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SHANGHAI, May 16, 2022 /PRNewswire/ -- On May 16, 2022, Junshi Bio announced that the company's self-developed anti-PD-1 monoclonal antibody Toripalimab Injection (Tuoyi® ) in combination with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC) was approved by the National Medical Products Administration (NMP.
Esophageal cancer is one of the most common malignant tumors in the digestive tra.
The approval of this new indication is mainly based on data from a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial JUPITER-06 (NCT0382996
The research results of JUPITER-06 were published in Cancer Cell, a top international oncology journal (impact factor: 374
Professor Xu Ruihua, principal investigator of JUPITER-06 and Sun Yat-Sen University Cancer Center, said: "China is one of the countries with a high incidence of esophageal cancer, but due to the different etiology and pathological characteristics of patients in the East and the West, the main subtypes of esophageal squamous cell carcinoma in China are develop.
In overseas markets, Toripalimab has been granted Orphan-drug Designation by the.
"The onset of esophageal cancer is insidious, and many patients are in the advanced stage when they are first diagnos.
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About Toripalimab Injection (Tuoyi®)
Toripalimab injection (Tuoyi®), as the first domestically produced monoclonal antibody targeting PD-1 approved for marketing in China, has been supported by major national science and technology projects and won the highest award in the national patent field "China Patent Gold Awar.
In March 2021, toripalimab was included in the Breakthrough Therapy Drug Program by the NMPA for the first-line treatment of advanced mucosal melano.
Toripalimab started clinical research and development in early 201 So far, more than 30 clinical studies covering more than 15 indications have been carried out around the wor.
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Source: Junshi Biotechnology
