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In 2021, the National Medical Products Administration (NMPA) has approved a total of 83 new drugs, including 51 domestic new drugs and 32 imported new drugs; Roche and BeiGene have the most approved drugs, and 19 have been included through medical insurance negotiations.
The 83 new drugs approved in 2021 involve a total of 70 pharmaceutical companies, of which Roche and BeiGene have the most approved drugs, 4 respectively, Hengrui, Pfizer, CStone, CanSino, and Takeda.
Roche's 4 products are Mabaloxavir, which is indicated for influenza patients; Satrilizumab, which is indicated for AQP4 antibody-positive neuromyelitis optica spectrum disorders; Risprom oral solution, which is indicated for Spinal muscular atrophy; and otuzumab for follicular lymphoma
BeiGene’s 4 products are stuximab for injection, which is indicated for adult patients with idiopathic multicenter MCD (rare disease); dartuximab, which is indicated for high-risk neurological patients aged 12 months and above.
A number of local companies usher in the "first" commercial product
A number of domestic innovative drugs in China have ushered in the harvest period, and many of them are the first commercial products of the company
Donafenib, the first domestic first-line targeted drug for liver cancer developed by Zejing Bio;
Antengene's selective nuclear export protein (SINE) inhibitor selinisol;
Azvudine, the first dual-target anti-HIV-1 drug developed by Real Bio;
Contezolid, a new generation of oxazolidinone antibacterial drug developed by Mengke Pharmaceutical after 12 years;
Ascentage Pharma's third-generation BCR-ABL TKI orebatinib;
The new crown neutralizing antibody cocktail therapy Ambavirumab/Romisevirumab jointly developed by Tengsheng Biopharmaceuticals/Tsinghua University/Shenzhen Third People's Hospital;
The anti-PD-1 antibody saipalimumab developed by Yuheng Bio;
Huahao Zhongtian epothilone anticancer drug Utilide,
These are the company's first approved new drugs
Milestone progress: a number of "first" new drugs have attracted much attention
The first domestic ADC was approved
.
On June 9, Rongchang Bio’s vedicitumab for injection was approved for marketing, which is suitable for the treatment of patients with HER2-overexpressing locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least 2 kinds of systemic chemotherapy.
treatment
.
This is the first ADC drug independently developed in China
.
China ushered in the first CAR-T therapy
.
On June 23, Fosun Kite's akirenxe injection was approved for marketing for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after receiving second-line or above systemic therapy
.
This is the first CAR-T therapy approved in China
.
Of the 83 new drugs, 19 have entered the National Medical Insurance Catalogue
Of the 83 new drugs approved by the NMPA in 2021, 19 have been included in the 2021 National Medical Insurance List through medical insurance negotiations, including 13 domestic new drugs and 6 imported new drugs
.
