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January 1, 2019

Innovent Announces First Patient Dosed in a Phase III Clinical Trial of Anti-PD-1 Antibody Tyvyt® (Sintilimab injection) as First-line Treatment for Patients with Advanced Esophageal Cancer

SUZHOU, ChinaJan. 1, 2019 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, announced today that the first patient has been dosed in a phase III clinical trial (ORIENT-15) that is to evaluate Tyvyt® (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection), in combination with paclitaxel and cisplatin, as first-line treatment in patients with advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).

The ORIENT-15 study is a randomized, double-blind, multi-center, phase III trial conducted in China to evaluate the efficacy and safety of Tyvyt® (sintilimab injection) or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced, recurrent or metastatic ESCC. The phase III study will enroll 640 patients. The study follows a phase Ib study that evaluated Tyvyt® (sintilimab injection) in patients with esophageal cancer and a phase II study that evaluated Tyvyt® (sintilimab injection) versus paclitaxel/irinotecan as second-line therapy for patients with advanced/metastatic ESCC.

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