Sanhe Pharmaceutical's third-generation EGFR-TKI inhibitor "Oritinib" applied for listing

Article source: Medical Cube Info

Author: Pickup

On December 28, CDE's official website showed that Nanjing Shenghe Pharmaceutical's application for marketing of a new class 1 drug, ouritinib mesylate, was accepted by the NMPA

Oritinib mesylate tablet (SH-1028 tablet) is a third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) mainly developed by Nanjing Shenghe, which irreversibly binds to mutant forms of EGFR (T790M, L858R and Exon 19 deletion), mainly acts on the kinase domain of EGFR, competitively binds to the ATP site on the kinase, inhibits the phosphorylation process of EGFR, and blocks the activation of downstream signaling pathways

At the 2021 World Conference on Lung Cancer (WCLC) held in September 2021, an open-label, multi-center phase Ib clinical study of the efficacy and safety of oclitinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) The results were published in a poster format

The trial results showed that among the 59 subjects with positive EGFR T790M mutation, the ORR assessed by BICR was 57.

In terms of safety, among all study drug-related adverse events (TRAEs), most were mild or moderate, and only 10 (16.

Up to now, three third-generation EGFR-TKIs have been launched in China.

Hansoh Ametinib is the first domestically produced third-generation EGFR-TKI approved for marketing in China, and has been approved by the NMPA for first-line and second-line treatment of NSCLC

Alis Pharmaceuticals' fumetinib is the third EGFR-TKI approved for marketing in China.

In addition, there are Betta Pharmaceuticals (befotinib), Hequan Pharmaceuticals (Rizaltinib), Essen Pharmaceuticals (avitinib), and Osaikang (ASK120067) to apply for the launch of their respective third-generation EGFR-TKI new drugs.

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