People's Daily health client Li Caoyi
In 2021, the State Drug Administration (NMPA) approved a total of 83 new drugs, 51 of which are made in China and 32 are imported; Roche and BeiGene have the largest number of approved drugs, and 19 have been included in the 2021 national medical insurance catalogue through medical insurance negotiations.
83 new drugs Roche and BeiGene were approved to tie for the top spot
A total of 70 pharmaceutical companies involved a total of 70 pharmaceutical companies in the 83 new drugs approved in 2021, of which Roche and BeiGene had the largest number of drugs approved for listing, 4 of which were respectively, and five pharmaceutical companies such as Hengrui, Pfizer, CStone Pharmaceuticals, CanSino and Takeda were approved to list 3 drugs.
Roche's four models are mabaroxavir, which is indicated for influenza patients; satlizumab, which has an indication of AQP4 antibody positive optic neuromyelitis spectrum disease; rispramine oral solution dispersed for patients with spinal muscular atrophy; and otolizumab, which is indicated as follicular lymphoma.
The four models in BeiGene are stuximab for injection, which is indicated for adult patients with idiopathic multicenter MCD (rare disease); dateuximab, which is indicated for patients with high-risk neuroblastoma 12 months of age and older; Pamipali capsules, which are indicated for ovarian, tubal or peritoneal cancer patients; and Carfizomi, which is an injection developed by Amgen and BeiGene in cooperation with Multiple Myeloma.
A number of local companies ushered in the "first" commercial products
A number of local innovative drugs in China have ushered in the harvest period, and many drugs are the first commercial products of enterprises. For example, the third-generation EGFR-TKI voltmetinib developed by Airis Pharma, the first domestic first-line targeted drug for liver cancer developed by Zejing Bio, the selective nuclear output protein (SINE) inhibitor Selinisole of Deqi Pharmaceutical, the first dual-target anti-HIV-1 drug azifudine developed by real organisms, the new generation of xazolidinone antibacterial drug contezolib developed by Mengke Pharmaceutical after 12 years, the third-generation BCR-ABL TKI orebatinib of Yasheng Pharmaceutical, Tengsheng Bo Pharmaceutical/Tsinghua University/ Shenzhen Third People's Hospital jointly developed the new crown neutralization antibody cocktail therapy ampavirinumab / romimavir monoclonal antibody, Yuheng Biological development of anti-PD-1 antibody cypririmonumab, Huahao Zhongtian ebomycin anticancer drug Utidelong, etc. are the first approved new drugs of these companies.
Milestones: A number of "first" new drugs are in the spotlight
The first domestic ADC was approved. On June 9, Rongchang Bio's vidicetizumab for injection was approved 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. This is the first self-developed ADC drug in China.
China ushered in the first CAR-T therapy. On 23 June, Fosun Kate's Agilense Injection was approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after previous systemic treatment of second-line or above. This is the first CAR-T therapy approved in China.
Of the 83 new drugs, 19 have entered the national medical insurance directory
Of the 83 new drugs approved by THE NMPA in 2021, 19 have been included in the 2021 national medical insurance catalogue through medical insurance negotiations, including 13 domestic new drugs and 6 imported new drugs.
