{"id":1980,"date":"2022-11-24T06:03:51","date_gmt":"2022-11-24T06:03:51","guid":{"rendered":"https:\/\/dianhuaminglu.com\/%e5%90%9b%e5%ae%9e%e7%94%9f%e7%89%a9%e5%ae%a3%e5%b8%83%e3%80%8a%e6%96%b0%e8%8b%b1%e6%a0%bc%e5%85%b0%e5%8c%bb%e5%ad%a6%e6%9d%82%e5%bf%97%e3%80%8b%e5%8f%91%e8%a1%a8%e5%8f%a3%e6%9c%8d%e6%8a%97%e6%96%b0\/"},"modified":"2023-03-17T06:18:31","modified_gmt":"2023-03-17T06:18:31","slug":"%e5%90%9b%e5%ae%9e%e7%94%9f%e7%89%a9%e5%ae%a3%e5%b8%83%e3%80%8a%e6%96%b0%e8%8b%b1%e6%a0%bc%e5%85%b0%e5%8c%bb%e5%ad%a6%e6%9d%82%e5%bf%97%e3%80%8b%e5%8f%91%e8%a1%a8%e5%8f%a3%e6%9c%8d%e6%8a%97%e6%96%b0","status":"publish","type":"post","link":"https:\/\/dianhuaminglu.com\/en\/%e5%90%9b%e5%ae%9e%e7%94%9f%e7%89%a9%e5%ae%a3%e5%b8%83%e3%80%8a%e6%96%b0%e8%8b%b1%e6%a0%bc%e5%85%b0%e5%8c%bb%e5%ad%a6%e6%9d%82%e5%bf%97%e3%80%8b%e5%8f%91%e8%a1%a8%e5%8f%a3%e6%9c%8d%e6%8a%97%e6%96%b0\/","title":{"rendered":"Junshi Biosciences Announces Submission of a Marketing Authorization Application for Toripalimab to the UK Medicines and Healthcare Products Regulatory Agency"},"content":{"rendered":"\n
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SHANGHAI, China, November 24, 2022 (GLOBE NEWSWIRE) \u2013 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 today that the company has submitted a marketing authorization application (\u201cMAA\u201d) to the United Kingdom\u2019s Medicines and Healthcare products Regulatory Agency (\u201cMHRA\u201d) for toripalimab. The indications requested in the MAA are: 1) Toripalimab, in combination with cisplatin and gemcitabine, for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (\u201cNPC\u201d) and 2)Toripalimab, in combination with paclitaxel and cisplatin, for the first-line treatment of patients with unresectable locally advanced\/recurrent or metastatic esophageal squamous cell carcinoma (\u201cESCC\u201d). Junshi Biosciences also submitted a MAA to the European Medicines Agency (\u201cEMA\u201d) for toripalimab for the same indications in mid-November.<\/p>\n\n\n\n
\u201cWithin a single month, we were able to submit marketing authorization applications for toripalimab to two major European regulatory agencies,\u201d said Dr. Patricia Keegan, Chief Medical Officer of Junshi\/TopAlliance Biosciences. \u201cThis is emblematic of our determination and corporate efficiency in bringing innovative drugs to patients worldwide. In the coming days, we will work closely with the MHRA to promote the clinical development and application of emerging therapies in the UK.\u201d<\/p>\n\n\n\n
The MAA submission for NPC and ESCC is based on the results from JUPITER-02 (an international randomized, placebo-controlled, double-blinded Phase III trial, NCT03581786) and JUPITER-06 (a randomized, placebo-controlled, double-blinded, multi-center Phase III trial, NCT03829969).<\/p>\n\n\n\n
The JUPITER-02 results were first presented in the plenary session of the American Society of Clinical Oncology (\u201cASCO\u201d) 2021 annual meeting (#LBA2) and subsequently published in detail as the cover article of the September 2021 issue of Nature Medicine<\/em><\/a>. According to its final progression-free survival (PFS) analysis, the toripalimab plus chemotherapy arm had a significantly longer PFS than the placebo plus chemotherapy arm as assessed by a blinded independent radiology committee (BIRC) with median PFS of 21.4 vs. 8.2 months, hazard ratio (HR)=0.52 (95% CI: 0.37-0.73), two-sided p<0.0001.<\/p>\n\n\n\n In 2021, two indications for the treatment of NPC were approved by the China National Medical Products Administration (\u201cNMPA\u201d), thereby making toripalimab the world\u2019s first immune checkpoint inhibitor approved for the treatment of NPC. In the the United States, the NPC indications of toripalimab have been granted 2 Breathrough Therapy Designations and 1 Orphan Drug Designaion by the Food and Drug Administration (\u201cFDA\u201d), while the Biologics License Application (\u201cBLA\u201d) for toripalimab for the treatment of NPC is under review. If approved, toripalimab will be the first and only drug approved for the treatment of NPC in the U.S. In Europe, toripalimab was designated as an orphan medicinal product by the European Commission (\u201cEC\u201d) for the treatment of NPC.<\/p>\n\n\n\n