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RTNominal up67.850 +2.250 (+3.430%)

23/09/2021 10:27

Innovent Bio (01801) gets sNDA accepted

[ET Net News Agency, 23 September 2021] Innovent Biologics, Inc. (01801) said the
National Medical Products Administration (the NMPA) has accepted the supplemental New Drug
Application (sNDA) for TYVYT (sintilimab injection) in combination with chemotherapy
(cisplatin plus paclitaxel/cisplatin plus 5-fluorouracil) for the first-line treatment of
esophageal squamous cell carcinoma (ESCC).
The sNDA application is based on the interim analysis of the global randomized,
double-blind, multi-centre Phase 3 ORIENT-15 clinical trial, which evaluated sintilimab in
combination with chemotherapy compared to placebo in combination with chemotherapy as
first-line therapy for ESCC. (RC)

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