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Fast Track Designation (FTD), established by the U.S. FDA, aims to accelerate the development of novel drugs for serious diseases with unmet clinical needs.

Following the granting of FTD, applicants gain enhanced opportunities for communication with the FDA during subsequent drug development and review processes. This facilitates early identification and resolution of issues in development, thereby expediting the drug’s approval and commercialization. Additionally, applicants may submit investigational data for New Drug Applications (NDA/BLA) via a rolling submission, significantly streamlining the regulatory pathway. These benefits will strongly support the rapid development and approval of OVV-01, accelerating its journey to market.

Dr. Zhou Guoqing, Founder and CEO of Joint Bisciences, commented: "We are very pleased to achieve consecutive milestones in the field of oncolytic virus development. The FTD designation will accelerate the clinical development of OVV-01 and underscores its potential to address serious diseases and unmet clinical needs, as recognized by the U.S. FDA. We will actively engage with the FDA to expedite the commercialization of this therapy and strive to provide safer, more effective treatment options for advanced soft tissue sarcoma patients worldwide."

About OVV-01

OVV-01 is a recombinant vesicular stomatitis virus (VSV) engineered to carry the NY-ESO-1 tumor-associated antigen. It selectively replicates within tumor cells, lysing them and releasing tumor antigens while expressing the highly immunogenic NY-ESO-1 antigen. This dual mechanism modulates the tumor immune microenvironment, induces tumor-specific immune responses, and promotes T-cell activation, expansion, and recruitment. By enhancing T-cell infiltration into tumors and counteracting immunosuppression, OVV-01 achieves potent antitumor activity.