According to the latest clinical trial data of the CheckMate-078 (NCT02613507, CTR20150767) of Opdivo (nivolumab) conducted among the Chinese lung cancer patients published by BMS on April 13, Opdivo could significantly benefit the overall survival (HR 0.68, p=0.0006) of Chinese patients with previously treated non-small cell lung cancer (NSCLC) compared to docetaxel, and the results will be reported orally at AACR Annual Meeting 2018 on April 16. Currently, BMS’ nivolumab, MSD’s pembrolizumab, and Junshi Biosciences’ teruipuli monoclonal antibody are in the first echelon of anti-PD-(L)1 antibody marketing in China, and BMS’ Opdivo is very likely to become the first anti-PD-(L)1 antibody to enter China.

I. Update on review progress of the 3 anti-PD-(L)1 antibodies
BMS took the lead in applying for marketing of nivolumab in China on November 1, 2017, to formally start the marketing process in China, which is expected to be formally approved in the second half of 2018.
|
S/N |
Acceptance No. |
Pharmaceutical product name |
Time of entering CDE |
Indication |
Pharmacology and toxicology |
Clinical data |
Pharmacy |
|
11 |
JXSS1700015 |
Nivolumab注射液 Nivolumab injection |
2017-11-01 November 1, 2017 |
经治NSCLC Previously treated NSCLC |
完成 Completed |
完成 Completed |
待审评 To be reviewed |
|
12 |
JXSS1700016 |
Nivolumab注射液 Nivolumab injection |
2017-11-01 November 1, 2017 |
经治NSCLC Previously treated NSCLC |
完成 Completed |
完成 Completed |
待审评 To be reviewed |
|
31 |
JXSS1800002 |
帕博利珠单抗注射液 Pembrolizumab injection |
2018-02-11 February 11, 2018 |
黑色素瘤 Melanoma |
待审评 To be reviewed |
待审评 To be reviewed |
待审评 To be reviewed |
|
37 |
CXSS1800006 |
特瑞普利单抗注射液 Teruipuli monoclonal antibody injection |
2018-03-20 March 20, 2018 |
黑色素瘤 Melanoma ...Read More
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