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君实生物(01877):特瑞普利单抗获得欧洲药品管理局人用药品委员会积极意见

Junshi Bio (01877): Teriprizumab received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency.

Zhitong Finance ·  Jul 26 09:44

Junshi Bio (01877) announced that Teripulidumab (European commodity name: LOQTORZI) ...

Junshi Bio (01877) announced that the application for the marketing authorization of Teripulidumab (European commodity name: LOQTORZI) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending its approval for two indications: Teripulidumab combined with cisplatin and gemcitabine for first-line treatment of recurrent, unresectable or metastatic nasopharyngeal carcinoma in adults who are not suitable for curative treatment with surgery or radiotherapy, and Teripulidumab combined with cisplatin and paclitaxel for first-line treatment of unresectable advanced/recurrent or metastatic esophageal squamous cell carcinoma in adults. The European Commission will take into account the positive opinion of CHMP in order to make the final approval decision for Teripulidumab's marketing authorization application.

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