Beda Pharmaceuticals: Ektinist tablets of hydrochloric acid are officially entering the CDE priority review process.

Drug Basics Product Name: Ektini tablets hydrochloric acid Application: Domestic production drug registration Applicant: Beida Pharmaceutical Co., Ltd. Acceptance Number: CXHS2000030 Country Registration Classification: Chemicals 2.4 Types of Adaptation: Non-small cell lung cancer (NSCLC) patients with sensitive mutations in the skin growth factor (EGFR) gene assisted treatment.
Reasons for Priority Review: After examination, this application complies with the relevant requirements of the Measures for the Administration of Drug Registration and the Announcement of the State Drug Administration on the Release of the Procedure for the Review of Breakthrough Therapeutic Drugs (Trial) and Other Three Documents (No. 82 of 2020), and agrees to be incorporated into the priority review and approval procedure in accordance with the priority review scope (6) the State Drug Administration's provisions for other priority review and approval.
Ektini is the company's independent research and development of China's first small molecule with independent intellectual property rights to target anti-cancer drugs, its efficacy is accurate, low hepatotoxicity, high safety, evidence-based medical clinical evidence is rich, Chinese groups of data, in the CSCO guidelines, health care committee Medical norms and brain transfer population, 21-L858R NSCLC patients were recommended as a priority, is currently the only one to continue the follow-up free drug program of the generation of EGFR-TKI original research drugs, compared with competing products have a significant differentiation advantage.
Extoni's application for a listing license for postoperative assisted therapy was approved by NMPA on September 22, 2020, and this time it was included in the priority review process, which will strongly promote the early approval of ecstasy-assisted therapy indications, further strengthen Ektini's differentiated competitive advantage, and provide a highly effective postoperative assistive treatment pathway for early NSCLC patients with EGFR gene-sensitive mutations.
source: Beda Pharmaceuticals Company Announcement.