-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
Medical Network News, June 4, in recent years, antibody-drug conjugates (ADC) research and development has continued to rise, and many domestic and foreign pharmaceutical companies have deployed ADC drugs in order to get a share of the pie.
ADC market heats up
ADC is formed by coupling a monoclonal antibody targeting a specific antigen and a small molecule cytotoxic drug through a linker.
It combines the powerful killing effect of traditional small molecule chemotherapy and the targeting of antibody drugs.
It is mainly used in the field of tumor treatment.
Its mechanism of action is simple and clear-after ADC drugs enter the human body, the antibody part specifically binds to the target cells expressing tumor antigens, and after being endocytosed by tumor cells, it is degraded by lysosomes.
Small molecule cytotoxic drugs are highly effective in the cells.
The active form is released in sufficient quantity to achieve the killing of tumor cells.
It combines the powerful killing effect of traditional small molecule chemotherapy and the targeting of antibody drugs.
It is mainly used in the field of tumor treatment.
Its mechanism of action is simple and clear-after ADC drugs enter the human body, the antibody part specifically binds to the target cells expressing tumor antigens, and after being endocytosed by tumor cells, it is degraded by lysosomes.
Small molecule cytotoxic drugs are highly effective in the cells.
The active form is released in sufficient quantity to achieve the killing of tumor cells.
The first ADC drug was approved for marketing in 2000, but ADC has been tepid in the industry for a long time thereafter.
In the past two years, ADC drugs ushered in the peak period of marketing.
The US FDA approved 5 ADC drugs, namely Polivy, Padcev, Enhertu, Blenrep and Trodelvy; in January 2021, Akalux was approved for marketing in Japan.
The ADC market is heating up and competition is getting fiercer.
In the past two years, ADC drugs ushered in the peak period of marketing.
The US FDA approved 5 ADC drugs, namely Polivy, Padcev, Enhertu, Blenrep and Trodelvy; in January 2021, Akalux was approved for marketing in Japan.
The ADC market is heating up and competition is getting fiercer.
ADC drug inventory
At present, there are many pharmaceutical companies at home and abroad laying out ADC tracks.
As of early April, a total of 11 ADC drugs worldwide have been approved, 6 ADC new drugs are applying for marketing, and about 90 ADC drugs are in the clinical research stage.
As of early April, a total of 11 ADC drugs worldwide have been approved, 6 ADC new drugs are applying for marketing, and about 90 ADC drugs are in the clinical research stage.
Listed ADC drugs
Currently, the 11 ADC drugs that have been on the market are: Seagen/Takeda’s Adcetris, Roche’s Kadcyla and Polivy, Pfizer/Wyeth’s Besponsa and Mylotarg, Seagen/Astellas’ Padcev, AstraZeneca’s Lumoxiti, and No.
3 Co/AstraZeneca’s Enhertu, Immunomedics’ Trodelvy, GSK’s Blenrep and Rakuten Medical’s Akalux.
Among them, there are 2 ADC drugs entering the Chinese market, Roche’s Kadcyla and Seagen/Takeda’s Adcetris, which were approved by the State Food and Drug Administration in January and May 2020.
3 Co/AstraZeneca’s Enhertu, Immunomedics’ Trodelvy, GSK’s Blenrep and Rakuten Medical’s Akalux.
Among them, there are 2 ADC drugs entering the Chinese market, Roche’s Kadcyla and Seagen/Takeda’s Adcetris, which were approved by the State Food and Drug Administration in January and May 2020.
According to the technical characteristics of ADC drugs at various stages, the industry divides ADCs into three generations.
The first-generation ADC has high off-target toxicity and low drug efficacy; the second-generation ADC has good clinical efficacy and safety, but the therapeutic window is narrow; the third-generation ADC has improved stability and pharmacokinetics.
The first-generation ADC has high off-target toxicity and low drug efficacy; the second-generation ADC has good clinical efficacy and safety, but the therapeutic window is narrow; the third-generation ADC has improved stability and pharmacokinetics.
The first-generation ADC representative Mylotarg Mylotarg is the world's first ADC drug to be marketed.
It is also the first drug to be delisted among all new drugs approved by the FDA, and it is also the first ADC drug to be re-listed after delisting.
The original research company of the drug is Pfizer, which is formed by coupling a monoclonal antibody targeting CD33 with the anti-tumor antibiotic calicheamicin.
In 2000, the drug was approved by the FDA for the treatment of acute myeloid leukemia.
However, due to its cytotoxicity, Pfizer voluntarily withdrew the drug from the market in 2010 and made a series of adjustments to it.
In 2017, Mylotarg was approved by the FDA to re-market.
It is also the first drug to be delisted among all new drugs approved by the FDA, and it is also the first ADC drug to be re-listed after delisting.
The original research company of the drug is Pfizer, which is formed by coupling a monoclonal antibody targeting CD33 with the anti-tumor antibiotic calicheamicin.
In 2000, the drug was approved by the FDA for the treatment of acute myeloid leukemia.
However, due to its cytotoxicity, Pfizer voluntarily withdrew the drug from the market in 2010 and made a series of adjustments to it.
In 2017, Mylotarg was approved by the FDA to re-market.
The second-generation ADC represents Adcetris.
Adcetris was jointly developed by Seagen and Millennium Pharmaceuticals (acquired by Takeda in 2008).
It is formed by coupling a monoclonal antibody targeting CD30 protein and a microtubule disrupting agent through a protease-sensitive cross-linking agent.
The approved indications are mainly classic Hodgkin lymphoma and anaplastic large cell lymphoma.
It is the first new drug specifically for anaplastic large cell lymphoma and the first first-line drug for refractory Hodgkin's lymphoma approved by the FDA in the past 40 years.
Adcetris was jointly developed by Seagen and Millennium Pharmaceuticals (acquired by Takeda in 2008).
It is formed by coupling a monoclonal antibody targeting CD30 protein and a microtubule disrupting agent through a protease-sensitive cross-linking agent.
The approved indications are mainly classic Hodgkin lymphoma and anaplastic large cell lymphoma.
It is the first new drug specifically for anaplastic large cell lymphoma and the first first-line drug for refractory Hodgkin's lymphoma approved by the FDA in the past 40 years.
The second-generation ADC represents Kadcyla Kadcyla's R&D company is Roche, which is a HER2-targeted antibody-drug conjugate.
After it was approved for marketing in February 2013, it met the treatment needs of breast cancer patients who are resistant to first-line treatment.
It is the world's first ADC drug approved for breast cancer treatment, and it is also the first ADC drug approved for marketing in my country.
The approved indication is a neoadjuvant based on taxanes combined with trastuzumab.
Adjuvant treatment of HER2-positive early breast cancer patients who still have aggressive lesions after treatment.
After it was approved for marketing in February 2013, it met the treatment needs of breast cancer patients who are resistant to first-line treatment.
It is the world's first ADC drug approved for breast cancer treatment, and it is also the first ADC drug approved for marketing in my country.
The approved indication is a neoadjuvant based on taxanes combined with trastuzumab.
Adjuvant treatment of HER2-positive early breast cancer patients who still have aggressive lesions after treatment.
The third-generation ADC represents Enhertu Enhertu’s original research company is Japan’s Daiichi Sankyo and AstraZeneca.
The drug consists of trastuzumab and exenotecan derivatives.
The drug consists of trastuzumab and exenotecan derivatives.
ADC drugs that have been applied for marketing
As of early April, a total of 6 ADC new drugs have been applied for listing worldwide, covering tumor treatment fields such as cervical cancer, bladder cancer, and urothelial cancer.
ADC drugs in clinical research
According to statistics from Yaorongyun, as of early April, there are about 90 ADC drugs in the clinical research phase (including drugs that have been marketed for expansion indications).
Among them, there are 8 drugs in the phase III clinical research phase, 39 drugs in the phase II clinical research phase, and 43 drugs in the phase I clinical research phase.
Among them, there are 8 drugs in the phase III clinical research phase, 39 drugs in the phase II clinical research phase, and 43 drugs in the phase I clinical research phase.
Differentiated R&D is the breakthrough point
The data shows that among the companies that deploy ADC drugs , Seagen self-developed or cooperated with other companies has the most ADC drug pipelines, with a total of 35 drugs; Roche ranked second with a total of 25 drugs; followed by Gilead, with a total of 23 drugs (see figure for details).
It is worth mentioning that in September 2020, Gilead acquired ADC company Immunomedics at a premium of 108% of the closing price, 88 US dollars per share, and a total value of 21 billion US dollars.
This caused great concern in the industry, showing Gilead’s ambition to deploy ADCs.
It is worth mentioning that in September 2020, Gilead acquired ADC company Immunomedics at a premium of 108% of the closing price, 88 US dollars per share, and a total value of 21 billion US dollars.
This caused great concern in the industry, showing Gilead’s ambition to deploy ADCs.
The ADC molecular structure is complex, and the R&D investment is much larger than that of ordinary antibody molecules.
When designing an ADC drug, it is necessary to consider factors such as efficacy, toxicity, antibodies, linkers, toxins, and connection methods.
One of the important challenges is to balance the efficacy and toxic side effects.
Choose which antibody and toxic drug can suppress side effects while suppressing side effects.
Ensuring the effect and expanding the treatment window are issues that need to be considered and resolved urgently.
In terms of research and development, the value of getting together for indications and running is limited.
Companies that deploy ADC drugs can seek differentiated breakthroughs in terms of linkers, toxins, and targets.
(Contributed by Yaorong Circle)
When designing an ADC drug, it is necessary to consider factors such as efficacy, toxicity, antibodies, linkers, toxins, and connection methods.
One of the important challenges is to balance the efficacy and toxic side effects.
Choose which antibody and toxic drug can suppress side effects while suppressing side effects.
Ensuring the effect and expanding the treatment window are issues that need to be considered and resolved urgently.
In terms of research and development, the value of getting together for indications and running is limited.
Companies that deploy ADC drugs can seek differentiated breakthroughs in terms of linkers, toxins, and targets.
(Contributed by Yaorong Circle)
Medical Network News, June 4, in recent years, antibody-drug conjugates (ADC) research and development has continued to rise, and many domestic and foreign pharmaceutical companies have deployed ADC drugs in order to get a share of the pie.
ADC market heats up
ADC is formed by coupling a monoclonal antibody targeting a specific antigen and a small molecule cytotoxic drug through a linker.
It combines the powerful killing effect of traditional small molecule chemotherapy and the targeting of antibody drugs.
It is mainly used in the field of tumor treatment.
Its mechanism of action is simple and clear-after ADC drugs enter the human body, the antibody part specifically binds to the target cells expressing tumor antigens, and after being endocytosed by tumor cells, it is degraded by lysosomes.
Small molecule cytotoxic drugs are highly effective in the cells.
The active form is released in sufficient quantity to achieve the killing of tumor cells.
It combines the powerful killing effect of traditional small molecule chemotherapy and the targeting of antibody drugs.
It is mainly used in the field of tumor treatment.
Its mechanism of action is simple and clear-after ADC drugs enter the human body, the antibody part specifically binds to the target cells expressing tumor antigens, and after being endocytosed by tumor cells, it is degraded by lysosomes.
Small molecule cytotoxic drugs are highly effective in the cells.
The active form is released in sufficient quantity to achieve the killing of tumor cells.
The first ADC drug was approved for marketing in 2000, but ADC has been tepid in the industry for a long time thereafter.
In the past two years, ADC drugs ushered in the peak period of marketing.
The US FDA approved 5 ADC drugs, namely Polivy, Padcev, Enhertu, Blenrep and Trodelvy; in January 2021, Akalux was approved for marketing in Japan.
The ADC market is heating up and competition is getting fiercer.
In the past two years, ADC drugs ushered in the peak period of marketing.
The US FDA approved 5 ADC drugs, namely Polivy, Padcev, Enhertu, Blenrep and Trodelvy; in January 2021, Akalux was approved for marketing in Japan.
The ADC market is heating up and competition is getting fiercer.
ADC drug inventory
At present, there are many pharmaceutical companies at home and abroad laying out ADC tracks.
As of early April, a total of 11 ADC drugs worldwide have been approved, 6 ADC new drugs are applying for marketing, and about 90 ADC drugs are in the clinical research stage.
As of early April, a total of 11 ADC drugs worldwide have been approved, 6 ADC new drugs are applying for marketing, and about 90 ADC drugs are in the clinical research stage.
Listed ADC drugs
Currently, the 11 ADC drugs that have been on the market are: Seagen/Takeda’s Adcetris, Roche’s Kadcyla and Polivy, Pfizer/Wyeth’s Besponsa and Mylotarg, Seagen/Astellas’ Padcev, AstraZeneca’s Lumoxiti, and No.
3 Co/AstraZeneca’s Enhertu, Immunomedics’ Trodelvy, GSK’s Blenrep and Rakuten Medical’s Akalux.
Among them, there are 2 ADC drugs entering the Chinese market, Roche’s Kadcyla and Seagen/Takeda’s Adcetris, which were approved by the State Food and Drug Administration in January and May 2020.
3 Co/AstraZeneca’s Enhertu, Immunomedics’ Trodelvy, GSK’s Blenrep and Rakuten Medical’s Akalux.
Among them, there are 2 ADC drugs entering the Chinese market, Roche’s Kadcyla and Seagen/Takeda’s Adcetris, which were approved by the State Food and Drug Administration in January and May 2020.
According to the technical characteristics of ADC drugs at various stages, the industry divides ADCs into three generations.
The first-generation ADC has high off-target toxicity and low drug efficacy; the second-generation ADC has good clinical efficacy and safety, but the therapeutic window is narrow; the third-generation ADC has improved stability and pharmacokinetics.
The first-generation ADC has high off-target toxicity and low drug efficacy; the second-generation ADC has good clinical efficacy and safety, but the therapeutic window is narrow; the third-generation ADC has improved stability and pharmacokinetics.
The first-generation ADC representative Mylotarg Mylotarg is the world's first ADC drug to be marketed.
It is also the first drug to be delisted among all new drugs approved by the FDA, and it is also the first ADC drug to be re-listed after delisting.
The original research company of the drug is Pfizer, which is formed by coupling a monoclonal antibody targeting CD33 with the anti-tumor antibiotic calicheamicin.
In 2000, the drug was approved by the FDA for the treatment of acute myeloid leukemia.
However, due to its cytotoxicity, Pfizer voluntarily withdrew the drug from the market in 2010 and made a series of adjustments to it.
In 2017, Mylotarg was approved by the FDA to re-market.
It is also the first drug to be delisted among all new drugs approved by the FDA, and it is also the first ADC drug to be re-listed after delisting.
The original research company of the drug is Pfizer, which is formed by coupling a monoclonal antibody targeting CD33 with the anti-tumor antibiotic calicheamicin.
In 2000, the drug was approved by the FDA for the treatment of acute myeloid leukemia.
However, due to its cytotoxicity, Pfizer voluntarily withdrew the drug from the market in 2010 and made a series of adjustments to it.
In 2017, Mylotarg was approved by the FDA to re-market.
The second-generation ADC represents Adcetris.
Adcetris was jointly developed by Seagen and Millennium Pharmaceuticals (acquired by Takeda in 2008).
It is formed by coupling a monoclonal antibody targeting CD30 protein and a microtubule disrupting agent through a protease-sensitive cross-linking agent.
The approved indications are mainly classic Hodgkin lymphoma and anaplastic large cell lymphoma.
It is the first new drug specifically for anaplastic large cell lymphoma and the first first-line drug for refractory Hodgkin's lymphoma approved by the FDA in the past 40 years.
Adcetris was jointly developed by Seagen and Millennium Pharmaceuticals (acquired by Takeda in 2008).
It is formed by coupling a monoclonal antibody targeting CD30 protein and a microtubule disrupting agent through a protease-sensitive cross-linking agent.
The approved indications are mainly classic Hodgkin lymphoma and anaplastic large cell lymphoma.
It is the first new drug specifically for anaplastic large cell lymphoma and the first first-line drug for refractory Hodgkin's lymphoma approved by the FDA in the past 40 years.
The second-generation ADC represents Kadcyla Kadcyla's R&D company is Roche, which is a HER2-targeted antibody-drug conjugate.
After it was approved for marketing in February 2013, it met the treatment needs of breast cancer patients who are resistant to first-line treatment.
It is the world's first ADC drug approved for breast cancer treatment, and it is also the first ADC drug approved for marketing in my country.
The approved indication is a neoadjuvant based on taxanes combined with trastuzumab.
Adjuvant treatment of HER2-positive early breast cancer patients who still have aggressive lesions after treatment.
After it was approved for marketing in February 2013, it met the treatment needs of breast cancer patients who are resistant to first-line treatment.
It is the world's first ADC drug approved for breast cancer treatment, and it is also the first ADC drug approved for marketing in my country.
The approved indication is a neoadjuvant based on taxanes combined with trastuzumab.
Adjuvant treatment of HER2-positive early breast cancer patients who still have aggressive lesions after treatment.
The third-generation ADC represents Enhertu Enhertu’s original research company is Japan’s Daiichi Sankyo and AstraZeneca.
The drug consists of trastuzumab and exenotecan derivatives.
The drug consists of trastuzumab and exenotecan derivatives.
ADC drugs that have been applied for marketing
As of early April, a total of 6 ADC new drugs have been applied for listing worldwide, covering tumor treatment fields such as cervical cancer, bladder cancer, and urothelial cancer.
ADC drugs in clinical research
According to statistics from Yaorongyun, as of early April, there are about 90 ADC drugs in the clinical research phase (including drugs that have been marketed for expansion indications).
Among them, there are 8 drugs in the phase III clinical research phase, 39 drugs in the phase II clinical research phase, and 43 drugs in the phase I clinical research phase.
Among them, there are 8 drugs in the phase III clinical research phase, 39 drugs in the phase II clinical research phase, and 43 drugs in the phase I clinical research phase.
Differentiated R&D is the breakthrough point
The data shows that among the companies that deploy ADC drugs , Seagen self-developed or cooperated with other companies has the most ADC drug pipelines, with a total of 35 drugs; Roche ranked second with a total of 25 drugs; followed by Gilead, with a total of 23 drugs (see figure for details).
It is worth mentioning that in September 2020, Gilead acquired ADC company Immunomedics at a premium of 108% of the closing price, 88 US dollars per share, and a total value of 21 billion US dollars.
This caused great concern in the industry, showing Gilead’s ambition to deploy ADCs.
It is worth mentioning that in September 2020, Gilead acquired ADC company Immunomedics at a premium of 108% of the closing price, 88 US dollars per share, and a total value of 21 billion US dollars.
This caused great concern in the industry, showing Gilead’s ambition to deploy ADCs.
The ADC molecular structure is complex, and the R&D investment is much larger than that of ordinary antibody molecules.
When designing an ADC drug, it is necessary to consider factors such as efficacy, toxicity, antibodies, linkers, toxins, and connection methods.
One of the important challenges is to balance the efficacy and toxic side effects.
Choose which antibody and toxic drug can suppress side effects while suppressing side effects.
Ensuring the effect and expanding the treatment window are issues that need to be considered and resolved urgently.
In terms of research and development, the value of getting together for indications and running is limited.
Companies that deploy ADC drugs can seek differentiated breakthroughs in terms of linkers, toxins, and targets.
(Contributed by Yaorong Circle)
When designing an ADC drug, it is necessary to consider factors such as efficacy, toxicity, antibodies, linkers, toxins, and connection methods.
One of the important challenges is to balance the efficacy and toxic side effects.
Choose which antibody and toxic drug can suppress side effects while suppressing side effects.
Ensuring the effect and expanding the treatment window are issues that need to be considered and resolved urgently.
In terms of research and development, the value of getting together for indications and running is limited.
Companies that deploy ADC drugs can seek differentiated breakthroughs in terms of linkers, toxins, and targets.
(Contributed by Yaorong Circle)
Medical Network News, June 4, in recent years, antibody-drug conjugates (ADC) research and development has continued to rise, and many domestic and foreign pharmaceutical companies have deployed ADC drugs in order to get a share of the pie.
ADC market heats up
ADC market heats up ADC is formed by coupling a monoclonal antibody targeting a specific antigen and a small molecule cytotoxic drug through a linker.
It combines the powerful killing effect of traditional small molecule chemotherapy and the targeting of antibody drugs.
It is mainly used in the field of tumor treatment.
Its mechanism of action is simple and clear-after ADC drugs enter the human body, the antibody part specifically binds to the target cells expressing tumor antigens, and after being endocytosed by tumor cells, it is degraded by lysosomes.
Small molecule cytotoxic drugs are highly effective in the cells.
The active form is released in sufficient quantity to achieve the killing of tumor cells.
Tumor tumor tumorIt combines the powerful killing effect of traditional small molecule chemotherapy and the targeting of antibody drugs.
It is mainly used in the field of tumor treatment.
Its mechanism of action is simple and clear-after ADC drugs enter the human body, the antibody part specifically binds to the target cells expressing tumor antigens, and after being endocytosed by tumor cells, it is degraded by lysosomes.
Small molecule cytotoxic drugs are highly effective in the cells.
The active form is released in sufficient quantity to achieve the killing of tumor cells.
The first ADC drug was approved for marketing in 2000, but ADC has been tepid in the industry for a long time thereafter.
In the past two years, ADC drugs ushered in the peak period of marketing.
The US FDA approved 5 ADC drugs, namely Polivy, Padcev, Enhertu, Blenrep and Trodelvy; in January 2021, Akalux was approved for marketing in Japan.
The ADC market is heating up and competition is getting fiercer.
In the past two years, ADC drugs ushered in the peak period of marketing.
The US FDA approved 5 ADC drugs, namely Polivy, Padcev, Enhertu, Blenrep and Trodelvy; in January 2021, Akalux was approved for marketing in Japan.
The ADC market is heating up and competition is getting fiercer.
ADC drug inventory
ADC drug inventory At present, there are many pharmaceutical companies at home and abroad laying out ADC tracks.
As of early April, a total of 11 ADC drugs worldwide have been approved, 6 ADC new drugs are applying for marketing, and about 90 ADC drugs are in the clinical research stage.
As of early April, a total of 11 ADC drugs worldwide have been approved, 6 ADC new drugs are applying for marketing, and about 90 ADC drugs are in the clinical research stage.
Listed ADC drugs
Listed ADC drugs Currently, the 11 ADC drugs that have been on the market are: Seagen/Takeda’s Adcetris, Roche’s Kadcyla and Polivy, Pfizer/Wyeth’s Besponsa and Mylotarg, Seagen/Astellas’ Padcev, AstraZeneca’s Lumoxiti, and No.
3 Co/AstraZeneca’s Enhertu, Immunomedics’ Trodelvy, GSK’s Blenrep and Rakuten Medical’s Akalux.
Among them, there are 2 ADC drugs entering the Chinese market, Roche’s Kadcyla and Seagen/Takeda’s Adcetris, which were approved by the State Food and Drug Administration in January and May 2020.
3 Co/AstraZeneca’s Enhertu, Immunomedics’ Trodelvy, GSK’s Blenrep and Rakuten Medical’s Akalux.
Among them, there are 2 ADC drugs entering the Chinese market, Roche’s Kadcyla and Seagen/Takeda’s Adcetris, which were approved by the State Food and Drug Administration in January and May 2020.
According to the technical characteristics of ADC drugs at various stages, the industry divides ADCs into three generations.
The first-generation ADC has high off-target toxicity and low drug efficacy; the second-generation ADC has good clinical efficacy and safety, but the therapeutic window is narrow; the third-generation ADC has improved stability and pharmacokinetics.
The first-generation ADC has high off-target toxicity and low drug efficacy; the second-generation ADC has good clinical efficacy and safety, but the therapeutic window is narrow; the third-generation ADC has improved stability and pharmacokinetics.
The first-generation ADC representative Mylotarg Mylotarg is the world's first ADC drug to be marketed.
It is also the first drug to be delisted among all new drugs approved by the FDA, and it is also the first ADC drug to be re-listed after delisting.
The original research company of the drug is Pfizer, which is formed by coupling a monoclonal antibody targeting CD33 with the anti-tumor antibiotic calicheamicin.
In 2000, the drug was approved by the FDA for the treatment of acute myeloid leukemia.
However, due to its cytotoxicity, Pfizer voluntarily withdrew the drug from the market in 2010 and made a series of adjustments to it.
In 2017, Mylotarg was approved by the FDA to re-market.
It is also the first drug to be delisted among all new drugs approved by the FDA, and it is also the first ADC drug to be re-listed after delisting.
The original research company of the drug is Pfizer, which is formed by coupling a monoclonal antibody targeting CD33 with the anti-tumor antibiotic calicheamicin.
In 2000, the drug was approved by the FDA for the treatment of acute myeloid leukemia.
However, due to its cytotoxicity, Pfizer voluntarily withdrew the drug from the market in 2010 and made a series of adjustments to it.
In 2017, Mylotarg was approved by the FDA to re-market.
The second-generation ADC represents Adcetris.
Adcetris was jointly developed by Seagen and Millennium Pharmaceuticals (acquired by Takeda in 2008).
It is formed by coupling a monoclonal antibody targeting CD30 protein and a microtubule disrupting agent through a protease-sensitive cross-linking agent.
The approved indications are mainly classic Hodgkin lymphoma and anaplastic large cell lymphoma.
It is the first new drug specifically for anaplastic large cell lymphoma and the first first-line drug for refractory Hodgkin's lymphoma approved by the FDA in the past 40 years.
Adcetris was jointly developed by Seagen and Millennium Pharmaceuticals (acquired by Takeda in 2008).
It is formed by coupling a monoclonal antibody targeting CD30 protein and a microtubule disrupting agent through a protease-sensitive cross-linking agent.
The approved indications are mainly classic Hodgkin lymphoma and anaplastic large cell lymphoma.
It is the first new drug specifically for anaplastic large cell lymphoma and the first first-line drug for refractory Hodgkin's lymphoma approved by the FDA in the past 40 years.
The second-generation ADC represents Kadcyla Kadcyla's R&D company is Roche, which is a HER2-targeted antibody-drug conjugate.
After it was approved for marketing in February 2013, it met the treatment needs of breast cancer patients who are resistant to first-line treatment.
It is the world's first ADC drug approved for breast cancer treatment, and it is also the first ADC drug approved for marketing in my country.
The approved indication is a neoadjuvant based on taxanes combined with trastuzumab.
Adjuvant treatment of HER2-positive early breast cancer patients who still have aggressive lesions after treatment.
After it was approved for marketing in February 2013, it met the treatment needs of breast cancer patients who are resistant to first-line treatment.
It is the world's first ADC drug approved for breast cancer treatment, and it is also the first ADC drug approved for marketing in my country.
The approved indication is a neoadjuvant based on taxanes combined with trastuzumab.
Adjuvant treatment of HER2-positive early breast cancer patients who still have aggressive lesions after treatment.
The third-generation ADC represents Enhertu Enhertu’s original research company is Japan’s Daiichi Sankyo and AstraZeneca.
The drug consists of trastuzumab and exenotecan derivatives.
The drug consists of trastuzumab and exenotecan derivatives.
ADC drugs that have been applied for marketing
ADC drugs that have been applied for marketing As of early April, a total of 6 ADC new drugs have been applied for listing worldwide, covering tumor treatment fields such as cervical cancer, bladder cancer, and urothelial cancer.
ADC drugs in clinical research
ADC drugs in clinical research According to statistics from Yaorongyun, as of early April, there are about 90 ADC drugs in the clinical research phase (including drugs that have been marketed for expansion indications).
Among them, there are 8 drugs in the phase III clinical research phase, 39 drugs in the phase II clinical research phase, and 43 drugs in the phase I clinical research phase.
Among them, there are 8 drugs in the phase III clinical research phase, 39 drugs in the phase II clinical research phase, and 43 drugs in the phase I clinical research phase.
Differentiated R&D is the breakthrough point
Differentiated R&D is the breakthrough point The data shows that among the companies that deploy ADC drugs , Seagen self-developed or cooperated with other companies has the most ADC drug pipelines, with a total of 35 drugs; Roche ranked second with a total of 25 drugs; followed by Gilead, with a total of 23 drugs (see figure for details).
It is worth mentioning that in September 2020, Gilead acquired ADC company Immunomedics at a premium of 108% of the closing price, 88 US dollars per share, and a total value of 21 billion US dollars.
This caused great concern in the industry, showing Gilead’s ambition to deploy ADCs.
Enterprise business enterpriseIt is worth mentioning that in September 2020, Gilead acquired ADC company Immunomedics at a premium of 108% of the closing price, 88 US dollars per share, and a total value of 21 billion US dollars.
This caused great concern in the industry, showing Gilead’s ambition to deploy ADCs.
The ADC molecular structure is complex, and the R&D investment is much larger than that of ordinary antibody molecules.
When designing an ADC drug, it is necessary to consider factors such as efficacy, toxicity, antibodies, linkers, toxins, and connection methods.
One of the important challenges is to balance the efficacy and toxic side effects.
Choose which antibody and toxic drug can suppress side effects while suppressing side effects.
Ensuring the effect and expanding the treatment window are issues that need to be considered and resolved urgently.
In terms of research and development, the value of getting together for indications and running is limited.
Companies that deploy ADC drugs can seek differentiated breakthroughs in terms of linkers, toxins, and targets.
(Contributed by Yaorong Circle)
When designing an ADC drug, it is necessary to consider factors such as efficacy, toxicity, antibodies, linkers, toxins, and connection methods.
One of the important challenges is to balance the efficacy and toxic side effects.
Choose which antibody and toxic drug can suppress side effects while suppressing side effects.
Ensuring the effect and expanding the treatment window are issues that need to be considered and resolved urgently.
In terms of research and development, the value of getting together for indications and running is limited.
Companies that deploy ADC drugs can seek differentiated breakthroughs in terms of linkers, toxins, and targets.
(Contributed by Yaorong Circle)
