OBiO, Refreshgene Partner on Commercialization of Gene Therapy

OBiO Technology, a contract development and manufacturing organization (CDMO) for cell and gene therapy, entered into an agreement with Refreshgene Therapeutics. Under the agreement, OBiO will leverage its capabilities of process development, large-scale cGMP commercial production and global business development to provide high-quality CDMO/CMO services and authorized cooperation services for Refreshgene’s RRG-001 pipeline, and jointly promote the development of advanced therapies to benefit patients around the world.

Refreshgene develops new gene therapy and drugs to satisfy unmet clinical needs via highly druggable and tissue-specific gene delivery technology. Refreshgene owns well-established research and technology system of AAV gene therapy and built-up clinic-stage pipeline in the field of retinal diseases and congenital deafness.

In a statement, Refreshgene said that it is the first gene therapy company in the world to apply dual AAV vector technology into clinical trials in congenital deafness. OBiO and Refreshgene intend to establish a comprehensive strategic partnership for clinical application, clinical & commercial production, and global commercial cooperation of RRG-001 gene therapy product.

OBiO focuses on one-stop CRO/CDMO services from preclinical research, CMC, and clinical manufacturing to commercial large-scale manufacturing for drug developers in the field of gene and cell therapy. Currently, OBiO possesses 15 vector production lines and 20 cell production lines, which can meet GMP production requirements of different scales. It has laid out a variety of innovative process systems, including production lines with single-use technology, filling lines integrated with lyophilizers, and cell therapy production lines for positive sample. OBiO is at the forefront of the industry.

Liu Xinxing, CEO of Refreshgene said, “In the CMC development of RRG001 pipeline’s IND enabling, we chose to cooperate with OBiO, which is proved to be an experienced and collaborative CDMO. As a result, we further strengthen and expand the scope of strategic cooperation with OBiO. We look forward to efficiently bringing this drug to market and meeting the unmet medical needs on the behave of patients’ benefit.”

Jia Guodong, CEO of OBiO, said, “This cooperation is an important milestone for both parties to promote the clinical application and the launch of gene therapy drugs. As a leading CRO/CDMO focusing on the field of gene and cell therapy, we always pay active attention to the innovative progress in the global gene and cell therapy, and the demand for large-scale GMP manufacturing, continuously providing efficient and high-quality services.”