Ceritinib, a Novartis ALK inhibitor, has been accepted by CDE

Ceratinib, an ALK inhibitor of Novartis, submitted a clinical application in China under the generic name of "seretinib", which was undertaken by CDE on May 22, 2015 and entered the evaluation center In NSCLC patients, about 5% of them may produce rearrangement of the gene of anaplastic lymphoma kinase (ALK), which will accelerate the growth of cancer cells Ceritinib is a small molecule ALK tyrosine kinase inhibitor developed by Novartis for this indication, which is suitable for the patients with relapsed ALK rearrangement NSCLC who have been previously treated with Pfizer crizotinib Certifinib (zykadia) was approved by FDA at the end of April 2014, which is the second ALK inhibitor listed in the world after xalkori Another ALK inhibitor is alectinib developed by Roche, but the drug is only available in Japan and has not yet submitted an application to the FDA Pfizer, as the first-line treatment drug for ALK to rearrange NSCLC, had sales of nearly $440 million in 2014 Bloomberg forecasts that the sales volume of certifinib will reach 423 million US dollars in 2018 Although it can't catch up with Pfizer, certifinib not only won the FDA's breakthrough treatment drug qualification, but also won the UK MHRA's promising innovative drug qualification (PIM) After more than a year of listing in the United States, ceritinib was approved by the European Union in early May 2015 In China, Novartis has finally submitted a clinical application However, there is no doubt that the competition for imitation of domestic certifinib has already begun Since November 2014, three enterprises have applied for the drug ahead of the original research enterprise (see the figure below).