Inventory of new drugs approved and accepted by NMPA in the first half of 2021

Text | Sunshine

With the end of centralized procurement, the adjustment of the medical insurance drug catalogue started, and it is already more than half of 2021

As of June 30, NMPA has approved a total of 41 new drugs to be marketed in China (new drugs are limited to category 1 or 5.

In terms of drug types, there are 28 chemical drugs, 9 biological drugs, 3 new crown vaccines and 1 cell therapy product

In terms of pharmaceutical formulations, the new drugs approved in 2021 are still mainly injections, accounting for 48.

From the field of disease, the new drugs approved by the NMPA in 2021 mainly focus on oncology drugs.

It is worth noting that among 41 new drugs, 29 drugs were listed through priority review, accounting for 70.

Clinical urgent need for overseas medication

The following will select the 10 most noteworthy varieties and discuss them briefly with you

Vidicuzumab

Reason for attention: the first domestic ADC

Brief overview: Vidicuzumab is an antibody-conjugated drug (ADC) independently developed by Rongchang Biotech.

The approval of vedicitumumab broke the situation that there is no original domestic new drug in the ADC drug field, and filled the gap in the treatment of patients with HER2 overexpression gastric cancer.

Achilles

Reason for attention: China's first CAR-T therapy

Brief overview: Akirensai injection is a genetically modified autologous CAR-T cell injection targeting CD19 developed by Gilead/Kite.

The approval of Akirensai injection has filled the gap in the commercialization of CAR-T in China and marked that the field of cell therapy in China has entered a new stage

Smeglutide

Reason for attention: Gospel of diabetic patients, recognized as breakthrough therapy

Brief overview: Simeglutide is a long-acting glucagon-like peptide-1 receptor (GLP-1R) agonist developed by Novo Nordisk.

GLP-1RA not only has a significant hypoglycemic effect, but also has a small risk of hypoglycemia when used alone.

Mabaloxavir

Reason for attention: new mechanism of anti-influenza drugs, clinical need for new overseas drugs

Brief overview: Mabaloxavir tablets are oral antiviral drugs jointly developed by Shiono Yoshio/Roche.

Platinib

Reason for attention: China's first RET inhibitor, breakthrough therapy

Brief overview: Pratinib is a potent and selective RET inhibitor introduced by CStone Pharmaceuticals.

The listing of pratinib marks the first selective RET inhibitor in China, and CStone Pharmaceuticals is also the first commercially available product

Tacitep

Reason for attention: the first dual target treatment of systemic lupus erythematosus

Brief overview: Taltazep is an innovative drug biological preparation independently developed by Rongchang Biotech.
It was approved by the Food and Drug Administration on March 11 for the treatment of systemic lupus erythematosus
.
Tatacept is an antibody fusion protein drug molecule designed and invented by Professor Fang Jianmin, CEO and Chief Scientific Officer of Rongchang Biotech
.
As the world's first new dual-target biological drug approved for the treatment of systemic lupus erythematosus, Taltazep simultaneously inhibits the overexpression of the two cytokines BLyS and APRIL, "two-pronged" to prevent the differentiation and maturation of abnormal B cells, thereby preventing the differentiation and maturation of abnormal B cells.
Reduce the body's immune response, increase the effectiveness of the treatment while improving the safety of the drug
.

Taltazep was approved for marketing, marking that China has once again ushered in a blockbuster new drug in the treatment of systemic lupus erythematosus, which can provide patients with more treatment options
.

Lisporan

Reason for attention: the first domestic small molecule gene splicing agent

Brief overview: Lisporan oral solution powder is a rare disease treatment drug for children developed by Roche.
It was approved by the Food and Drug Administration on June 16 for the treatment of spinal muscular atrophy (SMA) in patients aged 2 months and older.
)
.
Lisporan directly targets the underlying molecular defects of the disease and increases the production of functional SMN protein in central and peripheral tissues
.
The listing of this variety provides a new treatment option for patients with spinal muscular atrophy
.

Sevotinib

Reason for attention: the first domestic selective Met inhibitor

Brief overview: Saivotinib is a small molecule c-Met inhibitor developed by Hutchison Pharmaceuticals.
It was approved by the Food and Drug Administration on June 22 for the treatment of mesenchymal-epithelial conversion factor (MET) exon 14 skips.
Locally advanced or metastatic non-small cell lung cancer
.
It is a potent and highly selective oral MET tyrosine kinase inhibitor, which shows clinical activity in advanced solid tumors and can block mutations (such as exon 14 skip mutations or other point mutations) or genes Abnormal activation of MET receptor tyrosine kinase signaling pathway caused by amplification
.

The approval of Syvotinib has successfully filled the gap in domestic MET inhibitors and is expected to become the first lung cancer targeted innovative drug that represents China and goes global
.

Pamipali

Reasons for attention: meeting clinical needs and improving patient accessibility

Brief overview: Pamidarib is a type 1 new type of potent and selective oral inhibitor of PARP-1 and PARP-2 developed by BeiGene.
It was approved by the Food and Drug Administration on April 30.
It is suitable for the existence of known Patients with disease-causing or suspected disease-causing germline BRCA mutations who have previously received two or more lines of chemotherapy for advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
.
Pamidaril can inhibit the repair of single-stranded DNA damage in tumor cells and repair defects by homologous recombination, and play a synthetic lethal effect on tumor cells.
It is especially sensitive to DNA repair-deficient tumor cells carrying BRCA gene mutations
.

The launch of Pamipali capsules provides new treatment options for cancer patients
.

Vometinib

Reasons for attention: Meeting clinical needs and improving patient accessibility

Brief overview: Vometinib mesylate is a class 1 small molecule targeted drug developed by Iris.
It was approved by the Food and Drug Administration on March 2 for the treatment of previous transepidermal growth factor receptor (EGFR) tyrosine.
The disease progresses during or after treatment with TKI, and the presence of locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients with positive EGFR T790M mutation has been confirmed by testing
.

Vometinib is a highly selective and irreversible third-generation EGFR-TKI
.
The listing of this variety provides a new treatment option for adult patients with non-small cell lung cancer (NSCLC)
.

Now that I've said that, let me add a little bit of a summary of the IND and NDA applications accepted by the NMPA in 2021
.
According to statistics from the Medical Rubik's Cube database, as of June 30, NMPA has accepted a total of 328 IND applications, including 89 imported drugs and 239 domestic drugs
.
Among these new medicines, there are 181 chemical medicines, 143 biological products and 4 traditional Chinese medicines
.

Types of IND drugs accepted by NMPA in 2021

NMPA accepted 43 NDA applications, including 30 chemical drugs and 13 biological products
.
There are 14 domestic drugs and 29 imported drugs
.

Attached table: New drugs approved by NMPA in the first half of 2021