Frontier Biotechnologies Inc. products

Licensed with exclusive rights for greater China from AFFiRiS AG, a clinical-stage biotechnology company in Austria, FB6001 is an investigational therapeutic peptide vaccine targeting PCSK9 to treat hypercholesterolemia. PCSK9 is a clinically validated target and FB6001 is a potential first-in-class immunotherapy for hypercholesteremia. FB6001 is expected to be administered subcutaneously every 3-6 months. AFFiRiS’ phase 1 clinical data has shown FB6001 is safe and tolerable with potent cholesterol-lowing effect. Frontier Biotech plans to start clinical development in China soon.

FB2001 (generic name: Bofutrelvir) is a SARS-CoV-2 3CL protease inhibitor under clinical development for hospitalized patients as well as for post-exposure prophylaxis of Covid-19. It is a peptidomimetic compound targeting 3CL-protease based on three-dimensional crystal structure of the protease. Preclinical data has shown it has potent activities in vitro and in vivo against SARS-CoV-2 variants such as Alpha, Beta, Delta, and Omicron. Clinical data from two phase 1 trials conducted in the US and China has shown that Bofutrelvir is safe and tolerable with a PK profile (without using a booster like ritonavir) supporting further clinical development. It is currently in a pivotal global phase 2/3 clinical trial for hospitalized Covid-19 patients.

To develop an all-injectable long-acting HIV therapy, Frontier Biotech has designed and developed a combination regimen of Albuvirtide (ABT) and 3BNC117, a recombinant fully human monoclonal antibody with broadly neutralizing effects to HIV-1 viruses.

FB3001, a new transdermal topical patch, is a musculoskeletal joint pain treatment, currently under clinical development. Through collaboration with ABsize, FB3001`s Phase II clinical trial for treating lower back pain has been completed in the United States. The clinical data demonstrates that FB3001 provides superior pain relief for patients with chronic lower back pain compared to placebo. FB3001 minimizes systemic drug exposure with limited side effects that are common in oral therapies. Frontier Biotech also filed an Investigational New Drug (IND) application for FB3001 in China and was granted approval by the National Medical Products Administration (NMPA) in March 2019. A Phase I bridging pharmacokinetic study has been completed.

Aikening ® is a long-acting HIV fusion inhibitor for the treatment of HIV infection and AIDS.  Aikening ® represents multiple technological breakthroughs in the aspects of the polypeptide sequence, chemical modification, molecular target, as well as distribution and metabolism in the human body. In combination with other antiretroviral therapies (the “ART” or “ARTs”), Aikening ® can be used in treatment-experienced HIV patients who are still experiencing viral replication. Effective against most HIV-1 strains including drug-resistant strains, Aikening ® has demonstrated potent anti-HIV efficacy to reduce patients’ HIV viral load to an undetectable level, along with a good clinical safety profile.