US FDA Authorized AffaMed’s Bispecific Biologic for Treating Retinal Vascular Diseases


The company ‘AffaMed Therapeutics’, a clinical stage biotechnology company that is dedicated to the commercialization and development of the transformative pharmaceutical, surgical and digital products announced that, the Food and Drug Administration (FDA) of the United States has now cleared the application of the Investigational New Drug (IND) for the clinical development of the AM712, used for the treatment of the retinal vascular diseases.

Under this application of the Investigational New Drug (IND), the company is soon going to be initiating a phase 1 trial in the country for the purpose of investigating the tolerability, efficacy, safety and pharmacokinetics of the AM712 in subject with the neovascular AMD.

The company ‘AffaMed Therapeutics’ has recently entered into a licensing agreement along with the AskGene Pharma Inc. for the rights for developing, commercializing and manufacturing the AM712 in regions across the globe.

Dr. Dayao Zhao, chief executive officer of AffaMed said, they are very excited for partnering with the company ‘AskGene’ and also receiving the company’s first Investigational New Drug (IND) approval from the US FDA. He also said, as being a part of the company’s global innovation strategy for the purpose of leveraging the strong presence of AffaMed in China and also the United States for the purpose of advancing the therapeutics for the markets across the world.

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Dr. Dayao Zhao added that, this partnership is further going to strengthen their global ophthalmology pipeline of the company and he is very pleased for witnessing their fast execution of this strategy from the license to the approval with close cooperation with AskGene.