Singapore-based Golden Age Health, a specialty pharmaceutical company focused on rare and specialty diseases, has entered into a 10-year exclusive promotion service agreement with China-headquartered Innostellar Biotherapeutics Co., Ltd. This strategic partnership secures the exclusive commercialization and promotion rights to Innostellar’s first-in-class gene therapy candidate LX-101 in Mainland China.
LX-101: A Novel Gene Therapy for Inherited Retinal Dystrophy
LX-101 is an adeno-associated virus (AAV)-based gene therapy designed to deliver functional RPE65 genes directly to retinal cells. The primary goal of this therapy is to restore the visual cycle in patients with inherited retinal dystrophy (IRD) caused by biallelic RPE65 mutations. This innovative approach aims to address a significant unmet medical need in the treatment of IRD.
Clinical Development and Regulatory Pathway
LX-101 is currently undergoing a Phase III clinical study in China. Topline results from this study are anticipated in the fourth quarter of 2025. Following these results, Innostellar plans to submit a marketing authorization application to China’s National Medical Products Administration (NMPA).-Fineline Info & Tech
