According to the information on the website of the State Drug Administration of China (SDA) on May 23, the approval status of the marketing application of the Class1 new drug Albuvirtide independently developed by Frontier Biotechnologies has been changed to "Approval completed – to be issued certificate". As revealed by an insider, SDA (formerly, CFDA) has approved the production application of this drug, and Frontier Biotechnologies is expected to obtain the formal approval in the near future, meaning that Albuvirtide will be marketed soon.
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Pharmaceutical Product Registration Progress Query Results |
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Acceptance No. |
CXHS1600006SU |
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Enterprise name |
Frontier Biotechnologies Inc. |
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Handling status |
Approval completed – to be issued certificate |
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Status start time |
May 23, 2018, 17:18:40 |
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Notification time |
Nil |
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Date of receiving receipt of reference standard |
Not required |
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Charge |
No charge |
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Charge collection date |
|
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Date of receiving inspection report |
Not submitted |
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Pharmaceutical product approval No. |
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Content of notice |
Nil |
(Source: SDA (formerly, CFDA) official website)
The world’s first long-acting anti-AIDS drug
As a fusion inhibitor that targets gp41, Albuvirtide has the action site of the viral-envelope transmembrane glycoprotein gp41, and blocks HIV replication by inhibiting the fusion of viral envelope and human cell membrane, therefore, it is a fusion inhibitor that belongs to inhibitors. Albuvirtide can be used in combination with other antiretroviral drugs, with the innovation being that it replaces the current daily oral taking method as a weekly injection. It mainly has the following 4 characteristics: 1. The brand-new molecular mechanism of action: effective against resistant viruses; 2. The drug safety is better than most anti-AIDS drugs at present; 3. Long acting: weekly administration, with administration time more flexible than oral drugs (repeated administration can fall on any day between day 6 and day 8 after the administration), to improve patients’ medication compliance and improve their life quality; 4. The simplified treatment combination between Albuvirtide and lopinavir/ritonavir.
The marketing application of Albuvirtide, a Class 1 new drug independently developed by the Chinese company Frontier Biotechnologies and also the world’s first long-acting anti-AIDS drug, was undertaken and accepted by CDE on July 18, 2016, and received the special review and approval: it was included in the priority review on November 3, 2016 by reason...
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