Celltrion (KRX:068270) has submitted a marketing authorization application to South Korea's Ministry of Food and Drug Safety for CT-P51, its biosimilar candidate to the cancer drug Keytruda, according to a Monday filing with the Korea Exchange.
Keytruda is a prescription immunotherapy medicine used to treat various types of cancer.
The application, submitted Aug. 21, takes into account several cancer indications, including melanoma, non-small cell lung cancer, urothelial cancer, esophageal cancer, gastric cancer, endometrial carcinoma, cervical cancer, and triple-negative breast cancer.
The marketing authorization application was supported by a double-blind, randomized, active-controlled, parallel-group phase one trial involving 228 patients with resected melanoma.
Shares of Celltrion rose nearly 1% in recent trade.