Blog Big Molecule Watch January 06, 2022

China Accepts Innovent Biologics’ Supplemental New Drug Application for Sintilimab Plus Bevacizumab Biosimilar Injection

On December 24th, 2021, Innovent Biologics announced that China’s National Medical Products Administration had accepted its Supplemental New Drug Application (sNDA) for TYVYT®, a sintilimab plus bevacizumab biosimilar injection and chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung-cancer (nsqNSCLC) who progressed after EGFR-TKI therapy.

The sNDA is based on a random, double-blind multi-center Phase 3 clinical trial that evaluated sintilimab in combination with or without bevacizumab biosimilar and chemotherapy compared to placebo in combination with chemotherapy for patients with EGFR-mutated nsqNSCLC who had disease progression after EGFR-TKI therapy.  According to the press release, the study showed that sintilimab in combination with bevacizumab and chemotherapy demonstrated a statistically significant improvement in the primary endpoint of IRRC-assessed progression-free survival compared to a placebo in combination with chemotherapy.  The press release also noted that additional key secondary endpoints also improved when using the sintilimab, bevacizumab and chemotherapy combination.  Dr. Hui Zhou, the Senior Vice President of Innovent, explained that the approval represented “an important milestone in demonstrating the potential value of sintilimab plus bevacizumab and chemotherapy in patients with EGFR-mutated nsqNSCLC who progressed after EGFR-TKI therapy.”

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