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[Pharmaceutical Network Industry News] Recently, Hainan Boao Lecheng International Medical Tourism Pilot Zone has successfully introduced the invasive fungal disease treatment drug-AmBisome (Amphotericin B liposome for injection), which will provide domestic invasive fungal diseases.
new treatment options for patients
.
Invasive fungal disease (IFD) is a disease characterized by pathophysiological changes such as inflammatory response, tissue damage and organ dysfunction, which is a serious threat to the growth and reproduction of fungi in various tissues of the human body, including blood, after invading the human body.
Human life and health
.
Typical invasive fungal diseases include invasive candidiasis, invasive aspergillosis and invasive mucormycosis
.
Among them, invasive mucormycosis is relatively rare, which is a filamentous pathogenic fungus, and the most common causes of human diseases are Aspergillus fumigatus and Aspergillus flavus
.
Diagnosis of patients with invasive mucormycosis is difficult and currently available treatment options are very limited, resulting in a huge unmet clinical need
.
AmBisome was developed by Gilead Sciences and has been widely used around the world for 30 years.
It is the preferred drug for clinical antifungal treatment in the world, and is known as the "swordsman" in the treatment of fungal infections in the industry
.
In a study in the treatment of invasive aspergillosis, AmBisome has been shown to be the primary first-line treatment for the immunocompromised
.
The overall response rate of this study demonstrates that AmBisome is effective in the treatment of invasive aspergillosis
.
Another randomized, double-blind, multinational non-inferiority study in adults and children evaluated the therapeutic effect of AmBisome
.
The results of this trial show that Ambisome is significantly more effective than micafungin in the treatment of patients with deep fungal infections, and the product can improve the remission rate, quality of life and disease progression of patients
.
According to the industry, in recent years, new antifungal drugs have been continuously developed, but most of them do not have the unique pharmacokinetic and biodistribution characteristics of AmBiome liposomal formulations
.
Currently, there are no AmBisome or its generic products listed in the Chinese mainland market
.
In August 2020, it was reported that 3SBio announced that the registration application of the company's partner Taiwan Liposome Co.
, Ltd.
("TLC") for Ampholipad has been accepted by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration.
It is a chemical generic drug of Gilead's AmBisome (Amphotericin B liposome injection) for the treatment of systemic fungal infections
.
It is understood that mpholipad has been approved for sale in Taiwan for many years, and the annual output can exceed one million pieces
.
TLC has authorized partner 3SBio to commercialize Ampholipad in mainland China
.
This drug registration application is based on the consistent test data of Ampholipad
.
The clinical data of Ampholipad verified the bioequivalence with AmBisome not only in the overall blood drug concentration and the blood drug concentration in the form of encapsulated liposomes, but also in the plasma concentration of the unencapsulated form of liposomes, which is difficult to meet the international regulations.
sex
.
At the same time, Ampholipad's comprehensive chemical and manufacturing control information also demonstrates its drug equivalence with AmBisome
.
Now, after the successful introduction of the original drug AmBisome into the Lecheng Pioneer Zone, it means that domestic patients with invasive fungal diseases can use the original research drug in the Lecheng Pioneer Zone without going abroad in the future, which will better meet the clinical treatment requirements.
demand
.
It is reported that with the support of the Hainan Free Trade Port and the policy advantages of the Lecheng Pilot Zone, and the concerted efforts of relevant institutions, AmBisome has successfully landed in Boao Lecheng.
.
This "first-in-first-out trial" is also expected to further provide strong evidence for real-world data research and help more global innovative medical devices benefit Chinese patients in a more convenient way
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
new treatment options for patients
.
Invasive fungal disease (IFD) is a disease characterized by pathophysiological changes such as inflammatory response, tissue damage and organ dysfunction, which is a serious threat to the growth and reproduction of fungi in various tissues of the human body, including blood, after invading the human body.
Human life and health
.
Typical invasive fungal diseases include invasive candidiasis, invasive aspergillosis and invasive mucormycosis
.
Among them, invasive mucormycosis is relatively rare, which is a filamentous pathogenic fungus, and the most common causes of human diseases are Aspergillus fumigatus and Aspergillus flavus
.
Diagnosis of patients with invasive mucormycosis is difficult and currently available treatment options are very limited, resulting in a huge unmet clinical need
.
AmBisome was developed by Gilead Sciences and has been widely used around the world for 30 years.
It is the preferred drug for clinical antifungal treatment in the world, and is known as the "swordsman" in the treatment of fungal infections in the industry
.
In a study in the treatment of invasive aspergillosis, AmBisome has been shown to be the primary first-line treatment for the immunocompromised
.
The overall response rate of this study demonstrates that AmBisome is effective in the treatment of invasive aspergillosis
.
Another randomized, double-blind, multinational non-inferiority study in adults and children evaluated the therapeutic effect of AmBisome
.
The results of this trial show that Ambisome is significantly more effective than micafungin in the treatment of patients with deep fungal infections, and the product can improve the remission rate, quality of life and disease progression of patients
.
According to the industry, in recent years, new antifungal drugs have been continuously developed, but most of them do not have the unique pharmacokinetic and biodistribution characteristics of AmBiome liposomal formulations
.
Currently, there are no AmBisome or its generic products listed in the Chinese mainland market
.
In August 2020, it was reported that 3SBio announced that the registration application of the company's partner Taiwan Liposome Co.
, Ltd.
("TLC") for Ampholipad has been accepted by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration.
It is a chemical generic drug of Gilead's AmBisome (Amphotericin B liposome injection) for the treatment of systemic fungal infections
.
It is understood that mpholipad has been approved for sale in Taiwan for many years, and the annual output can exceed one million pieces
.
TLC has authorized partner 3SBio to commercialize Ampholipad in mainland China
.
This drug registration application is based on the consistent test data of Ampholipad
.
The clinical data of Ampholipad verified the bioequivalence with AmBisome not only in the overall blood drug concentration and the blood drug concentration in the form of encapsulated liposomes, but also in the plasma concentration of the unencapsulated form of liposomes, which is difficult to meet the international regulations.
sex
.
At the same time, Ampholipad's comprehensive chemical and manufacturing control information also demonstrates its drug equivalence with AmBisome
.
Now, after the successful introduction of the original drug AmBisome into the Lecheng Pioneer Zone, it means that domestic patients with invasive fungal diseases can use the original research drug in the Lecheng Pioneer Zone without going abroad in the future, which will better meet the clinical treatment requirements.
demand
.
It is reported that with the support of the Hainan Free Trade Port and the policy advantages of the Lecheng Pilot Zone, and the concerted efforts of relevant institutions, AmBisome has successfully landed in Boao Lecheng.
.
This "first-in-first-out trial" is also expected to further provide strong evidence for real-world data research and help more global innovative medical devices benefit Chinese patients in a more convenient way
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
