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Article source: Medical Rubik's Cube Info
Author: Sunshine
On September 22, the official website of CDE showed that Cinda BioSintilimab injection's new indications for listing application were accepted
Sintilimab (trade name Daboshu) is an innovative PD-1 inhibitor drug jointly developed by Innovent and Eli Lilly
At present, Sintilimab has been approved for four indications in China, namely: for the treatment of relapsed or refractory classic Hodgkin's lymphoma that has undergone at least second-line chemotherapy; combined with pemetrexed and platinum Chemotherapy is used for the first-line treatment of EGFR or ALK-negative advanced non-squamous NSCLC; combined with gemcitabine and platinum-based chemotherapy is suitable for the first-line treatment of non-resectable locally advanced or metastatic squamous NSCLC; combined with Dayton® (bevac Monoclonal antibody injection) is used for the first-line treatment of hepatocellular carcinoma
The marketing application is based on the international multi-center phase III clinical (ORIENT-15) data of combined cisplatin and paclitaxel/cisplatin and 5-fluorouracil for the first-line treatment of advanced or metastatic esophageal squamous cell carcinoma