[Global Pharmaceutical Research] In February 2022, CDE accepted 691 registrations, and continued to expand the capacity of point-to-face combination

In February 2022, the National Center for Drug Evaluation (CDE) accepted a total of 691 new registration applications (according to the acceptance number, excluding one-time import applications), including 492 chemical drugs, 107 biological products, and 92 traditional Chinese medicines
.

2022-02 Registration Application Acceptance Status

2022-02 Registration Application Acceptance Status

This article is limited in space and only focuses on the overview of the approved drugs for marketing
.

In February 2022, the National Medical Products Administration (NMPA) approved a total of 38 drug marketing applications
.

Among them, 31 domestic drugs and 7 imported drugs

38

Approved domestically

Approved domestically

In February 2022, the State Food and Drug Administration approved 31 domestic drug listing applications, including 29 chemical drugs and 2 biological products
.

According to the generic names of drugs, there are 25 varieties, involving 9 major categories of treatment

In February 2022 , the domestic drug marketed varieties have been approved

In February 2022 , the domestic drug marketed varieties have been approved

(Note: Repeated descriptions of the same product name have different specifications)

Divided by treatment categories, anti-infective drugs are the most, with a total of 8 drugs; blood and hematopoietic system drugs, nervous system drugs, cardiovascular system drugs and miscellaneous drugs are next, with 4 drugs; digestive system drugs and psychiatric disorders drugs have 1 drug each Approved
.

Distribution of domestic drug treatment categories approved in February 2022

Distribution of domestic drug treatment categories approved in February 2022

Oseltamivir (Tamiflu): the "magic medicine" for influenza, the halo is no longer

Oseltamivir (Tamiflu): the "magic medicine" for influenza, the halo is no longer

Oseltamivir is a specific inhibitor of neuraminidase, which inhibits the separation of mature influenza virus from host cells, thereby inhibiting the spread of influenza virus in the human body to play a role in the treatment of influenza
.

Oseltamivir is a successful case of structure-based rational drug design
.

On the basis of zanamivir, oseltamivir is obtained by rational drug design according to the molecular structure of the natural substrate of neuraminidase and the spatial structure of the catalytic center of neuraminidase

Oseltamivir was first synthesized in 1996 and obtained a US patent on February 26, 1998.
It was first launched in Sweden in October 1999, and subsequently entered the Canadian, EU and US markets, and was approved for launch in China in 2002
.

In the domestic market, there are currently four companies competing in the competition: Roche (original research), Yichang Dongguang Sunshine, Shanghai Pharmaceuticals, and Borui Pharmaceuticals

From the perspective of the brand market structure, Roche's market share has plummeted in recent years, and Shanghai Pharmaceuticals' sales has always accounted for no more than 10%.
The vast majority of the market share of this species
.

From the perspective of sales, due to the impact of the new crown epidemic, the domestic population flow has decreased, the number of hospital diagnosis and treatment activities and the number of prescriptions have decreased, and the sales of oseltamivir have declined significantly in the past two years
.

According to PDB domestic sample hospital market data, the total sales of oseltamivir in 2019 was as high as 867 million yuan, the sales in 2020 were less than half of those in 2019, which was 351 million yuan, and the annual sales in 2021 were 111 million yuan, only in 2019.

Analysis of sales growth of oseltamivir over the years

Analysis of sales growth of oseltamivir over the years

In the seventh batch of national centralized procurement catalogues announced recently, oseltamivir oral normal-release dosage forms are listed impressively, and five companies including Dongyang Sunshine, Shanghai Pharmaceuticals, Borui Pharmaceuticals, CSPC Ouyi Pharmaceuticals and Kelun Pharmaceuticals are listed.
Oseltamivir phosphate capsules passed/deemed to pass the consistency evaluation, and are expected to participate in the competition on the same stage.
It is expected that under full competition and large-scale procurement, the sales of oseltamivir will not return to the peak in 2019
.

approved for import

approved for import

In February 2022, the State Food and Drug Administration approved a total of 7 applications for the marketing of imported drugs, all of which are chemical drugs
.

According to the generic name of the drug, there are 5 varieties, involving 5 kinds of treatment categories

In February 2022, the listed varieties of imported drugs have been approved

In February 2022, the listed varieties of imported drugs have been approved

(Note: Repeated descriptions of the same product name have different specifications)

Clopidogrel: the gold standard for dual antiplatelet therapy

Clopidogrel: the gold standard for dual antiplatelet therapy

Dual antiplatelet therapy (aspirin and clopidogrel) is routinely used to prevent perioperative and postoperative thrombotic events with stents
.

Clinical guidelines recommend that, without contraindications, for most patients after cardiac stenting, clopidogrel should be used for at least one year

Clopidogrel is an antiplatelet drug that selectively and specifically interferes with ADP-mediated platelet activation and irreversibly inhibits platelet aggregation and adhesion
.

It is mainly used to prevent the recurrence of stroke, myocardial infarction and peripheral arterial thrombotic disease

Adenosine diphosphate (ADP) is the first known low molecular weight platelet aggregation inducer.
ADP is stored in dense granules of platelets at high concentrations.
When platelets are stimulated and activated, ADP is released from dense granules.
As a secondary agonist, by acting on a variety of receptors, it can enhance the induction of platelets by itself and other inducers and contribute to the stabilization of thrombus
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As an ADP receptor antagonist, clopidogrel can inhibit the expression, binding and activity of ADP receptors, thereby effectively inhibiting platelet aggregation, which plays an important role in the treatment of thrombotic diseases
.

In 2018, clopidogrel was included in the first round of "4+7" centralized procurement, and Xinlitai's clopidogrel hydrogen sulfate tablets won the bid
.
In September 2019, the "4+7" national expansion and centralized procurement was announced, and three companies including Sanofi, CSPC Ouyi, and Lepu Pharmaceutical won the bid
.

According to PDB domestic sample hospital market data, after the first round of "4+7" centralized procurement was officially launched, the total sales volume of clopidogrel hydrogen sulfate tablets in 2019 increased slightly, but the sales amount has dropped significantly compared to 2018
.
In 2020, after the "4+7" nationwide expansion and centralized procurement was officially implemented, the sales amount of clopidogrel dropped off a cliff
.
For medicines with sufficient competition, purchasing with quantity has a significant effect on compressing price and moisture
.

Analysis of sales growth of clopidogrel over the years

Analysis of sales growth of clopidogrel over the years

The above is an overview of NMPA drug approvals in February 2022
.