Baili Tianheng (688506.SH): Phase III clinical trial of Yizekang® for maintenance treatment of non-resectable EGFR mutant non-small cell lung cancer after simultaneous radiotherapy completed the first patient enrollment

Zhitong Finance App News, Baili Tianheng (688506.SH) announced that the world's first (First-in-class), New Concept (New Concept), and the world's first and only EGFR × HER3 dual antibody ADC, Yizekang® (lenkang elontolumab, BL-B01D1/iza-Bren) is used to treat patients with unresectable EGFR mutant stage III non-small cell lung cancer that did not progress after platinum-containing chemoradiotherapy compared with BL-B01D1 in patients with stage III non-small cell lung cancer The phase III randomized controlled clinical trial of tinib monotherapy (PanKu-lung08) recently completed the first patient enrollment.

Up to now, Yizekang® has conducted over 45 clinical trials on various tumor types in China and the US, including 20 phase III clinical studies (including phase II/III). Yizekang® has been included in the list of breakthrough treatment varieties by the Drug Evaluation Center (CDE) of the China Drug Administration (CDE), 2 indications have been included in the CDE list of priority review varieties, and 1 indication has been included in the list of breakthrough treatment varieties by the US Food and Drug Administration (FDA).

Yizekang® has obtained marketing approval from the National Drug Administration (NMPA) for 2 indications for recurrent or metastatic nasopharyngeal cancer and recurrent or metastatic esophageal squamous cell carcinoma; the drug marketing application (NDA) for the treatment of locally advanced or metastatic triple-negative breast cancer has also been accepted by CDE; it is used to treat locally advanced or metastatic EGFR mutant non-small cell lung cancer and HR+HER2- breast cancer, and a total of 2 midterm analyses reached the main end.