CHENGDU, China, Sept. 22, 2022 /PRNewswire/ — Keymed Biosciences (HKEX:02162) announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted CMG901 the Breakthrough Therapy Designation for the treatment of advanced gastric and gastroesophageal junction(GEJ) cancer which have relapsed and/or are intolerant to prior therapies.
CMG901 is a Claudin 18.2-targeted antibody-drug conjugate (ADC) developed for the treatment of Claudin 18.2-expressing solid tumors. In April 2022, the U.S. Food and Drug Administration (FDA) granted CMG901 Fast Track Designation[i] and Orphan Drug Designation[ii] as monotherapy for the treatment of unresectable or metastatic gastric and gastroesophageal junction (GEJ) cancer which are resistant/refractory to prior therapies.
About CDE’s Breakthrough Therapy Designation
CDE’s Breakthrough Therapy Designation is designed to expedite the clinical development of innovative drugs presenting significant clinical advantages. A breakthrough therapy must provide effective treatment for a seriously debilitating or life-threatening condition that has no effective therapy or demonstrate substantial improvement over available therapies. According to the CDE, BTD provides opportunities for more intensive CDE guidance and discussion with respect to clinical trials and development strategy, and for priority review later.
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[i] FDA granted CMG901 fast track designation for unresectable or metastatic gastric and gastroesophageal junction cancer which have relapsed and/or are refractory to approved therapies. News release. Keymed Biosciences. April 19, 2022. Accessed September 12, 2022. https://prn.to/3jXET0G
[ii] CMG901 for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma was granted the orphan-drug designation by the Food and Drug Administration of the United States. News release. Keymed Biosciences. April 12, 2022. Accessed September 12, 2022. https://prn.to/3vGqR9o