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On September 8, CDE issued a notice on the public solicitation of "Guidelines for the Design of Clinical Trials of Cetuximab Injection Biosimilar Drugs (Draft for Solicitation of Comments)"
.
It is reported that Cetuximab is a human-mouse chimeric monoclonal antibody targeting the IgG1 subtype of human epidermal growth factor receptor (EGFR).
It was developed and marketed by Merck, Germany, and was approved for marketing in Mainland China in 2007.
Named Erbitux, currently approved indications include colorectal cancer and head and neck squamous cell carcinoma
.
.
It is reported that Cetuximab is a human-mouse chimeric monoclonal antibody targeting the IgG1 subtype of human epidermal growth factor receptor (EGFR).
It was developed and marketed by Merck, Germany, and was approved for marketing in Mainland China in 2007.
Named Erbitux, currently approved indications include colorectal cancer and head and neck squamous cell carcinoma
.
The global patent of cetuximab has expired in 2017.
Currently, many domestic pharmaceutical companies , including Kelun Pharmaceutical, Qilu Pharmaceutical, Sansheng Guojian, and Shenzhou Cell, are developing their biosimilar drugs, but there are no biosimilar drugs yet.
Approved
.
In order to further clarify the technical principles, CDE organized the writing of the guiding principle document and formed a draft for soliciting opinions
.
From the perspective of the industry, this move is clearly intended to help improve the efficiency of corporate research and development, and to provide a reference for the research and development of such drugs
.
Currently, many domestic pharmaceutical companies , including Kelun Pharmaceutical, Qilu Pharmaceutical, Sansheng Guojian, and Shenzhou Cell, are developing their biosimilar drugs, but there are no biosimilar drugs yet.
Approved
.
In order to further clarify the technical principles, CDE organized the writing of the guiding principle document and formed a draft for soliciting opinions
.
From the perspective of the industry, this move is clearly intended to help improve the efficiency of corporate research and development, and to provide a reference for the research and development of such drugs
.
Local pharmaceutical companies compete for layout
Has reached clinical stage III at the fastest
As the first anti-EGFR monoclonal antibody approved in the world, cetuximab injection has global sales of nearly 1.
5 billion U.
S.
dollars in 2019
.
In the Chinese market, the sales data of cetuximab injection, which entered the 2018 National Medical Insurance Negotiation Catalogue with a decline of more than 65%, has grown astonishing
.
According to data from Menet.
com, in 2019, the sales of terminal cetuximab in public medical institutions in China reached 1.
576 billion yuan, with an annual growth rate of 117.
23%
.
5 billion U.
S.
dollars in 2019
.
In the Chinese market, the sales data of cetuximab injection, which entered the 2018 National Medical Insurance Negotiation Catalogue with a decline of more than 65%, has grown astonishing
.
According to data from Menet.
com, in 2019, the sales of terminal cetuximab in public medical institutions in China reached 1.
576 billion yuan, with an annual growth rate of 117.
23%
.
Sales of terminal cetuximab in public medical institutions in China (100 million yuan)
In March 2020, the National Food and Drug Administration approved the combination of cetuximab injection with platinum and fluorouracil chemotherapy for the first-line treatment of recurrent and/or metastatic head and neck squamous cell carcinoma.
The contract was successfully renewed in the new version of the medical insurance catalog.
With the addition of new indications, cetuximab injection is expected to achieve a new peak in market sales
.
The huge market cake has also attracted local pharmaceutical companies, including Kelun Pharmaceutical, Qilu Pharmaceutical, Sansheng Guojian, and Shenzhou Cell
.
The contract was successfully renewed in the new version of the medical insurance catalog.
With the addition of new indications, cetuximab injection is expected to achieve a new peak in market sales
.
The huge market cake has also attracted local pharmaceutical companies, including Kelun Pharmaceutical, Qilu Pharmaceutical, Sansheng Guojian, and Shenzhou Cell
.
According to incomplete statistics from reporters of the "Pharmaceutical Economics Daily", as of now, more than 10 local companies have deployed cetuximab biosimilar drugs, but no company has submitted a listing application for the time being
.
Among them, Kelun Pharmaceuticals, Maibote Pharmaceuticals and Ampuze Biopharmaceuticals took the lead, and related products have undergone phase III clinical trials; GPGJ602 of Sansheng Guojian and SCT200 of Shenzhou Cell followed closely behind and entered Phase II clinical trials; pharmaceutical companies such as Jinmante Biology, Guilin Sanjin/Baochuan Biology, Fuhong Henlius, and Qilu Pharmaceutical are also stepping up
.
.
Among them, Kelun Pharmaceuticals, Maibote Pharmaceuticals and Ampuze Biopharmaceuticals took the lead, and related products have undergone phase III clinical trials; GPGJ602 of Sansheng Guojian and SCT200 of Shenzhou Cell followed closely behind and entered Phase II clinical trials; pharmaceutical companies such as Jinmante Biology, Guilin Sanjin/Baochuan Biology, Fuhong Henlius, and Qilu Pharmaceutical are also stepping up
.
According to the newly disclosed semi-annual report, Kelun Pharmaceuticals stated that the phase III head-to-head study of A140 compared to the original cetuximab was completed last year before the start-up.
In February this year, the first research center was launched and the first case was enrolled; Maibo Pharmaceuticals is implementing CMAB009's phase III clinical trial for colorectal cancer, and is expected to submit a new drug listing application to the National Food and Drug Administration in the third quarter of 2022; while Shenzhou Cell is completing SCT200 for colorectal cancer phase I For clinical research, preparations for database lock-in for Phase II clinical studies and related preparations for clinical research reports are in progress, and exploratory phase I or phase II clinical studies for 6 other projects have been carried out
.
In February this year, the first research center was launched and the first case was enrolled; Maibo Pharmaceuticals is implementing CMAB009's phase III clinical trial for colorectal cancer, and is expected to submit a new drug listing application to the National Food and Drug Administration in the third quarter of 2022; while Shenzhou Cell is completing SCT200 for colorectal cancer phase I For clinical research, preparations for database lock-in for Phase II clinical studies and related preparations for clinical research reports are in progress, and exploratory phase I or phase II clinical studies for 6 other projects have been carried out
.
Cetuximab biosimilar research and development progress of domestic companies
| Serial number | Drug Name | manufacturer | Indications | R & D progress |
| 1 | CMAB009 | Maibo Pharmaceutical/Shanghai Zhangjiang Biological | Colorectal cancer | Clinical Phase III |
| 2 | A140 | Kelun Pharmaceutical | Colorectal cancer | Clinical Phase III |
| 3 | APZ001 | Ampuze Biomedical | Colorectal cancer | Clinical Phase III |
| 4 | GPGJ602 | Sansheng Guojian | Colorectal cancer | Clinical Phase II |
| 5 | SCT200 | Shenzhou Cell | Colorectal cancer | Clinical Phase II |
| 6 | JMT-101 | Zinmant Bio | Solid tumor | Clinical Phase I |
| 7 | CDP1 | Guilin Three Golds / Bao Chuansheng Thing | Colorectal cancer | Clinical Phase I |
| 8 | HLX07 | Fuhong Henlius | Advanced solid tumor | Clinical Phase I |
| 9 | QL1105 | Qilu Pharmaceutical | Solid tumor | Clinical Phase I |
According to Frost & Sullivan’s statistics and predictions, the colorectal cancer and nasopharyngeal cancer market sales of EGFR monoclonal antibodies in China in 2018 will be 1.
28 billion yuan, and in 2023 and 2030, the market sales of colorectal cancer and nasopharyngeal cancer will be The amount will increase to 3.
85 billion yuan and 6.
62 billion yuan respectively
.
If EGFR monoclonal antibody can be approved for indications for other tumor types in the future, its market size is expected to further expand
.
Under the new guiding principles of clinical trial design, which local pharmaceutical company will take the lead in crossing the line, waiting to see
.
28 billion yuan, and in 2023 and 2030, the market sales of colorectal cancer and nasopharyngeal cancer will be The amount will increase to 3.
85 billion yuan and 6.
62 billion yuan respectively
.
If EGFR monoclonal antibody can be approved for indications for other tumor types in the future, its market size is expected to further expand
.
Under the new guiding principles of clinical trial design, which local pharmaceutical company will take the lead in crossing the line, waiting to see
.
In the context of centralized procurement
Accelerated development of biosimilars
In the context of the industry in which the consistency evaluation of generic chemical drugs has entered the zone, the promotion of the development of biosimilar drugs has also been put on the agenda
.
In February of this year, CDE issued the "Technical Guidelines for the Evaluation of the Similarity of Biosimilars and the Extrapolation of Indications".
Based on the previous "Technical Guidelines for the Development and Evaluation of Biosimilars (Trial)", the CDE further supplemented the similarities of biosimilars.
Guiding suggestions for the extrapolation of evaluation and indications, to further standardize and guide the development and evaluation of biosimilar drugs
.
.
In February of this year, CDE issued the "Technical Guidelines for the Evaluation of the Similarity of Biosimilars and the Extrapolation of Indications".
Based on the previous "Technical Guidelines for the Development and Evaluation of Biosimilars (Trial)", the CDE further supplemented the similarities of biosimilars.
Guiding suggestions for the extrapolation of evaluation and indications, to further standardize and guide the development and evaluation of biosimilar drugs
.
At the same time, CDE has successively issued clinical guidelines for biosimilars of single species such as liraglutide, trastuzumab, rituximab, adalimumab and bevacizumab, and has a great The kinetics, effectiveness comparison study, safety and immunogenicity study and other evaluation indicators of the clinical experimental design and end points are explained, and the main research end points are recommended for each drug
.
This time, for cetuximab injection biosimilar drugs, CDE also takes into account the characteristics of this variety, and puts forward many suggestions for pharmaceutical companies to carry out clinical comparison studies in a targeted manner
.
.
This time, for cetuximab injection biosimilar drugs, CDE also takes into account the characteristics of this variety, and puts forward many suggestions for pharmaceutical companies to carry out clinical comparison studies in a targeted manner
.
According to relevant statistics, as of the end of 2020, about 270 biosimilar drugs in China are in the state of research and development, more than half of which are still in the preclinical research stage, and 65 drugs have submitted clinical trial applications
.
Currently, blockbuster biologic drugs including rituximab, adalimumab, bevacizumab, trastuzumab, and infliximab have been approved for the marketing of biosimilar drugs, and competition for some varieties has become a red sea.
.
Insiders pointed out that the series of single-variety guiding principles issued by CDE will to a large extent prevent pharmaceutical companies from getting together in the field of biosimilar drugs and have the same layout, and will effectively reduce repeated investment in construction
.
.
Currently, blockbuster biologic drugs including rituximab, adalimumab, bevacizumab, trastuzumab, and infliximab have been approved for the marketing of biosimilar drugs, and competition for some varieties has become a red sea.
.
Insiders pointed out that the series of single-variety guiding principles issued by CDE will to a large extent prevent pharmaceutical companies from getting together in the field of biosimilar drugs and have the same layout, and will effectively reduce repeated investment in construction
.
Domestic approved monoclonal antibody biosimilar drugs and their original research products
A few meters within the network, in recent years the anti -tumor drug market continued expansion in 2020 in China terminal sales in public sector exceeded 100 billion yuan, variety of heavy biological medicine hospital sales topped the list
.
Under the top-level design that should be harvested, insulin is on the string as a test for centralized procurement of biological drugs
.
It is only a matter of time before the remaining varieties that meet the requirements of centralized procurement will be included .
From the current point of view, the top players such as Fuhong Henlius, Cinda Biologicals, Qilu Pharmaceuticals have basically formed, and large production capacity and low cost will become the magic weapon for winning the domestic bio-similar drug market in the future
.
.
Under the top-level design that should be harvested, insulin is on the string as a test for centralized procurement of biological drugs
.
It is only a matter of time before the remaining varieties that meet the requirements of centralized procurement will be included .
From the current point of view, the top players such as Fuhong Henlius, Cinda Biologicals, Qilu Pharmaceuticals have basically formed, and large production capacity and low cost will become the magic weapon for winning the domestic bio-similar drug market in the future
.
On September 8, CDE issued a notice on the public solicitation of "Guidelines for the Design of Clinical Trials of Cetuximab Injection Biosimilar Drugs (Draft for Solicitation of Comments)"
.
It is reported that Cetuximab is a human-mouse chimeric monoclonal antibody targeting the IgG1 subtype of human epidermal growth factor receptor (EGFR).
It was developed and marketed by Merck, Germany, and was approved for marketing in Mainland China in 2007.
Named Erbitux, currently approved indications include colorectal cancer and head and neck squamous cell carcinoma
.
.
It is reported that Cetuximab is a human-mouse chimeric monoclonal antibody targeting the IgG1 subtype of human epidermal growth factor receptor (EGFR).
It was developed and marketed by Merck, Germany, and was approved for marketing in Mainland China in 2007.
Named Erbitux, currently approved indications include colorectal cancer and head and neck squamous cell carcinoma
.
The global patent of cetuximab has expired in 2017.
Currently, many domestic pharmaceutical companies , including Kelun Pharmaceutical, Qilu Pharmaceutical, Sansheng Guojian, and Shenzhou Cell, are developing their biosimilar drugs, but there are no biosimilar drugs yet.
Approved
.
In order to further clarify the technical principles, CDE organized the writing of the guiding principle document and formed a draft for soliciting opinions
.
From the perspective of the industry, this move is clearly intended to help improve the efficiency of corporate research and development, and to provide a reference for the research and development of such drugs
.
Currently, many domestic pharmaceutical companies , including Kelun Pharmaceutical, Qilu Pharmaceutical, Sansheng Guojian, and Shenzhou Cell, are developing their biosimilar drugs, but there are no biosimilar drugs yet.
Approved
.
In order to further clarify the technical principles, CDE organized the writing of the guiding principle document and formed a draft for soliciting opinions
.
From the perspective of the industry, this move is clearly intended to help improve the efficiency of corporate research and development, and to provide a reference for the research and development of such drugs
.
Local pharmaceutical companies compete for layout
Has reached clinical stage III at the fastest
As the first anti-EGFR monoclonal antibody approved in the world, cetuximab injection has global sales of nearly 1.
5 billion U.
S.
dollars in 2019
.
In the Chinese market, the sales data of cetuximab injection, which entered the 2018 National Medical Insurance Negotiation Catalogue with a decline of more than 65%, has grown astonishing
.
According to data from Menet.
com, in 2019, the sales of terminal cetuximab in public medical institutions in China reached 1.
576 billion yuan, with an annual growth rate of 117.
23%
.
5 billion U.
S.
dollars in 2019
.
In the Chinese market, the sales data of cetuximab injection, which entered the 2018 National Medical Insurance Negotiation Catalogue with a decline of more than 65%, has grown astonishing
.
According to data from Menet.
com, in 2019, the sales of terminal cetuximab in public medical institutions in China reached 1.
576 billion yuan, with an annual growth rate of 117.
23%
.
Sales of terminal cetuximab in public medical institutions in China (100 million yuan)
In March 2020, the National Food and Drug Administration approved the combination of cetuximab injection with platinum and fluorouracil chemotherapy for the first-line treatment of recurrent and/or metastatic head and neck squamous cell carcinoma.
The contract was successfully renewed in the new version of the medical insurance catalog.
With the addition of new indications, cetuximab injection is expected to achieve a new peak in market sales
.
The huge market cake has also attracted local pharmaceutical companies, including Kelun Pharmaceutical, Qilu Pharmaceutical, Sansheng Guojian, and Shenzhou Cell
.
The contract was successfully renewed in the new version of the medical insurance catalog.
With the addition of new indications, cetuximab injection is expected to achieve a new peak in market sales
.
The huge market cake has also attracted local pharmaceutical companies, including Kelun Pharmaceutical, Qilu Pharmaceutical, Sansheng Guojian, and Shenzhou Cell
.
According to incomplete statistics from reporters of the "Pharmaceutical Economics Daily", as of now, more than 10 local companies have deployed cetuximab biosimilar drugs, but no company has submitted a listing application for the time being
.
Among them, Kelun Pharmaceuticals, Maibote Pharmaceuticals and Ampuze Biopharmaceuticals took the lead, and related products have undergone phase III clinical trials; GPGJ602 of Sansheng Guojian and SCT200 of Shenzhou Cell followed closely behind and entered Phase II clinical trials; pharmaceutical companies such as Jinmante Biology, Guilin Sanjin/Baochuan Biology, Fuhong Henlius, and Qilu Pharmaceutical are also stepping up
.
.
Among them, Kelun Pharmaceuticals, Maibote Pharmaceuticals and Ampuze Biopharmaceuticals took the lead, and related products have undergone phase III clinical trials; GPGJ602 of Sansheng Guojian and SCT200 of Shenzhou Cell followed closely behind and entered Phase II clinical trials; pharmaceutical companies such as Jinmante Biology, Guilin Sanjin/Baochuan Biology, Fuhong Henlius, and Qilu Pharmaceutical are also stepping up
.
According to the newly disclosed semi-annual report, Kelun Pharmaceuticals stated that the phase III head-to-head study of A140 compared to the original cetuximab was completed last year before the start-up.
In February this year, the first research center was launched and the first case was enrolled; Maibo Pharmaceuticals is implementing CMAB009's phase III clinical trial for colorectal cancer, and is expected to submit a new drug listing application to the National Food and Drug Administration in the third quarter of 2022; while Shenzhou Cell is completing SCT200 for colorectal cancer phase I For clinical research, preparations for database lock-in for Phase II clinical studies and related preparations for clinical research reports are in progress, and exploratory phase I or phase II clinical studies for 6 other projects have been carried out
.
In February this year, the first research center was launched and the first case was enrolled; Maibo Pharmaceuticals is implementing CMAB009's phase III clinical trial for colorectal cancer, and is expected to submit a new drug listing application to the National Food and Drug Administration in the third quarter of 2022; while Shenzhou Cell is completing SCT200 for colorectal cancer phase I For clinical research, preparations for database lock-in for Phase II clinical studies and related preparations for clinical research reports are in progress, and exploratory phase I or phase II clinical studies for 6 other projects have been carried out
.
Cetuximab biosimilar research and development progress of domestic companies
| Serial number | Drug Name | manufacturer | Indications | R & D progress |
| 1 | CMAB009 | Maibo Pharmaceutical/Shanghai Zhangjiang Biological | Colorectal cancer | Clinical Phase III |
| 2 | A140 | Kelun Pharmaceutical | Colorectal cancer | Clinical Phase III |
| 3 | APZ001 | Ampuze Biomedical | Colorectal cancer | Clinical Phase III |
| 4 | GPGJ602 | Sansheng Guojian | Colorectal cancer | Clinical Phase II |
| 5 | SCT200 | Shenzhou Cell | Colorectal cancer | Clinical Phase II |
| 6 | JMT-101 | Zinmant Bio | Solid tumor | Clinical Phase I |
| 7 | CDP1 | Guilin Three Golds / Bao Chuansheng Thing | Colorectal cancer | Clinical Phase I |
| 8 | HLX07 | Fuhong Henlius | Advanced solid tumor | Clinical Phase I |
| 9 | QL1105 | Qilu Pharmaceutical | Solid tumor | Clinical Phase I |
According to Frost & Sullivan’s statistics and predictions, the colorectal cancer and nasopharyngeal cancer market sales of EGFR monoclonal antibodies in China in 2018 will be 1.
28 billion yuan, and in 2023 and 2030, the market sales of colorectal cancer and nasopharyngeal cancer will be The amount will increase to 3.
85 billion yuan and 6.
62 billion yuan respectively
.
If EGFR monoclonal antibody can be approved for indications for other tumor types in the future, its market size is expected to further expand
.
Under the new guiding principles of clinical trial design, which local pharmaceutical company will take the lead in crossing the line, waiting to see
.
28 billion yuan, and in 2023 and 2030, the market sales of colorectal cancer and nasopharyngeal cancer will be The amount will increase to 3.
85 billion yuan and 6.
62 billion yuan respectively
.
If EGFR monoclonal antibody can be approved for indications for other tumor types in the future, its market size is expected to further expand
.
Under the new guiding principles of clinical trial design, which local pharmaceutical company will take the lead in crossing the line, waiting to see
.
In the context of centralized procurement
Accelerated development of biosimilars
In the context of the industry in which the consistency evaluation of generic chemical drugs has entered the zone, the promotion of the development of biosimilar drugs has also been put on the agenda
.
In February of this year, CDE issued the "Technical Guidelines for the Evaluation of the Similarity of Biosimilars and the Extrapolation of Indications".
Based on the previous "Technical Guidelines for the Development and Evaluation of Biosimilars (Trial)", the CDE further supplemented the similarities of biosimilars.
Guiding suggestions for the extrapolation of evaluation and indications, to further standardize and guide the development and evaluation of biosimilar drugs
.
.
In February of this year, CDE issued the "Technical Guidelines for the Evaluation of the Similarity of Biosimilars and the Extrapolation of Indications".
Based on the previous "Technical Guidelines for the Development and Evaluation of Biosimilars (Trial)", the CDE further supplemented the similarities of biosimilars.
Guiding suggestions for the extrapolation of evaluation and indications, to further standardize and guide the development and evaluation of biosimilar drugs
.
At the same time, CDE has successively issued clinical guidelines for biosimilars of single species such as liraglutide, trastuzumab, rituximab, adalimumab and bevacizumab, and has a great The kinetics, effectiveness comparison study, safety and immunogenicity study and other evaluation indicators of the clinical experimental design and end points are explained, and the main research end points are recommended for each drug
.
This time, for cetuximab injection biosimilar drugs, CDE also takes into account the characteristics of this variety, and puts forward many suggestions for pharmaceutical companies to carry out clinical comparison studies in a targeted manner
.
.
This time, for cetuximab injection biosimilar drugs, CDE also takes into account the characteristics of this variety, and puts forward many suggestions for pharmaceutical companies to carry out clinical comparison studies in a targeted manner
.
According to relevant statistics, as of the end of 2020, about 270 biosimilar drugs in China are in the state of research and development, more than half of which are still in the preclinical research stage, and 65 drugs have submitted clinical trial applications
.
Currently, blockbuster biologic drugs including rituximab, adalimumab, bevacizumab, trastuzumab, and infliximab have been approved for the marketing of biosimilar drugs, and competition for some varieties has become a red sea.
.
Insiders pointed out that the series of single-variety guiding principles issued by CDE will to a large extent prevent pharmaceutical companies from getting together in the field of biosimilar drugs and have the same layout, and will effectively reduce repeated investment in construction
.
.
Currently, blockbuster biologic drugs including rituximab, adalimumab, bevacizumab, trastuzumab, and infliximab have been approved for the marketing of biosimilar drugs, and competition for some varieties has become a red sea.
.
Insiders pointed out that the series of single-variety guiding principles issued by CDE will to a large extent prevent pharmaceutical companies from getting together in the field of biosimilar drugs and have the same layout, and will effectively reduce repeated investment in construction
.
Domestic approved monoclonal antibody biosimilar drugs and their original research products
A few meters within the network, in recent years the anti -tumor drug market continued expansion in 2020 in China terminal sales in public sector exceeded 100 billion yuan, variety of heavy biological medicine hospital sales topped the list
.
Under the top-level design that should be harvested, insulin is on the string as a test for centralized procurement of biological drugs
.
It is only a matter of time before the remaining varieties that meet the requirements of centralized procurement will be included .
From the current point of view, the top players such as Fuhong Henlius, Cinda Biologicals, Qilu Pharmaceuticals have basically formed, and large production capacity and low cost will become the magic weapon for winning the domestic bio-similar drug market in the future
.
.
Under the top-level design that should be harvested, insulin is on the string as a test for centralized procurement of biological drugs
.
It is only a matter of time before the remaining varieties that meet the requirements of centralized procurement will be included .
From the current point of view, the top players such as Fuhong Henlius, Cinda Biologicals, Qilu Pharmaceuticals have basically formed, and large production capacity and low cost will become the magic weapon for winning the domestic bio-similar drug market in the future
.
On September 8, CDE issued a notice on the public solicitation of "Guidelines for the Design of Clinical Trials of Cetuximab Injection Biosimilar Drugs (Draft for Solicitation of Comments)"
.
It is reported that Cetuximab is a human-mouse chimeric monoclonal antibody targeting the IgG1 subtype of human epidermal growth factor receptor (EGFR).
It was developed and marketed by Merck, Germany, and was approved for marketing in Mainland China in 2007.
Named Erbitux, currently approved indications include colorectal cancer and head and neck squamous cell carcinoma
.
.
It is reported that Cetuximab is a human-mouse chimeric monoclonal antibody targeting the IgG1 subtype of human epidermal growth factor receptor (EGFR).
It was developed and marketed by Merck, Germany, and was approved for marketing in Mainland China in 2007.
Named Erbitux, currently approved indications include colorectal cancer and head and neck squamous cell carcinoma
.
The global patent of cetuximab has expired in 2017.
Currently, many domestic pharmaceutical companies , including Kelun Pharmaceutical, Qilu Pharmaceutical, Sansheng Guojian, and Shenzhou Cell, are developing their biosimilar drugs, but there are no biosimilar drugs yet.
Approved
.
In order to further clarify the technical principles, CDE organized the writing of the guiding principle document and formed a draft for soliciting opinions
.
From the perspective of the industry, this move is clearly intended to help improve the efficiency of corporate research and development, and to provide a reference for the research and development of such drugs
.
Enterprise business enterpriseCurrently, many domestic pharmaceutical companies , including Kelun Pharmaceutical, Qilu Pharmaceutical, Sansheng Guojian, and Shenzhou Cell, are developing their biosimilar drugs, but there are no biosimilar drugs yet.
Approved
.
In order to further clarify the technical principles, CDE organized the writing of the guiding principle document and formed a draft for soliciting opinions
.
From the perspective of the industry, this move is clearly intended to help improve the efficiency of corporate research and development, and to provide a reference for the research and development of such drugs
.
Local pharmaceutical companies compete for layout
Local pharmaceutical companies compete for layout Has reached clinical stage III at the fastest
Has reached clinical stage III at the fastest As the first anti-EGFR monoclonal antibody approved in the world, cetuximab injection has global sales of nearly 1.
5 billion U.
S.
dollars in 2019
.
In the Chinese market, the sales data of cetuximab injection, which entered the 2018 National Medical Insurance Negotiation Catalogue with a decline of more than 65%, has grown astonishing
.
According to data from Menet.
com, in 2019, the sales of terminal cetuximab in public medical institutions in China reached 1.
576 billion yuan, with an annual growth rate of 117.
23%
.
5 billion U.
S.
dollars in 2019
.
In the Chinese market, the sales data of cetuximab injection, which entered the 2018 National Medical Insurance Negotiation Catalogue with a decline of more than 65%, has grown astonishing
.
According to data from Menet.
com, in 2019, the sales of terminal cetuximab in public medical institutions in China reached 1.
576 billion yuan, with an annual growth rate of 117.
23%
.
Sales of terminal cetuximab in public medical institutions in China (100 million yuan)
In March 2020, the National Food and Drug Administration approved the combination of cetuximab injection with platinum and fluorouracil chemotherapy for the first-line treatment of recurrent and/or metastatic head and neck squamous cell carcinoma.
The contract was successfully renewed in the new version of the medical insurance catalog.
With the addition of new indications, cetuximab injection is expected to achieve a new peak in market sales
.
The huge market cake has also attracted local pharmaceutical companies, including Kelun Pharmaceutical, Qilu Pharmaceutical, Sansheng Guojian, and Shenzhou Cell
.
The contract was successfully renewed in the new version of the medical insurance catalog.
With the addition of new indications, cetuximab injection is expected to achieve a new peak in market sales
.
The huge market cake has also attracted local pharmaceutical companies, including Kelun Pharmaceutical, Qilu Pharmaceutical, Sansheng Guojian, and Shenzhou Cell
.
According to incomplete statistics from reporters of the "Pharmaceutical Economics Daily", as of now, more than 10 local companies have deployed cetuximab biosimilar drugs, but no company has submitted a listing application for the time being
.
Among them, Kelun Pharmaceuticals, Maibote Pharmaceuticals and Ampuze Biopharmaceuticals took the lead, and related products have undergone phase III clinical trials; GPGJ602 of Sansheng Guojian and SCT200 of Shenzhou Cell followed closely behind and entered Phase II clinical trials; pharmaceutical companies such as Jinmante Biology, Guilin Sanjin/Baochuan Biology, Fuhong Henlius, and Qilu Pharmaceutical are also stepping up
.
.
Among them, Kelun Pharmaceuticals, Maibote Pharmaceuticals and Ampuze Biopharmaceuticals took the lead, and related products have undergone phase III clinical trials; GPGJ602 of Sansheng Guojian and SCT200 of Shenzhou Cell followed closely behind and entered Phase II clinical trials; pharmaceutical companies such as Jinmante Biology, Guilin Sanjin/Baochuan Biology, Fuhong Henlius, and Qilu Pharmaceutical are also stepping up
.
According to the newly disclosed semi-annual report, Kelun Pharmaceuticals stated that the phase III head-to-head study of A140 compared to the original cetuximab was completed last year before the start-up.
In February this year, the first research center was launched and the first case was enrolled; Maibo Pharmaceuticals is implementing CMAB009's phase III clinical trial for colorectal cancer, and is expected to submit a new drug listing application to the National Food and Drug Administration in the third quarter of 2022; while Shenzhou Cell is completing SCT200 for colorectal cancer phase I For clinical research, preparations for database lock-in for Phase II clinical studies and related preparations for clinical research reports are in progress, and exploratory phase I or phase II clinical studies for 6 other projects have been carried out
.
In February this year, the first research center was launched and the first case was enrolled; Maibo Pharmaceuticals is implementing CMAB009's phase III clinical trial for colorectal cancer, and is expected to submit a new drug listing application to the National Food and Drug Administration in the third quarter of 2022; while Shenzhou Cell is completing SCT200 for colorectal cancer phase I For clinical research, preparations for database lock-in for Phase II clinical studies and related preparations for clinical research reports are in progress, and exploratory phase I or phase II clinical studies for 6 other projects have been carried out
.
Cetuximab biosimilar research and development progress of domestic companies
Cetuximab biosimilar research and development progress of domestic companies| Serial number | Drug Name | manufacturer | Indications | R & D progress |
| 1 | CMAB009 | Maibo Pharmaceutical/Shanghai Zhangjiang Biological | Colorectal cancer | Clinical Phase III |
| 2 | A140 | Kelun Pharmaceutical | Colorectal cancer | Clinical Phase III |
| 3 | APZ001 | Ampuze Biomedical | Colorectal cancer | Clinical Phase III |
| 4 | GPGJ602 | Sansheng Guojian | Colorectal cancer | Clinical Phase II |
| 5 | SCT200 | Shenzhou Cell | Colorectal cancer | Clinical Phase II |
| 6 | JMT-101 | Zinmant Bio | Solid tumor | Clinical Phase I |
| 7 | CDP1 | Guilin Three Golds / Bao Chuansheng Thing | Colorectal cancer | Clinical Phase I |
| 8 | HLX07 | Fuhong Henlius | Advanced solid tumor | Clinical Phase I |
| 9 | QL1105 | Qilu Pharmaceutical | Solid tumor | Clinical Phase I |
| Serial number | Drug Name | manufacturer | Indications | R & D progress |
| 1 | CMAB009 | Maibo Pharmaceutical/Shanghai Zhangjiang Biological | Colorectal cancer | Clinical Phase III |
| 2 | A140 | Kelun Pharmaceutical | Colorectal cancer | Clinical Phase III |
| 3 | APZ001 | Ampuze Biomedical | Colorectal cancer | Clinical Phase III |
| 4 | GPGJ602 | Sansheng Guojian | Colorectal cancer | Clinical Phase II |
| 5 | SCT200 | Shenzhou Cell | Colorectal cancer | Clinical Phase II |
| 6 | JMT-101 | Zinmant Bio | Solid tumor | Clinical Phase I |
| 7 | CDP1 | Guilin Three Golds / Bao Chuansheng Thing | Colorectal cancer | Clinical Phase I |
| 8 | HLX07 | Fuhong Henlius | Advanced solid tumor | Clinical Phase I |
| 9 | QL1105 | Qilu Pharmaceutical | Solid tumor | Clinical Phase I |
Serial number
Drug Name
manufacturer
Indications
R & D progress
1
CMAB009
Maibo Pharmaceutical/Shanghai Zhangjiang Biological
Colorectal cancer
Clinical Phase III
2
A140
Kelun Pharmaceutical
Colorectal cancer
Clinical Phase III
3
APZ001
Ampuze Biomedical
Colorectal cancer
Clinical Phase III
4
GPGJ602
Sansheng Guojian
Colorectal cancer
Clinical Phase II
5
SCT200
Shenzhou Cell
Colorectal cancer
Clinical Phase II
6
JMT-101
Zinmant Bio
Solid tumor
Clinical Phase I
7
CDP1
Guilin Three Golds / Bao Chuansheng
Thing
Colorectal cancer
Clinical Phase I
8
HLX07
Fuhong Henlius
Advanced solid tumor
Clinical Phase I
9
QL1105
Qilu Pharmaceutical
Solid tumor
Clinical Phase I
Serial number
Drug Name
manufacturer
Indications
R & D progress
Serial number
Serial number
Drug Name
Drug Name
manufacturer
manufacturer
Indications
Indications
R & D progress
R & D progress
1
CMAB009
Maibo Pharmaceutical/Shanghai Zhangjiang Biological
Colorectal cancer
Clinical Phase III
1
1
CMAB009
CMAB009
Maibo Pharmaceutical/Shanghai Zhangjiang Biological
Maibo Pharmaceutical/Shanghai Zhangjiang Biological
Colorectal cancer
Colorectal cancer
Clinical Phase III
Clinical Phase III
2
A140
Kelun Pharmaceutical
Colorectal cancer
Clinical Phase III
2
2
A140
A140
Kelun Pharmaceutical
Kelun Pharmaceutical
Colorectal cancer
Colorectal cancer
Clinical Phase III
Clinical Phase III
3
APZ001
Ampuze Biomedical
Colorectal cancer
Clinical Phase III
3
3
APZ001
APZ001
Ampuze Biomedical
Ampuze Biomedical
Colorectal cancer
Colorectal cancer
Clinical Phase III
Clinical Phase III
4
GPGJ602
Sansheng Guojian
Colorectal cancer
Clinical Phase II
4
4
GPGJ602
GPGJ602
Sansheng Guojian
Sansheng Guojian
Colorectal cancer
Colorectal cancer
Clinical Phase II
Clinical Phase II
5
SCT200
Shenzhou Cell
Colorectal cancer
Clinical Phase II
5
5
SCT200
SCT200
Shenzhou Cell
Shenzhou Cell
Colorectal cancer
Colorectal cancer
Clinical Phase II
Clinical Phase II
6
JMT-101
Zinmant Bio
Solid tumor
Clinical Phase I
6
6
JMT-101
JMT-101
Zinmant Bio
Zinmant Bio
Solid tumor
Solid tumor
Clinical Phase I
Clinical Phase I
7
CDP1
Guilin Three Golds / Bao Chuansheng
Thing
Colorectal cancer
Clinical Phase I
7
7
CDP1
CDP1
Guilin Three Golds / Bao Chuansheng
Thing
Guilin Three Golds / Bao Chuansheng
Thing
Colorectal cancer
Colorectal cancer
Clinical Phase I
Clinical Phase I
8
HLX07
Fuhong Henlius
Advanced solid tumor
Clinical Phase I
8
8
HLX07
HLX07
Fuhong Henlius
Fuhong Henlius
Advanced solid tumor
Advanced solid tumor
Clinical Phase I
Clinical Phase I
9
QL1105
Qilu Pharmaceutical
Solid tumor
Clinical Phase I
9
9
QL1105
QL1105
Qilu Pharmaceutical
Qilu Pharmaceutical
Solid tumor
Solid tumor
Clinical Phase I
Clinical Phase I
According to Frost & Sullivan’s statistics and predictions, the colorectal cancer and nasopharyngeal cancer market sales of EGFR monoclonal antibodies in China in 2018 will be 1.
28 billion yuan, and in 2023 and 2030, the market sales of colorectal cancer and nasopharyngeal cancer will be The amount will increase to 3.
85 billion yuan and 6.
62 billion yuan respectively
.
If EGFR monoclonal antibody can be approved for indications for other tumor types in the future, its market size is expected to further expand
.
Under the new guiding principles of clinical trial design, which local pharmaceutical company will take the lead in crossing the line, waiting to see
.
28 billion yuan, and in 2023 and 2030, the market sales of colorectal cancer and nasopharyngeal cancer will be The amount will increase to 3.
85 billion yuan and 6.
62 billion yuan respectively
.
If EGFR monoclonal antibody can be approved for indications for other tumor types in the future, its market size is expected to further expand
.
Under the new guiding principles of clinical trial design, which local pharmaceutical company will take the lead in crossing the line, waiting to see
.
In the context of centralized procurement
In the context of centralized procurement Accelerated development of biosimilars
Accelerated development of biosimilars In the context of the industry in which the consistency evaluation of generic chemical drugs has entered the zone, the promotion of the development of biosimilar drugs has also been put on the agenda
.
In February of this year, CDE issued the "Technical Guidelines for the Evaluation of the Similarity of Biosimilars and the Extrapolation of Indications".
Based on the previous "Technical Guidelines for the Development and Evaluation of Biosimilars (Trial)", the CDE further supplemented the similarities of biosimilars.
Guiding suggestions for the extrapolation of evaluation and indications, to further standardize and guide the development and evaluation of biosimilar drugs
.
.
In February of this year, CDE issued the "Technical Guidelines for the Evaluation of the Similarity of Biosimilars and the Extrapolation of Indications".
Based on the previous "Technical Guidelines for the Development and Evaluation of Biosimilars (Trial)", the CDE further supplemented the similarities of biosimilars.
Guiding suggestions for the extrapolation of evaluation and indications, to further standardize and guide the development and evaluation of biosimilar drugs
.
At the same time, CDE has successively issued clinical guidelines for biosimilars of single species such as liraglutide, trastuzumab, rituximab, adalimumab and bevacizumab, and has a great The kinetics, effectiveness comparison study, safety and immunogenicity study and other evaluation indicators of the clinical experimental design and end points are explained, and the main research end points are recommended for each drug
.
This time, for cetuximab injection biosimilar drugs, CDE also takes into account the characteristics of this variety, and puts forward many suggestions for pharmaceutical companies to carry out clinical comparison studies in a targeted manner
.
.
This time, for cetuximab injection biosimilar drugs, CDE also takes into account the characteristics of this variety, and puts forward many suggestions for pharmaceutical companies to carry out clinical comparison studies in a targeted manner
.
According to relevant statistics, as of the end of 2020, about 270 biosimilar drugs in China are in the state of research and development, more than half of which are still in the preclinical research stage, and 65 drugs have submitted clinical trial applications
.
Currently, blockbuster biologic drugs including rituximab, adalimumab, bevacizumab, trastuzumab, and infliximab have been approved for the marketing of biosimilar drugs, and competition for some varieties has become a red sea.
.
Insiders pointed out that the series of single-variety guiding principles issued by CDE will to a large extent prevent pharmaceutical companies from getting together in the field of biosimilar drugs and have the same layout, and will effectively reduce repeated investment in construction
.
.
Currently, blockbuster biologic drugs including rituximab, adalimumab, bevacizumab, trastuzumab, and infliximab have been approved for the marketing of biosimilar drugs, and competition for some varieties has become a red sea.
.
Insiders pointed out that the series of single-variety guiding principles issued by CDE will to a large extent prevent pharmaceutical companies from getting together in the field of biosimilar drugs and have the same layout, and will effectively reduce repeated investment in construction
.
Domestic approved monoclonal antibody biosimilar drugs and their original research products
A few meters within the network, in recent years the anti -tumor drug market continued expansion in 2020 in China terminal sales in public sector exceeded 100 billion yuan, variety of heavy biological medicine hospital sales topped the list
.
Under the top-level design that should be harvested, insulin is on the string as a test for centralized procurement of biological drugs
.
It is only a matter of time before the remaining varieties that meet the requirements of centralized procurement will be included .
From the current point of view, the top players such as Fuhong Henlius, Cinda Biologicals, Qilu Pharmaceuticals have basically formed, and large production capacity and low cost will become the magic weapon for winning the domestic bio-similar drug market in the future
.
Tumor tumor tumor .
Under the top-level design that should be harvested, insulin is on the string as a test for centralized procurement of biological drugs
.
It is only a matter of time before the remaining varieties that meet the requirements of centralized procurement will be included .
From the current point of view, the top players such as Fuhong Henlius, Cinda Biologicals, Qilu Pharmaceuticals have basically formed, and large production capacity and low cost will become the magic weapon for winning the domestic bio-similar drug market in the future
.
