20 drugs/vaccines approved by the State Food and Drug Administration in the first half of 2021

The main responsibility of the National Medical Products Administration (NMPA) is to be responsible for the registration and supervision and management of drugs, cosmetics, and medical devices

The editor of Bio Valley Pharmaceuticals has made statistics on the important news published on the NMPA website: In the first half of 2021 (as of June 30), a total of 20 “star” drugs/vaccines were approved for marketing by the State Food and Drug Administration “Official Announcement” , Including 3 new crown vaccines and 12 category 1 innovative drugs

1.

1.

Ainuovirine is a HIV-1 non-nucleoside reverse transcriptase inhibitor that inhibits the replication of HIV-1 through non-competitive binding of HIV-1 reverse transcriptase

2.

2.

Hypermebe can inhibit the absorption of cholesterol dependent on the sterol carrier Niemann-Pick C1-like1 (NPC1L1), thereby reducing the transport of cholesterol in the small intestine to the liver, lowering blood cholesterol levels, and reducing liver cholesterol storage

3.

3.

Tenofovir Amibufenamide is a phosphoramidite prodrug of Tenofovir, which is a nucleoside reverse transcriptase inhibitor

4.

4.

Savolitinib can selectively inhibit the phosphorylation of MET kinase, and has a significant inhibitory effect on the proliferation of tumor cells with MET 14 exon transition

5.

5.

Akirensai injection is a kind of autoimmune cell injection, which is prepared by self-targeting human CD19 chimeric antigen receptor T cells (CAR-T) genetically modified by retroviral vector carrying CD19 CAR gene
.
The listing of this variety provides a new treatment option for adult patients with relapsed or refractory large B-cell lymphoma after receiving second-line or above systemic treatment
.

6.
The National Food and Drug Administration approves the listing of Hetropopaethanolamine Tablets

6.
The National Food and Drug Administration approves the listing of Hetropopaethanolamine Tablets

June 17 official declared: State Drug Administration priority review approval procedures by Jiangsu Hengrui Medicine Co.
, Ltd.
declared a Class 1 drug innovation Haiqu Park Pa ethanolamine film (trade name: Hang song) on the market
.
This drug is an innovative drug independently researched and developed by China with independent intellectual property rights.
It is used for chronic primary immune thrombocytopenia that has not responded well to treatments such as glucocorticoids and immunoglobulins due to thrombocytopenia and clinical conditions that increase the risk of bleeding.
Adult patients with severe aplastic anemia (ITP), as well as adults with severe aplastic anemia (SAA) who do not respond well to immunosuppressive therapy
.
Among them, the SAA indication is conditional approval
.

Herombopag Olamine is a small molecule human thrombopoietin receptor agonist
.
The listing of this variety provides new treatment options for patients with ITP and SAA
.

7.
The National Medical Products Administration approved the listing of lisporan oral solution powder

7.
The National Medical Products Administration approved the listing of lisporan oral solution powder

Official announcement on June 17: The National Medical Products Administration approved the first class innovative drug Lisporan oral solution powder (trade name: Aimanxin) declared by Roche Pharmaceuticals through the priority review and approval procedure.
This product is for children.
Rare disease treatment drugs, indicated for spinal muscular atrophy (SMA) in patients aged 2 months and above
.

Spinal muscular atrophy is an inherited neuromuscular disease caused by a defect in the function of SMN protein caused by mutations in the survival motor neuron gene 1 (SMN1).
It is one of the autosomal recessive genetic diseases that cause death in infants and young children.
The "List of the First Batch of Rare Diseases" jointly issued by five departments including the Health Commission
.
Lisporan directly targets the underlying molecular defects of the disease and increases the production of functional SMN protein in central and peripheral tissues
.
The listing of this variety provides a new treatment option for patients with spinal muscular atrophy
.

8.
The National Food and Drug Administration approved the listing of Donafinil Toluenesulfonate Tablets

8.
The National Food and Drug Administration approved the listing of Donafinil Toluenesulfonate Tablets

Official announcement on June 9th: The National Medical Products Administration passed the priority review and approval procedure to approve the listing of the Class 1 innovative drug Donafenib Tosylate (trade name: Zeprosan) declared by Suzhou Zejing Biopharmaceutical Co.
, Ltd.

.
The drug is an innovative drug independently researched and developed by China with independent intellectual property rights.
It is used for patients with unresectable hepatocellular carcinoma who have not received systemic treatment in the past
.

Donafenib (Donafenib) is a multi-kinase inhibitor class of small molecule anti-tumor drugs
.
The listing of this variety provides a new treatment option for patients with hepatocellular carcinoma
.

9.
The State Food and Drug Administration has conditionally approved the listing of Vidicuzumab for injection

9.
The State Food and Drug Administration has conditionally approved the listing of Vidicuzumab for injection

June 9 officer declared: Listed: State Drug Administration approved Rongchang biopharmaceutical (Yantai) Co.
, Ltd.
declared injection Wei Dixi trastuzumab (trade name, love and hope) through priority review approval process conditional
.
The drug is an innovative antibody-conjugated drug (ADC) independently developed by China, which is suitable for the treatment of patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least 2 types of systemic chemotherapy
.

Vedixituzumab for injection is an antibody-conjugated drug that contains the human epidermal growth factor receptor-2 (HER2) antibody portion, linker and the cytotoxic drug monomethyl auristatin E (MMAE)
.
The launch of this variety provides a new treatment option for patients with locally advanced or metastatic gastric cancer
.

10.
The State Food and Drug Administration approved the listing of Contizolamide tablets

10.
The State Food and Drug Administration approved the listing of Contizolamide tablets

Official announcement on June 2nd: The National Medical Products Administration approved the listing of the Class 1 innovative drug Contizolamide (trade name: Uxitai) declared by Shanghai Mengke Pharmaceutical Co.
, Ltd.
through the priority review and approval procedure
.
The drug is an innovative drug independently researched and developed by China with independent intellectual property rights.
It is used to treat Staphylococcus aureus (methicillin sensitive and resistant strains), Streptococcus pyogenes or Streptococcus agalactiae that are sensitive to contizolamide Complicated skin and soft tissue infections caused by
.

Contezolid (Contezolid) is a fully synthetic new oxazolidinone antibacterial drug.
In vitro studies have shown that it inhibits the growth of bacteria by inhibiting the formation of a functional 70S initiation complex necessary for the process of bacterial protein synthesis.

.
The launch of this variety provides a new treatment option for patients with complicated skin and soft tissue infections
.

11.
The State Food and Drug Administration has conditionally approved the listing of Pamipali Capsules

11.
The State Food and Drug Administration has conditionally approved the listing of Pamipali Capsules

Official announcement on May 7: The National Medical Products Administration passed the priority review and approval procedure with conditional approval of the Class 1 innovative drug Pamipalil Capsules (trade name: Baihuize) declared by BeiGene (Suzhou) Biotechnology Co.
, Ltd.
It is marketed for the treatment of patients with recurrent advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with germline BRCA (gBRCA) mutations who have undergone second-line or above chemotherapy
.

Pamiparib is a potent and selective inhibitor of PARP-1 and PARP-2
.
It inhibits the repair of tumor cell DNA single-strand damage and homologous recombination to repair defects, and has a synthetic lethal effect on tumor cells, and is particularly sensitive to DNA repair-deficient tumor cells carrying BRCA gene mutations
.
The marketing of Pamipali capsules provides a new treatment option for patients with recurrent advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer
.
The State Drug Administration requires the holders of the marketing authorization of this variety to continue to complete the relevant post-marketing research work in accordance with the attached conditions and requirements
.

12.
The State Food and Drug Administration has conditionally approved the listing of pratinib capsules

12.
The State Food and Drug Administration has conditionally approved the listing of pratinib capsules

Official announcement on March 24: The National Medical Products Administration passed the priority review and approval procedure and conditionally approved the listing of the Class 1 innovative drug pratinib capsule (trade name: Phuket Hua) declared by Blueprint Medicines Corporation
.
Pratinib is a receptor tyrosine kinase RET (Rearranged during Transfection) inhibitor.
It can selectively inhibit RET kinase activity, inhibit the phosphorylation of RET and its downstream molecules in a dose-dependent manner, and effectively inhibit the expression of RET (wild type and multiple Kind of mutant) cell proliferation
.

This variety is used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients who have previously received platinum-containing chemotherapy for transfection rearrangement (RET) gene fusion positive
.
The listing of this variety provides a new treatment option for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
.

13.
The State Food and Drug Administration approved the listing of Utidelon injection

13.
The State Food and Drug Administration approved the listing of Utidelon injection

March 15 official declared: State Drug Administration priority review approval procedures by Chengdu, China Hao transit Pharmaceutical Co.
, Ltd.
declared a Class 1 priority for innovative drugs Deron injection (trade name: Excellent for the Emperor) on the market
.
Utidrolone is a derivative of epothilone, which can promote tubulin polymerization and stabilize the structure of microtubules, and induce cell apoptosis
.
The drug is an innovative drug independently researched and developed by China with independent intellectual property rights
.

Utidrolone injection combined with capecitabine is used for patients with recurrent or metastatic breast cancer who have received at least one chemotherapy regimen in the past
.
The listing of this variety provides new treatment options for patients with advanced breast cancer
.

14.
The National Food and Drug Administration approved the listing of Tetazep for injection

14.
The National Food and Drug Administration approved the listing of Tetazep for injection

Official announcement on March 12: The National Medical Products Administration passed the priority review and approval procedure and conditionally approved Rongchang Biopharmaceuticals (Yantai) Co.
, Ltd.
to list the therapeutic biological product injection tytacept (trade name: Taiai)
.
The drug is an innovative drug independently developed by China, combined with conventional treatment, and is suitable for adult patients with systemic lupus erythematosus (SLE) who are still active and autoantibodies with high disease activity on the basis of conventional treatment
.

Taitacept for injection is a combination of the extracellular specific soluble part of B lymphocyte stimulating factor (BLyS) receptor transmembrane protein activator (TACI) and the crystallizable fragment (Fc) of human immunoglobulin G1 (IgG1) The constructed fusion protein
.
Because the TACI receptor has a high affinity for BLyS and proliferation-inducing ligand (APRIL), Tetalicept can prevent the interaction between BLyS and APRIL and their cell membrane receptors, B cell maturation antigens, and B cell activation molecular receptors.
Interaction, so as to achieve the effect of inhibiting the biological activity of BLyS and APRIL
.
The listing of this variety provides patients with new treatment options
.

15.
The State Food and Drug Administration has conditionally approved the listing of vometinib mesylate tablets

15.
The State Food and Drug Administration has conditionally approved the listing of vometinib mesylate tablets

Official announcement on March 3: The National Medical Products Administration passed the priority review and approval procedure and conditionally approved the Class 1 innovative drug vometinib mesylate (trade name: Ivor) declared by Shanghai Ailisi Pharmaceutical Technology Co.
, Ltd Sha) listed
.
This drug is an innovative drug independently researched and developed by China with independent intellectual property rights.
This product is suitable for disease progression during or after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), and has been tested Confirm the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive EGFR T790M mutation
.

The drug is the third representative of the EGFR kinase inhibitor
.
The listing of this variety provides a new treatment option for adult patients with non-small cell lung cancer (NSCLC)
.

16.
The National Food and Drug Administration approved the listing of Qingfei Paidu Granules, Huashi Baidu Granules, and Xuanfei Baidu Granules

16.
The National Food and Drug Administration approved the listing of Qingfei Paidu Granules, Huashi Baidu Granules, and Xuanfei Baidu Granules

Official announcement on March 2nd: The National Medical Products Administration approved the Qingfei Paidu Granules of the Institute of Clinical Basic Medicine of Chinese Academy of Chinese Medical Sciences through special approval procedures, the Huashibaidu Granules of Guangdong Yifang Pharmaceutical Co.
, Ltd.
, and Shandong Buchang Pharmaceutical Co.
, Ltd.
Xuanfeibaidu Granules of Co.
, Ltd.
went public
.

Qingfei Paidu Granules, Huashibaidu Granules, and Xuanfeibaidu Granules have been effective prescriptions for Qingfei Paidu Decoction, Huashibaidu Decoction, Huashibaidu Recipe and Xuanfeibai The transformation of the results of poison prescriptions is also the first time after the reform of the registration classification of Chinese medicines, in accordance with the "Registration Classification and Application Information Requirements of Chinese Medicines" (No.
68 of 2020) "3.
2 Classes of Other Traditional Chinese Medicine Compound Preparations Derived from Ancient Classical Recipes".

.

Qingfei Paidu Granules, Huashi Baidu Granules, Xuanfei Baidu Granules are all derived from ancient classic recipes
.
Qingfei Paidu Granules are used to feel the diseases caused by cold and damp epidemics, Huashibaidu Granules are used for diseases caused by damp toxins invading the lungs, and Xuanfeibaidu Granules are used for diseases caused by damp toxins in the lungs
.
The launch of Qingfei Paidu Granules, Huashi Baidu Granules, and Xuanfei Baidu Granules provides more options for the treatment of new coronary pneumonia
.

17.
The State Food and Drug Administration has conditionally approved the registration application for the recombinant new coronavirus vaccine (type 5 adenovirus vector) of Cansino Biotech Co.
, Ltd.

17.
The State Food and Drug Administration has conditionally approved the registration application for the recombinant new coronavirus vaccine (type 5 adenovirus vector) of Cansino Biotech Co.
, Ltd.

February 25 official declared: State Drug Administration conditionally approved the Kangxi Nuo biological stock company restructuring novel coronavirus vaccine (adenovirus type 5 vector) application for registration
.
This vaccine is the first domestically-made adenovirus vector new coronavirus vaccine approved and is suitable for the prevention of diseases caused by new coronavirus infection (COVID-19)
.

According to the relevant provisions of the "Vaccine Administration Law" and "Drug Administration Law", the State Food and Drug Administration conducts emergency review and approval in accordance with the special drug approval procedures, and approves the application for listing registration with conditions
.
The State Food and Drug Administration requires the holder of the vaccine marketing license to continue to carry out relevant research work, complete the conditional requirements, and submit follow-up research results in a timely manner
.

18.
The State Food and Drug Administration has conditionally approved the registration application of the new coronavirus inactivated vaccine (Vero cell) of Sinopharm Zhongsheng Wuhan Company

18.
The State Food and Drug Administration has conditionally approved the registration application of the new coronavirus inactivated vaccine (Vero cell) of Sinopharm Zhongsheng Wuhan Company

February 25 official declared: State Drug Administration conditionally approved the registration application of biological China National Pharmaceutical Group Wuhan Institute of Biological Products Co.
, Ltd.
of novel coronavirus inactivated vaccine (Vero cells)
.
The vaccine is suitable for preventing the disease (COVID-19) caused by the new coronavirus infection
.

According to the relevant provisions of the "Vaccine Administration Law" and "Drug Administration Law", the State Food and Drug Administration conducts emergency review and approval in accordance with the special drug approval procedures, and approves the application for listing registration with conditions
.
The State Food and Drug Administration requires the holder of the vaccine marketing license to continue to carry out relevant research work, complete the conditional requirements, and submit follow-up research results in a timely manner
.

19.
The State Food and Drug Administration has conditionally approved Beijing Kexing Zhongwei Biotechnology Co.
, Ltd.
new coronavirus inactivated vaccine (Vero cell) registration application

19.
The State Food and Drug Administration has conditionally approved Beijing Kexing Zhongwei Biotechnology Co.
, Ltd.
new coronavirus inactivated vaccine (Vero cell) registration application

Official announcement on February 6: The State Drug Administration has conditionally approved Beijing Kexing Zhongwei Biotechnology Co.
, Ltd.
's new coronavirus inactivated vaccine (Vero cell) registration application
.
The vaccine is suitable for preventing the disease caused by the new coronavirus infection (COVID-19)
.

According to the relevant provisions of the "Vaccine Administration Law" and "Drug Administration Law", the State Food and Drug Administration conducts emergency review and approval in accordance with the special drug approval procedures, and approves the application for listing registration with conditions
.
The State Food and Drug Administration requires the holder of the vaccine marketing license to continue to carry out relevant research work, complete the conditional requirements, and submit follow-up research results in a timely manner
.

20.
The State Food and Drug Administration has conditionally approved the listing of Brozoyuumab injection

20.
The State Food and Drug Administration has conditionally approved the listing of Brozoyuumab injection

Official announcement on January 15: The National Medical Products Administration approved the listing of Kyowa Kirin Inc.
's Brosoyuumab injection with conditions through the priority review and approval procedure
.
The drug is used for the treatment of X-linked hypophosphatemia (XLH) in adults and children aged 1 year and older, and is included in the "Second Batch of New Drug Lists in Urgent Need for Clinically"
.

Brozoyuumab is a recombinant fully human IgG1 monoclonal antibody targeting fibroblast growth factor 23 (FGF23) antigen, which can bind to and inhibit the activity of FGF23 to increase serum phosphorus levels
.
The listing of this variety provides patients with new treatment options
.