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According to the latest announcement by the State Drug Administration, the recombinant humanized anti-HER2 monoclonal antibody-AS269 conjugate (ARX788) for injection developed by Zhejiang Pharmaceutical's subsidiary Xinma Biotechnology has ended its announcement on May 25 and officially included in the breakthrough treatment.
Product catalog, the proposed indication is the second-line treatment of HER2-positive advanced breast cancer.
Currently, breast cancer on the official website of the National Food and Drug Administration has become the world’s most morbidity cancer, and HER2 positive accounts for about 20% to 25% of all breast cancers.
Such patients often have the characteristics of poor prognosis, easy recurrence of the disease, and short survival.
At present, no anti-HER2-ADC drugs have been approved for marketing in the second-line treatment of HER2-positive advanced breast cancer in my country, and the huge clinical demand needs to be filled.
ARX788 is a HER2-positive tumor antibody drug conjugate (ADC) jointly developed by Xinma Biology and Ambrx.
The product is made of two cytotoxin molecules AS269 and trastuzumab with the help of unnatural amino acid patented site-specific coupling technology, which can realize the precise coupling of toxins on the monoclonal antibody molecules, thereby achieving higher safety and stability .
The picture is from Xinma Biology.
At present, the phase I clinical study of ARX788 for the treatment of HER2-positive advanced breast cancer is underway.
According to the data released by Xinma Biologics, as of January 21, 2021, 33 of 69 patients achieved objective remission, with an overall objective remission rate (ORR) of 47.
8%, of which 1.
5 mg/kg Q3W (recommended dose for phase II) The ORR of the dose group was 65.
5%, and the adverse reactions of patients after treatment were mainly mild to moderate, indicating that the product has good safety.
It is reported that phase II/III clinical studies of ARX788 for breast and gastric cancer have been launched one after another, and the domestic development progress is faster than Europe and the United States.
In the United States, ARX788 has been granted Fast Track status by the FDA for the treatment of advanced or metastatic HER2-positive breast cancer that has received one or more anti-HER2 treatments, and the FDA has granted orphan drug status for the treatment of HER2-positive gastric cancer and gastroesophagus Joint cancer.
In addition to ARX788, domestic her2-ADC products include Rongchang Biotech's Vidicituzumab (RC48) and Toyo Pharmaceutical's TAA013 have entered the critical clinical stage, and Kelun Botai A166 has entered the clinical phase 2, Fosun Pharma The FS-1502 has also entered the clinic.
End reference materials: [1] Xinma Biology official website[2] State Drug Administration official website[3] s/utnfO13QMye6ld5-fdRhuw
Product catalog, the proposed indication is the second-line treatment of HER2-positive advanced breast cancer.
Currently, breast cancer on the official website of the National Food and Drug Administration has become the world’s most morbidity cancer, and HER2 positive accounts for about 20% to 25% of all breast cancers.
Such patients often have the characteristics of poor prognosis, easy recurrence of the disease, and short survival.
At present, no anti-HER2-ADC drugs have been approved for marketing in the second-line treatment of HER2-positive advanced breast cancer in my country, and the huge clinical demand needs to be filled.
ARX788 is a HER2-positive tumor antibody drug conjugate (ADC) jointly developed by Xinma Biology and Ambrx.
The product is made of two cytotoxin molecules AS269 and trastuzumab with the help of unnatural amino acid patented site-specific coupling technology, which can realize the precise coupling of toxins on the monoclonal antibody molecules, thereby achieving higher safety and stability .
The picture is from Xinma Biology.
At present, the phase I clinical study of ARX788 for the treatment of HER2-positive advanced breast cancer is underway.
According to the data released by Xinma Biologics, as of January 21, 2021, 33 of 69 patients achieved objective remission, with an overall objective remission rate (ORR) of 47.
8%, of which 1.
5 mg/kg Q3W (recommended dose for phase II) The ORR of the dose group was 65.
5%, and the adverse reactions of patients after treatment were mainly mild to moderate, indicating that the product has good safety.
It is reported that phase II/III clinical studies of ARX788 for breast and gastric cancer have been launched one after another, and the domestic development progress is faster than Europe and the United States.
In the United States, ARX788 has been granted Fast Track status by the FDA for the treatment of advanced or metastatic HER2-positive breast cancer that has received one or more anti-HER2 treatments, and the FDA has granted orphan drug status for the treatment of HER2-positive gastric cancer and gastroesophagus Joint cancer.
In addition to ARX788, domestic her2-ADC products include Rongchang Biotech's Vidicituzumab (RC48) and Toyo Pharmaceutical's TAA013 have entered the critical clinical stage, and Kelun Botai A166 has entered the clinical phase 2, Fosun Pharma The FS-1502 has also entered the clinic.
End reference materials: [1] Xinma Biology official website[2] State Drug Administration official website[3] s/utnfO13QMye6ld5-fdRhuw
