AffaMed Therapeutics

AffaMed Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing transformative pharmaceutical, digital, and surgical products for ophthalmological, neurological, and psychiatric disorders. The company operates in Greater China and globally, with a strong presence in China and the US. AffaMed's product pipeline includes several innovative therapies in various stages of development.

One of AffaMed's key products is DEXTENZA, a corticosteroid intracanalicular insert designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA is being developed for the treatment of ocular inflammation and pain following ophthalmic surgery. In October 2023, AffaMed announced positive top line results from a real-world study in China, demonstrating DEXTENZA's efficacy in reducing ocular inflammation and pain after cataract surgery.

Another significant product in AffaMed's pipeline is Risuteganib (Luminate), a first-in-class integrin regulator for the treatment of intermediate dry age-related macular degeneration (AMD). In September 2023, AffaMed received approval from China's National Medical Products Administration to initiate a Phase 3 clinical trial for Risuteganib, positioning it to potentially become the first product in China to enter Phase 3 development for dry AMD treatment.

AffaMed is also developing AM712, a novel bispecific biologic molecule designed for ocular use. AM712 provides dual inhibition of vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) for the treatment of retinal vascular diseases. In May 2022, the company dosed its first patient in a US Phase 1 clinical trial of AM712 for neovascular age-related macular degeneration (nAMD).

The company's subsidiary, AffaMed Digital, is dedicated to developing evidence-based, clinically evaluated digital therapeutics and diagnosis systems for ophthalmic, neurological, and psychiatric disorders. This includes a collaboration with Beijing Infinite Brain Technologies to develop digital therapeutic programs for post-stroke cognitive impairment and other indications.