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pp-116

Solution for injection/infusion

Dossier type
CTD
Dossier status
Under development
Country of origin
China
Comments
Indication: Advanced or metastatic solid tumors; expanded investigation in high‑risk non‑muscle‑invasive bladder cancer (NMIBC), including BCG‑unresponsive patients where immunotherapy options are limited Clinical stage: Phase I / Phase I–II clinical development globally (multiple open‑label studies in advanced solid tumors and NMIBC) Modality: Biologic (bi‑functional fusion protein / engineered antibody) Mechanism / Target: Binds PD‑L1 to block the PD‑1/PD‑L1 immunosuppressive pathway and delivers attenuated IL‑15/IL‑15Rα sushi domain to the tumor microenvironment to activate NK cells and CD8+ T cells, combining immune checkpoint blockade with cytokine‑driven immune activation Route / form: Intravenous infusion (injection) Differentiation: Designed as a dual‑mechanism cancer immunotherapy combining immune checkpoint blockade with local cytokine stimulation to overcome resistance seen with PD‑(L)1 inhibitors alone; engineered IL‑15 portion aims to increase tolerability and tumor‑focused activation while minimizing systemic toxicity
Manufacturer #39090

Clinical-stage pharmaceutical company focused on oncology, neuroscience, and autoimmune diseases. Develops innovative and generic medicines with growing global ambitions. Strategy includes partnerships and selective international expansion.

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