WuXi Biologics, which happens to be a leading global contract research, development, and manufacturing organization (CRDMO), on June 9, 2025, happened to announce a strategic partnership with Virogen Biotechnology Inc. (Virogen). Under this agreement, Wuxi Biologics is going to offer comprehensive services that include technology transfer, process validation, as well as commercial manufacturing when it comes to both drug substance (DS) and drug product (DP) for VG712, which is the lead clinical-stage asset of Virogen. The collaboration is anticipated to advance VG712 pathway to worldwide market approval.
It is well to be noted that VG712 happens to be the first in class and a to-CD3 immunotoxin, which is designed in order to restore the immune function by way of fast depletion. When it comes to patients’ existing T-cell pool, which is a novel therapeutic strategy called immunological reset. By way of targeting T cell dysregulation, which happens to lie at the core of cancers, autoimmune diseases, as well as other conditions, this pathbreaking approach enables the immune system to regrow right from a clean slate and also regain the innate capacity to control diseases, thereby offering new hope for sustained remission and, over a period of time in some cases, a clinical cure.
Optimizing its end-to-end microbial fermentation platform, the DS and DP manufacturing capabilities, which are indeed industry-leading, along with world-class quality systems, WuXi Biologics will help Virogen to advance VG712 from a late-stage development into commercial-scale production. Apparently, VG712 has already received Fast Track designation from the US FDA. And at present there is a very important phase 2 trial that is currently underway. It is worth noting that a Biologics License Application (BLA) submission is targeted somewhere between 2027 and 2028 with an objective to address prominent unmet medical requirements.
Dr. Chris Chen, CEO of WuXi Biologics, stated: “We are delighted to partner with Virogen on this groundbreaking therapy which further demonstrates our capabilities in enabling the Research, Development, and Manufacturing of complex molecules through our integrated microbial fermentation platform. The construction of our Chengdu microbial manufacturing site marks a significant expansion of our global network, allowing us to deliver more agile, efficient, and scalable solutions to our partners. In addition, we can bring more strategic resources to Virogen throughout its development journey. Together, we aspire to drive new breakthroughs in immunotherapy and bring renewed hope to patients worldwide.”
Su Chen, Founder of Virogen, commented: “This collaboration marks a major milestone for Virogen. WuXi Biologics’ strong track record in translating innovative science into commercial therapies makes it an ideal partner as we prepare for VG712’s global launch. We remain committed to delivering transformative treatments in immunotherapy that can truly save lives.”
