Exegenesis Bio Announces FDA Approval of IND Application for EXG102-031 Ophthalmic Injection to Treat Wet Age-Related Macular Degeneration

Hangzhou Jiayin Biotechnology Co., Ltd.(Exegenesis Bio, Hangzhou Jiayin)Announced, the U.S. Food and Drug Administration(FDA)Approved.NewTypeGene TherapyEXG102-031InjectionResearch onTypeNew Drug(IND)ofApplication for Therapeutic UseWetnessSex-related and age-relatedofMacular Degeneration(wAMD)。

“We are thrilled by the progress our company has made and by reaching this critical milestone, which marks the approval of our second new drug IND and Hangzhou Jiayin’s first IND approval in the United States since its establishment three years ago,” said Wu Zhenhua, CEO of Hangzhou Jiayin. “This serves as strong validation of our world-class capabilities in R&D, CMC, quality, and regulatory affairs. We look forward to further accelerating the development of innovative gene therapy products targeting areas with high unmet clinical needs, bringing good news to patients worldwide.”

Age-related macular degeneration (AMD) is a progressive eye disease caused by damage to the macula, the central part of the retina, which can lead to blurred vision and blindness. There are over 50 million AMD patients in China alone, one-tenth of whom (approximately 5 million) have neovascular age-related macular degeneration, also known as wet AMD (wAMD). wAMD is an ophthalmic condition that causes severe vision loss and irreversible blindness, resulting from abnormal blood vessel growth and leakage of blood or fluid into the macula, leading to scarring and rapid loss of central vision. Of the approximately 50 million cases of AMD-related blindness worldwide, wAMD accounts for about 90%.

EXG102-031, an ophthalmic injection for intravitreal administration, is a clinical-stage gene therapy for the treatment of wet age-related macular degeneration (wAMD). Unlike existing antibody-based therapies that require repeated injections, EXG102-031 is administered as a single dose, enabling sustained in vivo expression and effectively treating abnormal angiogenesis and vascular leakage in the retina. The Phase I clinical trial of EXG102-031 will evaluate its safety and tolerability in patients with wAMD, as well as its efficacy in improving visual acuity.

Hangzhou Jiayin Biotechnology Co., Ltd. is a global, clinical-stage gene therapy company. The design of its innovative gene therapy products is based on three AI-assisted platforms: viral capsid engineering, promoter engineering, and unique protein engineering. Meanwhile, the company possesses world-class cGMP manufacturing facilities. Currently, two drug candidates from the company have entered clinical trials: 1) EXG001-307, an AAV-based gene therapy for the treatment of Type I Spinal Muscular Atrophy (SMA); and 2) EXG102-031, an AAV-based gene therapy for the treatment of wet Age-related Macular Degeneration (wAMD).