-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
With the opening of special review and approval channels such as "priority review", "fast track", "breakthrough therapy", and "conditional approval", the speed of review and approval of innovative drugs has been greatly improved
Among the 36 new drugs approved for marketing in 2021, 22 are imported new drugs and 14 are domestic new drugs
Furmonertinib
On March 2, 2021, NMPA reviewed and conditionally approved the third representative skin growth factor receptor (EGFR) kinase inhibitor vomitinib (trade name: Ivesa) of Shanghai Ailisi Pharmaceutical.
Telitacicept
On March 9, 2021, NMPA prioritized review and conditionally approved Rongchang Biotech’s Taltazep (trade name: Tai'ai), combined with conventional treatment, suitable for activities with high disease activity on the basis of conventional treatment Adult patients with sexual, autoantibody-positive systemic lupus erythematosus (SLE)
Utidelone
On March 11, 2021, NMPA gave priority to Chengdu Huahao Zhongtian Pharmaceutical Co.
Fospropofol (Fospropofol Disodium)
On May 19, 2021, NMPA approved Renfu's short-acting intravenous general anesthetic, propofolPamiparib
On April 30, 2021, NMPA prioritized review and conditionally approved BeiGene's Pamipali (trade name: Baihuize) for use in previous second-line or above chemotherapy and susceptibility to germline breast cancer Treatment of patients with recurrent advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with gene (gBRCA) mutations
Contezolid
On June 1, 2021, NMPA prioritized the review and approval of Shanghai Mengke Pharmaceutical's Contizolamide (trade name: Uxitai) for the treatment of Staphylococcus aureus (methicillin) sensitive to Contizolamide Sensitive and resistant strains), Streptococcus pyogenes or Streptococcus agalactiae caused complex skin and soft tissue infections
Donafenib
On June 8, 2021, the NMPA prioritized review and approved Suzhou Zejing Biopharmaceutical's Donafinil Tosylate (trade name: Zeprosyn) for use in unresectable liver cells that have not previously received systemic treatment.
Disitamab Vedotin
On June 8, 2021, NMPA prioritized review and conditional approval of Rongchang Biopharmaceutical's vedicitumumab (trade name: Aidixi) for the locally advanced HER2 overexpression that has received at least two systemic chemotherapy Or the treatment of patients with metastatic gastric cancer (including adenocarcinoma of the gastroesophageal junction)
Savolitinib
On June 22, 2021, the NMPA prioritized review and conditionally approved Hutchison Whampoa’s Saivotinib (trade name: Oresa/ORPATHYS) for use in disease progression or intolerance criteria after platinum-containing chemotherapy.Tenofovir Amibufenamide
June 22, 2021, NMPA priority review approval Jiangsu Stockhausen Amy tenofovir (brand name: Hang Mu), for the treatment of adult patients with chronic hepatitis
Hybutimibe
On June 25, 2021, NMPA prioritized the review and approval of Zhejiang Hisun Pharmaceutical D Haibo Maibu (trade name: ), as an adjuvant treatment other than diet control, which can be used alone or in combination with HMG-CoA reductase inhibition Drugs (statins) are used in combination to treat primary (heterozygous familial or non-familial) hypercholesterolemia
Ainuovirine
On June 25, 2021, NMPA passed the priority review and approved Jiangsu Aidi Pharmaceuticals' non-nucleoside reverse transcriptase inhibitor Ainovirin (trade name: Aibond) for use in combination with nucleoside antiretroviral drugs , Treatment of adult HIV-1 infection newly-treated patients
Levornidazole Disodium
On May 26, 2021, NMPA approved Yangtze River’s Levoornidazole Disodium, which is the prodrug of the nitroimidazole antibiotic Levoornidazole, which can be rapidly degraded into Levoornidazole Play a therapeutic role
.
Before this product was approved, Yangzijiang had completed three pharmacokinetics and one safety and effectiveness study
.
In the safety and effectiveness study (CTR20180384), a total of 147 people joined the clinical trial, which was completed in 2019, and detailed data has not been disclosed
.
In addition to the above 14 domestic new drugs, it is worth mentioning that NMPA also approved the first CAR-T akirenzine for the treatment of relapsed or refractory large B-cell lymphoma
.
Since Axicabtagene Ciloleucel is a cell therapy, which is different from traditional drugs, the author will not discuss it here
.
New domestic or imported drugs approved by my country in the first half of the year
The above data is only based on the author's personal statistics.
It contains chemical medicines and therapeutic biological products, but does not contain Chinese medicines, proteins, vaccines, blood products and cell products.
The deadline is June 30