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March 31, 2025, ShanghaiMarch 31, 2025, Shanghai — Shanghai Joint Biosciences Co., Ltd. announced today that its first-in-class oncolytic vesicular stomatitis virus (VSV) injection, OVV-01, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of soft tissue sarcoma (STS). This designation recognizes OVV-01’s clinical potential in addressing unmet needs for this rare and aggressive malignancy, offering new hope to patients worldwide.

ODD Accelerates Clinical Development to Address Rare Cancers

The FDA’s Orphan Drug Designation incentivizes the development of therapies for diseases affecting fewer than 200,000 patients in the U.S. Benefits include:

7-year market exclusivity post-approval.Tax credits for clinical trial costs.Expedited regulatory pathways (e.g., priority review). These incentives will accelerate OVV-01’s clinical development and global commercialization.

Soft Tissue Sarcoma: An Urgent Unmet Need

Soft tissue sarcoma, a rare and heterogeneous cancer originating in connective tissues, accounts for only 1% of adult malignancies. Characterized by high recurrence, metastasis, and limited treatment options, advanced STS has a dismal 5-year survival rate below 15%. Current therapies (surgery, radiation, chemotherapy) offer limited efficacy, underscoring the critical need for innovative approaches like OVV-01.

Dr. Geroge Zhou, Founder and CEO of Joint Biosciences, stated: "The FDA’s ODD for OVV-01 marks a pivotal milestone in our global strategy to deliver transformative therapies for rare cancers. This designation not only validates OVV-01's innovation but also accelerates its clinical advancement. We will collaborate closely with global regulators and clinicians to expedite development and bring this therapy to patients in need."