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On May 30, the NMPA official website revealed that the listing application for new indications of Sintilimab (acceptance number: CXSS2000043) has entered the "under review" status and is expected to be approved in the near future.
It is worth mentioning that the indications of Sintilimab for the first-line treatment of non-squamous NSCLC were approved in February this year, and the indications for the second-line treatment of squamous NSCLC were also declared in January.
Last Friday (May 27), the listing application has left the new newspaper task queue.
In May 2020, Cinda and Eli Lilly announced that a randomized, double-blind, phase III controlled clinical study (ORIENT-12) of Sintilizumab has reached the primary study endpoint.
The ORIENT-12 study is a randomized, double-blind, phase III controlled clinical study evaluating the effectiveness and safety of sintilimab or placebo combined with gemcitabine and platinum for the first-line treatment of advanced or metastatic squamous NSCLC (NCT03629925 ), a total of 57 subjects were enrolled.
The results showed that the combination therapy of sintilimab significantly prolonged the progression-free survival (PFS).
Currently, Sintilimab has applied for a total of 5 indications.
Sintilimab indication status
According to Cinda's announcement, the sales of Sintilimab in 2021 Q1 has exceeded 700 million yuan.
About 35% of Chinese NSCLC patients are squamous NSCLC.
Note: The original text has been deleted
