Osecon announced that Jiangsu Aosaikang Biomedical Co., Ltd., a subsidiary of the company, recently received the “Notice of Acceptance” from the State Drug Administration, and the application for registration and marketing license for the domestic production of the company's innovative drug olmetotazumab injection was accepted. The key phase III clinical trial of the drug combined with tirelizumab and chemotherapy for first-line treatment of CLDN18.2 positive gastric or gastroesophageal junction adenocarcinoma has reached the main end point of progression-free survival assessed by an independent review committee; compared with the control group, this indicator showed statistically significant and clinically significant improvements. Marketing applications still need to go through review, on-site inspection and approval of drug clinical trials, etc., and the timing and results of drug registration approval are uncertain.

Zhitongcaijing · 1d ago
Osecon announced that Jiangsu Aosaikang Biomedical Co., Ltd., a subsidiary of the company, recently received the “Notice of Acceptance” from the State Drug Administration, and the application for registration and marketing license for the domestic production of the company's innovative drug olmetotazumab injection was accepted. The key phase III clinical trial of the drug combined with tirelizumab and chemotherapy for first-line treatment of CLDN18.2 positive gastric or gastroesophageal junction adenocarcinoma has reached the main end point of progression-free survival assessed by an independent review committee; compared with the control group, this indicator showed statistically significant and clinically significant improvements. Marketing applications still need to go through review, on-site inspection and approval of drug clinical trials, etc., and the timing and results of drug registration approval are uncertain.