Recently, a company within Zhongguan Village Life Science ParkInnovecbioAnnounce,IVB102 Injection Receives Clinical Trial Approval from the U.S. Food and Drug Administration; Currently, the Product Has Completed IIT Clinical Study Enrollment at Peking Union Medical College Hospital.
Estimated reading time: 2 minutesRetinoschisis (XLRS) is a type of X-linked recessive inherited retinal disease, with a prevalence of approximately 1/15,000 to 1/30,000, primarily affecting males. The disease can manifest as early as two to three years of age, causing varying degrees of vision impairment, characterized by inner retinal schisis, macular schisis leading to spoke-wheel changes, and peripheral retinal schisis. Electroretinogram (ERG) shows a negative waveform with a significantly reduced b-wave amplitude. Complications may include vitreous hemorrhage and retinal detachment, making "waiting for blindness" seem an inevitable fate for patients. RS1 is the only known causative gene for XLRS identified so far, yet there are currently no effective treatments available for XLRS in China or internationally.IVB102 Injection is a drug developed based on Innovecbio's independently researched and developed novel vector for the treatment of XLRS through intravitreal injection. Preclinical animal studies have shown that the treated model animals not only exhibited disappearance of retinoschisis cystic cavities but also restoration of electroretinogram waveforms to levels comparable to those of wild-type animals, demonstrating "best in class" potential.IVB102 Injection has successively received the Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA), demonstrating the FDA's recognition of the early development of IVB102 Injection.
InnoVec Biotherapeutics Inc. is a clinical-stage gene therapy company driven by vector innovation. The companyCommitted to Developing Gene Therapy Delivery Tools for Human Application，Addressing the Challenge of Translating Delivery Tool Development from Animals to Humans, with the goal of finding gene delivery tools for all tissues and organs, enabling gene therapy to be widely applied to both rare and common diseases.Innovecbio has efficient teams in technical development, pipeline research, process optimization, and clinical operations. It has established a leading technology development platform, covering multiple disease areas such as ophthalmology, neurology, and muscular diseases. Several innovative products have entered the IIT and IND stages.
