OBiO and CHINAGENE to provide gene therapy commercial manufacturing services under strategic agreement.

30 April 2023 | Sunday | News


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.
Image Source : Public Domain

Image Source : Public Domain

"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.

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