Wed Sep 25 03:33:32 UTC 2024: ## Junshi Biosciences’ Toripalimab Approved in Europe for Nasopharyngeal and Esophageal Cancers
**SHANGHAI, Sept. 24, 2024** – Shanghai Junshi Biosciences Co., Ltd. (Junshi Biosciences) announced today that the European Commission (EC) has approved toripalimab (European trade name: LOQTORZI®) for the treatment of two indications: nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC). This approval makes toripalimab the first and only drug in Europe for the treatment of NPC and the only first-line treatment for advanced or metastatic ESCC, regardless of PD-L1 status.
The approval is based on the results of two pivotal Phase III clinical trials, JUPITER-02 and JUPITER-06, which demonstrated significant survival benefits for patients with NPC and ESCC, respectively. In the JUPITER-02 study, toripalimab combined with chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37% compared to chemotherapy alone. In the JUPITER-06 study, toripalimab in combination with chemotherapy showed superior progression-free survival and overall survival in patients with advanced or metastatic ESCC.
“The outstanding results from the JUPITER-02 and JUPITER-06 studies reflect the pioneering leadership of Chinese researchers in the diagnosis, treatment, and clinical research of NPC and EC,” said Professor Ruihua XU, Principal Investigator and President of Sun Yat-sen University Cancer Center. “We hope that this ‘Chinese Solution’ will truly transform the outlook for patients around the world who have long lacked effective treatment options for these cancers.”
This European approval marks a significant milestone for Junshi Biosciences as it expands its global reach. “‘In China, For Global’ has been a core strategic goal of Junshi Biosciences since its inception,” said Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences. “The approval of toripalimab by the EC signifies that, following our success in China and the US, our global commercial strategy has officially expanded into Europe.”
Toripalimab is an anti-PD-1 monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, boosting the immune system’s ability to fight cancer cells. Junshi Biosciences has conducted over forty clinical trials for toripalimab across fifteen indications worldwide, including China, the United States, Southeast Asia, and Europe.
This approval represents a major step forward in the fight against NPC and ESCC and highlights the growing role of innovative therapies from China in addressing global healthcare needs.
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