Over 30 new drugs approved in China in the third quarter of 2021!

Article source: Pharmaceutical Guanlan

The third quarter of 2021 is over

Four local Class 1 new drugs approved for the first time

According to the acceptance number, in the third quarter, more than ten new drugs developed by Chinese companies were approved, including four Class 1 new drugs from WuXi Junuo, Yuheng Biological, Kangfang Biological / Zhengda Tianqing, and Real Biological

Ruiji Orenxil injection developed by WuXi Biotech is a CD19-targeting autologous chimeric antigen receptor T (CAR-T) cell therapy product

Azivudine developed by RealBio is a new nucleoside reverse transcriptase and accessory protein Vif inhibitor, and is also the first anti-HIV-1 drug targeting these two targets

The other two approved Class 1 new drugs are anti-PD-1 monoclonal antibodies, namely Paimprizumab jointly developed by Kangfang Biological and Zhengda Tianqing, and Sepalizumab developed by Yuheng Biological

In addition to the above four drugs, there are some other local new drugs approved in the third quarter

Approximately 20 imported new drugs have been approved, most of which are anti-cancer drugs

In the third quarter, about 20 imported new drugs were approved for marketing or approved for new indications in China, of which category 5.

In the field of cancer, the three PD-1/PD-L1 inhibitors have ushered in new indications, bringing new first-line treatment options for different cancer patients

At the same time, a number of new anti-cancer drugs were approved in China for the first time, including the second-generation proteasome inhibitor carfilzomib jointly developed by Amgen and BeiGene, and anti-GD2 introduced by BeiGene from EUSA Pharma.

In addition to cancer, the approved indications for imported new drugs include rheumatoid arthritis, patients with atopic dermatitis, plaque psoriasis, type 2 diabetes, diabetic macular edema, hemophilia A, hyperphosphatemia, etc.

Among them, Amgen's Apomilast tablets were approved for the first time in China for adult patients with moderate to severe plaque psoriasis

In addition to the above-mentioned drugs, many other new drugs were also approved in China in the third quarter.

Note: The original text has been deleted

Reference materials:

[1] Information released by China National Medical Products Administration.

[3] Kangtai Bio: Announcement on obtaining the drug registration certificate for the 13-valent pneumococcal polysaccharide conjugate vaccine.

[4] BeiGene and EUSA Pharma announced that Kaiserbai® (Datuximab β) was approved in China for the treatment of patients with high-risk neuroblastoma.