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france'sPharmaceutical(http://giant Sanofi and its partner Regeneron announced inthat the EuropeanMedicines(http://Authority (http://)(http:// for
human medicine sin
(http:// http://) productsCHMP) has issued an active review recommending conditional approval of PD-1 tumor immunotherapy Libalo (cemiplimab) for treatment in adult patients who are not suitable for metastatic or localized advanced skin squamous cell carcinoma (CSCC) that are not suitable for curative surgery or curative radiotherapynow, CHMP's opinion will be submitted to the European Commission (EC), which will refer to CHMP's opinion and make a final review decision in the next 2-3 monthsCHMP recommended approval of Libtayo, based on open label, multi-center, non-random phase II research EMPOWER-CSCC-1 (Study 1540), and aggregatedanalysis(http://data from two late CSCC extended queues in Phase I (Study 1423)The analysis included a total of 75 patients with metastatic CSCC and 33 patients with local advanced CSCCdata show that the objective remission rate confirmed by Libtayo treatment was 47% (95% CI: 38-57), of which the full remission rate was 4%, and all complete remission occurred in patients with metastatic CSCCAt the time of the last assessment, some patients continued to resonate for more than 15 months, and 61% of patients sustained remission for at least 6 monthsIn terms of safety, the most common adverse reactions include fatigue, rashes and diarrheaAs part of the conditional approval, Sanofi and Regeneration are required to provide additional data from the EMPOWER-CSCC-1 study, including the results of a newly addedTest(http://group to further confirm Libtayo's risk profileLibtayo is a PD-(L)1 tumor immunotherapy that was created and optimized using theVelocimmune technology platform of the Patented(http:// of Regenerative Element
s, and is currently being jointly developed within the framework of the Global Cooperation Agreement with Sanofi for the treatment of a wide range of cancers