Over 40 new drugs (including new indications) approved in China in the first quarter of 2022｜Inventory

The first quarter of 2022 has just ended

Most of the indications are cancer and immune diseases , and several other antiviral products such as oral new coronavirus treatment drugs, non-nucleoside cytomegalovirus (CMV) inhibitors, and anti-rabies virus monoclonal antibodies are also worthy of attention

Highlight 1: These "first" new drugs are approved in China

Among the new drugs approved for marketing in China in the first quarter, many products set the record of "China's first"

It may represent the hope of improving symptoms and prolonging life for a certain type of patients who have no treatment options, or it may mean the validation of a new target, new technology and new treatment model

In terms of innovative targets, taking PI3K as an example, this signaling pathway is regarded by researchers as one of the key targets for the development of cancer therapeutics.

The world's first approved oral dual inhibitor of phosphatidylinositol-3-kinase PI3K-delta and PI3K-gamma, and the first PI3K selective inhibitor approved in China

Another example is IDH, the development of tumor-targeted therapy based on this target is also one of the current frontier research directions.

Avonib is the first and only IDH1 inhibitor approved in China

In terms of approved indications, many of the new drugs approved in the first quarter brought new treatment options to specific patient groups

The first innovative drug approved for the treatment of beta thalassemia in China in more than ten years The first targeted drug approved for second-line treatment of advanced gastric cancer in China The first biologic in China covering the indications of systemic lupus erythematosus and lupus nephritis

Highlight 2: The majority of tumor and immune disease treatment products

Highlight 2: The majority of tumor and immune disease treatment products

Oncology and immune diseases are two major research fields that are currently being valued by the biopharmaceutical industry, and good progress has been made in the development of innovative therapies

In the field of anti-tumor, new treatment options are available for patients with multiple types of tumors , including lung cancer, lymphoma, gastric cancer, and microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors

In the field of anti-tumor, new treatment options are available for patients with multiple types of tumors , including lung cancer, lymphoma, gastric cancer, and microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors

There are also some new drugs that have previously been approved in China that have received new oncology indications in the first quarter

In terms of immune diseases, new drugs were approved in the first quarter for the treatment of atopic dermatitis, rheumatoid arthritis, lupus nephritis, and immune thrombocytopenia

In terms of immune diseases, new drugs were approved in the first quarter for atopic dermatitis, rheumatoid arthritis, lupus nephritis, and immune thrombocytopenia.

Pfizer (Pfizer) Oral Small Molecule Novel Coronavirus Treatment Drug Neimatevir Tablets/Ritonavir Tablets Combination of Recombinant Human Anti-rabies Virus Monoclonal Antibody Injection Developed by Huabei Pharmaceutical Omitevirumab Merck (MSD) Novel Non-nuclear glycoside cytomegalovirus inhibitor letermovir

Highlight 3: A variety of new drugs are welcome in the field of rare diseases and pediatric medicine

Highlight 3: A variety of new drugs are welcome in the field of rare diseases and pediatric medicine

In recent years, the research and development of drugs for rare diseases and children's drugs has also attracted the attention of the industry.

In the field of rare diseases, such as Sobi's IFNγ antibody emapalumab, which was approved in China through priority review for refractory, relapsed or progressive disease or intolerance to conventional HLH therapy Treatment of primary hemophagocytic lymphohistiocytosis (HLH) in adult and pediatric patients

Primary hemophagocytic lymphohistiocytosis (HLH)

Another example is the innovative product inebilizumab introduced by Hansoh Pharma from Viela Bio, which was approved by NMPA for "anti-aquaporin 4 (AQP4) antibody-positive adult patients with neuromyelitis optica spectrum disorder (NMOSD) " treatment

Neuromyelitis optica spectrum disorder (NMOSD)

In the field of children's medicine, the lidocaine hydrochloride powder needle-free percutaneous injection drug delivery system (English trade name: Zingo) and nitric oxide for inhalation (English trade name: INOmax) from Lee's Pharmaceutical Factory have passed the Priority review was approved in China

Hypoxic respiratory failure with clinical or echocardiographic evidence of pulmonary hypertension in neonates under local skin anesthesia before venipuncture or peripheral venous cannulation in minors 3 to 18 years of age

Moderate -to-severe atopic dermatitis in children and adults 6 years of age and older with selected children and adolescents with venous thromboembolism (VTE) under 18.
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In addition to the above drugs, other new drugs were also approved in China in the first quarter.
Due to space limitations, this article will not introduce them one by one
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Congratulations to these new drugs approved in China, bringing more treatment options to patients
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References:

References:

[1] Official website of China National Medical Products Administration (NMPA).
from https:// Official website of China National Medical Products Administration (NMPA).
from https:// [2] Press releases and public information of each company

[2] Press releases and public information of each company