According to the information updated on the website of the National Medical Products Administration of China (NMPA) on May 30, the marketing approval progress of the Camrelizumab for Injection independently developed by Hengrui Medicine was updated to "Approval completed-to be issued certificate", which means that the camrelizumab of Hengrui will finally be marketed after 15 months!
As the third Chinese-produced anti-PD-1 monoclonal antibody approved for marketing in China, the marketing of camrelizumab means the ending of the marketing speed competition of the anti-PD-1 monoclonal antibody drugs in China and beginning of the next stage of competition for layouts centering on multiple new indications.
5 anti-PD-1 monoclonal antibody products approved for marketing in China
There have been 5 anti-PD-1 monoclonal antibody drugs marketed in China so far, including 2 imported products and 3 Chinese-produced products.
On May 30 when the inside information that Hengrui obtained the approval for its anti-PD-1 monoclonal antibody camrelizumab was flooding the screen, BeiGene announced its supplemental new drug application (sNDA) of the anti-PD-1 tislelizumab for urothelial carcinoma (UC) had been accepted by the NMPA. The first marketing application of tislelizumab in China for the treatment of relapsed/refractory classical Hodgkin lymphoma was accepted by CDE in Sep. 2018, which received the priority review in November of the same year and is currently "under review and approval". It is expected to become the 6th drug in its class approved in China.
Anti-PD-1 Monoclonal Antibodies Approved/to be Approved in the Chinese Market
Anti-PD-1 Monoclonal Antibodies Approved/to be Approved in the Chinese Market | |||
Drug name | Applying enterprise | Approval time/progress | Imported/Chinese-produced |
Nivolumab | BMS | June 2018 | Imported |
Pembrolizumab | MSD | July 2018 | Imported |
Toripalimab | Junshi Biosciences | Dec. 2018 | Chinese-produced |
Sintilimab | Innovent | Dec. 2018 | Chinese-produced |
Camrelizumab | Jiangsu Hengrui | May 2019 | Chinese-produced |
Tislelizumab | BeiGene | Under review and approval | Chinese-produced |
"All roads lead to Rome": layouts of multiple clinical indications
As broad-spectrum anticancer drugs marketed early, anti-PD-1 monoclonal antibodies represented by BMS’ nivolumab (Opdivo) and MSD’s pembrolizumab (Keytruda) have been approved many indications worldwide: Opdivo has been approved 11 indications and Keytruda has been approved 12 indications so far.









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