme

To implement the spirit of the State Council Executive Meeting,The State Drug Administration has continued to advance to accelerate clinical urgent needs of overseas drugs to be released in my country。Recently,My stake betting appthe National Drug Administration approved the Lanadelumab Injection of Lanadelumab。

Genetic vascular edema (HAE) is a kind of ingredients of vitality explicitly genetic disease,Both in Europe and the United States and my country are considered rare diseases,Nearly half of patients may experience upper respiratory mucosal edema and cause suffocation and endanger life,Limited domestic treatment means,There are unsatisfied clinical needs。This product is a kind of all-person-dialized monoclonal antibody (IGG1/K-light chain),Can be combined with plasma release enzymes to inhibit its protein hydrolysis activity,To control the mild peptide production of patients with HAE patients。

06.

Application Company: Beida Pharmaceutical Co., Ltd.

Target/action mechanism: ALK inhibitor

Recently,The State Drug Administration approves the first type of innovative drug hydrochloride capsules (product name: Bel Meina) for the first type of innovative drug hydrochloride in Beida Pharmaceutical Co., Ltd.,It is used by patients with a positive local advanced or metastatic non -small cell lung carcinoma (NSCLC) patients that were previously treated after clipininini treatment or tolerated citetininib. treat。

Enshantinib is an inter -degenerated lymphoma kinase (ALK) inhibitor。This variety provides new treatment options for patients with non -small cell lung cancer。

07.

Application Company: Ge Li Biotechnology (Hangzhou) Co., Ltd.

Target/action mechanism: NS5A inhibitor

Recently,The State Drug Administration stake sports betting appstake sports betting appapproves the priority review and approval procedure to approve Ge Li Biotechnology (Hangzhou) Co., Ltd. Category 1 Innovation Drug Hydrochloride Film (Commodity Name: Xinlilai) listing,Unite Litnaville's reinforced Danorovir sodium tablets and Libavirin,Gene 1B chronic hepatitis C virus infection for the treatment of preliminary treatment for the treatment of preliminary treatment,Not as a single medicine treatment。

Lava Hydrochloride is NS5A inhibitor,Can inhibit virus RNA copy。NS5A is a multifunctional protein,is the basic component of HCV copy complex。The listing of this product will provide more medication for non -liver hardening adult patients infected by gene 1B chronic hepatitis C virus infection。

08.

Application Company: Baiji Shenzhou (Suzhou) Biotechnology Co., Ltd.

Target/action mechanism: BTK inhibitor

Recently,The State Drug Administration approves Parksida Shenzhou (Suzhou) Biotechnology Co., Ltd. 1 -type Innovation Medicine Zhebutinib Capsule (Commodity: Beroyer) listing,It is used in patients who have received at least one adult cases of adult cells (MCL) and adult chronic lymphocyte leukemia (CLL)/small lymphocyte lymphoma (SLL) patients who have received at least one treatment.。

Zelbutinib is a selective inhibitor of Brunton tyrosine (BTK)。Subutini Capsule is an innovative medicine that independently develops and has independent intellectual property rights in my country。The listing of this product will be adult cells lymphoma、Adult chronic lymphocyte leukemia/small lymphocyte lymphoma provides more medicine selection。

The State Drug Administration requires the drug listing license holder to continue to complete the confirmation clinical research as planned after the listing of this product。

09, the State Drug Administration approved the injection of the injecting of the Ronzyrase thick solution

Application Company: Genzyme Company

Target/action mechanism: Enzyme replacement therapy

Recently,The State Drug Administration approves Genzyme's injection by priority review and approval procedures for priority review and approval procedures.,Long -term enzyme replacement therapy for patients with type I of adhesive polysaccharides,Non -nervous system manifestations used to treat diseases。

Vision Domgose Storage Type I (MPS i) is a rare disease with hidden inheritance of ingredients,Caused by the lack of α-L-Audu glycogenase lack,Excessive accumulation can cause excessive accumulation of glycosamine in the body and tissue in the body,Then life -threatening life。The medicine approved this time as an enzyme replacement therapy for such patients,It has been included in the second batch of clinical urgent need for overseas marketing drugs。

Since the release of overseas drug catalogs in clinical urgently needed,The State Drug Administration has approved more than 30 varieties of import registration。Next,The State Drug Administration will continue to implement the relevant requirements of the reform of the system of deepening drug review and approval,Continuously accelerate the listing of urgent need of clinical needed medicines in my country,better meet the needs of the people for medication。

10.

Application Company: Novartis Pharma Ag

Target/action mechanism: S1P receptor regulator

Recently,My stake betting appthe National Drug Administration approved the first type of innovative drugs (product name: Wanli Neng) listing stake online sports bettingby the National Drug Administration approved NOVARTIS PHARMA AG,It is used to treat adult recursive models multiple sclerosis,Including clinical isolation syndrome、Reunion-Active disease and activity secondary progressive disease。

 

Sinimod is a kind of amphenosamidol-1-phosphate (S1P) receptor regulator,Selectors and S1P receptor subcontments 1 (S1P1) and subtype 5 (S1P5) high -affinity combination,Stop lymphocytes from leaving lymph nodes,Reduce the quantity of peripheral blood lymphocytes。The listing of this variety provides new treatment options for patients with multiple hardening patients with recurs.,better meets Stake Sports Bettingstake online sports bettingthe clinical needs of patients。

11, the State Drug Administration approved the listing of phenylbinal ammonium bromide nasal spray

Application Company: Yingu Pharmaceutical Co., Ltd.

target/action mechanism: M1/m3 choline energy receptor antagonist

Recently,My stake betting appthe National Drug Administration approves the approval of the approval procedure of the priority review and approval procedure.,Flowing nose for improving allergic rhinitis、Nasal congestion、Symptoms of nasal itching and sneezing。Yingu Pharmaceutical Co., Ltd.。

Benzene cylindrium bromide is a selective M choline energy receptor antagonist,It may be inhibited by glandular secretion and inflammatory reactions by inhibiting chiloine neuropathy,Relieve the symptoms of mutant rhinitis。

Benzylecoplasmium bromide nasal spray is an innovative medicine that independently develops and has independent intellectual property rights。This variety provides new medication for patients with allergic rhinitis,better meets Stake Sports Bettingstake online sports bettingthe clinical needs of patients。

12.

Application Company: Jiangsu Haosen Pharmaceutical Group Co., Ltd.

target/action mechanism: third-generation EGFR-TKI

Recently,The State Drug Administration approves type 1 innovative drug methionon sulfonic acid (commodity name: Amele) listing through priority review and approval procedures.,It is used to develop disease progress during the treatment of the previous epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) or after treatment,and confirmed that the EGFR T790M mutant positive local advanced or metastatic non -small cell lung cancer adult patient。Jiangsu Haosen Pharmaceutical Group Co., Ltd.。

Ameitinibicinininic acid is a kinase inhibitor of the epidermal growth factor receptor。Amedininib tablets of methadodine are innovative medicines that have independently developed and have independent intellectual property rights in my country。The listing of this product helps improve the progress of the disease after the first generation of EGFR-TKI treatment and the drug can be available in patients with T790M positive non-small cell lung cancer,Provide new medication for patients with non -small cell lung cancer。

The State Drug Administration requires the drug listing license holder to continue to complete the clinical research currently carried out according to the plan after the listing of this product。

13、The State Drug Administration approved the listing of chronic hepatitis C hepatitis Copyloline hydrochloride capsules

Declaration Company: Beijing Kainge Ladies Biotechnology Co., Ltd.

Target/action mechanism: NS5A inhibitor

Recently,My stake betting appthe National Drug Administration approves Beijing Kainge collar biotechnology Co., Ltd. 1 type innovative drug hydrochloride capsule (commodity name: Keliwei) listing through priority review approval procedures。This product is used with Sodi Boibiro,Genes of the treatment of initial treatment or interferon menstrual treatment 1、stake sports betting app2、Stake Sports Betting3、6 adult chronic hepatitis C virus (HCV) infection,Can be combined or not compensated for sexual cirrhosis。

Corol Pyrapee Hydrochloride is a NS5A inhibitor,Blocking the replication and assembly of the HCV virus by inhibiting NS5A protein。The listing of cocoli Pable capsules hydrochloric acid helps to increase the availability of domestic anti -hepatitis C virus drugs,Meet the needs of clinical medication。

In addition,Available on the field of tumor,Innovative product "Oncology Electric Garth Treatment Instrument" is also approved for listing。

Innovation is the engine of the continuous growth of the pharmaceutical economy,It is expected to be in the future for a long time,The value of innovative drugs will also continue to dominate the global pharmaceutical market。2020 NMPA approved 13 approved drugs,10 models are domestic innovative products,Under this tone,China Innovation Pharmaceuticals will be hotter in 2021!