On April 21, 2023, OBiO Technology (Shanghai) Corp., Ltd. (OBiO) announced a strategic agreement of commercial manufacturing collaboration with CHINAGENE. Under the agreement, OBiO will provide holistic contract development and manufacturing services to CHINAGENE for their gene therapy products, including large-scale cGMP manufacturing service for clinical trials, process characterization and validation services, product formulation and filling services, and commercial manufacturing. In addition, OBiO and CHINAGENE will continue to expand the cooperation in academic communication globally, to promote the innovation of gene therapy.
"This agreement signed by OBiO and CHINAGENE is a continuation and sublimation from previous cooperation", Guodong Jia, CEO of OBiO said, "CHINAGENE is a leading biotech among the ophthalmic gene therapy developer. OBiO is a leading gene and cell therapy CDMO in China. OBiO will continue to improve the capability of process development and cGMP management system, to promote the gene therapy product of CHINAGENE."
"OBiO has abundant experience in gene therapy manufacturing and cGMP quality、management. We are happy to continue our collaboration to accelerate the commercialization of our ophthalmic gene therapy product ZVS101e." Xi Chen, the Vice President of CHINAGENE said, "In past, OBiO had helped us to get the investigational new drug (IND) approvals from National Medical Products Administration of China (NMPA) and the U.S. Food and Drug Administration (FDA). In future, we will continue to work closely with our own abilities, to help more patients. "
On August 2021, ZVS101e, a gene therapy production from CHINAGENE, was authorized by the U.S. Food and Drug Administration (FDA) as an orphan drug. Data from an exploratory clinical trial (IIT) of ZVS101e for bietti crystalline dystrophy (BCD disease) showed good safety and efficacy. In December 2022, ZVS101e was approved to conduct the Investigational New Drug (IND approval) clinical trials for the treatment of crystallization-like retinitis pigmentosa caused by CYP4V2 biallelic mutations, by NMPA and FDA.
About CHINAGENE TECH
CHINAGENE TECH is a developer of clinical genetic diagnosis, fertility prevention and gene therapy drug for hereditary eye diseases. The company specializes in developing ophthalmic gene therapy drugs backed by accurate gene diagnosis, providing reliable ophthalmic gene pharmaceuticals for the public.
About OBiO Technology
OBiO Technology (Shanghai) Corp., Ltd. (OBiO, SSE:688238.SH) is a gene and cell therapy-focused biotechnology company founded in 2013. In China for global customers, we offer holistic research, development, and manufacturing solutions for vectorology studies, functional genomics, process and analytical development, IND-enabling CMC, clinical and commercial manufacturing. With "enable gene therapy for better lives" as our mission, we are committed to providing high-quality service to global customers, advancing your product from bench to clinic, and bringing benefit to populations around the world. For more information about OBiO, visit www.obio-tech.com.
In the 26th annual meeting of American Society for Gene and Cell Therapy (ASCGT), OBiO will present the progress of in-house discovery regarding noval gene vectors, and advanced process development. OBiO will hold 2 oral presentations and 5 posters in the meeting. Welcome to OBiO's booth (#747) to get more information or attend our oral presentation in room 515AB on May 16 th 1:45pm to 2:00pm，other one is room 511 on May 17th. We also have 5 posters (#1644, #1445, #940, #871，#792) to show our innovation.