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newscratchers| Kangfang Biotech: The new drug Idafone ® has been approved by the State Food and Drug Administration for marketing

Pets 2024-05-24 12:58 23 editor

newscratchers| Kangfang Biotech: The new drug Idafone ® has been approved by the State Food and Drug Administration for marketing

Kangfang Biotech (09926) issued an announcementnewscratchers, China's State Food and Drug Administration has approved the new drug marketing application for the company's independently developed new bispecific antibody drug, Idafone ® (Evosil Injectable, PD-1/ VEGF). The indication is combination chemotherapy for the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer that has progressed after treatment with epidermal growth factor receptor tyrosine stimulation inhibitors.

The NMPA approval for marketing of Idarfang ® is based on AK112 - 301/ HARMONi-A (CTR20213079), a randomized, double-blind, multicenter phase III clinical study conducted in China. The primary endpoint of the study is progression-free survival (PFS) and the secondary endpoint is overall survival (OS).

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