Hengrui, Hausen... Great Harvest Won 24 New Anti-tumor Class 1 Drugs

Medical Network, June 10 News, on June 9, the official website of the State Food and Drug Administration showed that two domestically produced anti-tumor Class 1 new drugs were approved for marketing, namely Rongchang Biotech's vedicitumumab for injection and Zejing Biotech's toluene Donafinil Sulfonate Tablets
.
According to incomplete statistics, there are currently 24 domestically produced anti-tumor class 1 new drugs approved, involving Hengrui, Hausen, Chia Tai Tianqing and other companies.
Among them, 7 class 1 new drugs will be used in Chinese public medical institutions and cities in China in 2020.
The total sales of physical pharmacies exceeded 1 billion yuan
.
Fifteen anti-tumor Class 1 new drugs have been submitted for marketing applications and are currently under review and approval.
Many of them are expected to win the domestic/domestic first
.

 

The first domestically-made ADC drug was born, and 24 domestically-made anti-tumor Class 1 new drugs have been approved

 

On June 9, the State Food and Drug Administration approved the listing of Rongchang Biologic’s vedicitumumab for injection, becoming the first domestic antibody-drug conjugate (ADC) in China, suitable for those who have received at least 2 types of systemic chemotherapy HER2 overexpression in patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma)
.
On the same day, Suzhou Zejing Biologics Class 1 new drug Donafenib tosylate was approved for marketing.
This is a multi-kinase inhibitor type small molecule anti-tumor drug for the treatment of advanced (inoperable or metastatic) hepatocellular carcinoma , Is the first domestically-made first-line targeted drug for liver cancer in China
.

 

According to incomplete statistics, there are currently 24 domestic anti-tumor Class 1 new drugs (excluding vaccines, APIs, etc.
, the same below) have been approved for marketing, 18 are chemical drugs, and 6 therapeutic biological products are all antibody products.
Four of them are PD-1 monoclonal antibodies
.

 

　　A new domestic anti-tumor class 1 drug that has been approved for marketing

　　Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

 

　　There are 24 types of Class 1 new drugs involving 17 companies .
Hengrui Pharmaceuticals leads with 4 varieties, BeiGene is closely followed by 3 varieties, and Haosen Pharmaceuticals, Betta Pharmaceuticals, and Hutchison Whampoa have 2 companies.
Three varieties were approved
.

 

　　Based on the earliest start date, a maximum of 2 Class 1 new drugs will be approved each year before 2018.
After 2018, there will be "high yields".
In 2018 and 2019, there will be 4 Class 1 new drugs approved, and there will be 6 Class 1 new drugs in 2020.
Approved, 6 Class 1 new drugs have been approved since 2021
.

 

　　In terms of approved indications, 24 new category 1 drugs cover non-small cell lung cancer, urothelial cancer, nasopharyngeal carcinoma, melanoma, breast cancer, mantle cell lymphoma, Hodgkin’s lymphoma, ovarian cancer, and hepatocellular carcinoma , Leukemia, rectal cancer and other diseases, concentrated in non-small cell lung cancer, breast cancer, Hodgkin’s lymphoma, ovarian cancer, leukemia and so on
.

 

　　In terms of therapeutic targets, the main targets of 24 new class 1 drugs include PD-1, EGFR, VEGFR, PARP, BTK, etc.
Among them, the research and development of targets such as PD-1, EGFR, and PARP are more popular
.

 

　　The 100 billion market continues to expand, and these Class 1 new drugs exceed 500 million in the first year of launch.

 

　　Thanks to the rigid demand for anti-tumor drugs, the support of relevant policies, and the surge in the number of new drugs approved for marketing in recent years, the domestic anti-tumor drug market has expanded year by year
.
Meters within the network data show that in 2020 China's urban public hospitals , county-level public hospitals, urban community centers and township hospitals (referred to as the Chinese public medical institutions) and Chinese cities entity pharmacy terminal anti -tumor of the drug market size exceeded 120 billion yuan, an increase of 12.
43%
.

 

　　Sales of terminal anti-tumor chemicals in Chinese public medical institutions and physical pharmacies in cities in China

　　Source: Mi Nei Net Database

 

　　The nine category 1 new drugs approved at the end of 2020 and 2021 have not yet generated sales in 2020.
Excluding these new drugs, the remaining 15 category 1 new drugs will be sold at the terminals of Chinese public medical institutions and Chinese urban physical pharmacies in 2020.
The amount exceeds 20 billion yuan
.

 

　　Among them, the sales of seven category 1 new drugs exceeded 1 billion yuan, including Hengrui's carrelizumab, pyrrotinib and apatinib, Zhengda Tianqing's anlotinib, and Cinda's Sindili Monoclonal antibodies, Junshi’s Teriplizumab, Beda’s Icotinib
.

 

　　The sales of 6 Class 1 new drugs exceeded 500 million yuan (including 500 million yuan) in the first year of listing.
4 domestically produced PD-1s were successively approved from the end of 2018 to the beginning of 2020.
Among them, Hengrui’s products were launched less than half a year ago Breaking through 1 billion yuan, Cinda and BeiGene's products reached a sales scale of nearly 1 billion yuan in the first year of launch; Chia Tai Tianqing's Anlotinib was approved in May 2018, and its annual sales in 2018 reached 6.
6 100 million yuan; Hausen's ametinib was approved in March 2020, and its annual sales in 2020 will be about 500 million yuan
.

 

　　15 domestic Class 1 new drugs are under review, many of which are expected to win the first domestic/domestic drug

 

　　According to incomplete statistics, there are currently 15 domestic anti-tumor category 1 new drug applications (excluding applications for new indications for marketed products) are still under review, of which 8 are chemical drugs and 7 are for therapeutic use.
The proportion of biological products and biological drugs has increased, and the development of PD-(L)1 therapeutic targets is booming
.

 

　　Domestic anti-tumor class 1 new drugs that have been submitted for marketing and are under review

 

　　Hengrui Medicine’s self-developed SHR6390 tablets are expected to become the first domestically produced CDK4/6 inhibitors.
The drugs currently on the market with the same target in China include Pfizer’s pipercillide and Eli Lilly’s abesilire; in addition, the company and Yingli Linpris tablets jointly developed by the pharmaceutical industry are the first PI3Kδ selective inhibitors submitted for marketing applications in China.
It is used to treat follicular lymphoma.
In addition, it is also developing peripheral T/NK cell lymphoma and peripheral T cell lymphoma in China.
clinical study tumor, B cell hematological malignancies and other indications
.

 

　　Corning Jerry's Envolimab Injection (KN035) is the world's first single-domain antibody for tumor immunotherapy and is expected to become the world's first subcutaneous PD-L1 inhibitor
.
Compared with the PD-(L)1 antibody currently on the market and under research, KN035 has different advantages such as good safety, subcutaneous injection, stability at room temperature, and greatly shortening the administration time
.

 

　　Ascent Pharma’s oribatinib tablets are the first three-generation Bcr-Abl targeted drug-resistant chronic myelogenous leukemia (CML) treatment drug in China.
It is effective against BCR-ABL and a variety of BCR- including T315I mutations.
The ABL mutant has outstanding effects
.
Oribatinib obtained the FDA clinical trial approval in July 2019 and directly entered the phase Ib clinical study.
In May 2020, it successively obtained the orphan drug qualification and the fast-track review qualification granted by the FDA
.

 

　　Volitinib tablets from Hutchison Whampoa are expected to become the first domestically-made MET inhibitors.
Currently, domestically targeted drugs include Pfizer's crizotinib
.
In addition to the reported indications for non-small cell lung cancer with MET 14 exon skipping mutations, voritinib is also undergoing clinical trials for gastric cancer, gastroesophageal junction adenocarcinoma, advanced or metastatic pulmonary sarcomatoid cancer and other indications
.

 

　　Source: Mynet database, official website of the State Drug Administration, etc.

　　Medical Network, June 10 News, on June 9, the official website of the State Food and Drug Administration showed that two domestically produced anti-tumor Class 1 new drugs were approved for marketing, namely Rongchang Biotech's vedicitumumab for injection and Zejing Biotech's toluene Donafinil Sulfonate Tablets
.
According to incomplete statistics, there are currently 24 domestically produced anti-tumor class 1 new drugs approved, involving Hengrui, Hausen, Chia Tai Tianqing and other companies.
Among them, 7 class 1 new drugs will be used in Chinese public medical institutions and cities in China in 2020.
The total sales of physical pharmacies exceeded 1 billion yuan
.
Fifteen anti-tumor Class 1 new drugs have been submitted for marketing applications and are currently under review and approval.
Many of them are expected to win the domestic/domestic first
.

 

　　The first domestically-made ADC drug was born, and 24 domestically-made anti-tumor Class 1 new drugs have been approved

 

　　On June 9, the State Food and Drug Administration approved the listing of Rongchang Biologic’s vedicitumumab for injection, becoming the first domestic antibody-drug conjugate (ADC) in China, suitable for those who have received at least 2 types of systemic chemotherapy HER2 overexpression in patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma)
.
On the same day, Suzhou Zejing Biologics Class 1 new drug Donafenib tosylate was approved for marketing.
This is a multi-kinase inhibitor type small molecule anti-tumor drug for the treatment of advanced (inoperable or metastatic) hepatocellular carcinoma , Is the first domestically-made first-line targeted drug for liver cancer in China
.

 

　　According to incomplete statistics, there are currently 24 domestic anti-tumor Class 1 new drugs (excluding vaccines, APIs, etc.
, the same below) have been approved for marketing, 18 are chemical drugs, and 6 therapeutic biological products are all antibody products.
Four of them are PD-1 monoclonal antibodies
.

 

　　A new domestic anti-tumor class 1 drug that has been approved for marketing

　　Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

 

　　There are 24 types of Class 1 new drugs involving 17 companies .
Hengrui Pharmaceuticals leads with 4 varieties, BeiGene is closely followed by 3 varieties, and Haosen Pharmaceuticals, Betta Pharmaceuticals, and Hutchison Whampoa have 2 companies.
Three varieties were approved
.

 

　　Based on the earliest start date, a maximum of 2 Class 1 new drugs will be approved each year before 2018.
After 2018, there will be "high yields".
In 2018 and 2019, there will be 4 Class 1 new drugs approved, and there will be 6 Class 1 new drugs in 2020.
Approved, 6 Class 1 new drugs have been approved since 2021
.

 

　　In terms of approved indications, 24 new category 1 drugs cover non-small cell lung cancer, urothelial cancer, nasopharyngeal carcinoma, melanoma, breast cancer, mantle cell lymphoma, Hodgkin’s lymphoma, ovarian cancer, and hepatocellular carcinoma , Leukemia, rectal cancer and other diseases, concentrated in non-small cell lung cancer, breast cancer, Hodgkin’s lymphoma, ovarian cancer, leukemia and so on
.

 

　　In terms of therapeutic targets, the main targets of 24 new class 1 drugs include PD-1, EGFR, VEGFR, PARP, BTK, etc.
Among them, the research and development of targets such as PD-1, EGFR, and PARP are more popular
.

 

　　The 100 billion market continues to expand, and these Class 1 new drugs exceed 500 million in the first year of launch.

 

　　Thanks to the rigid demand for anti-tumor drugs, the support of relevant policies, and the surge in the number of new drugs approved for marketing in recent years, the domestic anti-tumor drug market has expanded year by year
.
Meters within the network data show that in 2020 China's urban public hospitals , county-level public hospitals, urban community centers and township hospitals (referred to as the Chinese public medical institutions) and Chinese cities entity pharmacy terminal anti -tumor of the drug market size exceeded 120 billion yuan, an increase of 12.
43%
.

 

　　Sales of terminal anti-tumor chemicals in Chinese public medical institutions and physical pharmacies in cities in China

　　Source: Mi Nei Net Database

 

　　The nine category 1 new drugs approved at the end of 2020 and 2021 have not yet generated sales in 2020.
Excluding these new drugs, the remaining 15 category 1 new drugs will be sold at the terminals of Chinese public medical institutions and Chinese urban physical pharmacies in 2020.
The amount exceeds 20 billion yuan
.

 

　　Among them, the sales of seven category 1 new drugs exceeded 1 billion yuan, including Hengrui's carrelizumab, pyrrotinib and apatinib, Zhengda Tianqing's anlotinib, and Cinda's Sindili Monoclonal antibodies, Junshi’s Teriplizumab, Beda’s Icotinib
.

 

　　The sales of 6 Class 1 new drugs exceeded 500 million yuan (including 500 million yuan) in the first year of listing.
4 domestically produced PD-1s were successively approved from the end of 2018 to the beginning of 2020.
Among them, Hengrui’s products were launched less than half a year ago Breaking through 1 billion yuan, Cinda and BeiGene's products reached a sales scale of nearly 1 billion yuan in the first year of launch; Chia Tai Tianqing's Anlotinib was approved in May 2018, and its annual sales in 2018 reached 6.
6 100 million yuan; Hausen's ametinib was approved in March 2020, and its annual sales in 2020 will be about 500 million yuan
.

 

　　15 domestic Class 1 new drugs are under review, many of which are expected to win the first domestic/domestic drug

 

　　According to incomplete statistics, there are currently 15 domestic anti-tumor category 1 new drug applications (excluding applications for new indications for marketed products) are still under review, of which 8 are chemical drugs and 7 are for therapeutic use.
The proportion of biological products and biological drugs has increased, and the development of PD-(L)1 therapeutic targets is booming
.

 

　　Domestic anti-tumor class 1 new drugs that have been submitted for marketing and are under review

 

　　Hengrui Medicine’s self-developed SHR6390 tablets are expected to become the first domestically produced CDK4/6 inhibitors.
The drugs currently on the market with the same target in China include Pfizer’s pipercillide and Eli Lilly’s abesilire; in addition, the company and Yingli Linpris tablets jointly developed by the pharmaceutical industry are the first PI3Kδ selective inhibitors submitted for marketing applications in China.
It is used to treat follicular lymphoma.
In addition, it is also developing peripheral T/NK cell lymphoma and peripheral T cell lymphoma in China.
clinical study tumor, B cell hematological malignancies and other indications
.

 

　　Corning Jerry's Envolimab Injection (KN035) is the world's first single-domain antibody for tumor immunotherapy and is expected to become the world's first subcutaneous PD-L1 inhibitor
.
Compared with the PD-(L)1 antibody currently on the market and under research, KN035 has different advantages such as good safety, subcutaneous injection, stability at room temperature, and greatly shortening the administration time
.

 

　　Ascent Pharma’s oribatinib tablets are the first three-generation Bcr-Abl targeted drug-resistant chronic myelogenous leukemia (CML) treatment drug in China.
It is effective against BCR-ABL and a variety of BCR- including T315I mutations.
The ABL mutant has outstanding effects
.
Oribatinib obtained the FDA clinical trial approval in July 2019 and directly entered the phase Ib clinical study.
In May 2020, it successively obtained the orphan drug qualification and the fast-track review qualification granted by the FDA
.

 

　　Volitinib tablets from Hutchison Whampoa are expected to become the first domestically-made MET inhibitors.
Currently, domestically targeted drugs include Pfizer's crizotinib
.
In addition to the reported indications for non-small cell lung cancer with MET 14 exon skipping mutations, voritinib is also undergoing clinical trials for gastric cancer, gastroesophageal junction adenocarcinoma, advanced or metastatic pulmonary sarcomatoid cancer and other indications
.

 

　　Source: Mynet database, official website of the State Drug Administration, etc.

 　Source: Meinenet MED2.
0 Chinese Drug Evaluation Database