RemeGen and Santen announce NDA acceptance in China for RC28-E in diabetic macular edema

On September 30, RemeGen (Stock Codes: 688331.SH/09995.HK) and Santen Pharmaceutical Co., Ltd. jointly announced that the New Drug Application (NDA) for RC28-E—a VEGF/FGF dual-target fusion protein for ocular neovascular diseases independently developed by RemeGen—for the treatment of diabetic macular edema (DME) has been accepted for review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration.

The application is supported by a multicenter, randomized, double-blind, active-controlled Phase III clinical study. Led by Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, the trial randomized eligible subjects in a 1:1 ratio to receive either 2.0 mg of RC28-E or 2.0 mg of aflibercept. The primary endpoint was the mean change from baseline in Best Corrected Visual Acuity (BCVA) at Week 52.

RC28-E was administered as a 2.0 mg dose via intravitreal injection. During weeks 0-16, injections were given every four weeks for a total of five doses; thereafter until week 48, dosing occurred every eight weeks.

The trial enrolled 316 subjects. Results demonstrated that RC28-E met the pre-specified primary endpoint, confirming its non-inferiority to the active control aflibercept, with a favorable safety and tolerability profile.

Diabetic Macular Edema (DME) is a common and serious ocular complication in diabetic patients and a leading cause of vision impairment and blindness among the working-age population. Its core pathology involves the formation of abnormal blood vessels and proliferative lesions. According to a Frost & Sullivan report, the number of DME patients in China is projected to reach 8.85 million by 2030, with prevalence rates continuing to rise amid an accelerating aging population.

RC28-E is a novel VEGF/FGF dual-target fusion protein developed by RemeGen for ocular neovascular diseases. By simultaneously inhibiting the binding of both VEGF and FGF to their respective receptors, RC28-E is designed to produce synergistic effects across multiple pathways—including anti-inflammatory, anti-fibrotic, anti-angiogenic activity—potentially offering enhanced efficacy over single-target inhibitors.

On August 19, RemeGen announced it had granted an exclusive license for its proprietary drug RC28-E in Greater China and Asia to Santen (China) Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Santen Pharmaceutical. Leveraging its extensive experience in the Chinese and Southeast Asian markets, Santen will provide robust support for the rapid commercialization of RC28-E through its well-established commercial network, exceptional academic promotion capabilities, and deep insight into the ophthalmic disease area. This collaboration is expected to accelerate the innovative therapeutic's market penetration and patient access.