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Drug Name: Carelli Beads Sepsal Sepsati: Injection Application: Clinical TrialS Acceptance No: CXSL2000089 Approval Conclusion: According to the Drug Administration Law of the People's Republic of China and the relevant provisions, reviewed, April 23, 2020 accepted injection carelli In accordance with the relevant requirements of drug registration, it was agreed to conduct a double-blind, randomized, parallel control, multi-center Phase III clinical study (program number: SHR-1210-III-322) for the new complementary treatment of carellizumab combined chemotherapy compared to placebo combined chemotherapy.
injection of Carelli zumas is a humanized anti-PD-1 monoclonal antibody that binds to human PD-1 receptors and blocks the PD-1/PD-L1 pathway to restore the body's anti-tumor immunity, thus forming the basis of cancer immunotherapy.
inquiries, there are currently 3 foreign PD-1 monoclonal antibodies approved for listing, respectively, Paboli Zhu monosar (Mersadong, commodity name Coreida), NavuliYu mono-resist (100-time Meishi Squibb, commodity name Odivo) and cemiplimab (regenerative yuan pharmaceutical, commodity name Libtayo).
Paboli Zhu-Sing and NavuliU-Sing- have been approved for listing in China.
in addition to Hengrui Pharmaceuticals, there are three other PD-1 monoclonal antibodies approved for listing, respectively, Trepri monoantine (Shanghai Junshi, commodity name Toi, approved in 2018), Cindy Singli singantis (Cinda Bio, commodity name Dabershu, approved in 2018) and For reliance Onaji Zhu monoantine (Baiji Shenzhou, commodity name BaiZean, approved in 2019).
querying the IQVIA database, global sales of anti-PD-1 antibodies in 2019 will be approximately $18.809 billion.
so far, the product has invested about 1057.25 million yuan in research and development.
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