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.

 (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 of "anti-AIDS innovative drug".

Excellent safety and efficacy

Regarding the safety and efficacy of Albuvirtide, Xie Dong, Ph.D., Founder of Frontier Biotechnologies, reported the results of the Phase III clinical trial of the drug in Glasgow HIV Drug Therapy 2016. This study named TALENT study enrolled 389 HIV infected people who had experienced first-line treatment but failed the virology. Subjects were randomly divided into two groups, with one given simplified regime (injected Albuvirtide once every week + lopinavir/ritonavir twice a day), and the other given the standard triple regime (lopinavir/ritonavir twice a day + two NRTIs (lamivudine + tenofovir/abacavir/zidovudine)), for 48 weeks of treatment.

According to the data analysis results, the viral load (VL) of 80.4% subjects in the simplified regime group was <50 copies/ml, while that of 66% subjects in the triple regime control group was <50 copies/ml, showing that the Albuvirtide simplified regime was not inferior to the triple regime in terms of the efficacy as a second-line therapy, and subjects were not detected the drug-resistant mutation to Albuvirtide. Furthermore, the tolerance of Albuvirtide was good: the most common adverse reaction in the group was diarrhea, with separately two cases of headache and dizziness observed, and the most common laboratory abnormalities were high cholesterol and high triglycerides. Albuvirtide simplified regime did not lead to the significant increase of serum creatinine or significant decrease of eGFR compared to the triple regime that contained TDF, therefore, it would not cause significant renal burden.

Furthermore, compared to the world’s first fusion inhibitor enfuvirtide (T-20, marketed in 2003) that targets gp41, Albuvirtide also has clear advantages. T-20 can offer very good antiviral effect in combination with other drugs, however, T-20 is an injection that requires patients to inject themselves twice a day on arm, thigh or abdomen, etc., with many adverse reactions: 98% patients would have redness, swelling or itch of the injection site and even severe allergy, therefore, it can only serve as the alternative rescue regime when patients are intolerant to other therapeutic regimens or are drug resistant.

Seeking for the "cocktail" formula

Frontier Biotechnologies entered into a cooperation agreement with The Rockefeller University in July 2017, to obtain the global rights to the broad-spectrum HIV neutralizing antibody 3BNC117, and plan to use Albuvirtide in combination with 3BNC117 into two all-injectable long-acting drug formulas with new mechanism of action. The company will start the clinical trial in 2018 to study the effect and safety thereof and induce patients to produce the in vivo immune response to HIV.

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