Shanghai-based OBiO Technology, a CDMO, entered into a strategic commercial manufacturing collaboration agreement with CHINAGENE under which OBiO will provide contract development and manufacturing services to CHINAGENE for their gene therapy products, including large-scale cGMP manufacturing service for clinical trials, process characterization, validation, product formulation and filling, and commercial manufacturing.

“This agreement signed by OBiO and CHINAGENE is a continuation from previous cooperation,” said Guodong Jia, CEO of OBiO. “CHINAGENE is a leading biotech ophthalmic gene therapy developer. OBiO will continue to improve the capability of the process development and cGMP management system to promote CHINAGENE’s gene therapy product of.”

“We are happy to continue our collaboration to accelerate the commercialization of our ophthalmic gene therapy product ZVS101e.” added Xi Chen, the vice president of CHINAGENE, “In the past, OBiO had helped us get IND approvals from the National Medical Products Administration of China (NMPA) and the FDA. In the future, we will continue to work closely to help more patients.”

The FDA granted ZVS101e orphan drug status, according to Chen. Data from an exploratory clinical trial of ZVS101e for bietti crystalline dystrophy (BCD disease) showed good safety and efficacy, he noted. In December 2022, ZVS101e received IND approval to conduct clinical trials for the treatment of crystallization-like retinitis pigmentosa caused by CYP4V2 biallelic mutations by the NMPA and FDA.

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