Beda Pharmaceuticals‘ CFT8919 Capsule Clinical Trial Application Accepted
Time:2024-07-11
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On 9 July, Beda Pharmaceuticals and C4 Therapeutics, Inc. (C4T) received the Notice of Acceptance (Acceptance No. CXHL2400676 and CXHL2400677) from the State Drug Administration (SDA) for its CFT8919 capsule, which is intended to be used in patients with non-small-cell lung cancer carrying EGFR mutations.In December 2023, Beda Pharmaceuticals received approval from the Chinese NMPA to conduct clinical trials for CFT8919 tablets, and the current acceptance is for a clinical trial application for capsules.
CFT8919 is an orally bioavailable variant BiDAC™ degradable agent. In preclinical studies, CFT8919 was shown to be active in ex vivo and in vivo models of EGFR L858R-driven NSCLC, targeting a broad range of on-target resistance mutations with intracranial activity, with the potential to prevent or treat brain metastases in patients.CFT8919 has demonstrated potential to prevent or treat brain metastases in patients by binding to the variant site of the L858R mutation. L858R mutation, CFT8919 demonstrates good selectivity by binding to the variant site and is also effective against EGFR secondary resistance mutations like T790M or C797S mutations. In addition, CFT8919 has good cell proliferation inhibitory activity not only against L858R single mutations but also against L858R secondary resistance mutations generated after ositinib and erlotinib resistance, while demonstrating good EGFR wild-type selectivity.
For the research and development of lung cancer therapeutic drugs, SZEB focuses on the supply of impurity controls for pemetrexed, ositinib, gefitinib and other drugs used in the research, and more information on impurities can be found on the official website: www/ex-biotech.com .
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