AffaMed Therapeutics Announces FDA IND Approval for AM712, a Novel Bispecific Molecule Targeting VEGF and Ang-2 for Retinal Vascular Diseases

Shanghai, February 15, 2022 /PRNewswire/ -- AffaMed Therapeutics, a clinical-stage biopharmaceutical company dedicated to addressing global unmet medical needs in ophthalmology, neurology, and psychiatry, today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for AM712 (ASKG712). AM712 is a novel bispecific biomolecule designed to simultaneously block vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) for the treatment of retinal vascular diseases.

Following the approval of this IND application, AffaMed Therapeutics will soon initiate a Phase 1 clinical trial in the United States to investigate the safety, tolerability, pharmacokinetics, and efficacy of AM712 (ASKG712) in patients with neovascular AMD.

AffaMed Therapeutics recently entered into a licensing agreement with AskGene Pharma Inc. ("AskGene") to obtain exclusive rights to develop, manufacture, and commercialize AM712 (ASKG712) in regions outside of Asia and the Japanese market.

Dr. Dayao Zhao, CEO of AffaMed Therapeutics, stated: "We are delighted to collaborate with AskGene and have received our first IND approval from the FDA. As an integral part of AffaMed Therapeutics' international innovation strategy that balances operations in both China and the U.S., aiming to provide differentiated therapies for the global market, this collaboration further strengthens our global ophthalmology pipeline. From signing the licensing agreement to receiving FDA approval, I am pleased to witness the acceleration of this strategy and look forward to closely collaborating with AskGene moving forward."

Dr. Jianfeng Lu, CEO of AskGene, stated: "AskGene is committed to accelerating the delivery of safe and effective drugs to patients through innovative technologies. We are very pleased to collaborate with AffaMed Therapeutics in the development of the promising anti-VEGF/Ang-2 bispecific molecule AMG712 (ASKG712), benefiting patients worldwide. The outstanding capabilities and extensive global project experience of AffaMed Therapeutics' team in the ophthalmology field were key factors in forming this collaboration. Both parties will work closely together to jointly expedite the global development progress of ASKG712."

Dr. Ji Li, President of AffaMed Therapeutics, stated: "We believe that AM712 (ASKG712) has the potential to become the best-in-class anti-VEGF/Ang-2 bispecific biomolecule, better addressing the significant unmet medical needs of patients with retinal diseases. We are very pleased to have received IND approval from the United States just two months after reaching the licensing agreement with AskGene, which fully demonstrates the excellent execution capability of the entire team."