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Ovarian cancer is one of the most common gynecological tumors in China, with more than 55,000 new cases every year
.
It is understood that clinically, about 70% of ovarian cancer patients are in the advanced stage when they are first diagnosed, and such patients generally face a large unmet need for treatment
.
In recent years, with the advancement of medical technology and the improvement of clinical diagnosis and treatment of ovarian cancer, some new drugs and new programs have gradually been born, bringing new hope to patients
.
According to recent news, Huadong Medicine's new class 1 biological product Mirvetuximab Soravtansine (IMGN853, referred to as Mirvetuximab) for the treatment of ovarian cancer is expected to submit a biological product license application BLA in the United States this month
.
It is understood that Mirvetuximab is the world's first ADC drug under development for folate receptor alpha (FRα) positive ovarian cancer jointly developed by Huadong Medicine and ImmunoGen in the field of antibody conjugated drugs (ADC), and is also a part of Huadong Medicine's innovative oncology drug pipeline.
Focus on research products
.
According to the announcement issued by Huadong Medicine on March 21, the company's overseas partner ImmunoGen announced all the research results of the US pivotal single-arm clinical trial (SORAYA) of Mirvetuximab
.
SORAYA is a single-arm clinical trial of mirvetuximab in patients with platinum-resistant ovarian cancer whose tumors express FRα and who have received one to three prior regimens, at least one of which includes bevac beadzumab
.
The primary endpoint of the study was investigator-assessed confirmed objective response rate (ORR), and the key secondary endpoint was duration of response (DOR)
.
The study is to further improve the 12% ORR of single-agent chemotherapy (AURELIA study, patients received 1 or 2 chemotherapy regimens)
.
The results of the study show that the current trial has reached the primary study endpoint, with a confirmed objective response rate (ORR) of 32.
4%, including 5 complete responses; the updated median duration of response (mDOR) was 6.
9 months, and the results of the clinical trial showed that Clinically meaningful antitumor activity, consistent safety, and good tolerability in platinum-resistant ovarian cancer with high folate receptor alpha (FRα) expression
.
From the data, it can be seen that Mirvetuximab has great potential in the treatment of ovarian cancer.
If the product is approved, the industry is expected to bring better new treatment options for ovarian cancer patients
.
In addition to the SORAYA trial, Mirvetuximab is currently conducting an international multi-center randomized controlled phase III study MIRASOL, and there are multiple combination therapies, including bevacizumab, carboplatin, etc.
, which can further improve the response rate of ovarian cancer
.
ImmunoGen expects to have top-line data from the MIRASOL trial in the third quarter of 2022
.
In addition, in the Chinese market, the first clinical trial application of Mirvetuximab in China was approved by the National Medical Products Administration (NMPA) in March 2021, including the above-mentioned international multi-center Phase III study and a safety evaluation in Chinese adult patients.
A phase I study of sex, tolerability, and pharmacokinetics
.
A pivotal single-arm clinical trial in China was also approved by the National Medical Products Administration (NMPA) in August 2021
.
According to the data, Huadong Medicine has continued to increase its differentiated and in-depth layout in the ADC field in recent years through investment, introduction, and cooperation.
Benefit Chinese ovarian cancer patients
.
Looking forward to the future, the company also stated that it will continue to increase the layout of ADC drugs in the field of oncology, and continue to develop innovative ADC drugs for different cancer types in the field of solid tumors and hematological tumors in response to unmet clinical needs, and enrich the company's innovative product pipeline in the field of oncology.
Strengthen and deepen the ecological chain in the ADC field, and realize the company's strong market competitiveness and international layout in the global tumor treatment field
.
.
It is understood that clinically, about 70% of ovarian cancer patients are in the advanced stage when they are first diagnosed, and such patients generally face a large unmet need for treatment
.
In recent years, with the advancement of medical technology and the improvement of clinical diagnosis and treatment of ovarian cancer, some new drugs and new programs have gradually been born, bringing new hope to patients
.
According to recent news, Huadong Medicine's new class 1 biological product Mirvetuximab Soravtansine (IMGN853, referred to as Mirvetuximab) for the treatment of ovarian cancer is expected to submit a biological product license application BLA in the United States this month
.
It is understood that Mirvetuximab is the world's first ADC drug under development for folate receptor alpha (FRα) positive ovarian cancer jointly developed by Huadong Medicine and ImmunoGen in the field of antibody conjugated drugs (ADC), and is also a part of Huadong Medicine's innovative oncology drug pipeline.
Focus on research products
.
According to the announcement issued by Huadong Medicine on March 21, the company's overseas partner ImmunoGen announced all the research results of the US pivotal single-arm clinical trial (SORAYA) of Mirvetuximab
.
SORAYA is a single-arm clinical trial of mirvetuximab in patients with platinum-resistant ovarian cancer whose tumors express FRα and who have received one to three prior regimens, at least one of which includes bevac beadzumab
.
The primary endpoint of the study was investigator-assessed confirmed objective response rate (ORR), and the key secondary endpoint was duration of response (DOR)
.
The study is to further improve the 12% ORR of single-agent chemotherapy (AURELIA study, patients received 1 or 2 chemotherapy regimens)
.
The results of the study show that the current trial has reached the primary study endpoint, with a confirmed objective response rate (ORR) of 32.
4%, including 5 complete responses; the updated median duration of response (mDOR) was 6.
9 months, and the results of the clinical trial showed that Clinically meaningful antitumor activity, consistent safety, and good tolerability in platinum-resistant ovarian cancer with high folate receptor alpha (FRα) expression
.
From the data, it can be seen that Mirvetuximab has great potential in the treatment of ovarian cancer.
If the product is approved, the industry is expected to bring better new treatment options for ovarian cancer patients
.
In addition to the SORAYA trial, Mirvetuximab is currently conducting an international multi-center randomized controlled phase III study MIRASOL, and there are multiple combination therapies, including bevacizumab, carboplatin, etc.
, which can further improve the response rate of ovarian cancer
.
ImmunoGen expects to have top-line data from the MIRASOL trial in the third quarter of 2022
.
In addition, in the Chinese market, the first clinical trial application of Mirvetuximab in China was approved by the National Medical Products Administration (NMPA) in March 2021, including the above-mentioned international multi-center Phase III study and a safety evaluation in Chinese adult patients.
A phase I study of sex, tolerability, and pharmacokinetics
.
A pivotal single-arm clinical trial in China was also approved by the National Medical Products Administration (NMPA) in August 2021
.
According to the data, Huadong Medicine has continued to increase its differentiated and in-depth layout in the ADC field in recent years through investment, introduction, and cooperation.
Benefit Chinese ovarian cancer patients
.
Looking forward to the future, the company also stated that it will continue to increase the layout of ADC drugs in the field of oncology, and continue to develop innovative ADC drugs for different cancer types in the field of solid tumors and hematological tumors in response to unmet clinical needs, and enrich the company's innovative product pipeline in the field of oncology.
Strengthen and deepen the ecological chain in the ADC field, and realize the company's strong market competitiveness and international layout in the global tumor treatment field
.
