JUNSHI BIO (688180.SH): Teplizumab Obtained Approval for Marketing by the European Commission.

JUNSHI BIO (688180.SH) announced that recently, the company's product Toripalimab (European trade name: LOQTORZI) has been approved by the European Commission (EC) for two indications: Toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of recurrent, unresectable or non-radiation, 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. This approval applies to all 27 member states of the European Union as well as Iceland, Norway, and Liechtenstein. Toripalimab has become the first and only drug in Europe for the treatment of nasopharyngeal cancer, as well as the only drug in Europe for first-line treatment of unresectable or metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression. According to the announcement, in terms of international deployment, Toripalimab was approved for marketing in the United States as the first drug for nasopharyngeal cancer in October 2023. In September 2024, Toripalimab for first-line treatment of advanced nasopharyngeal cancer and esophageal squamous cell carcinoma received approval from the European Commission for marketing. In addition, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has accepted applications for marketing authorization for Toripalimab in combination with cisplatin and gemcitabine for first-line treatment of locally recurrent or metastatic nasopharyngeal cancer patients, and in combination with paclitaxel and cisplatin for first-line treatment of unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma patients. The Therapeutic Goods Administration (TGA) in Australia and the Health Sciences Authority (HSA) in Singapore have respectively accepted applications for marketing authorization for Toripalimab in combination with cisplatin/gemcitabine for first-line treatment of metastatic or recurrent locally advanced nasopharyngeal cancer in adults, as well as for the treatment of recurrent, unresectable, or metastatic nasopharyngeal cancer in adults who have had disease progression following prior platinum-containing therapy or treatment. The publicly listed company stated that this approval applies to all 27 member states of the European Union as well as Iceland, Norway, and Liechtenstein, making Toripalimab the first and only drug in Europe for the treatment of nasopharyngeal cancer, and also the only drug in Europe for first-line treatment of unresectable or metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression. The European market is an important part of the company's overseas commercialization strategy, and this approval is favorable for the company to further expand its overseas market, enhance the international influence of its products, and is expected to have a positive impact on the company's long-term operational performance.