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On August 30, the official website of CDE showed that Qilu Pharmaceutical's Disulumab injection was declared for marketing
.
This is the first domestically reported biosimilar of desulumab
.
Click here to view/subscribe to the acceptance number
Disumumab was developed and marketed by Amgen.
According to different indications, there are two specifications of products, the trade names are: Xgeva® (70 mg/ml) and Prolia® (60 mg/ml)
.
Globally,desulimab isapproved for postmenopausal osteoporosis under the trade name Prolia®; it is approved for use in multiple myeloma and solid tumor bone under the trade name Xgeva® (trade name RANMARK® in Japan) Prevention of bone-related events (SREs) in metastatic patients, treatment of giant cell tumor of bone (GCTB) in adults and adolescents with mature bones
.
In China, Disumab (Angavi®) was approved for marketing in May 2019 for the treatment of giant cell tumors of bone that cannot be resected or surgically removed, which may cause severe dysfunction
.
In June 2020, its indication for osteoporosis in postmenopausal women with high fracture risk was approved by NMPA; in November of the same year, it was approved for bone-related events in patients with bone metastases from multiple myeloma and solid tumors Prevention
.
At present, Angarvey has negotiated a price cut by 80% and entered the medical insurance category B catalog.
The latest bid price is 1060 yuan/120mg (1.
7mL)/bottle.
It is limited to giant cell tumors of bone that may not be resectable or may cause severe dysfunction after surgical resection.
.
BeiGene cooperated with Amgen to commercialize this product.
After the implementation of medical insurance, the number of hospital admissions in Angarve in the first quarter reached 23 times the number before medical insurance was included, and subsequent growth is expected .
This year, Baekje will continue to participate in medical insurance negotiations for the indication of bone metastasis of solid tumors and the prevention of bone-related events in patients with multiple myeloma, with a view to including this indication in medical insurance .
However, the upcoming biosimilar drugs may pose a threat to Angarwei's sales .
At present, a total of 9 domestic biosimilars of disulumab are in clinical trials, 2 have been approved for clinical trials but have not yet started clinical trials, and 1 is in clinical application
.
Today, Qilu Pharmaceutical denosumab is the first reported production of bio-similar drugs, other products in clinical phase III were from Kang Ning Jierui, Shandong and Shanghai Maiwei Pok
.
Click here to inquire about the domestic competition pattern of "disulumab" from: Insight database (http://db.
dxy.
cn/v5/home/) Shandong Boan will start phase III clinical trials in June 2019, only late In Qilu for a month .
In January of this year, Boan Bio-Bio has announced the success of the Phase III clinical trial of Disulumab .
.
This is the first domestically reported biosimilar of desulumab
.
Click here to view/subscribe to the acceptance number
Disumumab was developed and marketed by Amgen.
According to different indications, there are two specifications of products, the trade names are: Xgeva® (70 mg/ml) and Prolia® (60 mg/ml)
.
Globally,desulimab isapproved for postmenopausal osteoporosis under the trade name Prolia®; it is approved for use in multiple myeloma and solid tumor bone under the trade name Xgeva® (trade name RANMARK® in Japan) Prevention of bone-related events (SREs) in metastatic patients, treatment of giant cell tumor of bone (GCTB) in adults and adolescents with mature bones
.
In China, Disumab (Angavi®) was approved for marketing in May 2019 for the treatment of giant cell tumors of bone that cannot be resected or surgically removed, which may cause severe dysfunction
.
In June 2020, its indication for osteoporosis in postmenopausal women with high fracture risk was approved by NMPA; in November of the same year, it was approved for bone-related events in patients with bone metastases from multiple myeloma and solid tumors Prevention
.
At present, Angarvey has negotiated a price cut by 80% and entered the medical insurance category B catalog.
The latest bid price is 1060 yuan/120mg (1.
7mL)/bottle.
It is limited to giant cell tumors of bone that may not be resectable or may cause severe dysfunction after surgical resection.
.
BeiGene cooperated with Amgen to commercialize this product.
After the implementation of medical insurance, the number of hospital admissions in Angarve in the first quarter reached 23 times the number before medical insurance was included, and subsequent growth is expected .
This year, Baekje will continue to participate in medical insurance negotiations for the indication of bone metastasis of solid tumors and the prevention of bone-related events in patients with multiple myeloma, with a view to including this indication in medical insurance .
However, the upcoming biosimilar drugs may pose a threat to Angarwei's sales .
At present, a total of 9 domestic biosimilars of disulumab are in clinical trials, 2 have been approved for clinical trials but have not yet started clinical trials, and 1 is in clinical application
.
Today, Qilu Pharmaceutical denosumab is the first reported production of bio-similar drugs, other products in clinical phase III were from Kang Ning Jierui, Shandong and Shanghai Maiwei Pok
.
Click here to inquire about the domestic competition pattern of "disulumab" from: Insight database (http://db.
dxy.
cn/v5/home/) Shandong Boan will start phase III clinical trials in June 2019, only late In Qilu for a month .
In January of this year, Boan Bio-Bio has announced the success of the Phase III clinical trial of Disulumab .
