Exclusive Summary

• World's First Nebulized Oncolytic Virus Delivery: Pioneers a non-invasive nebulization route for pulmonary tumors (primary & metastatic), enabling access to deep lesions and significantly improving patient compliance, with validated safety in IITs.
• Robust Clinical Proof-of-Concept (PoC) Data: IIT data demonstrates a best ORR of 27.3% and DCR of 81.8%, with a median OS of 8.62 months, outperforming PD-1 monotherapy in similar settings; achieved up to 422 days survival in recurrent Glioblastoma (GBM).
• Distinct NK-Cell Dependent Mechanism: Unlike traditional T-cell dependent OV therapies, it primarily relies on NK cells for anti-tumor effects and reverses PD-L1 expression. An oncolytic virus based on the recombinant human adenovirus type 5 and carrying the L-IFN gene exerts its antitumor effects through the coordinated action of multiple targets and pathways.
• Dual US/China Regulatory Clearance: UB085 has secured US FDA IND approval, while the parallel UB084 program is in Phase IIa in China, offering a derisked asset with clear global rights available for licensing.

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