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君实生物(688180.SH)：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 (688180.SH): The trupli monoclonal antibody has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency.

Gelonghui Finance ·  Jul 28 03:45

On July 28th, Glonhui reported that Junshi Bio (688180.SH) announced that the application for the marketing license of the company's product, Toripalimab (European commodity name: LOQTORZI), has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which recommends its approval for the treatment of two indications: toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of recurrent, unresectable or metastatic nasopharyngeal carcinoma in adults, and toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of unresectable, advanced/recurrent or metastatic esophageal squamous cell carcinoma in adults. The European Commission (EC) will take the positive opinion of the CHMP into consideration in order to make a final evaluation decision on the application for Toripalimab's marketing license. The approval of the marketing license application is uncertain.

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