Innovent Reports sNDA Acceptance of Tyvyt (sintilimab) + Byvasda (biosimilar, bevacizumab) as 1L Therapy for Hepatocellular Carcinoma

Shots:

• The acceptance of sNDA is based on P-III ORIENT-32 study assessing in sintilimab + bevacizumab vs sorafenib in 571 subjects in a ratio (2:1) as 1L treatment for patients with advanced HCC
• The study met the pre-defined efficacy criteria which showed significant improvement in OS and PFS as assessed by IRRC
• This marks the fifth NDA application of Tyvyt that has been accepted for review by NMPA. Meanwhile, the application also seeks the fourth indication for Byvasda

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