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Selected Study Results: Results presented at IAS 2021 showed that albuvirtide plus lopinavir/ritonavir was noninferior to two NRTIs plus lopinavir/ritonavir in suppressing viral load in participants who had treatment failure on standard first-line ART. 10

Fang, C.G.; Wang, A.; Huang, X.Y.; Zhang, G.Y.; Yang, M.Y.; Jiang, N. Improvement of a five-step iodometric method for measuring chlorine dioxide in disinfectants. Chin. J. Disinfect. 2007, 6, 507–509. [ Google Scholar] In vitroantiretroviral activity Albuvirtide-albumin conjugates against various HIV-1 strains showed the IC50of Albuvirtideagainst 8 HIV-1 subtypes (A, B, C, G and EA recombinants) was 0.5~4.8 nM in human peripheral blood mononuclear cells (PBMCs). The meanIC50 of Albuvirtide against 28 prevalent strains of CRF07-BC, CRF01-AE, and B' subtypes from China were 5.2 nM, 6.9 nM and 9.5 nM, respectively.The two-drug regimen with different targets is the future trend of ART research. It is worthy and we are looking forward to continuing to develop new HIV combinations of high efficacy and good tolerability for our patients."

Study Purpose: The purpose of this open-label study is to evaluate the safety and efficacy of combination therapy with albuvirtide plus 3BNC117 in participants with multidrug-resistant HIV. Frontier Biotechnologies Inc. A multicenter, two-arm, 24-week study of albuvirtide in combination with 3BNC117 in patients with multi-drug resistant (MDR) HIV-1 infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on September 17, 2020. NLM Identifier: NCT04560569. Accessed April 4, 2023 Note: It will be difficult to control the volume of sodium bicarbonate solution injected into the vial as the vials are sealed under vacuum (negative air pressure) which will likely create a suction.Albuvirtide is a human immunodeficiency virus type 1 (HIV-1) fusion inhibitorindicated in combination with other antiretroviralagent(s)for treatment of HIV-1 infection in treatment-experienced patients with HIV-1 replication despite ongoing antiretroviral therapy. Participants are adults with HIV on a stable ART regimen who initiated ART either within 6 months of primary HIV infection (cohort 1) or after 6 months of primary HIV infection (cohort 2). Wu H, Yao C, Zhang T, et al. Efficacy and safety of long acting HIV fusion inhibitor albuvirtide in treatment-experienced HIV-1 infected patients: week 48 analysis from the randomized controlled phase 3 TALENT study. Abstract presented at: IAS Conference on HIV Science; July 18-21, 2021; Virtual. Abstract PEB148. Accessed April 4, 2023 Dr Dong Xie, Chief Scientific Officer, Chairman, Frontier Biotechnologiessaid, "IAS is the world's most influential meeting on HIV science. It leads the collective response on every front of the global HIV community. Frontier Biotechnologiesis delighted to break the TALENT study results, through the investigators, at this prestigious meeting. ABT+LPV/r (Albuvirtide plus boosted Lopinavir combination) is a preferred two-drug regimen as ABT is active against most HIV strains, including resistant strains, and has a high resistance barrier, while LPV/r is widely available in China. This is a robust example of a combination of two classes of drugs with different mechanisms of action providing a combination of complementary efficacies. Two NRTIs were replaced with Aikening® as the core, and rapid and persistent viral suppression was achieved in patients who failed initial treatment." National Center for Biotechnology Information. PubChem Compound Summary for CID 134694278, Albuvirtide. Accessed April 4, 2023

Frontier Biotechnologies announced it obtained approval for Aikening® (albuvirtide for injection), the first long-acting fusion inhibitor treatment for HIV, from the National Pharmaceutical Regulatory Agency of Malaysia. Cheryl Tan, Global Head of Frontier Biotech's International Businesses, said, “Aikening® is the first new long-acting antiretroviral drug independently developed by Frontier Biotech. Since its launch in China in 2018, it has benefited many Chinese patients, and has provided new treatment options for severely ill hospitalized patients, drug-resistant patients, and patients with liver and kidney impairment. Multiple controlled clinical trials and accumulated real-world data show that Aikening® has high efficacy and safety, with minimal drug interactions with commonly used drugs amongst HIV patients and high resistance barriers. We are very happy to partner with R-Pharm to bring Chinese innovative drug to Russian AIDS patients". Acetyl-Trp-Glu-Glu-Trp-Asp-Arg-Glu-Ile-Asn-Asn-Tyr-Thr-(N-{2-[2-(N-(3-maleimidepropionyl)amino)ethoxy]ethoxy}acetyl)Lys-Leu-Ile-His-Glu-Leu-Ile-Glu-Glu-Ser-Gln-Asn-Gln-Gln-Glu-Lys-Asn-Glu-Gln-Glu-Leu-Leucinamide The TALENT study is a Phase 3 trial ( NCT02369965) that evaluated albuvirtide plus lopinavir/ritonavir versus lopinavir/ritonavir plus two NRTIs in treatment-experienced participants. At Week 48, 6% of participants in the albuvirtide group and 8% of participants in the comparator group had virological failure (HIV RNA levels at or above 400 copies/mL). Among the 11 albuvirtide-treated participants with virological failure, no gp41 resistance-associated mutations were detected. 10Purpose: The purpose of this study is to evaluate the safety of combination therapy with albuvirtide plus 3BNC117 and determine whether this combination can control viral load levels after an analytical treatment interruption of ART. 9 It is unknownwhether Albuvirtideis excreted in human breast milk. Mothers with HIV-infectionsshould not breast-feed infants so as to avoid HIV transmission. Mothers should not breastfeed infantsif they are receiving AIKENING TM.