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[Pharmaceutical Network Market Analysis] Recently, the CDE website showed that AstraZeneca/Daisankyo’s HER2-targeting antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) was declared for listing in China, with unknown indications
.
According to public information, Enhertu is an ADC targeting HER2, which is being developed globally by Daiichi Sankyo and AstraZeneca
.
In March 2019, AstraZeneca and Daiichi Sankyo entered into an immuno-oncology collaboration valued at up to $6.
9 billion to jointly develop Enhertu for the treatment of patients with various HER2 expression levels or HER2 mutations, including gastric cancer , colorectal and lung cancer, and breast cancer with low HER2 expression
.
Under the agreement, the two parties will jointly develop and commercialize Enhertu globally, with Daiichi Sankyo retaining exclusive rights to the Japanese market, and will be solely responsible for manufacturing and supply
.
In September 2020, Enhertu was approved in Japan for the treatment of patients with HER2-positive unresectable advanced or recurrent gastric cancer
.
Enhertu has previously been granted SAKIGAKE (Innovative Medicine) designation by the MHLW for the treatment of HER2-positive gastric cancer
.
In addition, Enhertu is the first ADC drug approved by the FDA for the treatment of HER2-positive gastric cancer
.
The industry is very optimistic about Enhertu's business prospects.
EvaluatePharma, a pharmaceutical market research organization, previously predicted that Enhertu's sales in 2024 are expected to reach $2 billion
.
However, some analysts believe that it is not so much that the industry is optimistic about Enhertu, but that it is the ADC track behind it
.
At present, the global ADC drug market scale has reached 10 billion US dollars, and there are more than 600 new ADC drug projects under development, but only 16 new ADC drugs have been approved for marketing, including trastuzumab, vebotuzumab, Goxatuximab, Tilimumab, Velbutuximab,
etc.
Due to the broad prospects of the ADC drug market, it has also stimulated the enthusiasm of enterprises for research and development.
In addition to foreign pharmaceutical companies, a large number of local pharmaceutical companies are also accelerating their deployment in this track
.
Recently, Rongchang Bio released a prospectus for listing on the Science and Technology Innovation Board, which shows that it will publicly issue 54.
4263 million shares and plan to raise 4 billion yuan for new biological drug industrialization projects, anti-tumor antibody new drug research and development projects, autoimmune and ophthalmic disease antibody new drugs R&D projects and supplementary working capital projects
.
It is understood that Rongchang Bio is an innovative drug company focusing on the field of therapeutic antibody drugs such as antibody drug conjugates (ADC), antibody fusion proteins, monoclonal antibodies and double antibodies
.
At present, more than 20 candidate innovative drug projects have been developed
.
There are 4 class 1 new drugs that have entered the clinical trial stage (excluding new drugs that have been marketed to develop new indications), namely RC88, RC98, RC108 and RC118
.
Among them, RC88, RC108, and RC118 are ADC drugs
.
It is worth noting that there are currently no drugs on the global market for the corresponding targets of RC88 (MSLN) and RC118 (CLDN18)
.
Of course, in addition to Rongchang Bio, there are many companies that have made breakthroughs in the ADC field
.
For example, Huadong Medicine announced on March 21 that ImmunoGen, the company’s overseas partner, announced all the research results of the US pivotal single-arm clinical trial (SORAYA) of the ADC drug Mirvetuximab Soravtansine (IMGN853, referred to as Mirvetuximab) for the treatment of ovarian cancer.
.
In addition, the ADC products of pharmaceutical companies such as Bio-Tech and TOT have entered the phase III clinical stage, and companies such as Hengrui and Kelun Pharmaceutical also have products in the clinical phase II stage
.
As the ADC field at home and abroad has entered a stage of rapid development, the competition of the same type of targets has intensified.
The industry expects that in the future, efficient clinical promotion and differentiated indication development strategies may become the key to ADC drug layout pharmaceutical companies to gain market competitiveness
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
According to public information, Enhertu is an ADC targeting HER2, which is being developed globally by Daiichi Sankyo and AstraZeneca
.
In March 2019, AstraZeneca and Daiichi Sankyo entered into an immuno-oncology collaboration valued at up to $6.
9 billion to jointly develop Enhertu for the treatment of patients with various HER2 expression levels or HER2 mutations, including gastric cancer , colorectal and lung cancer, and breast cancer with low HER2 expression
.
Under the agreement, the two parties will jointly develop and commercialize Enhertu globally, with Daiichi Sankyo retaining exclusive rights to the Japanese market, and will be solely responsible for manufacturing and supply
.
In September 2020, Enhertu was approved in Japan for the treatment of patients with HER2-positive unresectable advanced or recurrent gastric cancer
.
Enhertu has previously been granted SAKIGAKE (Innovative Medicine) designation by the MHLW for the treatment of HER2-positive gastric cancer
.
In addition, Enhertu is the first ADC drug approved by the FDA for the treatment of HER2-positive gastric cancer
.
The industry is very optimistic about Enhertu's business prospects.
EvaluatePharma, a pharmaceutical market research organization, previously predicted that Enhertu's sales in 2024 are expected to reach $2 billion
.
However, some analysts believe that it is not so much that the industry is optimistic about Enhertu, but that it is the ADC track behind it
.
At present, the global ADC drug market scale has reached 10 billion US dollars, and there are more than 600 new ADC drug projects under development, but only 16 new ADC drugs have been approved for marketing, including trastuzumab, vebotuzumab, Goxatuximab, Tilimumab, Velbutuximab,
etc.
Due to the broad prospects of the ADC drug market, it has also stimulated the enthusiasm of enterprises for research and development.
In addition to foreign pharmaceutical companies, a large number of local pharmaceutical companies are also accelerating their deployment in this track
.
Recently, Rongchang Bio released a prospectus for listing on the Science and Technology Innovation Board, which shows that it will publicly issue 54.
4263 million shares and plan to raise 4 billion yuan for new biological drug industrialization projects, anti-tumor antibody new drug research and development projects, autoimmune and ophthalmic disease antibody new drugs R&D projects and supplementary working capital projects
.
It is understood that Rongchang Bio is an innovative drug company focusing on the field of therapeutic antibody drugs such as antibody drug conjugates (ADC), antibody fusion proteins, monoclonal antibodies and double antibodies
.
At present, more than 20 candidate innovative drug projects have been developed
.
There are 4 class 1 new drugs that have entered the clinical trial stage (excluding new drugs that have been marketed to develop new indications), namely RC88, RC98, RC108 and RC118
.
Among them, RC88, RC108, and RC118 are ADC drugs
.
It is worth noting that there are currently no drugs on the global market for the corresponding targets of RC88 (MSLN) and RC118 (CLDN18)
.
Of course, in addition to Rongchang Bio, there are many companies that have made breakthroughs in the ADC field
.
For example, Huadong Medicine announced on March 21 that ImmunoGen, the company’s overseas partner, announced all the research results of the US pivotal single-arm clinical trial (SORAYA) of the ADC drug Mirvetuximab Soravtansine (IMGN853, referred to as Mirvetuximab) for the treatment of ovarian cancer.
.
In addition, the ADC products of pharmaceutical companies such as Bio-Tech and TOT have entered the phase III clinical stage, and companies such as Hengrui and Kelun Pharmaceutical also have products in the clinical phase II stage
.
As the ADC field at home and abroad has entered a stage of rapid development, the competition of the same type of targets has intensified.
The industry expects that in the future, efficient clinical promotion and differentiated indication development strategies may become the key to ADC drug layout pharmaceutical companies to gain market competitiveness
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
