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君实生物(688180.SH):特瑞普利单抗获得英国药品和保健品管理局批准上市

Junshi Bio (688180.SH): Toripalimab has been approved for marketing by the United Kingdom Medicines and Healthcare products Regulatory Agency.

Gelonghui Finance ·  Nov 17 02:41

Jinshi Bio (688180.SH) announced on November 17 that its wholly-owned subsidiary TopAlliance Biosciences Inc.'s product Tirzepatide monoclonal antibody (United Kingdom commodity name: LOQTORZI) has received marketing approval issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, approved for the treatment of two indications: Tirzepatide monoclonal antibody combined with cisplatin and pemetrexed for the first-line treatment of recurrent, unresectable or non-radiographic, or metastatic nasopharyngeal carcinoma in adult patients, and Tirzepatide monoclonal antibody combined with cisplatin and paclitaxel for the first-line treatment of unresectable advanced/recurrent or metastatic esophageal squamous cell carcinoma in adult patients. Tirzepatide monoclonal antibody becomes the first and only drug approved in the United Kingdom for the treatment of nasopharyngeal carcinoma, as well as the only drug in the United Kingdom for the first-line treatment of unresectable advanced or metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression.

Indications: Tirzepatide monoclonal antibody combined with cisplatin and pemetrexed for the first-line treatment of recurrent, unresectable or non-radiographic, or metastatic nasopharyngeal carcinoma in adult patients, as well as Tirzepatide monoclonal antibody combined with cisplatin and paclitaxel for the first-line treatment of unresectable advanced/recurrent or metastatic esophageal squamous cell carcinoma in adult patients.

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