He Yuan Bio and Dingxin Gene Announce Strategic Collaboration for Commercial Manufacturing of Gene Therapy Product RRG001
RRGENER
Biopharmaceutical R&D Developer
Press Release
On November 2, 2023, Obio Technology (Shanghai) Corp., Ltd. ("Obio Technology," stock code: 688238) announced a strategic partnership with RRGENER ("RRGENER"). According to the agreement, Obio Technology will leverage its advanced process development capabilities for gene therapy products, large-scale cGMP commercial production capacity, and global business expansion expertise to provide high-quality CDMO/CMO services and licensing cooperation for RRGENER's RRG001 product. Together, they will advance the development of cutting-edge therapies to benefit patients worldwide.
Win-Win Cooperation
RRGENER, driven by human genetics and translational medicine, selects gene precision delivery technologies with high drug-like properties to develop new gene therapies that meet unmet clinical needs. RRGENER has established a mature AAV gene therapy R&D and technology system in the fields of fundus diseases and congenital deafness. It is also the first gene therapy company globally to apply the AAV dual-vector delivery technology to clinical trials for congenital deafness. This time, Obio Technology (Shanghai) Corp., Ltd. and RRGENER plan to establish cooperation on the RRG001 pipeline.Comprehensive Strategic Partner for Clinical Declaration, Clinical Trial Sample Production, Commercial Production, and Global Commercial Collaboration of Gene Therapy Products"Relationship.
Obio Technology focuses on providing one-stop services for gene and cell therapy drug developers, covering preclinical research, CMC pharmaceutical research, clinical sample production, and large-scale commercial production, empowering the development of gene and cell therapy drugs. Currently,Obio Technology (Shanghai) Corp., Ltd. has 15 vector production lines and 20 cell production lines, which can meet GMP production requirements of different scales.. A variety of innovative process systems have been established, including single-use process carrier production lines, single-use process prokaryotic cell culture production lines, lyophilization and filling integrated formulation filling process systems for gene and cell therapy products, positive sample cell therapy product production lines, with innovation levels ranking among the forefront of the industry.
Dr. Liu Xinxing, General Manager of RRGENER"We chose to partner with an experienced and mature CDMO like Obio Technology for the pharmaceutical development of the RRG001 pipeline, providing significant support for RRG001 to enter clinical trials. Building on our previous collaboration, we are further strengthening and expanding the scope of our strategic partnership this time. We look forward to working together with Obio Technology in the future to successfully bring this drug to market, addressing more unmet needs and benefiting patients."
Dr. Guodong Jia, CEO of Obio Technology (Shanghai) Corp., Ltd.Said: "This strategic cooperation is an important milestone for both parties to promote gene therapy drugs into clinical application and subsequent drug launch. As a leading CRO/CDMO enterprise focusing on the gene and cell therapy field, we always pay attention to the innovative progress in the global gene and cell therapy field and the demand for large-scale GMP production capacity, continuously empowering the industry with efficient and high-quality service standards."
About RRGENER
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RRGENER is a company engaged in the research and development of innovative gene therapy drugs. Starting from the underlying delivery technology platform for gene therapy, it leverages AAV viral vectors and non-viral vectors to precisely address clinical treatment challenges in rare diseases and chronic conditions across ophthalmology, otology, cardiovascular metabolism, and other fields. The company focuses on developing affordable and effective gene therapies that patients can access.
About Obio Technology
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Obio Technology (Shanghai) Corp., Ltd. (Stock Code: 688238), established in 2013, is a biotechnology company focusing on the gene therapy field. It specializes in providing CRO services such as the development of gene therapy vectors and gene function research for fundamental studies in gene therapy. It also offers CDMO services including process development and testing, IND-CMC pharmaceutical research, and GMP production of clinical samples for the R&D of gene therapy drugs, such as recombinant viral vector drugs, oncolytic viruses, and CAR-T cell therapy products. With the mission of "Empowering Gene Therapy, Safeguarding Life and Health," and with a core focus on the R&D and production of gene therapy vectors, the company will continue to adhere to a customer-centric approach and the responsibility of providing professional services. It aims to build an internationally leading gene therapy CXO enterprise group, accelerating the basic research, drug discovery, pharmaceutical research, clinical, and commercialization processes of gene therapy, promoting the development of the gene therapy industry, and benefiting human health!
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