SHANGHAI, April 29, 2023 /PRNewswire/ — To April 21, 2023OBiO technology (shanghai) Corp., Ltd. (OBiO) announced a strategic commercial manufacturing collaboration agreement with CHINAGENE. Under the terms of the agreement, OBiO CHINAGENE will provide end-to-end contract development and manufacturing services for its gene therapy products, including large-scale cGMP manufacturing services for clinical trials, process characterization and validation, product formulation and filling services, and commercial manufacturing. In addition, OBiO and CHINAGENE will further expand cooperation in academic communication worldwide to promote gene therapy innovation.

“This agreement signed by OBiO and CHINAGENE is a continuation and sublimation of the previous collaboration”, Guodong JiaCEO of OBiO, said: “CHINAGENE is a leading biotechnology company among ophthalmic gene therapy developers. OBiO is a leading gene and cell therapy CDMO in China. OBiO will continue to improve the ability of process development and cGMP management system to promote CHINAGENE’s gene therapy product.”

“OBiO has extensive experience in gene therapy manufacturing and cGMP quality management. We are pleased to continue our collaboration to accelerate the commercialization of our ophthalmic gene therapy product ZVS101e.” Xi ChenVice President of CHINAGENE, said, “In the past, OBiO has helped us obtain Investigational Drug (IND) approvals from the National Medical Products Administration China (NMPA) and the US Food and Drug Administration (FDA). Going forward, we will continue to work closely with our own abilities to help more patients. “

At Aug 2021, ZVS101e, a gene therapy production of CHINAGENE, has been approved as an orphan drug by the US Food and Drug Administration (FDA). Data from an exploratory clinical study (IIT) of ZVS101e in Bietti’s Crystalline Dystrophy (BCD) showed good safety and efficacy. In December 2022ZVS101e was used to carry out the…

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