Rongchang Biotech's Ophthalmic Drug RC28-E Marketing Application Not Approved

Regulation
โดย 国家药监局官网·Read original
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Rongchang Biotech's self-developed ophthalmic drug, RC28-E, an intravitreal injection, has hit a roadblock in its marketing application. On July 28, information on drug notification letters published by the National Medical Products Administration showed that RC28-E submitted by Rongchang Biotech received a notification letter, which usually means the registration application was not approved or was voluntarily withdrawn. RC28-E is a VEGF/FGF dual-target fusion protein drug for ocular neovascular diseases. Its marketing application for the treatment of diabetic macular edema was accepted last September, based on a Phase III clinical study. In addition, a domestic marketing application for the indication of wet age-related macular degeneration is expected to be submitted in mid-2026, and Rongchang Biotech had already licensed the exclusive rights for RC28-E in Greater China and Asia to a subsidiary of Santen Pharmaceutical last August.

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