May 2021 Drug Registration Review and Approval Report

1.

1.

1.

In May 2021, the Drug Evaluation Center of the State Drug Administration (hereinafter referred to as the Center for Drug Evaluation) accepted a total of 820 acceptance numbers, an increase of 6% year-on-year and an increase of 14% compared to the same period last year.

Among the accepted drugs, chemical drugs accounted for 75%, biological products 16%, and Chinese medicine 9%, which did not include 2 in vitro diagnostic reagents.

Among the accepted drugs, chemical drugs accounted for 75%, biological products 16%, and Chinese medicine 9%, which did not include 2 in vitro diagnostic reagents.

2.

2.

In May 2021, the total number of chemical drugs accepted is 612, including a combination of medicine and equipment, which is not included in the figure below.

There are a total of 118 acceptance numbers for new applications of category 1 innovative drugs, including domestic and imported varieties.

There are a total of 118 acceptance numbers for new applications of category 1 innovative drugs, including domestic and imported varieties.

Figure 4 The acceptance status of chemical drugs by registration classification in May 2021

Figure 4 The acceptance status of chemical drugs by registration classification in May 2021

A total of 27 new category 1 chemical drugs were declared this month, involving 25 companies, and a total of 20 new domestic innovative drugs were declared this month.

A total of 27 new category 1 chemical drugs were declared this month, involving 25 companies, and a total of 20 new domestic innovative drugs were declared this month.

Table 1: Innovative chemical drugs for the first clinical application in May

Table 1: Innovative chemical drugs for the first clinical application in May

A total of 2 Class 1 new drugs have been declared for marketing this month.

A total of 2 Class 1 new drugs have been declared for marketing this month.

Rezetinib Mesylate Capsules

Rezetinib mesylate (BPI-7711) is an irreversible and highly selective third-generation small molecule epidermal growth factor receptor tyrosine kinase inhibitor (EGFR -TKI), with global compound patents, has significant inhibitory activity against EGFR sensitive single mutations and EGFR T790M+ resistant mutations.

Rezetinib mesylate (BPI-7711) is an irreversible and highly selective third-generation small molecule epidermal growth factor receptor tyrosine kinase inhibitor (EGFR -TKI), with global compound patents, has significant inhibitory activity against EGFR sensitive single mutations and EGFR T790M+ resistant mutations.

Obtained the national CFDA clinical approval in February 2017.
In vitro cell experiments showed significant anti-tumor activity against non-small cell lung cancer with EGFR (T790M/L858R, 19 exon deletion) gene mutations, and the effective inhibitory concentration (EC50) was 35 times lower than that of the wild-type EGFR gene The above reflects better security.

Obtained the national CFDA clinical approval in February 2017.
In vitro cell experiments showed significant anti-tumor activity against non-small cell lung cancer with EGFR (T790M/L858R, 19 exon deletion) gene mutations, and the effective inhibitory concentration (EC50) was 35 times lower than that of the wild-type EGFR gene The above reflects better security.

Limpris tablets

Limpris tablets

On May 17, 2021, Shanghai Yingli Pharmaceutical Co.
, Ltd.
independently developed an innovative drug PI3Kδ selective inhibitor linpris tablets (YY-20394) New Drug Listing Application (NDA) has been approved by the National Medical Products Administration (NMPA) The Center for Drug Evaluation (CDE) is officially undertook to treat patients with relapsed or refractory follicular lymphoma who have previously received second-line or above systemic treatment.

On May 17, 2021, Shanghai Yingli Pharmaceutical Co.
, Ltd.
independently developed an innovative drug PI3Kδ selective inhibitor linpris tablets (YY-20394) New Drug Listing Application (NDA) has been approved by the National Medical Products Administration (NMPA) The Center for Drug Evaluation (CDE) is officially undertook to treat patients with relapsed or refractory follicular lymphoma who have previously received second-line or above systemic treatment.

2.
Acceptance of biological products

2.
Acceptance of biological products

In May 2021, a total of 131 biological products and 117 therapeutic biological products were accepted.

In May 2021, a total of 131 biological products and 117 therapeutic biological products were accepted.

This month, a total of 19 bio-innovative drugs have newly declared 19 Class 1 bio-pharmaceuticals (Table 3).

This month, a total of 19 bio-innovative drugs have newly declared 19 Class 1 bio-pharmaceuticals (Table 3).

Table 2: Newly registered bio-innovative drugs

Table 2: Newly registered bio-innovative drugs

3.
Acceptance of Chinese medicine

This month, TCM accepted 75 acceptance numbers, including 3 listing applications for Class 1.
1 new drugs.

This month, TCM accepted 75 acceptance numbers, including 3 listing applications for Class 1.
1 new drugs.

1.
1 Chinese medicine compound preparations refer to preparations composed of multi-flavored decoction pieces and extracts under the guidance of Chinese medicine theory.

1.
1 Chinese medicine compound preparations refer to preparations composed of multi-flavored decoction pieces and extracts under the guidance of Chinese medicine theory.

Table 3: Class 1.
1 Chinese medicines newly registered clinically in May

Table 3: Class 1.
1 Chinese medicines newly registered clinically in May

2.
Drug acceptance status in May 2021

2.
Drug acceptance status in May 2021

According to incomplete statistics, this month, the State Medical Products Administration approved a total of 109 newly marketed drugs (calculated based on the approval number), 101 generic drugs, 5 new drugs, and 3 imported original drugs.

According to incomplete statistics, this month, the State Medical Products Administration approved a total of 109 newly marketed drugs (calculated based on the approval number), 101 generic drugs, 5 new drugs, and 3 imported original drugs.

Table 4: Drugs approved for marketing in May (partial)

Table 4: Drugs approved for marketing in May (partial)

Propofol Disodium Phosphate for Injection

Propofol Disodium Phosphate for Injection

Propofol disodium phosphate is a new short-acting intravenous general anesthetic, which is metabolized into the active substance propofol in the body to produce anesthesia.

Propofol disodium phosphate is a new short-acting intravenous general anesthetic, which is metabolized into the active substance propofol in the body to produce anesthesia.

Propofol is an intravenous general anesthetic widely used in clinical practice.
Propofol disodium phosphate does not require the fat emulsion carrier of propofol preparations.
In clinical application, it can reduce the pain of intravenous injection and avoid the lipid metabolism disorder that may be caused by the fat emulsion carrier.

Propofol is an intravenous general anesthetic widely used in clinical practice.
Propofol disodium phosphate does not require the fat emulsion carrier of propofol preparations.
In clinical application, it can reduce the pain of intravenous injection and avoid the lipid metabolism disorder that may be caused by the fat emulsion carrier.

The drug was first developed by Eisai, and was approved in the United States in 2008 under the trade name Lusedra.
It was withdrawn from the market four years later.

The drug was first developed by Eisai, and was approved in the United States in 2008 under the trade name Lusedra.
It was withdrawn from the market four years later.

In 2021, propofol disodium phosphate for injection developed by Yichang Renfu Pharmaceutical Co.
, Ltd.
was approved by the NMPA for the induction of general anesthesia in adults.

In 2021, propofol disodium phosphate for injection developed by Yichang Renfu Pharmaceutical Co.
, Ltd.
was approved by the NMPA for the induction of general anesthesia in adults.

Levoornidazole Phosphate Disodium for Injection

Levoornidazole Phosphate Disodium for Injection

Levoornidazole Disodium Phosphate is a nitroimidazole antibiotic.
It is the sodium salt of the phosphate derivative of the levorotatory isomer of Ornidazole, and is a prodrug of Levoornidazole that has been on the market.
Pharmacokinetic studies have shown that Levonidazole Disodium Phosphate can be rapidly decomposed into Levoornidazole in the body, and Levoornidazole as an active ingredient plays a role in anti-anaerobes and microorganisms.

Levoornidazole Disodium Phosphate is a nitroimidazole antibiotic.
It is the sodium salt of the phosphate derivative of the levorotatory isomer of Ornidazole, and is a prodrug of Levoornidazole that has been on the market.
Pharmacokinetic studies have shown that Levonidazole Disodium Phosphate can be rapidly decomposed into Levoornidazole in the body, and Levoornidazole as an active ingredient plays a role in anti-anaerobes and microorganisms.

This product is a Class 1 innovative drug jointly developed by Huachuang Synthetic Pharmaceuticals and Yangtze River, and belongs to the latest generation of nitroimidazole anti-infective drugs.

This product is a Class 1 innovative drug jointly developed by Huachuang Synthetic Pharmaceuticals and Yangtze River, and belongs to the latest generation of nitroimidazole anti-infective drugs.

Indications: 1.
For the treatment of Bacteroides fragilis, Bacteroides diundi, Bacteroides ovalifolia, Bacteroides polymorpha, Bacteroides vulgaris, Clostridium spp, Eubacterium, Peptococcus and Peptostreptococcus, Helicobacter pylori A variety of infectious diseases caused by sensitive anaerobic bacteria such as Bacteroides melaninosa, Fusobacterium, CO2 phagotrophic bacteria, Bacteroides gingivalis and other sensitive anaerobic bacteria, including: (1) Abdominal infections: peritonitis, intra-abdominal abscess, liver abscess, etc.
; ( 2) Pelvic infection: endometritis, uterine myositis, fallopian tube or ovarian abscess, pelvic soft tissue infection, Haemophilus vaginitis, etc.
; ( 3) Oral infection: periodontitis, periapical inflammation, pericoronitis, acute birth Ulcerative gingivitis, etc.
(4) Surgical infection: wound infection, epidermal abscess, bed sore ulcer infection, cellulitis, gas gangrene, etc.
; (5) Brain infection: meningitis, brain abscess; (6) Sepsis, bacteremia Severe anaerobic infections such as disease.
2.
For the prevention of infection before surgery and the treatment of anaerobic infection after surgery.
3.
Amoebiasis: various forms of histolytic amoebic intestinal infections, including amoebic dysentery.
All forms of amebiasis outside the intestine, especially liver amebiasis with abscess formation.

Indications: 1.
For the treatment of Bacteroides fragilis, Bacteroides diundi, Bacteroides ovalifolia, Bacteroides polymorpha, Bacteroides vulgaris, Clostridium spp, Eubacterium, Peptococcus and Peptostreptococcus, Helicobacter pylori A variety of infectious diseases caused by sensitive anaerobic bacteria such as Bacteroides melaninosa, Fusobacterium, CO2 phagotrophic bacteria, Bacteroides gingivalis and other sensitive anaerobic bacteria, including: (1) Abdominal infections: peritonitis, intra-abdominal abscess, liver abscess, etc.
; ( 2) Pelvic infection: endometritis, uterine myositis, fallopian tube or ovarian abscess, pelvic soft tissue infection, Haemophilus vaginitis, etc.
; ( 3) Oral infection: periodontitis, periapical inflammation, pericoronitis, acute birth Ulcerative gingivitis, etc.
(4) Surgical infection: wound infection, epidermal abscess, bed sore ulcer infection, cellulitis, gas gangrene, etc.
; (5) Brain infection: meningitis, brain abscess; (6) Sepsis, bacteremia Severe anaerobic infections such as disease.
2.
For the prevention of infection before surgery and the treatment of anaerobic infection after surgery.
3.
Amoebiasis: various forms of histolytic amoebic intestinal infections, including amoebic dysentery.
All forms of amebiasis outside the intestine, especially liver amebiasis with abscess formation.