About Toripalimab<\/strong><\/p>\n\n\n\n Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system\u2019s ability to attack and kill tumor cells.<\/p>\n\n\n\n More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and Europe. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.<\/p>\n\n\n\n In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI\u00ae). Currently, there are six approved indications for toripalimab in China:<\/p>\n\n\n\n <\/p>\n\n\n\n The first three indications have been included in the National Reimbursement Drug List (NRDL) (2022 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma.<\/p>\n\n\n\n In the United States, the Biologics License Application (BLA) for toripalimab in combination with gemcitabine\/cisplatin for the first-line treatment of patients with advanced recurrent or metastatic NPC and toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy is under review by the U.S. Food and Drug Administration (\u201cFDA\u201d). The FDA has granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (SCLC).<\/p>\n\n\n\n In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the United Kingdom\u2019s Medicines and Healthcare products Regulatory Agency (MHRA) for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced\/recurrent or metastatic ESCC, in December 2022 and February 2023.<\/p>\n\n\n\n SHANGHAI, China, May 23, 2023 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (\u201cJunshi Biosciences\u201d, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the National Medical Products Administration (\u201cNMPA\u201d) has accepted the supplemental new drug application (“sNDA\u201d) for the company\u2019s anti-PD-1 monoclonal antibody, toripalimab, used in combination with albumin-bound paclitaxel for the treatment of PD-L1 positive (CPS \u2265 1) untreated metastatic or recurrent metastatic triple-negative breast cancer (\u201cTNBC\u201d).<\/p>\n","protected":false},"author":3,"featured_media":2262,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[22],"tags":[],"yoast_head":"\n\n
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