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Pharm.
com News on March 30th, a large number of new drugs will be launched soon
com News on March 30th, a large number of new drugs will be launched soon
10 new drugs are on the market! Cornerstone, Takeda, Novartis.
.
.
.
.
During the period from March 13th to March 26th, the listing applications of 10 new drugs (15 acceptance numbers) had the review and approval status update.
Among them, CStone's pratinib capsules were conditionally approved for marketing, and Kyowa Fermented Kirin's brozoyuumab injection and Celgene's lenalidomide capsules were approved for new indications.
In addition, Zai Lab’s Ripretinib tablets, Takeda’s icatibant acetate injection, CStone’s apotinib tablets, and Novartis’s metformin and vildagliptin tablets II/Ⅲ.
.
.
the registration status has changed to "under approval ".
Among them, CStone's pratinib capsules were conditionally approved for marketing, and Kyowa Fermented Kirin's brozoyuumab injection and Celgene's lenalidomide capsules were approved for new indications.
In addition, Zai Lab’s Ripretinib tablets, Takeda’s icatibant acetate injection, CStone’s apotinib tablets, and Novartis’s metformin and vildagliptin tablets II/Ⅲ.
.
.
the registration status has changed to "under approval ".
(3.
13-3.
26) New drug listing application review and approval status update
13-3.
26) New drug listing application review and approval status update
Kyowa Fermented Kirin's brozoyuumab is the first recombinant fully human monoclonal IgG1 antibody targeting fibroblast growth factor 23 (FGF23).
Brozoyuumab was previously included in the second batch of clinically urgently needed overseas new drugs.
In January 2021, the State Food and Drug Administration has conditionally approved the marketing of brozoyuumab injection for X-linked hypophosphatemia (XLH) in adults and 1-year-old children.
The indication approved for marketing this time is tumor Related osteomalacia.
Brozoyuumab was previously included in the second batch of clinically urgently needed overseas new drugs.
In January 2021, the State Food and Drug Administration has conditionally approved the marketing of brozoyuumab injection for X-linked hypophosphatemia (XLH) in adults and 1-year-old children.
The indication approved for marketing this time is tumor Related osteomalacia.
Itibant is a rare disease drug of Takeda, a powerful and selective bradykinin B2 receptor antagonist, mainly used to treat acute attacks of hereditary angioedema (HAE).
The product was approved for marketing in the European Union in July 2008, and was approved for marketing in the United States in August 2011.
It is the third drug approved by the FDA for the treatment of HAE attacks.
Its global sales in 2019 were 32.
7 billion yen.
The product was approved for marketing in the European Union in July 2008, and was approved for marketing in the United States in August 2011.
It is the third drug approved by the FDA for the treatment of HAE attacks.
Its global sales in 2019 were 32.
7 billion yen.
Ripretinib tablets are a tyrosine kinase switch regulatory inhibitor introduced by Zai Lab from Deciphera in 2019 for the treatment of gastrointestinal stromal tumors (GIST) and other solid tumors driven by KIT/PDGFRα.
CStone's conditional approval of Pratinib Capsules is an oral, potent and highly selective RET inhibitor that has a broad and long-lasting anti-tumor effect on patients with RET fusion-positive NSCLC.
Pratinib is China's first selective RET inhibitor approved for marketing, and it is also CStone's first commercially available product.
CStone Pharmaceuticals is a biopharmaceutical company established at the end of 2015, focusing on the development and commercialization of innovative tumor immunotherapy and precision treatment drugs.
Pratinib is China's first selective RET inhibitor approved for marketing, and it is also CStone's first commercially available product.
CStone Pharmaceuticals is a biopharmaceutical company established at the end of 2015, focusing on the development and commercialization of innovative tumor immunotherapy and precision treatment drugs.
It is worth mentioning that the registration status of another new CStone drug, apotinib tablets, has been changed to "under approval", which is expected to usher in the good news of approval for listing.
Apotinib tablet is an oral, potent and highly selective KIT/PDGFRA mutant kinase inhibitor, which is the latest precise targeted therapy for such mutations.
Apotinib tablet is an oral, potent and highly selective KIT/PDGFRA mutant kinase inhibitor, which is the latest precise targeted therapy for such mutations.
At present, the research and development of anti-tumor drugs represented by tinibs in China are getting together, showing a "big bang" trend.
In less than 3 months, 3 tinib drugs have been approved for marketing in China, including Sofantinib, Vometinib and Pratinib.
Tinib, a tyrosine kinase inhibitor, is a small molecule protein kinase inhibitor that can block one or more protein kinases.
The potential of the tinib drug market is huge.
According to data from Meinenet, the sales of terminal protein kinase inhibitors in China's public medical institutions exceeded 20 billion yuan in 2019, a year-on-year increase of 59.
53%.
In less than 3 months, 3 tinib drugs have been approved for marketing in China, including Sofantinib, Vometinib and Pratinib.
Tinib, a tyrosine kinase inhibitor, is a small molecule protein kinase inhibitor that can block one or more protein kinases.
The potential of the tinib drug market is huge.
According to data from Meinenet, the sales of terminal protein kinase inhibitors in China's public medical institutions exceeded 20 billion yuan in 2019, a year-on-year increase of 59.
53%.
4 new drugs apply for listing! Hengrui PD-1 reports new indications
From March 13th to March 26th, the marketing applications for 4 new drugs (6 acceptance numbers) were accepted by CDE.
In terms of imported new drugs, Genting Xinyao’s ilacycline and Pono’s innovative pimecillin submitted applications for listing.
In terms of domestic new drugs, Hengrui Medicine’s Carrelizol (PD-1) declares new indications.
The four previously approved indications have all entered the national medical insurance catalogue.
In terms of imported new drugs, Genting Xinyao’s ilacycline and Pono’s innovative pimecillin submitted applications for listing.
In terms of domestic new drugs, Hengrui Medicine’s Carrelizol (PD-1) declares new indications.
The four previously approved indications have all entered the national medical insurance catalogue.
(3.
13-3.
26) Approved domestic/imported new drug listing application
13-3.
26) Approved domestic/imported new drug listing application
Huabei Pharmaceutical submitted a new indication marketing application for propofol fumarate tablets.
Profol tenofovir is a powerful antiviral drug for the treatment of chronic hepatitis B in adults and adolescents, and it is the first-line drug used in the treatment of hepatitis B in the world.
Profol tenofovir was developed by Gilead under the trade name Vemlidy, which is known as the "strongest hepatitis B drug in history".
According to data from Mi Nei.
com, Vemlidy's global sales in 2020 will be 659 million U.
S.
dollars, a year-on-year increase of 35%.
Profol tenofovir is a powerful antiviral drug for the treatment of chronic hepatitis B in adults and adolescents, and it is the first-line drug used in the treatment of hepatitis B in the world.
Profol tenofovir was developed by Gilead under the trade name Vemlidy, which is known as the "strongest hepatitis B drug in history".
According to data from Mi Nei.
com, Vemlidy's global sales in 2020 will be 659 million U.
S.
dollars, a year-on-year increase of 35%.
XeravaTM (Eracycline, Eravacycline) is a new type of fully synthetic broad-spectrum tetracycline parenteral antibiotics for injection.
It has extensive in vitro antibacterial activity against multi-drug-resistant gram-negative bacteria and other common drug-resistant bacteria in China.
.
Genting Xinyao obtained the commercial license of XeravaTM from Tetraphse Pharmaceuticals, and has the exclusive rights to develop and commercialize the drug in the major markets of Greater China, South Korea and some Southeast Asia.
It has extensive in vitro antibacterial activity against multi-drug-resistant gram-negative bacteria and other common drug-resistant bacteria in China.
.
Genting Xinyao obtained the commercial license of XeravaTM from Tetraphse Pharmaceuticals, and has the exclusive rights to develop and commercialize the drug in the major markets of Greater China, South Korea and some Southeast Asia.
Elacycline is currently approved for the treatment of complex intra-abdominal infection (cIAI) in the United States and Europe, and was approved in Singapore in April 2020.
Tigecycline has been listed in the domestic market for similar drugs such as tigecycline.
In recent years, the domestic market for tigecycline has continued to rise.
According to data from Meinenet, the terminal sales of tigecycline in China's public medical institutions exceeded 2.
6 billion in 2019.
Yuan, a year-on-year increase of 25.
35%.
Tigecycline has been listed in the domestic market for similar drugs such as tigecycline.
In recent years, the domestic market for tigecycline has continued to rise.
According to data from Meinenet, the terminal sales of tigecycline in China's public medical institutions exceeded 2.
6 billion in 2019.
Yuan, a year-on-year increase of 25.
35%.
Osaikang, Qilu, Dongyang Pharmaceutical.
.
.
43 new drugs were approved for clinical use
.
.
43 new drugs were approved for clinical use
From March 13th to March 26th, 43 new drugs (involving 59 acceptance numbers) received implied approval for clinical trials.
Among them, 31 varieties (41 acceptance numbers) are domestic new drugs, and 12 varieties (18 acceptance numbers) are imported new drugs.
In terms of types of medicines, there are 5 Chinese patent medicines, 17 chemical medicines, and 21 therapeutic biological products.
Among them, 31 varieties (41 acceptance numbers) are domestic new drugs, and 12 varieties (18 acceptance numbers) are imported new drugs.
In terms of types of medicines, there are 5 Chinese patent medicines, 17 chemical medicines, and 21 therapeutic biological products.
(3.
13-3.
26) Approved clinically domestic/imported new drugs
13-3.
26) Approved clinically domestic/imported new drugs
Iron maltol capsules were introduced by Osaikon from Shield TX in the United Kingdom and have been approved in the European Union and the United States for the treatment of adult iron deficiency.
The active ingredient of the medicine, iron maltol, is a new type of non-salt complex with stable chemical properties formed by iron and maltol, which has a unique absorption mechanism.
A series of clinical trials have confirmed that iron maltol capsules are an oral drug for the treatment of iron deficiency in adults with low incidence of adverse reactions , high bioavailability, low iron overload, and good tolerance.
According to data from Mi Nei.
com, the market size of terminal iron preparations in China's public medical institutions and Chinese urban physical pharmacies exceeded 4 billion yuan in 2019, an increase of about 12% year-on-year, and the potential patient group and market size are relatively large.
The active ingredient of the medicine, iron maltol, is a new type of non-salt complex with stable chemical properties formed by iron and maltol, which has a unique absorption mechanism.
A series of clinical trials have confirmed that iron maltol capsules are an oral drug for the treatment of iron deficiency in adults with low incidence of adverse reactions , high bioavailability, low iron overload, and good tolerance.
According to data from Mi Nei.
com, the market size of terminal iron preparations in China's public medical institutions and Chinese urban physical pharmacies exceeded 4 billion yuan in 2019, an increase of about 12% year-on-year, and the potential patient group and market size are relatively large.
Tosun Pharma’s Class 3.
3 biologic drug insulin degludec injection is a long-acting insulin for diabetic patients who need insulin treatment.
At present, only Novo Nordisk's insulin glutathione injection is approved for import in the domestic market.
According to data from Meinnet.
com, Novo Nordisk’s global sales of insulin deglubber will be 8.
968 billion Danish kroner in 2020, of which the sales in the Chinese market will be 418 million Danish kroner.
3 biologic drug insulin degludec injection is a long-acting insulin for diabetic patients who need insulin treatment.
At present, only Novo Nordisk's insulin glutathione injection is approved for import in the domestic market.
According to data from Meinnet.
com, Novo Nordisk’s global sales of insulin deglubber will be 8.
968 billion Danish kroner in 2020, of which the sales in the Chinese market will be 418 million Danish kroner.
The BC006 monoclonal antibody injection of Baochuan Biologics is a humanized IgG1 monoclonal antibody against macrophage colony stimulating factor 1 receptor (CSF-1R), which specifically targets CSF on the surface of mononuclear-macrophage mesangial cells.
-1R, intended for the treatment of advanced malignant tumors.
BC006 monoclonal antibody injection was approved for clinical use, marking that my country's first CSF-1R antibody drug has successfully entered the clinical development stage, filling the gap in the research and development of this target in China, and clinical research on this target abroad is also in the early stage.
-1R, intended for the treatment of advanced malignant tumors.
BC006 monoclonal antibody injection was approved for clinical use, marking that my country's first CSF-1R antibody drug has successfully entered the clinical development stage, filling the gap in the research and development of this target in China, and clinical research on this target abroad is also in the early stage.
Fosun Pharmaceutical subsidiary of Chongqing Friends of pharmaceutical drugs YP01001 capsules innovative small molecule chemical drugs, intended for the treatment of advanced solid tumors.
The domestically marketed YP01001 capsules of similar drugs include lenvatinib mesylate capsules and so on.
According to data from Meinnet.
com, sales of lenvatinib have soared since its listing.
In 2019, Eisai's global sales of lenvatinib reached 111.
9 billion yen.
The domestically marketed YP01001 capsules of similar drugs include lenvatinib mesylate capsules and so on.
According to data from Meinnet.
com, sales of lenvatinib have soared since its listing.
In 2019, Eisai's global sales of lenvatinib reached 111.
9 billion yen.
Qilu Pharmaceutical has two Class 1 new drugs approved for clinical trials, namely VB4-845 injection and QLS31901 for injection.
QLS31901 for injection is intended for the treatment of advanced solid tumors, and VB4-845 injection is used for the treatment of non-muscular invasive bladder cancer.
VB4-845 (Vicineum) is an antibody-drug conjugate (ADC) introduced by Qilu Pharmaceutical from Sesen Bio for US$35 million.
It is a human source that targets the Epithelial Cell Adhesion Molecule (EpCAM) antigen on the surface of tumor cells.
The scFv immunotoxin.
VB4-845 has been granted orphan drug status by the US FDA and EU EMA.
In December 2020, Sesen Bio submitted a complete biologics license application (BLA) for the drug to the US FDA, and it is expected to be approved in mid-2021.
QLS31901 for injection is intended for the treatment of advanced solid tumors, and VB4-845 injection is used for the treatment of non-muscular invasive bladder cancer.
VB4-845 (Vicineum) is an antibody-drug conjugate (ADC) introduced by Qilu Pharmaceutical from Sesen Bio for US$35 million.
It is a human source that targets the Epithelial Cell Adhesion Molecule (EpCAM) antigen on the surface of tumor cells.
The scFv immunotoxin.
VB4-845 has been granted orphan drug status by the US FDA and EU EMA.
In December 2020, Sesen Bio submitted a complete biologics license application (BLA) for the drug to the US FDA, and it is expected to be approved in mid-2021.
Lepu Medicine's Class 3.
3 Recombinant GLP-1 Receptor Agonist Injection is a biosimilar of dulaglutide injection.
Dulaglutide injection was developed by Eli Lilly and has been approved for the treatment of adult type 2 diabetes and the prevention of cardiovascular risk in patients with type 2 diabetes (T2DM).
According to data from Mi Nei.
com, Eli Lilly’s global sales of dulaglutide in 2020 were US$5.
068 billion, a year-on-year increase of 23%.
3 Recombinant GLP-1 Receptor Agonist Injection is a biosimilar of dulaglutide injection.
Dulaglutide injection was developed by Eli Lilly and has been approved for the treatment of adult type 2 diabetes and the prevention of cardiovascular risk in patients with type 2 diabetes (T2DM).
According to data from Mi Nei.
com, Eli Lilly’s global sales of dulaglutide in 2020 were US$5.
068 billion, a year-on-year increase of 23%.
Class 1 innovative drug PF-06882961 is an oral small molecule GLP-1 receptor agonist developed by Pfizer.
This small molecule drug is different from the injection and oral peptide GLP-1RA, and can provide a differentiated and innovative treatment for patients with diabetes and obesity.
This small molecule drug is different from the injection and oral peptide GLP-1RA, and can provide a differentiated and innovative treatment for patients with diabetes and obesity.
Cinda, Kelun, Eisai.
.
.
40 clinical applications for new drugs were accepted
.
.
40 clinical applications for new drugs were accepted
From March 13th to March 26th, clinical applications for 40 new drugs (involving 73 acceptance numbers) were accepted by the CDE.
Among them, 29 varieties (49 acceptance numbers) are domestic new drugs, and 11 varieties (24 acceptance numbers) are imported new drugs.
In terms of the types of medicines, there are 1 Chinese patent medicine, 26 chemical medicines, and 13 therapeutic biological products.
Among them, 29 varieties (49 acceptance numbers) are domestic new drugs, and 11 varieties (24 acceptance numbers) are imported new drugs.
In terms of the types of medicines, there are 1 Chinese patent medicine, 26 chemical medicines, and 13 therapeutic biological products.
(3.
13-3.
26) Accepted clinical applications for domestic/imported new drugs
13-3.
26) Accepted clinical applications for domestic/imported new drugs
Class 1 biological drug IBI302 is an innovative drug independently developed by Cinda for the treatment of ocular fundus diseases.
It is the world's first anti-VEGF-anti-complement dual target molecule.
IBI302 is intended for the treatment of neovascular age-related macular degeneration (nAMD).
Its dual-target design is expected to achieve more targeted treatment and intervention on the cause of AMD, and bring more clinical trials than VEGF single-target drugs Benefit.
It is the world's first anti-VEGF-anti-complement dual target molecule.
IBI302 is intended for the treatment of neovascular age-related macular degeneration (nAMD).
Its dual-target design is expected to achieve more targeted treatment and intervention on the cause of AMD, and bring more clinical trials than VEGF single-target drugs Benefit.
GZR18 is a once-a-week glucagon-like peptide 1 (GLP-1) receptor agonist drug independently developed by Ganli Pharmaceutical.
The indications include type II diabetes, obesity and overweight.
Globally, there are currently no GLP-1 receptor agonist drugs that are injected once a week have been approved for obesity and overweight treatment.
The indications include type II diabetes, obesity and overweight.
Globally, there are currently no GLP-1 receptor agonist drugs that are injected once a week have been approved for obesity and overweight treatment.
The ASC42 tablet of Golly Pharma is a best-in-class farnesoid X receptor (FXR) agonist.
In two animal models of NASH, ASC42 showed significant improvement in liver steatosis, inflammation and fibrosis.
In October 2020, ASC42 tablets were approved by the U.
S.
FDA for clinical trials for non-alcoholic steatohepatitis (NASH) indications.
It is worth mentioning that there are two other drugs under development in the NASH pipeline of Golly Pharmaceuticals, including ASC41 in phase I clinical trials and ASC40 tablets that have declared IND.
In two animal models of NASH, ASC42 showed significant improvement in liver steatosis, inflammation and fibrosis.
In October 2020, ASC42 tablets were approved by the U.
S.
FDA for clinical trials for non-alcoholic steatohepatitis (NASH) indications.
It is worth mentioning that there are two other drugs under development in the NASH pipeline of Golly Pharmaceuticals, including ASC41 in phase I clinical trials and ASC40 tablets that have declared IND.
Kelun Pharmaceutical's sildenafil citrate oral dissolving film is the first domestic company to submit a clinical application, and it is also the company's first oral dissolving film to be unveiled.
Sildenafil is a selective inhibitor of phosphodiesterase type 5 (PDE-5) used to treat erectile dysfunction (ED).
According to data from Meinenet, in 2019, the sales of sildenafil at the physical pharmacy terminal in Chinese cities exceeded 2.
3 billion yuan.
It is worth mentioning that Kelun Pharmaceutical's Sildenafil Citrate Orally Disintegrating Tablets has been the first to submit a listing application, which shows that the company attaches great importance to the andrology drug market.
Sildenafil is a selective inhibitor of phosphodiesterase type 5 (PDE-5) used to treat erectile dysfunction (ED).
According to data from Meinenet, in 2019, the sales of sildenafil at the physical pharmacy terminal in Chinese cities exceeded 2.
3 billion yuan.
It is worth mentioning that Kelun Pharmaceutical's Sildenafil Citrate Orally Disintegrating Tablets has been the first to submit a listing application, which shows that the company attaches great importance to the andrology drug market.
Dotinurad tablet is a urate reabsorption inhibitor, which can target to inhibit the activity of urate reabsorption transporter (URAT1).
On January 23, 2020, Dotinurad tablets were approved by Japan PMDA for the treatment of gout caused by hyperuricemia.
On February 25, 2020, Eisai Co.
, Ltd.
and Fuji Pharmaceutical Co.
, Ltd.
announced that they have reached a license agreement for Dotinurad, and Eisai will be responsible for the exclusive development and sales of its products in the Chinese market.
On January 23, 2020, Dotinurad tablets were approved by Japan PMDA for the treatment of gout caused by hyperuricemia.
On February 25, 2020, Eisai Co.
, Ltd.
and Fuji Pharmaceutical Co.
, Ltd.
announced that they have reached a license agreement for Dotinurad, and Eisai will be responsible for the exclusive development and sales of its products in the Chinese market.
At present, the leading domestic anti-gout drug market is febuxostat, which has been included in the third batch of centralized procurement.
According to data from Mi Nei.
com, in 2019, China's urban public hospitals , county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) and China's urban physical pharmacies terminal febuxostat sales approached 2 billion yuan.
According to data from Mi Nei.
com, in 2019, China's urban public hospitals , county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) and China's urban physical pharmacies terminal febuxostat sales approached 2 billion yuan.
Data source: Minet database, CDE, company announcement.
The data statistics period is from March 13th to March 26th.
Statistics are based on drug names (excluding preventive biological products, in vitro diagnostic reagents, etc.
, and supplementary applications).
If there are any omissions, please correct me!
The data statistics period is from March 13th to March 26th.
Statistics are based on drug names (excluding preventive biological products, in vitro diagnostic reagents, etc.
, and supplementary applications).
If there are any omissions, please correct me!
Note: Meinenet China's urban entity pharmacy terminal competition pattern database is an enlarged version of the urban entity pharmacy database that covers 293 cities and above cities across the country (excluding county and rural entity pharmacies), and continuously monitors all categories.
The above sales are calculated based on the average retail price of the product at the terminal.
The above sales are calculated based on the average retail price of the product at the terminal.
Pharm.
com News on March 30th, a large number of new drugs will be launched soon
com News on March 30th, a large number of new drugs will be launched soon
10 new drugs are on the market! Cornerstone, Takeda, Novartis.
.
.
.
.
During the period from March 13th to March 26th, the listing applications of 10 new drugs (15 acceptance numbers) had the review and approval status update.
Among them, CStone's pratinib capsules were conditionally approved for marketing, and Kyowa Fermented Kirin's brozoyuumab injection and Celgene's lenalidomide capsules were approved for new indications.
In addition, Zai Lab’s Ripretinib tablets, Takeda’s icatibant acetate injection, CStone’s apotinib tablets, and Novartis’s metformin and vildagliptin tablets II/Ⅲ.
.
.
the registration status has changed to "under approval ".
Among them, CStone's pratinib capsules were conditionally approved for marketing, and Kyowa Fermented Kirin's brozoyuumab injection and Celgene's lenalidomide capsules were approved for new indications.
In addition, Zai Lab’s Ripretinib tablets, Takeda’s icatibant acetate injection, CStone’s apotinib tablets, and Novartis’s metformin and vildagliptin tablets II/Ⅲ.
.
.
the registration status has changed to "under approval ".
(3.
13-3.
26) New drug listing application review and approval status update
13-3.
26) New drug listing application review and approval status update
Kyowa Fermented Kirin's brozoyuumab is the first recombinant fully human monoclonal IgG1 antibody targeting fibroblast growth factor 23 (FGF23).
Brozoyuumab was previously included in the second batch of clinically urgently needed overseas new drugs.
In January 2021, the State Food and Drug Administration has conditionally approved the marketing of brozoyuumab injection for X-linked hypophosphatemia (XLH) in adults and 1-year-old children.
The indication approved for marketing this time is tumor Related osteomalacia.
Brozoyuumab was previously included in the second batch of clinically urgently needed overseas new drugs.
In January 2021, the State Food and Drug Administration has conditionally approved the marketing of brozoyuumab injection for X-linked hypophosphatemia (XLH) in adults and 1-year-old children.
The indication approved for marketing this time is tumor Related osteomalacia.
Itibant is a rare disease drug of Takeda, a powerful and selective bradykinin B2 receptor antagonist, mainly used to treat acute attacks of hereditary angioedema (HAE).
The product was approved for marketing in the European Union in July 2008, and was approved for marketing in the United States in August 2011.
It is the third drug approved by the FDA for the treatment of HAE attacks.
Its global sales in 2019 were 32.
7 billion yen.
The product was approved for marketing in the European Union in July 2008, and was approved for marketing in the United States in August 2011.
It is the third drug approved by the FDA for the treatment of HAE attacks.
Its global sales in 2019 were 32.
7 billion yen.
Ripretinib tablets are a tyrosine kinase switch regulatory inhibitor introduced by Zai Lab from Deciphera in 2019 for the treatment of gastrointestinal stromal tumors (GIST) and other solid tumors driven by KIT/PDGFRα.
CStone's conditional approval of Pratinib Capsules is an oral, potent and highly selective RET inhibitor that has a broad and long-lasting anti-tumor effect on patients with RET fusion-positive NSCLC.
Pratinib is China's first selective RET inhibitor approved for marketing, and it is also CStone's first commercially available product.
CStone Pharmaceuticals is a biopharmaceutical company established at the end of 2015, focusing on the development and commercialization of innovative tumor immunotherapy and precision treatment drugs.
Pratinib is China's first selective RET inhibitor approved for marketing, and it is also CStone's first commercially available product.
CStone Pharmaceuticals is a biopharmaceutical company established at the end of 2015, focusing on the development and commercialization of innovative tumor immunotherapy and precision treatment drugs.
It is worth mentioning that the registration status of another new CStone drug, apotinib tablets, has been changed to "under approval", which is expected to usher in the good news of approval for listing.
Apotinib tablet is an oral, potent and highly selective KIT/PDGFRA mutant kinase inhibitor, which is the latest precise targeted therapy for such mutations.
Apotinib tablet is an oral, potent and highly selective KIT/PDGFRA mutant kinase inhibitor, which is the latest precise targeted therapy for such mutations.
At present, the research and development of anti-tumor drugs represented by tinibs in China are getting together, showing a "big bang" trend.
In less than 3 months, 3 tinib drugs have been approved for marketing in China, including Sofantinib, Vometinib and Pratinib.
Tinib, a tyrosine kinase inhibitor, is a small molecule protein kinase inhibitor that can block one or more protein kinases.
The potential of the tinib drug market is huge.
According to data from Meinenet, the sales of terminal protein kinase inhibitors in China's public medical institutions exceeded 20 billion yuan in 2019, a year-on-year increase of 59.
53%.
In less than 3 months, 3 tinib drugs have been approved for marketing in China, including Sofantinib, Vometinib and Pratinib.
Tinib, a tyrosine kinase inhibitor, is a small molecule protein kinase inhibitor that can block one or more protein kinases.
The potential of the tinib drug market is huge.
According to data from Meinenet, the sales of terminal protein kinase inhibitors in China's public medical institutions exceeded 20 billion yuan in 2019, a year-on-year increase of 59.
53%.
4 new drugs apply for listing! Hengrui PD-1 reports new indications
From March 13th to March 26th, the marketing applications for 4 new drugs (6 acceptance numbers) were accepted by CDE.
In terms of imported new drugs, Genting Xinyao’s ilacycline and Pono’s innovative pimecillin submitted applications for listing.
In terms of domestic new drugs, Hengrui Medicine’s Carrelizol (PD-1) declares new indications.
The four previously approved indications have all entered the national medical insurance catalogue.
In terms of imported new drugs, Genting Xinyao’s ilacycline and Pono’s innovative pimecillin submitted applications for listing.
In terms of domestic new drugs, Hengrui Medicine’s Carrelizol (PD-1) declares new indications.
The four previously approved indications have all entered the national medical insurance catalogue.
(3.
13-3.
26) Approved domestic/imported new drug listing application
13-3.
26) Approved domestic/imported new drug listing application
Huabei Pharmaceutical submitted a new indication marketing application for propofol fumarate tablets.
Profol tenofovir is a powerful antiviral drug for the treatment of chronic hepatitis B in adults and adolescents, and it is the first-line drug used in the treatment of hepatitis B in the world.
Profol tenofovir was developed by Gilead under the trade name Vemlidy, which is known as the "strongest hepatitis B drug in history".
According to data from Mi Nei.
com, Vemlidy's global sales in 2020 will be 659 million U.
S.
dollars, a year-on-year increase of 35%.
Profol tenofovir is a powerful antiviral drug for the treatment of chronic hepatitis B in adults and adolescents, and it is the first-line drug used in the treatment of hepatitis B in the world.
Profol tenofovir was developed by Gilead under the trade name Vemlidy, which is known as the "strongest hepatitis B drug in history".
According to data from Mi Nei.
com, Vemlidy's global sales in 2020 will be 659 million U.
S.
dollars, a year-on-year increase of 35%.
XeravaTM (Eracycline, Eravacycline) is a new type of fully synthetic broad-spectrum tetracycline parenteral antibiotics for injection.
It has extensive in vitro antibacterial activity against multi-drug-resistant gram-negative bacteria and other common drug-resistant bacteria in China.
.
Genting Xinyao obtained the commercial license of XeravaTM from Tetraphse Pharmaceuticals, and has the exclusive rights to develop and commercialize the drug in the major markets of Greater China, South Korea and some Southeast Asia.
It has extensive in vitro antibacterial activity against multi-drug-resistant gram-negative bacteria and other common drug-resistant bacteria in China.
.
Genting Xinyao obtained the commercial license of XeravaTM from Tetraphse Pharmaceuticals, and has the exclusive rights to develop and commercialize the drug in the major markets of Greater China, South Korea and some Southeast Asia.
Elacycline is currently approved for the treatment of complex intra-abdominal infection (cIAI) in the United States and Europe, and was approved in Singapore in April 2020.
Tigecycline has been listed in the domestic market for similar drugs such as tigecycline.
In recent years, the domestic market for tigecycline has continued to rise.
According to data from Meinenet, the terminal sales of tigecycline in China's public medical institutions exceeded 2.
6 billion in 2019.
Yuan, a year-on-year increase of 25.
35%.
Tigecycline has been listed in the domestic market for similar drugs such as tigecycline.
In recent years, the domestic market for tigecycline has continued to rise.
According to data from Meinenet, the terminal sales of tigecycline in China's public medical institutions exceeded 2.
6 billion in 2019.
Yuan, a year-on-year increase of 25.
35%.
Osaikang, Qilu, Dongyang Pharmaceutical.
.
.
43 new drugs were approved for clinical use
.
.
43 new drugs were approved for clinical use
From March 13th to March 26th, 43 new drugs (involving 59 acceptance numbers) received implied approval for clinical trials.
Among them, 31 varieties (41 acceptance numbers) are domestic new drugs, and 12 varieties (18 acceptance numbers) are imported new drugs.
In terms of types of medicines, there are 5 Chinese patent medicines, 17 chemical medicines, and 21 therapeutic biological products.
Among them, 31 varieties (41 acceptance numbers) are domestic new drugs, and 12 varieties (18 acceptance numbers) are imported new drugs.
In terms of types of medicines, there are 5 Chinese patent medicines, 17 chemical medicines, and 21 therapeutic biological products.
(3.
13-3.
26) Approved clinically domestic/imported new drugs
13-3.
26) Approved clinically domestic/imported new drugs
Iron maltol capsules were introduced by Osaikon from Shield TX in the United Kingdom and have been approved in the European Union and the United States for the treatment of adult iron deficiency.
The active ingredient of the medicine, iron maltol, is a new type of non-salt complex with stable chemical properties formed by iron and maltol, which has a unique absorption mechanism.
A series of clinical trials have confirmed that iron maltol capsules are an oral drug for the treatment of iron deficiency in adults with low incidence of adverse reactions , high bioavailability, low iron overload, and good tolerance.
According to data from Mi Nei.
com, the market size of terminal iron preparations in China's public medical institutions and Chinese urban physical pharmacies exceeded 4 billion yuan in 2019, an increase of about 12% year-on-year, and the potential patient group and market size are relatively large.
The active ingredient of the medicine, iron maltol, is a new type of non-salt complex with stable chemical properties formed by iron and maltol, which has a unique absorption mechanism.
A series of clinical trials have confirmed that iron maltol capsules are an oral drug for the treatment of iron deficiency in adults with low incidence of adverse reactions , high bioavailability, low iron overload, and good tolerance.
According to data from Mi Nei.
com, the market size of terminal iron preparations in China's public medical institutions and Chinese urban physical pharmacies exceeded 4 billion yuan in 2019, an increase of about 12% year-on-year, and the potential patient group and market size are relatively large.
Tosun Pharma’s Class 3.
3 biologic drug insulin degludec injection is a long-acting insulin for diabetic patients who need insulin treatment.
At present, only Novo Nordisk's insulin glutathione injection is approved for import in the domestic market.
According to data from Meinnet.
com, Novo Nordisk’s global sales of insulin deglubber will be 8.
968 billion Danish kroner in 2020, of which the sales in the Chinese market will be 418 million Danish kroner.
3 biologic drug insulin degludec injection is a long-acting insulin for diabetic patients who need insulin treatment.
At present, only Novo Nordisk's insulin glutathione injection is approved for import in the domestic market.
According to data from Meinnet.
com, Novo Nordisk’s global sales of insulin deglubber will be 8.
968 billion Danish kroner in 2020, of which the sales in the Chinese market will be 418 million Danish kroner.
The BC006 monoclonal antibody injection of Baochuan Biologics is a humanized IgG1 monoclonal antibody against macrophage colony stimulating factor 1 receptor (CSF-1R), which specifically targets CSF on the surface of mononuclear-macrophage mesangial cells.
-1R, intended for the treatment of advanced malignant tumors.
BC006 monoclonal antibody injection was approved for clinical use, marking that my country's first CSF-1R antibody drug has successfully entered the clinical development stage, filling the gap in the research and development of this target in China, and clinical research on this target abroad is also in the early stage.
-1R, intended for the treatment of advanced malignant tumors.
BC006 monoclonal antibody injection was approved for clinical use, marking that my country's first CSF-1R antibody drug has successfully entered the clinical development stage, filling the gap in the research and development of this target in China, and clinical research on this target abroad is also in the early stage.
Fosun Pharmaceutical subsidiary of Chongqing Friends of pharmaceutical drugs YP01001 capsules innovative small molecule chemical drugs, intended for the treatment of advanced solid tumors.
The domestically marketed YP01001 capsules of similar drugs include lenvatinib mesylate capsules and so on.
According to data from Meinnet.
com, sales of lenvatinib have soared since its listing.
In 2019, Eisai's global sales of lenvatinib reached 111.
9 billion yen.
The domestically marketed YP01001 capsules of similar drugs include lenvatinib mesylate capsules and so on.
According to data from Meinnet.
com, sales of lenvatinib have soared since its listing.
In 2019, Eisai's global sales of lenvatinib reached 111.
9 billion yen.
Qilu Pharmaceutical has two Class 1 new drugs approved for clinical trials, namely VB4-845 injection and QLS31901 for injection.
QLS31901 for injection is intended for the treatment of advanced solid tumors, and VB4-845 injection is used for the treatment of non-muscular invasive bladder cancer.
VB4-845 (Vicineum) is an antibody-drug conjugate (ADC) introduced by Qilu Pharmaceutical from Sesen Bio for US$35 million.
It is a human source that targets the Epithelial Cell Adhesion Molecule (EpCAM) antigen on the surface of tumor cells.
The scFv immunotoxin.
VB4-845 has been granted orphan drug status by the US FDA and EU EMA.
In December 2020, Sesen Bio submitted a complete biologics license application (BLA) for the drug to the US FDA, and it is expected to be approved in mid-2021.
QLS31901 for injection is intended for the treatment of advanced solid tumors, and VB4-845 injection is used for the treatment of non-muscular invasive bladder cancer.
VB4-845 (Vicineum) is an antibody-drug conjugate (ADC) introduced by Qilu Pharmaceutical from Sesen Bio for US$35 million.
It is a human source that targets the Epithelial Cell Adhesion Molecule (EpCAM) antigen on the surface of tumor cells.
The scFv immunotoxin.
VB4-845 has been granted orphan drug status by the US FDA and EU EMA.
In December 2020, Sesen Bio submitted a complete biologics license application (BLA) for the drug to the US FDA, and it is expected to be approved in mid-2021.
Lepu Medicine's Class 3.
3 Recombinant GLP-1 Receptor Agonist Injection is a biosimilar of dulaglutide injection.
Dulaglutide injection was developed by Eli Lilly and has been approved for the treatment of adult type 2 diabetes and the prevention of cardiovascular risk in patients with type 2 diabetes (T2DM).
According to data from Mi Nei.
com, Eli Lilly’s global sales of dulaglutide in 2020 were US$5.
068 billion, a year-on-year increase of 23%.
3 Recombinant GLP-1 Receptor Agonist Injection is a biosimilar of dulaglutide injection.
Dulaglutide injection was developed by Eli Lilly and has been approved for the treatment of adult type 2 diabetes and the prevention of cardiovascular risk in patients with type 2 diabetes (T2DM).
According to data from Mi Nei.
com, Eli Lilly’s global sales of dulaglutide in 2020 were US$5.
068 billion, a year-on-year increase of 23%.
Class 1 innovative drug PF-06882961 is an oral small molecule GLP-1 receptor agonist developed by Pfizer.
This small molecule drug is different from the injection and oral peptide GLP-1RA, and can provide a differentiated and innovative treatment for patients with diabetes and obesity.
This small molecule drug is different from the injection and oral peptide GLP-1RA, and can provide a differentiated and innovative treatment for patients with diabetes and obesity.
Cinda, Kelun, Eisai.
.
.
40 clinical applications for new drugs were accepted
.
.
40 clinical applications for new drugs were accepted
From March 13th to March 26th, clinical applications for 40 new drugs (involving 73 acceptance numbers) were accepted by the CDE.
Among them, 29 varieties (49 acceptance numbers) are domestic new drugs, and 11 varieties (24 acceptance numbers) are imported new drugs.
In terms of the types of medicines, there are 1 Chinese patent medicine, 26 chemical medicines, and 13 therapeutic biological products.
Among them, 29 varieties (49 acceptance numbers) are domestic new drugs, and 11 varieties (24 acceptance numbers) are imported new drugs.
In terms of the types of medicines, there are 1 Chinese patent medicine, 26 chemical medicines, and 13 therapeutic biological products.
(3.
13-3.
26) Accepted clinical applications for domestic/imported new drugs
13-3.
26) Accepted clinical applications for domestic/imported new drugs
Class 1 biological drug IBI302 is an innovative drug independently developed by Cinda for the treatment of ocular fundus diseases.
It is the world's first anti-VEGF-anti-complement dual target molecule.
IBI302 is intended for the treatment of neovascular age-related macular degeneration (nAMD).
Its dual-target design is expected to achieve more targeted treatment and intervention on the cause of AMD, and bring more clinical trials than VEGF single-target drugs Benefit.
It is the world's first anti-VEGF-anti-complement dual target molecule.
IBI302 is intended for the treatment of neovascular age-related macular degeneration (nAMD).
Its dual-target design is expected to achieve more targeted treatment and intervention on the cause of AMD, and bring more clinical trials than VEGF single-target drugs Benefit.
GZR18 is a once-a-week glucagon-like peptide 1 (GLP-1) receptor agonist drug independently developed by Ganli Pharmaceutical.
The indications include type II diabetes, obesity and overweight.
Globally, there are currently no GLP-1 receptor agonist drugs that are injected once a week have been approved for obesity and overweight treatment.
The indications include type II diabetes, obesity and overweight.
Globally, there are currently no GLP-1 receptor agonist drugs that are injected once a week have been approved for obesity and overweight treatment.
The ASC42 tablet of Golly Pharma is a best-in-class farnesoid X receptor (FXR) agonist.
In two animal models of NASH, ASC42 showed significant improvement in liver steatosis, inflammation and fibrosis.
In October 2020, ASC42 tablets were approved by the U.
S.
FDA for clinical trials for non-alcoholic steatohepatitis (NASH) indications.
It is worth mentioning that there are two other drugs under development in the NASH pipeline of Golly Pharmaceuticals, including ASC41 in phase I clinical trials and ASC40 tablets that have declared IND.
In two animal models of NASH, ASC42 showed significant improvement in liver steatosis, inflammation and fibrosis.
In October 2020, ASC42 tablets were approved by the U.
S.
FDA for clinical trials for non-alcoholic steatohepatitis (NASH) indications.
It is worth mentioning that there are two other drugs under development in the NASH pipeline of Golly Pharmaceuticals, including ASC41 in phase I clinical trials and ASC40 tablets that have declared IND.
Kelun Pharmaceutical's sildenafil citrate oral dissolving film is the first domestic company to submit a clinical application, and it is also the company's first oral dissolving film to be unveiled.
Sildenafil is a selective inhibitor of phosphodiesterase type 5 (PDE-5) used to treat erectile dysfunction (ED).
According to data from Meinenet, in 2019, the sales of sildenafil at the physical pharmacy terminal in Chinese cities exceeded 2.
3 billion yuan.
It is worth mentioning that Kelun Pharmaceutical's Sildenafil Citrate Orally Disintegrating Tablets has been the first to submit a listing application, which shows that the company attaches great importance to the andrology drug market.
Sildenafil is a selective inhibitor of phosphodiesterase type 5 (PDE-5) used to treat erectile dysfunction (ED).
According to data from Meinenet, in 2019, the sales of sildenafil at the physical pharmacy terminal in Chinese cities exceeded 2.
3 billion yuan.
It is worth mentioning that Kelun Pharmaceutical's Sildenafil Citrate Orally Disintegrating Tablets has been the first to submit a listing application, which shows that the company attaches great importance to the andrology drug market.
Dotinurad tablet is a urate reabsorption inhibitor, which can target to inhibit the activity of urate reabsorption transporter (URAT1).
On January 23, 2020, Dotinurad tablets were approved by Japan PMDA for the treatment of gout caused by hyperuricemia.
On February 25, 2020, Eisai Co.
, Ltd.
and Fuji Pharmaceutical Co.
, Ltd.
announced that they have reached a license agreement for Dotinurad, and Eisai will be responsible for the exclusive development and sales of its products in the Chinese market.
On January 23, 2020, Dotinurad tablets were approved by Japan PMDA for the treatment of gout caused by hyperuricemia.
On February 25, 2020, Eisai Co.
, Ltd.
and Fuji Pharmaceutical Co.
, Ltd.
announced that they have reached a license agreement for Dotinurad, and Eisai will be responsible for the exclusive development and sales of its products in the Chinese market.
At present, the leading domestic anti-gout drug market is febuxostat, which has been included in the third batch of centralized procurement.
According to data from Mi Nei.
com, in 2019, China's urban public hospitals , county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) and China's urban physical pharmacies terminal febuxostat sales approached 2 billion yuan.
According to data from Mi Nei.
com, in 2019, China's urban public hospitals , county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) and China's urban physical pharmacies terminal febuxostat sales approached 2 billion yuan.
Data source: Minet database, CDE, company announcement.
The data statistics period is from March 13th to March 26th.
Statistics are based on drug names (excluding preventive biological products, in vitro diagnostic reagents, etc.
, and supplementary applications).
If there are any omissions, please correct me!
The data statistics period is from March 13th to March 26th.
Statistics are based on drug names (excluding preventive biological products, in vitro diagnostic reagents, etc.
, and supplementary applications).
If there are any omissions, please correct me!
Note: Meinenet China's urban entity pharmacy terminal competition pattern database is an enlarged version of the urban entity pharmacy database that covers 293 cities and above cities across the country (excluding county and rural entity pharmacies), and continuously monitors all categories.
The above sales are calculated based on the average retail price of the product at the terminal.
The above sales are calculated based on the average retail price of the product at the terminal.
Pharm.
com News on March 30th, a large number of new drugs will be launched soon
com News on March 30th, a large number of new drugs will be launched soon
10 new drugs are on the market! Cornerstone, Takeda, Novartis.
.
.
10 new drugs are on the market! Cornerstone, Takeda, Novartis. .
.
.
.
During the period from March 13th to March 26th, the listing applications of 10 new drugs (15 acceptance numbers) had the review and approval status update.
Among them, CStone's pratinib capsules were conditionally approved for marketing, and Kyowa Fermented Kirin's brozoyuumab injection and Celgene's lenalidomide capsules were approved for new indications.
In addition, Zai Lab’s Ripretinib tablets, Takeda’s icatibant acetate injection, CStone’s apotinib tablets, and Novartis’s metformin and vildagliptin tablets II/Ⅲ.
.
.
the registration status has changed to "under approval ".
Among them, CStone's pratinib capsules were conditionally approved for marketing, and Kyowa Fermented Kirin's brozoyuumab injection and Celgene's lenalidomide capsules were approved for new indications.
In addition, Zai Lab’s Ripretinib tablets, Takeda’s icatibant acetate injection, CStone’s apotinib tablets, and Novartis’s metformin and vildagliptin tablets II/Ⅲ.
.
.
the registration status has changed to "under approval ".
(3.
13-3.
26) New drug listing application review and approval status update
13-3.
26) New drug listing application review and approval status update
Kyowa Fermented Kirin's brozoyuumab is the first recombinant fully human monoclonal IgG1 antibody targeting fibroblast growth factor 23 (FGF23).
Brozoyuumab was previously included in the second batch of clinically urgently needed overseas new drugs.
In January 2021, the State Food and Drug Administration has conditionally approved the marketing of brozoyuumab injection for X-linked hypophosphatemia (XLH) in adults and 1-year-old children.
The indication approved for marketing this time is tumor Related osteomalacia.
Brozoyuumab was previously included in the second batch of clinically urgently needed overseas new drugs.
In January 2021, the State Food and Drug Administration has conditionally approved the marketing of brozoyuumab injection for X-linked hypophosphatemia (XLH) in adults and 1-year-old children.
The indication approved for marketing this time is tumor Related osteomalacia.
Itibant is a rare disease drug of Takeda, a powerful and selective bradykinin B2 receptor antagonist, mainly used to treat acute attacks of hereditary angioedema (HAE).
The product was approved for marketing in the European Union in July 2008, and was approved for marketing in the United States in August 2011.
It is the third drug approved by the FDA for the treatment of HAE attacks.
Its global sales in 2019 were 32.
7 billion yen.
The product was approved for marketing in the European Union in July 2008, and was approved for marketing in the United States in August 2011.
It is the third drug approved by the FDA for the treatment of HAE attacks.
Its global sales in 2019 were 32.
7 billion yen.
Ripretinib tablets are a tyrosine kinase switch regulatory inhibitor introduced by Zai Lab from Deciphera in 2019 for the treatment of gastrointestinal stromal tumors (GIST) and other solid tumors driven by KIT/PDGFRα.
CStone's conditional approval of Pratinib Capsules is an oral, potent and highly selective RET inhibitor that has a broad and long-lasting anti-tumor effect on patients with RET fusion-positive NSCLC.
Pratinib is China's first selective RET inhibitor approved for marketing, and it is also CStone's first commercially available product.
CStone Pharmaceuticals is a biopharmaceutical company established at the end of 2015, focusing on the development and commercialization of innovative tumor immunotherapy and precision treatment drugs.
Pratinib is China's first selective RET inhibitor approved for marketing, and it is also CStone's first commercially available product.
CStone Pharmaceuticals is a biopharmaceutical company established at the end of 2015, focusing on the development and commercialization of innovative tumor immunotherapy and precision treatment drugs.
It is worth mentioning that the registration status of another new CStone drug, apotinib tablets, has been changed to "under approval", which is expected to usher in the good news of approval for listing.
Apotinib tablet is an oral, potent and highly selective KIT/PDGFRA mutant kinase inhibitor, which is the latest precise targeted therapy for such mutations.
Apotinib tablet is an oral, potent and highly selective KIT/PDGFRA mutant kinase inhibitor, which is the latest precise targeted therapy for such mutations.
At present, the research and development of anti-tumor drugs represented by tinibs in China are getting together, showing a "big bang" trend.
In less than 3 months, 3 tinib drugs have been approved for marketing in China, including Sofantinib, Vometinib and Pratinib.
Tinib, a tyrosine kinase inhibitor, is a small molecule protein kinase inhibitor that can block one or more protein kinases.
The potential of the tinib drug market is huge.
According to data from Meinenet, the sales of terminal protein kinase inhibitors in China's public medical institutions exceeded 20 billion yuan in 2019, a year-on-year increase of 59.
53%.
In less than 3 months, 3 tinib drugs have been approved for marketing in China, including Sofantinib, Vometinib and Pratinib.
Tinib, a tyrosine kinase inhibitor, is a small molecule protein kinase inhibitor that can block one or more protein kinases.
The potential of the tinib drug market is huge.
According to data from Meinenet, the sales of terminal protein kinase inhibitors in China's public medical institutions exceeded 20 billion yuan in 2019, a year-on-year increase of 59.
53%.
4 new drugs apply for listing! Hengrui PD-1 reports new indications
4 new drugs apply for listing! Hengrui PD-1 reports new indications From March 13th to March 26th, the marketing applications for 4 new drugs (6 acceptance numbers) were accepted by CDE.
In terms of imported new drugs, Genting Xinyao’s ilacycline and Pono’s innovative pimecillin submitted applications for listing.
In terms of domestic new drugs, Hengrui Medicine’s Carrelizol (PD-1) declares new indications.
The four previously approved indications have all entered the national medical insurance catalogue.
In terms of imported new drugs, Genting Xinyao’s ilacycline and Pono’s innovative pimecillin submitted applications for listing.
In terms of domestic new drugs, Hengrui Medicine’s Carrelizol (PD-1) declares new indications.
The four previously approved indications have all entered the national medical insurance catalogue.
(3.
13-3.
26) Approved domestic/imported new drug listing application
13-3.
26) Approved domestic/imported new drug listing application
Huabei Pharmaceutical submitted a new indication marketing application for propofol fumarate tablets.
Profol tenofovir is a powerful antiviral drug for the treatment of chronic hepatitis B in adults and adolescents, and it is the first-line drug used in the treatment of hepatitis B in the world.
Profol tenofovir was developed by Gilead under the trade name Vemlidy, which is known as the "strongest hepatitis B drug in history".
According to data from Mi Nei.
com, Vemlidy's global sales in 2020 will be 659 million U.
S.
dollars, a year-on-year increase of 35%.
Profol tenofovir is a powerful antiviral drug for the treatment of chronic hepatitis B in adults and adolescents, and it is the first-line drug used in the treatment of hepatitis B in the world.
Profol tenofovir was developed by Gilead under the trade name Vemlidy, which is known as the "strongest hepatitis B drug in history".
According to data from Mi Nei.
com, Vemlidy's global sales in 2020 will be 659 million U.
S.
dollars, a year-on-year increase of 35%.
XeravaTM (Eracycline, Eravacycline) is a new type of fully synthetic broad-spectrum tetracycline parenteral antibiotics for injection.
It has extensive in vitro antibacterial activity against multi-drug-resistant gram-negative bacteria and other common drug-resistant bacteria in China.
.
Genting Xinyao obtained the commercial license of XeravaTM from Tetraphse Pharmaceuticals, and has the exclusive rights to develop and commercialize the drug in the major markets of Greater China, South Korea and some Southeast Asia.
It has extensive in vitro antibacterial activity against multi-drug-resistant gram-negative bacteria and other common drug-resistant bacteria in China.
.
Genting Xinyao obtained the commercial license of XeravaTM from Tetraphse Pharmaceuticals, and has the exclusive rights to develop and commercialize the drug in the major markets of Greater China, South Korea and some Southeast Asia.
Elacycline is currently approved for the treatment of complex intra-abdominal infection (cIAI) in the United States and Europe, and was approved in Singapore in April 2020.
Tigecycline has been listed in the domestic market for similar drugs such as tigecycline.
In recent years, the domestic market for tigecycline has continued to rise.
According to data from Meinenet, the terminal sales of tigecycline in China's public medical institutions exceeded 2.
6 billion in 2019.
Yuan, a year-on-year increase of 25.
35%.
Medicine, medicine, medicineTigecycline has been listed in the domestic market for similar drugs such as tigecycline.
In recent years, the domestic market for tigecycline has continued to rise.
According to data from Meinenet, the terminal sales of tigecycline in China's public medical institutions exceeded 2.
6 billion in 2019.
Yuan, a year-on-year increase of 25.
35%.
Osaikang, Qilu, Dongyang Pharmaceutical.
.
.
43 new drugs were approved for clinical use
Osaikang, Qilu, Dongyang Pharmaceutical. .
.
43 new drugs were approved for clinical use
.
.
43 new drugs were approved for clinical use
From March 13th to March 26th, 43 new drugs (involving 59 acceptance numbers) received implied approval for clinical trials.
Among them, 31 varieties (41 acceptance numbers) are domestic new drugs, and 12 varieties (18 acceptance numbers) are imported new drugs.
In terms of types of medicines, there are 5 Chinese patent medicines, 17 chemical medicines, and 21 therapeutic biological products.
Among them, 31 varieties (41 acceptance numbers) are domestic new drugs, and 12 varieties (18 acceptance numbers) are imported new drugs.
In terms of types of medicines, there are 5 Chinese patent medicines, 17 chemical medicines, and 21 therapeutic biological products.
(3.
13-3.
26) Approved clinically domestic/imported new drugs
13-3.
26) Approved clinically domestic/imported new drugs
Iron maltol capsules were introduced by Osaikon from Shield TX in the United Kingdom and have been approved in the European Union and the United States for the treatment of adult iron deficiency.
The active ingredient of the medicine, iron maltol, is a new type of non-salt complex with stable chemical properties formed by iron and maltol, which has a unique absorption mechanism.
A series of clinical trials have confirmed that iron maltol capsules are an oral drug for the treatment of iron deficiency in adults with low incidence of adverse reactions , high bioavailability, low iron overload, and good tolerance.
According to data from Mi Nei.
com, the market size of terminal iron preparations in China's public medical institutions and Chinese urban physical pharmacies exceeded 4 billion yuan in 2019, an increase of about 12% year-on-year, and the potential patient group and market size are relatively large.
Adverse reactions adverse reactions adverse reactionsThe active ingredient of the medicine, iron maltol, is a new type of non-salt complex with stable chemical properties formed by iron and maltol, which has a unique absorption mechanism.
A series of clinical trials have confirmed that iron maltol capsules are an oral drug for the treatment of iron deficiency in adults with low incidence of adverse reactions , high bioavailability, low iron overload, and good tolerance.
According to data from Mi Nei.
com, the market size of terminal iron preparations in China's public medical institutions and Chinese urban physical pharmacies exceeded 4 billion yuan in 2019, an increase of about 12% year-on-year, and the potential patient group and market size are relatively large.
Tosun Pharma’s Class 3.
3 biologic drug insulin degludec injection is a long-acting insulin for diabetic patients who need insulin treatment.
At present, only Novo Nordisk's insulin glutathione injection is approved for import in the domestic market.
According to data from Meinnet.
com, Novo Nordisk’s global sales of insulin deglubber will be 8.
968 billion Danish kroner in 2020, of which the sales in the Chinese market will be 418 million Danish kroner.
3 biologic drug insulin degludec injection is a long-acting insulin for diabetic patients who need insulin treatment.
At present, only Novo Nordisk's insulin glutathione injection is approved for import in the domestic market.
According to data from Meinnet.
com, Novo Nordisk’s global sales of insulin deglubber will be 8.
968 billion Danish kroner in 2020, of which the sales in the Chinese market will be 418 million Danish kroner.
The BC006 monoclonal antibody injection of Baochuan Biologics is a humanized IgG1 monoclonal antibody against macrophage colony stimulating factor 1 receptor (CSF-1R), which specifically targets CSF on the surface of mononuclear-macrophage mesangial cells.
-1R, intended for the treatment of advanced malignant tumors.
BC006 monoclonal antibody injection was approved for clinical use, marking that my country's first CSF-1R antibody drug has successfully entered the clinical development stage, filling the gap in the research and development of this target in China, and clinical research on this target abroad is also in the early stage.
-1R, intended for the treatment of advanced malignant tumors.
BC006 monoclonal antibody injection was approved for clinical use, marking that my country's first CSF-1R antibody drug has successfully entered the clinical development stage, filling the gap in the research and development of this target in China, and clinical research on this target abroad is also in the early stage.
Fosun Pharmaceutical subsidiary of Chongqing Friends of pharmaceutical drugs YP01001 capsules innovative small molecule chemical drugs, intended for the treatment of advanced solid tumors.
The domestically marketed YP01001 capsules of similar drugs include lenvatinib mesylate capsules and so on.
According to data from Meinnet.
com, sales of lenvatinib have soared since its listing.
In 2019, Eisai's global sales of lenvatinib reached 111.
9 billion yen.
Medicine Medicine MedicineThe domestically marketed YP01001 capsules of similar drugs include lenvatinib mesylate capsules and so on.
According to data from Meinnet.
com, sales of lenvatinib have soared since its listing.
In 2019, Eisai's global sales of lenvatinib reached 111.
9 billion yen.
Qilu Pharmaceutical has two Class 1 new drugs approved for clinical trials, namely VB4-845 injection and QLS31901 for injection.
QLS31901 for injection is intended for the treatment of advanced solid tumors, and VB4-845 injection is used for the treatment of non-muscular invasive bladder cancer.
VB4-845 (Vicineum) is an antibody-drug conjugate (ADC) introduced by Qilu Pharmaceutical from Sesen Bio for US$35 million.
It is a human source that targets the Epithelial Cell Adhesion Molecule (EpCAM) antigen on the surface of tumor cells.
The scFv immunotoxin.
VB4-845 has been granted orphan drug status by the US FDA and EU EMA.
In December 2020, Sesen Bio submitted a complete biologics license application (BLA) for the drug to the US FDA, and it is expected to be approved in mid-2021.
QLS31901 for injection is intended for the treatment of advanced solid tumors, and VB4-845 injection is used for the treatment of non-muscular invasive bladder cancer.
VB4-845 (Vicineum) is an antibody-drug conjugate (ADC) introduced by Qilu Pharmaceutical from Sesen Bio for US$35 million.
It is a human source that targets the Epithelial Cell Adhesion Molecule (EpCAM) antigen on the surface of tumor cells.
The scFv immunotoxin.
VB4-845 has been granted orphan drug status by the US FDA and EU EMA.
In December 2020, Sesen Bio submitted a complete biologics license application (BLA) for the drug to the US FDA, and it is expected to be approved in mid-2021.
Lepu Medicine's Class 3.
3 Recombinant GLP-1 Receptor Agonist Injection is a biosimilar of dulaglutide injection.
Dulaglutide injection was developed by Eli Lilly and has been approved for the treatment of adult type 2 diabetes and the prevention of cardiovascular risk in patients with type 2 diabetes (T2DM).
According to data from Mi Nei.
com, Eli Lilly’s global sales of dulaglutide in 2020 were US$5.
068 billion, a year-on-year increase of 23%.
3 Recombinant GLP-1 Receptor Agonist Injection is a biosimilar of dulaglutide injection.
Dulaglutide injection was developed by Eli Lilly and has been approved for the treatment of adult type 2 diabetes and the prevention of cardiovascular risk in patients with type 2 diabetes (T2DM).
According to data from Mi Nei.
com, Eli Lilly’s global sales of dulaglutide in 2020 were US$5.
068 billion, a year-on-year increase of 23%.
Class 1 innovative drug PF-06882961 is an oral small molecule GLP-1 receptor agonist developed by Pfizer.
This small molecule drug is different from the injection and oral peptide GLP-1RA, and can provide a differentiated and innovative treatment for patients with diabetes and obesity.
This small molecule drug is different from the injection and oral peptide GLP-1RA, and can provide a differentiated and innovative treatment for patients with diabetes and obesity.
Cinda, Kelun, Eisai.
.
.
40 clinical applications for new drugs were accepted
Cinda, Kelun, Eisai. .
.
40 clinical applications for new drugs were accepted
.
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40 clinical applications for new drugs were accepted
From March 13th to March 26th, clinical applications for 40 new drugs (involving 73 acceptance numbers) were accepted by the CDE.
Among them, 29 varieties (49 acceptance numbers) are domestic new drugs, and 11 varieties (24 acceptance numbers) are imported new drugs.
In terms of the types of medicines, there are 1 Chinese patent medicine, 26 chemical medicines, and 13 therapeutic biological products.
Among them, 29 varieties (49 acceptance numbers) are domestic new drugs, and 11 varieties (24 acceptance numbers) are imported new drugs.
In terms of the types of medicines, there are 1 Chinese patent medicine, 26 chemical medicines, and 13 therapeutic biological products.
(3.
13-3.
26) Accepted clinical applications for domestic/imported new drugs
13-3.
26) Accepted clinical applications for domestic/imported new drugs
Class 1 biological drug IBI302 is an innovative drug independently developed by Cinda for the treatment of ocular fundus diseases.
It is the world's first anti-VEGF-anti-complement dual target molecule.
IBI302 is intended for the treatment of neovascular age-related macular degeneration (nAMD).
Its dual-target design is expected to achieve more targeted treatment and intervention on the cause of AMD, and bring more clinical trials than VEGF single-target drugs Benefit.
It is the world's first anti-VEGF-anti-complement dual target molecule.
IBI302 is intended for the treatment of neovascular age-related macular degeneration (nAMD).
Its dual-target design is expected to achieve more targeted treatment and intervention on the cause of AMD, and bring more clinical trials than VEGF single-target drugs Benefit.
GZR18 is a once-a-week glucagon-like peptide 1 (GLP-1) receptor agonist drug independently developed by Ganli Pharmaceutical.
The indications include type II diabetes, obesity and overweight.
Globally, there are currently no GLP-1 receptor agonist drugs that are injected once a week have been approved for obesity and overweight treatment.
The indications include type II diabetes, obesity and overweight.
Globally, there are currently no GLP-1 receptor agonist drugs that are injected once a week have been approved for obesity and overweight treatment.
The ASC42 tablet of Golly Pharma is a best-in-class farnesoid X receptor (FXR) agonist.
In two animal models of NASH, ASC42 showed significant improvement in liver steatosis, inflammation and fibrosis.
In October 2020, ASC42 tablets were approved by the U.
S.
FDA for clinical trials for non-alcoholic steatohepatitis (NASH) indications.
It is worth mentioning that there are two other drugs under development in the NASH pipeline of Golly Pharmaceuticals, including ASC41 in phase I clinical trials and ASC40 tablets that have declared IND.
In two animal models of NASH, ASC42 showed significant improvement in liver steatosis, inflammation and fibrosis.
In October 2020, ASC42 tablets were approved by the U.
S.
FDA for clinical trials for non-alcoholic steatohepatitis (NASH) indications.
It is worth mentioning that there are two other drugs under development in the NASH pipeline of Golly Pharmaceuticals, including ASC41 in phase I clinical trials and ASC40 tablets that have declared IND.
Kelun Pharmaceutical's sildenafil citrate oral dissolving film is the first domestic company to submit a clinical application, and it is also the company's first oral dissolving film to be unveiled.
Sildenafil is a selective inhibitor of phosphodiesterase type 5 (PDE-5) used to treat erectile dysfunction (ED).
According to data from Meinenet, in 2019, the sales of sildenafil at the physical pharmacy terminal in Chinese cities exceeded 2.
3 billion yuan.
It is worth mentioning that Kelun Pharmaceutical's Sildenafil Citrate Orally Disintegrating Tablets has been the first to submit a listing application, which shows that the company attaches great importance to the andrology drug market.
Sildenafil is a selective inhibitor of phosphodiesterase type 5 (PDE-5) used to treat erectile dysfunction (ED).
According to data from Meinenet, in 2019, the sales of sildenafil at the physical pharmacy terminal in Chinese cities exceeded 2.
3 billion yuan.
It is worth mentioning that Kelun Pharmaceutical's Sildenafil Citrate Orally Disintegrating Tablets has been the first to submit a listing application, which shows that the company attaches great importance to the andrology drug market.
Dotinurad tablet is a urate reabsorption inhibitor, which can target to inhibit the activity of urate reabsorption transporter (URAT1).
On January 23, 2020, Dotinurad tablets were approved by Japan PMDA for the treatment of gout caused by hyperuricemia.
On February 25, 2020, Eisai Co.
, Ltd.
and Fuji Pharmaceutical Co.
, Ltd.
announced that they have reached a license agreement for Dotinurad, and Eisai will be responsible for the exclusive development and sales of its products in the Chinese market.
On January 23, 2020, Dotinurad tablets were approved by Japan PMDA for the treatment of gout caused by hyperuricemia.
On February 25, 2020, Eisai Co.
, Ltd.
and Fuji Pharmaceutical Co.
, Ltd.
announced that they have reached a license agreement for Dotinurad, and Eisai will be responsible for the exclusive development and sales of its products in the Chinese market.
At present, the leading domestic anti-gout drug market is febuxostat, which has been included in the third batch of centralized procurement.
According to data from Mi Nei.
com, in 2019, China's urban public hospitals , county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) and China's urban physical pharmacies terminal febuxostat sales approached 2 billion yuan.
Hospital hospital hospital pharmacy pharmacy pharmacyAccording to data from Mi Nei.
com, in 2019, China's urban public hospitals , county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) and China's urban physical pharmacies terminal febuxostat sales approached 2 billion yuan.
Data source: Minet database, CDE, company announcement.
The data statistics period is from March 13th to March 26th.
Statistics are based on drug names (excluding preventive biological products, in vitro diagnostic reagents, etc.
, and supplementary applications).
If there are any omissions, please correct me!
The data statistics period is from March 13th to March 26th.
Statistics are based on drug names (excluding preventive biological products, in vitro diagnostic reagents, etc.
, and supplementary applications).
If there are any omissions, please correct me!
Note: Meinenet China's urban entity pharmacy terminal competition pattern database is an enlarged version of the urban entity pharmacy database that covers 293 cities and above cities across the country (excluding county and rural entity pharmacies), and continuously monitors all categories.
The above sales are calculated based on the average retail price of the product at the terminal.
The above sales are calculated based on the average retail price of the product at the terminal.
