Data In December 2021, China, the United States and Europe approved 25 new drugs for marketing

China approves 12 new drugs

China approves 12 new drugs

In December 2021, China approved 12 new drugs for marketing, of which 5 were independently developed and 2 were introduced and developed by Chinese pharmaceutical companies (see Table 1 for details)
.

In 2018, stuximab was included in the list of the "First Batch of Overseas New Drugs Urgently Needed for Clinical Use" because of the drug for rare diseases
.

In January 2020, BeiGene reached a partnership with EUSA Pharma to obtain the rights to develop and commercialize two drugs, including stuximab, in Greater China

The State Food and Drug Administration has urgently approved the registration applications of Tengsheng Huachuang Medicine's new coronavirus neutralizing antibody combination therapy drugs ambavirumab injection (BRII-196) and romisevirumab injection (BRII-198)
.

This is China's first approved novel coronavirus neutralizing antibody combination therapy drug with independent intellectual property rights

The multiple myeloma treatment drug Selinexol introduced by Antengene is an oral inhibitor of nuclear export protein 1 (XPO1)
.

The Selinisol regimen was approved in China based on the MARCH study conducted in the Chinese population

CStone's sugelimab injection is the fourth PD-L1 antibody drug approved in China and the second domestically produced PD-L1 antibody drug
.

The drug is indicated for the first-line treatment of patients with epidermal growth factor receptor (EGFR) gene mutation-negative and anaplastic lymphoma kinase (ALK)-negative metastatic non-squamous non-small cell lung cancer in combination with pemetrexed and carboplatin.

That month, Hengrui Medicine had two new drugs approved
.

Among them, Hengalijing Tablet is the first domestic sodium-glucose cotransporter 2 (SGLT2) inhibitor approved for marketing in China, which is suitable for improving the blood sugar control of adult patients with type 2 diabetes; Dalceili Tablet is an oral, High-efficiency and selective small-molecule cyclin-dependent kinase 4 and 6 (CDK4 and CDK6) inhibitors can block the cell cycle in G1 phase, thereby inhibiting tumor cell proliferation.

7 new drugs approved in the United States

7 new drugs approved in the United States

In December 2021, 7 new drugs were approved for marketing in the United States, 3 of which were emergency use authorization (EUA) drugs for the treatment of COVID-19 (see Table 2 for details)
.

According to the Phar madigger database, except for Incl isiran and Tralokinumab (tralokinumab), which were first approved in the EU, the rest of the new drugs are the first in the world

Tezepelumab, co-developed by AstraZeneca and Amgen, is the world's first antibody drug targeting thymic stromal lymphopoietin (TSLP), which blocks TSLP and prevents immune cells from releasing pro-inflammatory cytokines, thereby preventing asthma attacks and Improve asthma control
.

In September 2018, the U.

Efgartigimod is a neonatal Fc receptor (FcRn) antibody drug that binds to FcRn and reduces circulating IgG antibodies for the treatment of acetylcholine receptor (AChR) antibody-positive adults with generalized myasthenia gravis (gMG)
.

The action of acetylcholine receptor autoantibodies at the neuromuscular junction is a key driver of gMG

"Tixagevimab + Cilgavimab" is a combination of two long-acting antibodies
.
The two antibodies, first discovered by Vanderbilt University Medical Center, are derived from B cells of recovered patients and can bind to different sites on the SARS-CoV-2 spike protein
.
The combination is the first FDA-approved antibody therapy for COVID-19 pre-exposure prophylaxis
.

Molnupiravir is the first oral antiviral drug approved for the treatment of COVID-19
.
This EUA is based on the positive interim results of the Phase III MOVe-OUT study
.

Another oral antiviral drug for COVI D-19 is the "Nrmatrelvir + Ritonavir" combination, which, according to the EPIC-HR study, reduces the risk of hospitalization or death
.

EU approves 6 new drugs

EU approves 6 new drugs

In December 2021, the EU approved 6 new drugs for the market, but none of them were the first new drugs approved in the world.
There are 2 new drugs related to the prevention and treatment of new coronary pneumonia (see Table 3 for details)
.

It is worth mentioning that the new drug Abrocitinib approved this time was awarded the title of "Potential Innovative Drug (PIM)" by the UK Medicines and Health Products Administration in 2020
.
The drug, an oral Janus kinase 1 (JAK1) inhibitor, was approved based on the results of five Phase III clinical trials and a long-term extended clinical study involving more than 3,100 patients
.