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Article source: Medical Rubik's Cube Info
On June 3, the official website of the National Medical Products Administration (NMPA) showed that the innovative PD-1 inhibitor Sintilimab injection jointly developed by Innovent and Eli Lilly was used in the first-line squamous non-small cell lung cancer (sqNSCLC) The new indication for treatment (acceptance number: CXSS2000043) was officially approved by NMPA, which is the third indication for the product to be approved
.
Sintilimab was developed by Cinda Biologics in the early stage and reached a licensing agreement with Eli Lilly in 2015 to start joint development
.
Sintilimab was officially approved in China in December 2018 for the treatment of relapsed/refractory classic Hodgkin’s lymphoma, and was approved in China in February 2021 for combined pemetrexed and platinum For first-line treatment of non-squamous NSCLC
The approval of this indication is based on a randomized, double-blind, phase III controlled clinical study (ORIENT-12).
ORIENT-12 is the world's first PD-1 monoclonal antibody combined with gemcitabine and platinum (GP regimen) for advanced sqNSCLC A randomized, double-blind, phase III controlled clinical study of first-line treatment
.
A total of 357 subjects were enrolled in the study.
At the 2020 ESMO conference, Cinda announced the results of the study.
The mid-term analysis showed that the Sintilimab combination group significantly prolonged the progression-free survival (PFS)
.
The latest analysis showed that the median PFS assessed by the Independent Imaging Committee (IRRC) in the Sintilimab combination group and the chemotherapy group were 5.
In addition to the three approved indications, the listing application of Sintilizumab for the second-line treatment of squamous NSCLC and the first-line treatment of liver cancer in combination with Dayoto (bevacizumab) has also been accepted by the NMPA in January this year
.
At present, a total of 8 PD-1/PD-L1 monoclonal antibodies have been approved for marketing in China, including 4 domestically produced first-echelon PD-1 models, from Junshi, Xinda, BeiGene, Hengrui, and these 4 drugs All have been included in the 2020 medical insurance catalogue
.
In terms of approved indications, Hengrui PD-1 monoclonal antibody has been approved for 5 indications, and 3 of the other three have been approved
Domestic PD-1/L1 application and approval status
From the perspective of sales in 2020, Hengrui Carrelizumab has the highest sales, reaching 4.
5 billion yuan, followed by Cinda Sindilizumab (2.
29 billion yuan) and BeiGene Tilelizumab ( 1.
127 billion yuan), Junshi Teriplimumab (1.
003 billion yuan)
.
In terms of internationalization, with the exception of Hengrui, the other three companies have reached cooperative development agreements with foreign companies.
Domestic PD-1 sales
