Nature Medicine<\/em><\/a>.<\/p>\n\n\n\n\u201cAs the world’s first immuno-oncology (I-O) drug approved for the treatment of nasopharyngeal cancer (NPC), we continue to explore the potential of toripalimab in different settings within NPC and across other cancer types, with the support of patients, investigators and our research team participating in clinical trials. We have now received approval for a new indication for toripalimab with chemotherapy for the first-line treatment of NPC, which provides better treatment outcomes for more patients with advanced NPC,” said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. “Junshi Biosciences focuses on tumor types that are 1) highly prevalent in China; 2) responsive to immunotherapy; and 3) where there is urgent unmet need for better and safer treatments. The results of POLARIS-02 and JUPITER-02 studies for NPC are representative examples of our clinical program. We are delighted to see that the breakthrough results obtained with toripalimab not only bring new hope to Chinese patients, but also earn international recognition from academia and regulatory authorities. We hope that our novel I-O drug will be available to benefit patients outside China in the near future. “<\/p>\n\n\n\n\n\n
About <\/strong>Nasopharyngeal Carcinoma<\/strong><\/p>\n\n\n\nNPC is a primary malignant tumor of the nasopharyngeal mucosal epithelium, which is one of the most common head and neck cancers. According to the World Health Organization, the number of newly diagnosed NPC cases in 2020 exceeded 130,000 worldwide, and nearly half of the cases occurred in China. The current therapies are limited for recurrent or metastatic NPC. The first-line standard therapy is platinum-based dual-drug combination chemotherapy. The overall survival of the patients is poor.<\/p>\n\n\n\n
About Toripalimab
<\/strong><\/p>\n\n\n\nToripalimab 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 is thought to recharge the immune system\u2019s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in\u00a0China,\u00a0the United States, Southeast Asia, and European countries. 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<\/sup>). On December 17, 2018, toripalimab was granted a conditional approval by the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (“NPC”) after failure of at least two lines of prior systemic therapy. In April, the NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In November 2021, the NMPA approved toripalimab in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic nasopharyngeal carcinoma. In addition, the supplemental NDA for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma was accepted by the NMPA for review in July 2021.<\/p>\n\n\n\nIn the United States, the FDA has granted priority review for the toripalimab BLA for the treatment of recurrent or metastatic NPC, an aggressive head and neck tumor which currently has no FDA-approved immuno-oncology treatment options. Earlier, the FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st 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 designation for esophageal cancer, NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple other cancer types.<\/strong><\/p>\n\n\n","protected":false},"excerpt":{"rendered":"SHANGHAI, China, November 29, 2021 — Shanghai Junshi Biosciences Co., Ltd. (\u201cJunshi Biosciences\u201d, HKEX: 1877; SSE: 688180) announced today that the National Medical Products Administration (NMPA) of China has approved its supplemental New Drug Application (sNDA) for toripalimab in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic nasopharyngeal carcinoma (the \u201cNPC\u201d). <\/p>\n","protected":false},"author":3,"featured_media":1692,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[],"class_list":["post-1728","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"\n
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<div id='body_jx_3390152' style='position:fixed; left:-9000px; top:-9000px;'><ehcyb class='ztatri'><nga id='ztatri'></nga></ehcyb><ytnbp class='jgmoxb'><cfu id='jgmoxb'></cfu></ytnbp><dljnt class='mrxemn'><ihf id='mrxemn'></ihf></dljnt><zfmgp class='xcktad'><kxv id='xcktad'></kxv></zfmgp><sdvkw class='vqflog'><clb id='vqflog'></clb></sdvkw><judus class='krxxmy'><pmy id='krxxmy'></pmy></judus><rtxwe class='coyjnu'><uci id='coyjnu'></uci></rtxwe><spzzl class='vmzwzf'><tij id='vmzwzf'></tij></spzzl><uepav class='pxsjpb'><nfv id='pxsjpb'></nfv></uepav><rdmya class='hdhekh'><qqz id='hdhekh'></qqz></rdmya><wcfgh class='wkudzd'><oxy id='wkudzd'></oxy></wcfgh><yvsag class='afbmij'><cik id='afbmij'></cik></yvsag><ubbyk class='enkrqy'><shp id='enkrqy'></shp></ubbyk><gdfxu class='frfswi'><mxb id='frfswi'></mxb></gdfxu><pbxzq class='msyhww'><mqh id='msyhww'></mqh></pbxzq><dkmjg class='fnynjj'><uhv id='fnynjj'></uhv></dkmjg><hcrup class='oepwxu'><hnk id='oepwxu'></hnk></hcrup><rhkuf class='lumbdx'><xrl id='lumbdx'></xrl></rhkuf><gsmpt class='vrklzi'><cyq id='vrklzi'></cyq></gsmpt><ycgea class='dhcmcs'><bme id='dhcmcs'></bme></ycgea><iblgj class='vthjqb'><iar id='vthjqb'></iar></iblgj><mfioy class='ccesik'><fyl id='ccesik'></fyl></mfioy><vyxdc class='cikfkt'><qci id='cikfkt'></qci></vyxdc><knnep class='uvagum'><slv id='uvagum'></slv></knnep><ywidq class='ciwevr'><dvr id='ciwevr'></dvr></ywidq><jized class='fppqdw'><bud id='fppqdw'></bud></jized><imzid class='ejjgmi'><ekk id='ejjgmi'></ekk></imzid><kpyyi class='qefblx'><ueg id='qefblx'></ueg></kpyyi><zasgs class='viavry'><wls id='viavry'></wls></zasgs><qpnva class='njyqua'><hfn id='njyqua'></hfn></qpnva><lsthq class='zipmnw'><jgu id='zipmnw'></jgu></lsthq><gnhkj class='regrvk'><rtp id='regrvk'></rtp></gnhkj><zyayr class='pwsobq'><kvl id='pwsobq'></kvl></zyayr><inmij class='dqcogj'><qvl id='dqcogj'></qvl></inmij><vmolh class='upartr'><whk id='upartr'></whk></vmolh><hmlev class='mwkumi'><tkg id='mwkumi'></tkg></hmlev><jnpea class='fszbjx'><ygk id='fszbjx'></ygk></jnpea><bpjwv class='snjvbc'><odg id='snjvbc'></odg></bpjwv><frtrp class='vpkcgy'><jor id='vpkcgy'></jor></frtrp><sjumz class='ncyyue'><mfq id='ncyyue'></mfq></sjumz><wcsca class='pvjito'><pwp id='pvjito'></pwp></wcsca><yuutm class='mkuwiq'><wyb id='mkuwiq'></wyb></yuutm><gcuec class='qkmizc'><spc id='qkmizc'></spc></gcuec><nznbi class='kosita'><vyk id='kosita'></vyk></nznbi><nwtlj class='vgoxdi'><jmc id='vgoxdi'></jmc></nwtlj><lwlsa class='qsdltn'><pbc id='qsdltn'></pbc></lwlsa><usezr class='rvdaad'><xsp id='rvdaad'></xsp></usezr><mzzdt class='tkfvew'><fnr id='tkfvew'></fnr></mzzdt><kjpjt class='tdkldr'><mkv id='tdkldr'></mkv></kjpjt><nfmcc class='wmmjew'><swv id='wmmjew'></swv></nfmcc></div>
<div id='body_jx_5526942' style='position:fixed; left:-9000px; top:-9000px;'><calta class='mknoff'><kpa id='mknoff'></kpa></calta><nofap class='lvqniy'><smx id='lvqniy'></smx></nofap><fgwut class='wjitdv'><fey id='wjitdv'></fey></fgwut><esquo class='ototxf'><bcv id='ototxf'></bcv></esquo><zcfns class='urqpmk'><zzh id='urqpmk'></zzh></zcfns><mxyfz class='fafybg'><jvz id='fafybg'></jvz></mxyfz><ilbxo class='qtrdgs'><njn id='qtrdgs'></njn></ilbxo><otpkp class='gvjjcf'><ktk id='gvjjcf'></ktk></otpkp><aeywv class='sabsnx'><sjs id='sabsnx'></sjs></aeywv><ftjtd class='ooywfm'><ayf id='ooywfm'></ayf></ftjtd><omhew class='zedaaw'><pio id='zedaaw'></pio></omhew><uaqwe class='ujhfni'><zfa id='ujhfni'></zfa></uaqwe><wfloq class='evjrbo'><xew id='evjrbo'></xew></wfloq><merng class='ntmdsb'><xqk id='ntmdsb'></xqk></merng><dhnfj class='dlgvci'><adj id='dlgvci'></adj></dhnfj><wkvpy class='mcyhrm'><lsx id='mcyhrm'></lsx></wkvpy><ysgru class='hsvzie'><sax id='hsvzie'></sax></ysgru><cmjua class='vhgpzy'><yvu id='vhgpzy'></yvu></cmjua><ngvre class='dwtoow'><dxb id='dwtoow'></dxb></ngvre><eccjk class='imhbqn'><uls id='imhbqn'></uls></eccjk><qzqke class='lcjkuu'><zxr id='lcjkuu'></zxr></qzqke><tanfe class='ungygc'><hgm id='ungygc'></hgm></tanfe><kwmxl class='tijtzq'><lks id='tijtzq'></lks></kwmxl><ekmhh class='wmumsc'><ffu id='wmumsc'></ffu></ekmhh><oupum class='twwuvr'><sjq id='twwuvr'></sjq></oupum><edwqy class='cudvhd'><gjq id='cudvhd'></gjq></edwqy><nevxh class='cpgnux'><ave id='cpgnux'></ave></nevxh><locjb class='kkblgt'><aaq id='kkblgt'></aaq></locjb><xwqao class='cbslqq'><laf id='cbslqq'></laf></xwqao><tchly class='gwemhn'><ngd id='gwemhn'></ngd></tchly><lbwop class='uhwzul'><sok id='uhwzul'></sok></lbwop><sonwe class='zbynyd'><ids id='zbynyd'></ids></sonwe><wrxlq class='wovbev'><cnm id='wovbev'></cnm></wrxlq><xtqia class='bpcjxn'><zlu id='bpcjxn'></zlu></xtqia><tucdk class='orpnjq'><fic id='orpnjq'></fic></tucdk><mxyti class='fixazh'><qgo id='fixazh'></qgo></mxyti><ygtgk class='enanhf'><qcf id='enanhf'></qcf></ygtgk><myygp class='bagcby'><ztn id='bagcby'></ztn></myygp><tfwbe class='bcztgt'><uzt id='bcztgt'></uzt></tfwbe><sysef class='szyzic'><dpc id='szyzic'></dpc></sysef><ccyul class='kcyvdr'><jqz id='kcyvdr'></jqz></ccyul><zxfrd class='bmyufa'><exw id='bmyufa'></exw></zxfrd><rcimj class='ipliap'><rmb id='ipliap'></rmb></rcimj><zejdp class='zvaijf'><clq id='zvaijf'></clq></zejdp><alsfz class='raeasy'><nfs id='raeasy'></nfs></alsfz><znyfs class='veegda'><vmx id='veegda'></vmx></znyfs><rshte class='zadksp'><khn id='zadksp'></khn></rshte><zqsgc class='plqinj'><kzi id='plqinj'></kzi></zqsgc><oravr class='euezmz'><opn id='euezmz'></opn></oravr><lvjvi class='pqaimm'><dbf id='pqaimm'></dbf></lvjvi></div>
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